Al    (DrugBank: -)

9 diseases
告示番号疾患名(ページ内リンク)臨床試験数
5進行性核上性麻痺47
6パーキンソン病821
7大脳皮質基底核変性症13
28全身性アミロイドーシス154
51全身性強皮症190
67多発性嚢胞腎72
86肺動脈性肺高血圧症317
114非ジストロフィー性ミオトニー症候群3
127前頭側頭葉変性症52

5. 進行性核上性麻痺 [臨床試験数:82,薬物数:107(DrugBank:36),標的遺伝子数:60,標的パスウェイ数:90
Searched query = "Progressive supranuclear palsy", "PSP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
47 / 82 trials found
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1NCT04539041
(ClinicalTrials.gov)
January 19, 202125/8/2020Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of NIO752 in Progressive Supranuclear PalsyA Randomized, Participant, Investigator and Sponsor Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intrathecally Administered NIO752 in Participants With Progressive Supranuclear PalsyProgressive Supranuclear Palsy (PSP)Drug: antisense oligonucleotide;Drug: placeboNovartis PharmaceuticalsNULLNot yet recruiting40 Years75 YearsAll64Phase 1NULL
2NCT04253132
(ClinicalTrials.gov)
January 1, 202117/12/2019Evaluation of Tolfenamic Acid in Individuals With PSP at 12-WeeksA Phase 2a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Tolfenamic Acid for the Treatment of Progressive Supranuclear PalsyProgressive Supranuclear PalsyDrug: Tolfenamic Acid;Drug: PlacebosNeuroTau, Inc.The Cleveland ClinicNot yet recruiting40 Years85 YearsAll24Phase 1;Phase 2United States
3NCT04658199
(ClinicalTrials.gov)
December 20201/12/2020A Study to Test the Safety and Tolerability of Long-term UCB0107 Administration in Study Participants With Progressive Supranuclear PalsyAn Open-Label Extension Study to Evaluate the Safety and Tolerability of Long-Term UCB0107 Administration in Study Participants With Progressive Supranuclear PalsyProgressive Supranuclear PalsyDrug: UCB0107 (bepranemab)UCB Biopharma SRLNULLNot yet recruiting18 YearsN/AAll24Phase 1NULL
4NCT04193527
(ClinicalTrials.gov)
July 20202/12/2019A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese PatientsA Multicentre, Phase 3, Clinical Study to Compare the Striatal Uptake of a Dopamine Transporter Radioligand, DaTSCAN™ Ioflupane (123I) Injection, After Intravenous Administration to Chinese Patients With a Diagnosis of Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, or Essential Tremor and to Healthy ControlsParkinsonian Syndrome;Parkinson Disease(PD);Multiple System Atrophy (MSA);Progressive Supranuclear Palsy (PSP)Drug: DaTSCAN™ Ioflupane (123I) InjectionGE HealthcarePPDNot yet recruiting40 Years80 YearsAll172Phase 3China
5NCT04008355
(ClinicalTrials.gov)
June 22, 202018/6/2019A Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 in Patients With PSPA Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 on Cerebrospinal Fluid Biomarkers in 36 Patients With Progressive Supranuclear PalsyProgressive Supranuclear PalsyDrug: AZP2006 oral solution;Drug: Placebo oral solutionAlzProtect SASNULLRecruiting40 Years80 YearsAll36Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
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agemin
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agemax
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PhaseCountries
6NCT03446807
(ClinicalTrials.gov)
January 202020/2/2018Safety and Efficacy of Droxidopa for Fatigue in Patients With ParkinsonismSafety and Efficacy of Droxidopa for Fatigue in Patients With ParkinsonismParkinson Disease;Multiple System Atrophy;Progressive Supranuclear PalsyDrug: Droxidopa;Drug: Placebo Oral TabletLoma Linda UniversityH. Lundbeck A/SNot yet recruiting50 YearsN/AAll32Phase 2United States
7NCT04185415
(ClinicalTrials.gov)
December 3, 20192/12/2019A Study to Test the Safety and Tolerability of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP)A Participant-Blind, Investigator-Blind, Placebo-Controlled, Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP)Progressive Supranuclear PalsyDrug: bepranemab;Drug: PlaceboUCB Biopharma SRLNULLActive, not recruiting40 YearsN/AAll25Phase 1Belgium;Germany;Spain;United Kingdom
8NCT04184063
(ClinicalTrials.gov)
September 16, 201929/7/2019Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA)A Pilot Exploratory, Randomised, Placebo-controlled, Double Blinded, Cross-over , Phase 2a Study to Explore Efficacy and Safety of NBMI Treatment in Patients With Progressive Supranuclear Palsy (PSP) or Multiple System Atrophy (MSA)Progressive Supranuclear Palsy;Multiple System AtrophyDrug: NBMI;Other: PlaceboEmeraMedNULLRecruiting40 Years85 YearsAll16Phase 2Slovenia
9NCT03926702
(ClinicalTrials.gov)
June 18, 201922/4/2019Tau Imaging With JNJ067Tau Imaging With JNJ067Alzheimer Disease;Mild Cognitive Impairment;Progressive Supranuclear PalsyDrug: RadiopharmaceuticalsUniversity of California, BerkeleyUniversity of California, San FranciscoActive, not recruiting50 YearsN/AAll18Early Phase 1United States
10NCT04014387
(ClinicalTrials.gov)
June 2, 201911/4/2019Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)TreatmentDrug: Suvorexant;Drug: Zolpidem;Drug: Placebo oral capsuleUniversity of California, San FranciscoUS Department of Veterans AffairsRecruiting18 YearsN/AAll60Phase 4United States
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
11JPRN-UMIN000036908
2019/05/3131/05/2019A dementia study by 11C-PiB, 18F-FDG PETA dementia study by 11C-PiB, 18F-FDG PET - A dementia study by 11C-PiB, 18F-FDG PET mild cognitive impairment, Alzheimer's disease, dementia with Lewy bodies, cerebrovascular dementia, frontotemporal degeneration, progressive supranuclear palsy, corticobasal degeneration, Parkinson's disease with dementia, other neurodegenerative diseases, normal pressure hydrocephalus, hypoxic encephalopathy, brain tumor, brain injury etc.11C-PiB, 18F-FDG PETNagoya City Rehabilitation AgencyNULLRecruiting20years-oldNot applicableMale and Female150Not applicableJapan
12JPRN-jRCTs051180214
29/03/201927/03/2019The usefulness of flutemetamol for diagnostic imaging of neurogenerative diseaseThe usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease - The usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease Alzheimer's disease,Dementia with Lewy Bodies,Parkinson's syndrome,Frontotemporal lober degeneration
Alzheimer's disease, Dementia with Lewy Bodies, Parkinson's syndrome, Frontotemporal lober degeneration, Parkinson's disease, Mild cognitive impairment, Non-Alzheimer's disease, Progressive aphasia, Neurodegenerative disease, Cerebral corticobasal degeneration, Progressive supranuclear palsy
Amyloid PET: Given the flutemetamol (3mL) intravenously
FDG-PET:Given the FDG scanR (3mL) intravenously
Itoh YoshiakiNULLRecruitingAges 20 and overN/ABoth100N/AJapan
13NCT03413319
(ClinicalTrials.gov)
April 17, 201823/1/2018Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104Progressive Supranuclear Palsy (PSP)Drug: ABBV-8E12AbbVieNULLCompleted18 YearsN/AAll3Phase 1United States
14NCT03545789
(ClinicalTrials.gov)
March 12, 201815/3/2018Phase 1 Test-retest Evaluation of [18F]MNI-958 PETPhase 1 Test-retest Evaluation of [18F]MNI-958 PET as an Imaging Marker for Tau Protein in the Brain of Patients With Alzheimer's Disease and Probable PSP as Compared to Healthy VolunteersHealthy Volunteers;Alzheimer Disease;Progressive Supranuclear PalsyDrug: [18F]MNI-958InvicroNULLCompleted18 Years55 YearsAll16Phase 1United States
15NCT03391765
(ClinicalTrials.gov)
January 24, 20182/1/2018An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)Progressive Supranuclear Palsy (PSP)Drug: ABBV-8E12AbbVieNULLCompleted40 YearsN/AAll143Phase 2United States;Australia;Canada;Italy;Japan;France
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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16NCT03625128
(ClinicalTrials.gov)
January 2, 201812/7/201818F-PM-PBB3 PET Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal ControlsPhase 0 Evaluation of Clinical and Neuroimage (18F-PM-PBB3 PET) Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal ControlsAlzheimer's Disease;Cortical Basal Syndrome;Frontotemporal Dementia;Progressive Supranuclear Palsy;Vascular Cognitive ImpairmentDrug: F-18Chang Gung Memorial HospitalNULLCompleted20 Years90 YearsAll36Early Phase 1Taiwan
17NCT03545126
(ClinicalTrials.gov)
August 21, 201712/3/2018Human CNS Tau Kinetics in TauopathiesHuman CNS Tau Kinetics in TauopathiesProgressive Supranuclear Palsy (PSP);Corticobasal Degeneration (CBD);Frontotemporal Dementia (FTD MAPT Mutation)Other: 13C6 LeucineWashington University School of MedicineAssociation of Frontotemporal Degeneration;Tau ConsortiumRecruiting18 YearsN/AAll32United States
18NCT03068468
(ClinicalTrials.gov)
June 1, 201727/2/2017Study of BIIB092 in Participants With Progressive Supranuclear PalsyA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants With Progressive Supranuclear PalsySupranuclear Palsy, ProgressiveDrug: BIIB092;Drug: PlaceboBiogenNULLTerminated41 Years86 YearsAll490Phase 2United States;Australia;Austria;Canada;France;Germany;Greece;Italy;Japan;Korea, Republic of;Russian Federation;Spain;United Kingdom
19NCT03174938
(ClinicalTrials.gov)
May 15, 201728/5/2017The Swedish BioFINDER 2 StudyThe Swedish BioFINDER 2 StudyDementia;Alzheimer Disease;Parkinson Disease;Lewy Body Disease;Parkinson-Dementia Syndrome;Frontotemporal Degeneration;Semantic Dementia;Progressive Nonfluent Aphasia;Progressive Supranuclear Palsy;Corticobasal Degeneration;Multiple System Atrophy;Mild Cognitive ImpairmentDiagnostic Test: Flutemetamol F18 Injection;Diagnostic Test: [18F]-RO6958948;Diagnostic Test: Elecsys (Roche) Abeta42, Ttau and Ptau;Diagnostic Test: Lumipulse (Fujirebio) Abeta42, Ttau and PtauSkane University HospitalLund UniversityRecruiting20 Years100 YearsAll1505N/ASweden
20EUCTR2017-000094-36-SE
(EUCTR)
31/03/201730/01/2017The BioFINDER 2 study - improved diagnostics and increased understanding of the underlying mechanisms of cognitive disordersThe BioFINDER 2 study - improved diagnostics and increased understanding of the pathophysiology of cognitive disorders Neurodegenerative disorders with Tau-pathology; including, but not limited to, Alzheimers disease, progressive supranuclear palsy,frontotemporal dementia, corticobasal degeneration and mild cognitive impairment.
MedDRA version: 19.1;Level: PT;Classification code 10053643;Term: Neurodegenerative disorder;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.1;Classification code 10012267;Term: Dementia;Classification code 10067889;Term: Dementia with Lewy bodies;Level: HLGT;Classification code 10028037;Term: Movement disorders (incl parkinsonism);Classification code 10012271;Term: Dementia Alzheimer's type;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes);Level: LLT;Classification code 10009846;Term: Cognitive impairment;Classification code 10048598;Term: Cognitive disorders;Classification code 10001896;Term: Alzheimer's disease;Classification code 10012285;Term: Dementia due to Pick's disease;Classification code 10036813;Term: Progressive supranuclear palsy;Classification code 10074616;Term: Prodromal Alzheimer's;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Product Name: 18F-RO6958948
Trade Name: Vizamyl (flutemetamol(F-18))
Product Name: Vizamyl
Skåne University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Sweden
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
21NCT02985879
(ClinicalTrials.gov)
December 12, 20161/12/2016A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP).A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear PalsyProgressive Supranuclear PalsyDrug: placebo;Drug: ABBV-8E12AbbVieNULLCompleted40 YearsN/AAll378Phase 2United States;Australia;Canada;France;Germany;Italy;Japan;Spain
22NCT03058965
(ClinicalTrials.gov)
November 29, 201612/1/2017Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the BrainPhase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Probable Alzheimer's Disease or Progressive Supranuclear Palsy Compared With Healthy VolunteersAlzheimer Disease;Healthy Volunteers;Progressive Supranuclear PalsyDrug: [18F]MNI-958;Drug: [18F]Florbetapir;Drug: DaTscanMolecular NeuroImagingNULLCompleted50 Years90 YearsAll12Early Phase 1United States
23NCT03080051
(ClinicalTrials.gov)
August 201612/1/2017Evaluation of [18F]MNI-952 as a Potential PET Radioligand for Imaging Tau Protein in the BrainPhase 0 Evaluation of [18F]MNI-952 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Progressive Supranuclear Palsy or Alzheimer's Disease Compared to Healthy VolunteersProgressive Supranuclear Palsy;Alzheimer Disease;Healthy VolunteersDrug: [18F]MNI-952;Drug: [18F]FlorbetapirMolecular NeuroImagingNULLCompleted18 Years90 YearsAll6Early Phase 1United States
24NCT02839642
(ClinicalTrials.gov)
July 26, 201630/6/2016Efficacy of RIVAstigmine on Motor, Cognitive and Behavioural Impairment in Progressive Supranuclear PalsyRIVA-PSP: Efficacy of Rivastigmine on Motor, Cognitive and Behavioural Impairment in Progressive Supranuclear Palsy: A Randomised Double Blind Placebo-controlled Clinical TrialProgressive Supranuclear Palsy (PSP)Drug: Rivastigmine;Drug: PlaceboAssistance Publique Hopitaux De MarseilleNULLRecruiting41 Years80 YearsAll106Phase 3France
25NCT02994719
(ClinicalTrials.gov)
March 1, 201621/12/2015Gait Analysis in Neurological DiseaseGait Pattern Analysis in Neurological DiseaseParkinson's Disease;Parkinsonian Disorders;Atypical Parkinson Disease;Progressive Supranuclear Palsy;Multiple System Atrophy;Corticobasal Degeneration;Gait, Frontal;Huntington DiseaseDrug: Anti-Parkinson medication;Device: Deep Brain StimulationBeth Israel Deaconess Medical CenterNULLActive, not recruiting18 Years85 YearsAll120United States
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
26NCT02658916
(ClinicalTrials.gov)
February 22, 201613/1/2016Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003A Multicenter, Open-Label, Long-Term Treatment Study of Intravenously Administered BIIB092 in Patients With Progressive Supranuclear Palsy Who Participated in Study CN002003Supranuclear Palsy, ProgressiveDrug: BIIB092BiogenNULLTerminated41 Years86 YearsAll47Phase 1United States
27NCT02605785
(ClinicalTrials.gov)
November 20153/11/2015A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear PalsyA Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear PalsyProgressive Supranuclear PalsyDrug: F-18 AV 1451Mayo ClinicNULLRecruiting40 YearsN/AAll134N/AUnited States
28NCT02460094
(ClinicalTrials.gov)
October 2, 201520/5/2015Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear PalsyA Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intravenously Administered BMS-986168 in Patients With Progressive Supranuclear PalsyProgressive Supranuclear PalsyDrug: BIIB092;Drug: PlaceboBiogenNULLCompleted41 Years86 YearsAll48Phase 1United States
29NCT02494024
(ClinicalTrials.gov)
July 201530/6/2015Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear PalsyA Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear PalsyProgressive Supranuclear PalsyDrug: Single dose C2N-8E12;Drug: Single dose placeboC2N DiagnosticsNULLCompleted50 Years85 YearsAll32Phase 1United States
30NCT02460731
(ClinicalTrials.gov)
May 201519/5/2015Young Plasma Transfusions for Progressive Supranuclear PalsyA 6 Month, Open-Label, Pilot Futility Clinical Trial of Monthly Young Healthy Male Donor Plasma Transfusions for Progressive Supranuclear PalsyProgressive Supranuclear PalsyBiological: Fresh Frozen PlasmaUniversity of California, San FranciscoNULLCompleted50 Years85 YearsAll6Phase 1United States
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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31NCT02531360
(ClinicalTrials.gov)
May 20159/6/2015Evaluation of [18F]MNI-815 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With TauopathiesPhase 0 Evaluation of [18F]MNI-815 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Alzheimer's Disease and Other TauopathiesAlzheimer's Disease (AD);Progressive Supranuclear Palsy (PSP);Cortical Basal Syndrome (CBS);Frontal Temporal Dementia (FTD)Drug: [18F]MNI-815 (MNI-815)Molecular NeuroImagingPiramal Imaging SACompleted50 Years90 YearsBoth7Phase 0United States
32NCT02422485
(ClinicalTrials.gov)
April 20159/4/2015A 6 Month, Open-Label, Pilot Futility Clinical Trial of Oral Salsalate for Progressive Supranuclear PalsyA 6 Month, Open-Label, Pilot Futility Clinical Trial of Oral Salsalate for Progressive Supranuclear PalsyProgressive Supranuclear PalsyDrug: SalsalateAdam BoxerNULLUnknown status50 Years85 YearsAll10Phase 1United States
33EUCTR2014-000422-38-SE
(EUCTR)
19/09/201405/08/2014A study evaluating the diagnostic accuracy of [18F]-AV-1451 PET to detect and distinguish neurodegenerative disorders characterized by cerebral accumulation of the protein tauAn open-label study evaluating the diagnostic accuracy of [18F]-AV-1451 PET to detect and distinguish neurodegenerative disorders characterized by cerebral accumulation of tau Neurodegenerative disorders with Tau-pathology; including Alzheimer's disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration and important differential diagnostic conditions.
MedDRA version: 17.0;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes);System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0;Level: PT;Classification code 10053643;Term: Neurodegenerative disorder;Level: LLT;Classification code 10009846;Term: Cognitive impairment;Classification code 10001896;Term: Alzheimer's disease;Classification code 10012285;Term: Dementia due to Pick's disease;Classification code 10012267;Term: Dementia;Classification code 10067889;Term: Dementia with Lewy bodies;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Product Name: 18F-AV-1451Skåne University Hospital, Region SkåneNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Sweden
34NCT02167594
(ClinicalTrials.gov)
August 12, 201417/6/2014Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers18F-AV-1451 Injection for Brain Imaging of Tau in Subjects With Progressive Supranuclear Palsy (PSP), Subjects With Corticobasal Degeneration (CBD) and Healthy VolunteersProgressive Supranuclear Palsy;Corticobasal DegenerationDrug: Flortaucipir F18;Procedure: Brain PET scanAvid RadiopharmaceuticalsNULLCompleted50 Years85 YearsAll29Phase 1United States
35NCT02133846
(ClinicalTrials.gov)
May 20146/5/2014Safety Study of TPI-287 to Treat CBS and PSPA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohort, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TPI 287 in Patients With Primary Four Repeat Tauopathies: Corticobasal Syndrome or Progressive Supranuclear PalsyPrimary Four Repeat Tauopathies (4RT);Corticobasal Syndrome (CBS);Progressive Supranuclear Palsy (PSP);Corticobasal Degeneration (CBD)Drug: TPI 287 2 mg/m2;Drug: TPI-287 20 mg/m2;Drug: Placebo;Drug: TPI-287 6.3 mg/m2University of California, San FranciscoCBD Solutions;Tau ConsortiumCompleted50 Years85 YearsAll44Phase 1United States
No.TrialIDDate_
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36NCT02103894
(ClinicalTrials.gov)
February 201412/2/2014Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy SubjectsEvaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Clinically Diagnosed Tauopathies in Comparison to Healthy SubjectsAlzheimer's Disease (AD);Parkinson's Disease (PD);Chronic Traumatic Encephalopathy (CTE);Progressive Supranuclear Palsy (PSP);Frontal Temporal Dementia (FTD);Pick's Disease;TauopathiesDrug: [18F]T807 ([18F]MNI-777)Molecular NeuroImagingInstitute for Neurodegenerative DisordersCompleted18 Years85 YearsBoth16Phase 1United States
37EUCTR2010-019159-23-GB
(EUCTR)
22/12/201008/10/2010A Phase 2/3, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy.A Phase 2/3, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy. Progressive Supranuclear Palsy
MedDRA version: 14.0;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Allon Therapeutics IncNULLNot Recruiting Female: yes
Male: yes
300Phase 2;Phase 3France;United States;Canada;Australia;Germany;United Kingdom
38EUCTR2010-019159-23-DE
(EUCTR)
08/11/201027/08/2010A Phase 2/3, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy.A Phase 2/3, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy. Progressive Supranuclear Palsy
MedDRA version: 14.1;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Davunetide
Product Code: AL-108
INN or Proposed INN: Davunetide
Allon Therapeutics IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 2;Phase 3France;United States;Canada;Australia;Germany;United Kingdom
39NCT01110720
(ClinicalTrials.gov)
October 201023/4/2010Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear PalsyA Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear PalsyProgressive Supranuclear PalsyDrug: Davunetide;Drug: PlaceboAllon TherapeuticsNULLCompleted41 Years85 YearsBoth313Phase 2;Phase 3United States;Australia;Canada;France;Germany;United Kingdom
40NCT01537549
(ClinicalTrials.gov)
September 14, 20109/1/2012Alpha-lipoic Acid/L-acetyl Carnitine for Progressive Supranuclear PalsyAn Open-label Trial of Alpha-lipoic Acid/L-acetyl Carnitine for Progressive Supranuclear Palsy (PSP): Effect Upon Oxidative Damage and Mitochondrial BiomarkersProgressive Supranuclear PalsyDrug: alpha-lipoic acid and L-acetyl carnitineWeill Medical College of Cornell UniversityNULLCompleted40 Years75 YearsAll11Phase 1;Phase 2United States
No.TrialIDDate_
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41NCT01056965
(ClinicalTrials.gov)
January 201021/1/2010Davunetide (AL-108) in Predicted Tauopathies - Pilot StudyA 12 Week Randomized, Double Blind, Placebo-Controlled Pilot Study of Davunetide (NAP, AL-108) in Predicted TauopathiesPredicted Tauopathies, Including;Progressive Supranuclear Palsy;Frontotemporal Dementia With Parkinsonism Linked to Chromosome 17;Corticobasal Degeneration Syndrome;Progressive Nonfluent AphasiaDrug: davunetide (AL-108, NAP);Drug: Placebo nasal sprayUniversity of California, San FranciscoNULLCompleted40 Years85 YearsAll12Phase 1United States
42EUCTR2009-013097-40-ES
(EUCTR)
17/11/200929/07/2009Estudio doble-ciego, controlado con placebo, aleatorizado, de grupos paralelos, para evaluar la seguridad, tolerancia y eficacia de dos dosis orales diferentes de NP031112, un inhibidor de GSK3, versus placebo, como tratamiento de pacientes con Parálisis Supranuclear Progresiva leve o moderadaEstudio doble-ciego, controlado con placebo, aleatorizado, de grupos paralelos, para evaluar la seguridad, tolerancia y eficacia de dos dosis orales diferentes de NP031112, un inhibidor de GSK3, versus placebo, como tratamiento de pacientes con Parálisis Supranuclear Progresiva leve o moderada Parálisis Supranuclear Progresiva leve o moderada
MedDRA version: 9;Level: LLT;Classification code 10036813;Term: Progressive supranuclear palsy
MedDRA version: 9;Level: PT;Term: Progressive supranuclear palsy
Product Name: NP031112
Product Code: NP031112 600mg
Other descriptive name: 4-benzyl-2-naphtalen-1-yl-1,2,4-thiadiazolidine-3,5-dione
Product Name: NP031112
Product Code: NP031112 800mg
Other descriptive name: 4-benzyl-2-naphtalen-1-yl-1,2,4-thiadiazolidine-3,5-dione
Noscira S.A.NULLNot RecruitingFemale: yes
Male: yes
125Spain;Germany;United Kingdom
43NCT00703677
(ClinicalTrials.gov)
September 200820/6/2008A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal DegenerationA Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal DegenerationProgressive Supranuclear Palsy;Corticobasal DegenerationDrug: LithiumWestatNational Institute of Neurological Disorders and Stroke (NINDS)Completed40 Years80 YearsAll17Phase 1;Phase 2United States;United Kingdom
44NCT00382824
(ClinicalTrials.gov)
September 200628/9/2006Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP): A Multicenter, Randomized, Placebo-controlled, Double Blind StudyProgressive Supranuclear PalsyDietary Supplement: Coenzyme Q10;Other: PlaceboLahey ClinicNULLCompleted30 YearsN/AAll61N/AUnited States
45NCT00328874
(ClinicalTrials.gov)
May 200621/5/2006Study About Safety and Efficacy of Coenzyme Q10 in Progressive Supranuclear PalsyMono-center, Prospective, Double-blind, Placebo-controlled, Randomized Clinical Phase IIa Trial to Assess the Safety, Tolerability, and Immediate Biological Effects of Coenzyme Q10 - nanoQuinon® in Progressive Supranuclear PalsyProgressive Supranuclear PalsyDrug: Coenzyme Q10German Parkinson Study Group (GPS)MSE Pharmazeutika GmbH, Louisenstr.114D-61348 Bad Homburg, Germany;Pitzer Stiftung;Philipps University Marburg Medical CenterCompleted40 Years85 YearsAll20Phase 2Germany
No.TrialIDDate_
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PhaseCountries
46NCT00605930
(ClinicalTrials.gov)
April 200414/1/2008A Pilot Clinical Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy.Energy Metabolism in Neurodegenerative Diseases: A Randomized, Double Blind, Placebo-Controlled Clinical Pilot Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy.Progressive Supranuclear PalsyDietary Supplement: Pyruvate, creatine, niacinamide;Dietary Supplement: PlaceboUniversity of LouisvilleNULLCompletedN/AN/AAll20N/AUnited States
47NCT00532571
(ClinicalTrials.gov)
January 200418/9/2007Effects of Coenzyme Q10 in PSP and CBDEffects of Coenzyme Q10 in PSP and CBD, A Randomized, Placebo-Controlled, Double Blind Cross Over Pilot StudyProgressive Supranuclear Palsy;Neurological DisordersDrug: CoQ10Lahey ClinicNULLCompleted40 YearsN/AAllPhase 2;Phase 3United States

6. パーキンソン病 [臨床試験数:2,123,薬物数:2,046(DrugBank:324),標的遺伝子数:183,標的パスウェイ数:198
Searched query = "Parkinson disease"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
821 / 2,123 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
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agemin
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agemax
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PhaseCountries
1NCT04468919
(ClinicalTrials.gov)
July 1, 20218/7/2020Optimizing BCI-FIT: Brain Computer Interface - Functional Implementation ToolkitOptimizing BCI-FIT: Brain Computer Interface - Functional Implementation ToolkitAmyotrophic Lateral Sclerosis;Brainstem Stroke;Muscular Dystrophies;Parkinson's Disease and Parkinsonism;Multiple System Atrophy;Brain Tumor Adult;Spinal Cord Injuries;Locked-in SyndromeBehavioral: BCI-FIT multi-modal access;Behavioral: BCI-FIT adaptive signal modeling;Behavioral: BCI-FIT active querying;Behavioral: BCI-FIT language modelingOregon Health and Science UniversityNULLNot yet recruiting18 Years75 YearsAll60N/AUnited States
2NCT03309514
(ClinicalTrials.gov)
June 202110/10/2017Transplantation of Neural Stem Cell-Derived Neurons for Parkinson's DiseaseClinical Investigation of Transplantation of Neural Stem Cell-derived Neurons for the Treatment of Parkinson's DiseaseParkinson's DiseaseBiological: Intracerebral microinjectionsNeuroGenerationNULLNot yet recruiting35 Years85 YearsAll12Phase 1;Phase 2NULL
3NCT04287543
(ClinicalTrials.gov)
May 202121/2/2020Melatonin on Clock Genes in Parkinson's DiseaseEffect of Melatonin Administration on the PER1 and BMAL1 Clock Genes in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Melatonin;Drug: PlacebosInstituto Mexicano del Seguro SocialNULLWithdrawn20 YearsN/AAll0Phase 2;Phase 3Mexico
4NCT04665869
(ClinicalTrials.gov)
March 15, 20217/12/2020Long-term Effects of Combined Balance and Brisk Walking in Parkinson's DiseaseLong-term Effects of Combined Balance and Brisk Walking on Alleviating Motor and Non-motor Symptoms in Parkinson's Disease: a Randomized Controlled TrialParkinson DiseaseBehavioral: Combined balance and brisk walking training;Behavioral: Flexibility and strengthening exerciseThe Hong Kong Polytechnic UniversityNULLNot yet recruiting30 Years80 YearsAll70N/ANULL
5NCT04322461
(ClinicalTrials.gov)
March 15, 202124/3/2020Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders PopulationEffect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population : Pilot Project PARKAParkinson Disease;Alzheimer DiseaseDietary Supplement: Betaquik MCT supplementUniversité de SherbrookeNestléNot yet recruiting60 YearsN/AAll20N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04625361
(ClinicalTrials.gov)
January 1, 20219/11/2020Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC122505MsOH Tablets in Healthy Adult SubjectsA Single Center, Randomized, Double-Blind, Placebo-Controlled Study of Single/Multiple Ascending Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, and Single Center, Randomized, Double-Blind, Two Periods, Crossover, Food Effect Study of HEC122505MsOH Tablets in Healthy Chinese SubjectsParkinson DiseaseDrug: HEC122505MsOHSunshine Lake Pharma Co., Ltd.NULLNot yet recruiting18 Years45 YearsAll102Phase 1China
7NCT04373317
(ClinicalTrials.gov)
January 1, 202129/4/2020Pimavanserin vs. Quetiapine for the Treatment Parkinson's PsychosisCSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP)Parkinson's Disease PsychosisDrug: Pimavanserin;Drug: QuetiapineVA Office of Research and DevelopmentNULLNot yet recruiting40 YearsN/AAll358Phase 4United States
8NCT04497168
(ClinicalTrials.gov)
January 202129/7/2020Citalopram as a Posterior Cortical Protective Therapy in Parkinson DiseaseCitalopram as a Posterior Cortical Protective Therapy in Parkinson DiseaseParkinson DiseaseDrug: Citalopram 20mg;Drug: PlaceboUniversity of MichiganNational Institute on Aging (NIA)Not yet recruiting65 YearsN/AAll58Phase 2United States
9NCT04643327
(ClinicalTrials.gov)
January 202118/11/2020Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's DiseaseDouble-blind Randomised-controlled Within-subject Crossover Trial to Determine Levetiracetam Efficacy for Memory Impairment in Parkinson's Disease: A Proof-of-concept StudyParkinson Disease;Mild Cognitive Impairment;Memory ImpairmentDrug: Levetiracetam;Drug: PlaceboThe University of QueenslandQueensland University of Technology;Johns Hopkins University;Cleveland Clinic Lou Ruvo Center for Brain Health;Royal Brisbane and Women's HospitalNot yet recruitingN/AN/AAll28Phase 2NULL
10NCT04590612
(ClinicalTrials.gov)
January 202117/9/2020Improving Quality of Life in Early Parkinson's DiseaseThe Effects of Mood Symptoms Treatment on Quality of Life and Motor Function in de Novo Parkinson's Disease PatientsParkinson Disease;DepressionDrug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet;Drug: CitalopramWestern University, CanadaNULLNot yet recruiting50 Years80 YearsAll30N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04491383
(ClinicalTrials.gov)
January 202122/7/2020Tocotrienols in Parkinson's Disease (PD)Tocotrienols in Parkinson's Disease (PD): A Pilot, Randomised, Placebo-controlled TrialNeuro-Degenerative Disease;Parkinson DiseaseDrug: Tocovid Suprabio;Other: PlaceboNational Neuroscience InstituteHovid BerhadNot yet recruiting50 Years90 YearsAll100Phase 2Singapore
12NCT04584346
(ClinicalTrials.gov)
December 17, 202010/10/2020Acute Effects of Medium Chain Triglyceride (MCT) Nutritional Ketosis on Parkinson's Disease (PD) Symptoms and Biomarkers (MCT-PD)Acute Effects of Medium Chain Triglyceride (MCT) Nutritional Ketosis on Parkinson's Disease (PD) Symptoms and Biomarkers (MCT-PD)Parkinson's DiseaseDietary Supplement: Liquigen MCT oilNational Institute of Neurological Disorders and Stroke (NINDS)NULLRecruiting50 YearsN/AAll32Phase 1United States
13NCT04377945
(ClinicalTrials.gov)
December 1, 20204/5/2020Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual ComponentsA Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual ComponentsDyskinesia, Drug-InducedDrug: Part 1, JM-010 component Group A;Drug: Part 1, JM-010 component Group B;Drug: Part 1, JM-010 component Group C;Drug: Part 1, Placebo Group;Drug: Part 2, JM-010 combination Group A;Drug: Part 2, JM-010 combination Group B;Drug: Part 2, Placebo Group;Drug: Part 2, JM-010 component Group CBukwang PharmaceuticalNULLNot yet recruiting18 Years80 YearsAll188Phase 2United States
14NCT04346394
(ClinicalTrials.gov)
December 202010/3/2020The Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's DiseaseThe Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's Disease: Orthostatic Hypotension and Other Nonmotor SymptomsParkinson DiseaseDrug: Yohimbine HClNathaniel M. RobbinsNULLNot yet recruitingN/AN/AAll22Early Phase 1NULL
15NCT04147949
(ClinicalTrials.gov)
December 202027/10/2019AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced DyskinesiaRandomized, Double-Blind, Placebo-Controlled, Crossover, Proof-of-Concept Phase 2 Study to Test Efficacy and Safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced DyskinesiaParkinson Disease;Dyskinesia, Medication-Induced;L-Dopa Causing Adverse Effects in Therapeutic UseDrug: AV-101;Drug: PlaceboVistaGen Therapeutics, Inc.NULLNot yet recruiting30 Years80 YearsAll20Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
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size
PhaseCountries
16NCT04651153
(ClinicalTrials.gov)
December 202025/11/2020A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD)A Multicenter, Participant-Blind, Investigator-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of UCB7853 in Healthy Male Study Participants and Multiple Ascending Doses in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: UCB7853;Other: PlaceboUCB Biopharma SRLNULLNot yet recruiting18 Years80 YearsAll64Phase 1NULL
17NCT04658186
(ClinicalTrials.gov)
December 20201/12/2020A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's DiseaseA Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson's DiseaseEarly-stage Parkinson's DiseaseDrug: UCB0599;Drug: PlaceboUCB Biopharma SRLNULLNot yet recruiting40 Years70 YearsAll300Phase 2NULL
18NCT04634331
(ClinicalTrials.gov)
November 15, 20209/11/2020Dual-task Augmented Reality Treatment for Parkinson's DiseaseDual-task Augmented Reality Treatment for Parkinson's Disease (DART)Parkinson DiseaseBehavioral: Augmented Reality Multi-Modal Training;Behavioral: Traditional Multi-Modal TrainingThe Cleveland ClinicMichael J. Fox Foundation for Parkinson's ResearchRecruiting18 YearsN/AAll50Phase 2United States
19NCT04620382
(ClinicalTrials.gov)
November 9, 202027/10/2020Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure PatientsEffect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure PatientsNeurogenic Orthostatic Hypotension;Autonomic Failure;Pure Autonomic Failure;Multiple System Atrophy;Parkinson DiseaseDrug: Midodrine;Drug: Placebo pill;Device: Abdominal compression;Device: sham compressionVanderbilt University Medical CenterNULLRecruiting40 Years80 YearsAll31Early Phase 1United States
20NCT04506073
(ClinicalTrials.gov)
November 9, 202016/7/2020Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPDAllogeneic Bone Marrow-derived Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease: Phase IIa Double-blind Randomized Placebo Controlled TrialParkinson's DiseaseDrug: MSC+placebo;Drug: MSC;Drug: PlaceboThe University of Texas Health Science Center, HoustonMichael J. Fox Foundation for Parkinson's ResearchRecruiting50 Years79 YearsAll45Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
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agemin
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size
PhaseCountries
21NCT04277247
(ClinicalTrials.gov)
November 2, 202010/2/2020Botulinum Toxin Type A for Foot Dystonia-associated Pain in Parkinson's DiseaseBotulinum Toxin A (Onabotulinumtoxin A) for Foot Dystonia-associated Pain in Parkinson's Disease: A Randomized, Double-blind Placebo Control StudyDystonia Disorder;Parkinson DiseaseDrug: Botulinum toxin type A;Drug: PlaceboUniversity of CalgaryAllerganRecruiting30 Years100 YearsAll40Phase 2;Phase 3Canada
22ChiCTR2000038937
2020-11-012020-10-10Clinical study of early diagnosis of Parkinson's disease based on substantia nigra-striatal axis multimodal imagingClinical study of early diagnosis of Parkinson's disease based on substantia nigra-striatal axis multimodal imaging Parkinson's diseaseGold Standard:Clinical diagnosis by experienced movement disorder specialists after 2 years of follow-up.;Index test:Including traditional imaging feature algorithms (SUVR value, total cortical volume, bilateral cortical surface area, cortical thickness, etc.), high-dimensional imaging omics feature algorithms (energy entropy, gray-level co-occurrence matrix, and mutual information, etc.), and brain connection group Learning feature algorithm.;Huashan Hospital, Fudan UniversityNULLRecruiting4580BothTarget condition:105;Difficult condition:0China
23NCT04386317
(ClinicalTrials.gov)
November 1, 202024/4/2020Terazosin Effect on Cardiac Changes in Early Parkinson's DiseaseThe Effect of a1- Adrenergic Receptor Antagonist Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's DiseaseREM Sleep Behavior Disorder;Pre-motor Parkinson's Disease;Symptomatic Parkinson DiseaseDrug: TerazosinCedars-Sinai Medical CenterNULLRecruiting25 Years85 YearsAll15Phase 2United States
24NCT03903549
(ClinicalTrials.gov)
November 1, 20203/4/2019Initial Investigation of [18F]P17-059 in Parkinson's Disease Patients and Healthy VolunteersA Positron Emission Tomography (PET) Study to Investigate [18F]D6-FP-DTBZ ([18F]P17-059) for Potential Use as a Radioligand for Vesicular Monoamine Transporter (VMAT2)Parkinson DiseaseDrug: [18F]P17-059Five Eleven Pharma, Inc.NULLNot yet recruiting45 Years90 YearsAll26Phase 1United States
25NCT04435431
(ClinicalTrials.gov)
October 29, 202015/6/2020A Clinical Study of Mesdopetam in Patients With Parkinson's Disease Experiencing Levodopa Induced DyskinesiaA Randomized, Double-blind, Placebo-controlled Phase IIB Study Evaluating the Efficacy of Mesdopetam on Daily ON-time Without Troublesome Dyskinesia in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Mesdopetam;Drug: PlaceboIntegrative Research Laboratories ABNULLRecruiting30 Years79 YearsAll140Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
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agemax
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gender
Target_
size
PhaseCountries
26NCT04542499
(ClinicalTrials.gov)
October 27, 20202/9/2020Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial)Parkinson DiseaseDrug: Tavapadon;Drug: PlaceboCerevel Therapeutics, LLCNULLRecruiting40 Years80 YearsAll368Phase 3United States;Australia;Czechia;Germany;Hungary;Poland
27NCT03947216
(ClinicalTrials.gov)
October 23, 20207/5/2019Randomized Placebo Controlled Trial Evaluating the Efficacy of Pimavanserin, a Selective Serotonin 5-HydroxyTryptamine-2A (5HT2A) Inverse Agonist, to Treat Impulse Control Disorders in Parkinson's Disease.Study of Pimavanserin Efficacy for the Treatment of Impulse Control Disorders in Parkinson's DiseaseParkinson DiseaseDrug: Active drug: pimavanserin 17mg (2 strength tablets);Drug: Placebo: 2 tablets containing same excipients except active compound;Behavioral: Assessment of severity of ICD (impulse control disorders);Behavioral: Assessment of motor and non-motors symptoms of PD Evaluation of hyper- and hypodopaminergic behaviors;Behavioral: Assessment of quality of life;Behavioral: Assessment of depression;Behavioral: Assessment of cognition;Behavioral: Assessment of severity of Parkinson Disease;Procedure: Blood analysis;Procedure: Cardiac monitoringUniversity Hospital, Strasbourg, FranceNS-PARK;EUCLID;F-CRINRecruiting35 Years75 YearsAll130Phase 2France
28NCT04334317
(ClinicalTrials.gov)
October 21, 202030/3/2020Effect of TAK-071 on Falls in Participants With Parkinson Disease (PD)A Randomized, Double-blind, Placebo-Controlled, 2-Period Crossover, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral TAK-071 in Parkinson Disease Patients With Cognitive Impairment and an Elevated Risk of FallsParkinson's DiseaseDrug: TAK-071;Drug: PlaceboTakedaMichael J. Fox Foundation for Parkinson's ResearchRecruiting40 Years85 YearsAll64Phase 2United States
29NCT04380142
(ClinicalTrials.gov)
October 19, 20206/5/2020Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's DiseaseA Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease PatientsParkinson's Disease (PD)Drug: ABBV-951;Drug: Placebo for Levodopa/Carbidopa (LD/CD);Drug: Levodopa/Carbidopa (LD/CD);Drug: Placebo for ABBV-951AbbVieNULLRecruiting30 YearsN/AAll130Phase 3United States;Australia
30NCT04502550
(ClinicalTrials.gov)
October 15, 202030/7/2020Brain Networks and ConsciousnessSubcortical-cortical Network Dynamics of Anesthesia and ConsciousnessLoss of Consciousness;Parkinson Disease;Essential Tremor;AnesthesiaDrug: PropofolUniversity of California, Los AngelesNULLRecruiting18 YearsN/AAll48United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
31ChiCTR2000037239
2020-10-012020-08-27Construction and application of a diagnostic marker for Parkinson's disease based on gut microbiomicsConstruction and application of a diagnostic marker for Parkinson's disease based on gut microbiomics Parkinson's diseaseGold Standard:All patients satisfied the United Kingdom Parkinson's Disease Society Brain Bank criteria;Index test:Microbial gene detection chip;Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineNULLRecruiting5580BothTarget condition:500;Difficult condition:600China
32NCT04593511
(ClinicalTrials.gov)
October 202021/9/2020to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy VolunteersAn Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 After a Single Intramuscular InjectionParkinson's DiseaseDrug: LY03009 F1;Drug: LY03009 F2;Drug: LY03009 F3;Drug: LY03009 F4Luye Pharma Group Ltd.NULLNot yet recruiting18 Years65 YearsAll40Phase 1NULL
33NCT04338997
(ClinicalTrials.gov)
October 20203/4/2020PK Study in Patients With Parkinson's Disease With IZD174An Open-label Phase 1b Study to Evaluate the Pharmacokinetics and Pharmacodynamics in Plasma and Cerebrospinal Fluid (CSF), Safety and Tolerability of Oral IZD174 in Patients With Parkinson's DiseaseParkinson DiseaseDrug: IZD174Inflazome UK LtdNULLWithdrawn45 Years75 YearsAll0Phase 1NULL
34NCT03968133
(ClinicalTrials.gov)
September 30, 202028/5/2019Treating Anxiety in Parkinson's Disease With a Multi-Strain ProbioticTreating Anxiety in Parkinson's Disease With a Multi-Strain Probiotic - a Randomized, Placebo-controlled TrialParkinson Disease;AnxietyDietary Supplement: Probiotic;Dietary Supplement: PlaceboUniversity of British ColumbiaThe W. Garfield Weston FoundationNot yet recruiting40 Years80 YearsAll72Phase 2Canada
35NCT03665493
(ClinicalTrials.gov)
September 30, 20204/9/2018Dopamine Effect on Inhibitory ControlDopamine Effect on Inhibitory ControlIdiopathic Parkinson's DiseaseDrug: PD patients H&Y=1.5-2 Medications ON;Drug: PD patients H&Y=1.5-2 Medications OFF;Behavioral: Healthy age-matched controls;Drug: PD patients H&Y=3 Medications OFF;Drug: PD patients H&Y=3 Medications ONGiovanni MirabellaNULLRecruiting40 Years70 YearsAll102N/AItaly
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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agemax
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gender
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size
PhaseCountries
36NCT04591535
(ClinicalTrials.gov)
September 28, 202011/9/2020PK Study of WD-1603 in Healthy SubjectsAn Open Label, Balanced, Randomised, Four-treatment, Four-period, Four-sequence, Single Oral Dose, Crossover PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fed ConditionsParkinson DiseaseDrug: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETSHong Kong WD Pharmaceutical Co., LimitedNULLRecruiting18 Years45 YearsAll8Phase 1India
37NCT04553978
(ClinicalTrials.gov)
September 18, 202013/9/2020A Single Oral Dose, Crossover Comparative PK Study of WD-1603 in Healthy Subjects Under Fasting ConditionsAn Open Label, Balanced, Randomised, 2-treatment, 2-period, 2-sequence, Single Oral Dose, Corssover Comparative PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fasting ConditionsParkinson DiseaseDrug: WD-1603Hong Kong WD Pharmaceutical Co., LimitedNULLNot yet recruiting18 Years45 YearsAll8Phase 1NULL
38NCT04387773
(ClinicalTrials.gov)
September 15, 202011/5/2020Effect of GOCOVRI on Gait in Parkinson's DiseaseEffect of GOCOVRI on Quantity and Quality of Gait in Parkinson's DiseaseParkinson DiseaseDrug: GOCOVRIOregon Health and Science UniversityAdamas Pharmaceuticals, Inc.Not yet recruiting50 Years70 YearsAll12Phase 4United States
39NCT04476017
(ClinicalTrials.gov)
September 11, 202015/7/2020A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)An Open-Label Evaluation of the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive ImpairmentParkinson Disease;Cognitive DysfunctionDrug: SAGE-718Sage TherapeuticsNULLRecruiting50 Years75 YearsAll22Phase 2United States
40NCT04332276
(ClinicalTrials.gov)
September 202025/3/2020Dopaminergic restauratIon by intraVEntriculaire AdministrationA New Concept of Continuous Dopaminergic Stimulation by Cerebroventricular Administration of A-dopamine (Dopamine Stored in Anaerobia) for Severe Motor Fluctuations in Parkinson's Disease?Parkinson DiseaseDrug: A-dopamineUniversity Hospital, LilleInBrain PharmaNot yet recruiting45 Years75 YearsAll20Phase 1;Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT04524351
(ClinicalTrials.gov)
August 14, 202011/8/2020Posiphen® Dose-Finding, Biomarker Study in Early Alzheimer's and Parkinson's PatientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Posiphen® in Subjects With Early Alzheimer's Disease (AD) or Early Parkinson's Disease (PD)Alzheimer Disease;Parkinson DiseaseDrug: PosiphenAnnovis Bio Inc.ParexelRecruiting45 YearsN/AAll68Phase 1;Phase 2United States
42NCT04513340
(ClinicalTrials.gov)
August 13, 202012/8/2020WD-1603 PK Study Under Fasting and Fed Conditions in Healthy SubjectsAN OPEN LABEL, BALANCED, RANDOMISED, FOUR-TREATMENT, FOUR-PERIOD, FOUR-SEQUENCE, SINGLE INTRA-ORAL AND ORAL DOSE, CROSSOVER PHARMACOKINETICS STUDY OF WD-1603 EXTENDED-RELEASE CARBIDOPA/LEVODOPA TABLETS 25/100MG IN NORMAL, HEALTHY, ADULT HUMAN SUBJECTS UNDER FASTING AND FED CONDITIONSParkinson DiseaseDrug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETSHong Kong WD Pharmaceutical Co., LimitedNULLRecruiting18 Years45 YearsAll8Phase 1India
43NCT04449484
(ClinicalTrials.gov)
August 4, 202023/4/2019Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's DiseaseA Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of MEDI1341 in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: MEDI1341;Other: PlaceboAstraZenecaNULLRecruiting40 Years85 YearsAll36Phase 1United States
44NCT04483479
(ClinicalTrials.gov)
July 30, 202020/7/2020Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety Roll-over Study (Rollover)A Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered ENT-01 in Improving Constipation and Neurologic Symptoms in Patients With Parkinson's Disease and Constipation Over a 14-week PeriodParkinson Disease;ConstipationDrug: Active Investigational Treatment ENT-01Enterin Inc.NULLRecruiting30 Years90 YearsAll50Phase 2United States
45NCT04275492
(ClinicalTrials.gov)
July 24, 202018/11/2019Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release TabletsStudy on Bioequivalence of Pramipexole Dihydrochloride Sustained Release TabletsParkinson's DiseaseDrug: Praxol hydrochloride sustained release tablet Specification: 0.375mg/ tablet (in pramipexole hydrochloride);Drug: Pramipexole hydrochloride sustained-release tablet (Siforl®) Specification: 0.26mg/ tablet (in pramipexole)First Affiliated Hospital of Zhejiang UniversityHongguan biological pharmaceutical co.Recruiting18 Years45 YearsAll60N/AChina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT04630860
(ClinicalTrials.gov)
July 7, 20205/11/2020A Study to Evaluate the Pharmacokinetics and Safety of LY03003 in Patients With Advanced-stage PDA Randomized, Open-label, Multiple Ascending Dose Study in Patients With Advanced-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular InjectionsParkinson DiseaseDrug: LY03003Luye Pharma Group Ltd.NULLRecruiting18 Years80 YearsAll30Phase 1China
47NCT04193527
(ClinicalTrials.gov)
July 20202/12/2019A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese PatientsA Multicentre, Phase 3, Clinical Study to Compare the Striatal Uptake of a Dopamine Transporter Radioligand, DaTSCAN™ Ioflupane (123I) Injection, After Intravenous Administration to Chinese Patients With a Diagnosis of Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, or Essential Tremor and to Healthy ControlsParkinsonian Syndrome;Parkinson Disease(PD);Multiple System Atrophy (MSA);Progressive Supranuclear Palsy (PSP)Drug: DaTSCAN™ Ioflupane (123I) InjectionGE HealthcarePPDNot yet recruiting40 Years80 YearsAll172Phase 3China
48NCT04428112
(ClinicalTrials.gov)
June 5, 20209/6/2020Rural Dementia Caregiver ProjectEvaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural Caregivers of Individuals With Alzheimer's Disease and Related DementiasDepression;Stress, Psychological;Self Efficacy;Loneliness;Social Isolation;Health Care Utilization;Dementia;Dementia Alzheimers;Dementia of Alzheimer Type;Dementia, Vascular;Dementia Frontal;Dementia, Lewy Body;Dementia, Mixed;Dementia in Parkinsons Disease;Dementia, HIV;Dementia Frontotemporal;Dementia, Multi-InfarctBehavioral: Building Better Caregivers Workshop;Behavioral: Attention ControlUniversity of California, San FranciscoNational Institute on Aging (NIA)Recruiting18 YearsN/AAll640N/AUnited States
49NCT04384666
(ClinicalTrials.gov)
June 2, 20208/5/2020A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy VolunteersA Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy VolunteersParkinson DiseaseDrug: LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection);Other: Neupro 4 mg / 24 Hr. Transdermal PatchLuye Pharma Group Ltd.NULLCompleted18 Years45 YearsAll56Phase 1United States
50NCT04414813
(ClinicalTrials.gov)
June 202021/5/2019Stereotactic Transplantation of hAESCs for Parkinson's DiseaseClinical Study of Stereotactic Transplantation of Human Amniotic Epithelial Stem Cells (hAESCs) in the Treatment of Parkinson's Disease (PD)Parkinson's DiseaseBiological: Human Amniotic Epithelial Stem CellsShanghai East HospitalShanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaNot yet recruiting30 Years70 YearsAll3Early Phase 1NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT04379050
(ClinicalTrials.gov)
May 19, 20201/5/2020Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's DiseaseAn Open-label Extension of Study M15-741 to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's DiseaseParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLEnrolling by invitation30 YearsN/AAll121Phase 3United States;Australia;Belgium;Canada;Denmark;Italy;Japan;Netherlands;Spain;United Kingdom
52NCT03568968
(ClinicalTrials.gov)
May 15, 202014/6/2018A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's DiseaseA Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease: the NOPARK StudyParkinson DiseaseDietary Supplement: Nicotinamide Riboside;Drug: PlaceboHaukeland University HospitalNULLRecruiting18 YearsN/AAll400N/ANorway
53NCT04571164
(ClinicalTrials.gov)
May 11, 202021/9/2020A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PDA Multi-centre,Randomized,Double-blind,Placebo Parallel Controlled Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PDParkinson DiseaseDrug: LY03003(Rotigotine,extended-release microspheres);Drug: Placebo,extended-release microspheresLuye Pharma Group Ltd.ParexelRecruiting30 YearsN/AAll294Phase 3China
54NCT04265209
(ClinicalTrials.gov)
May 20206/2/2020[18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential TremorNon-inferiority Study of the Molecular Imaging of Dopamine Transporters Using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to Distinguish Between Parkinson's Disease and Essential Tremor.Parkinson Disease;Essential TremorDrug: SPECT;Drug: PETZionexaNULLNot yet recruiting35 Years80 YearsAll112Phase 3NULL
55NCT04459052
(ClinicalTrials.gov)
April 30, 202026/6/2020FDOPA PET and Nutritional Support in Parkinson's DiseasePhase II: Physiological Effects of Nutritional Support in Patients With Parkinson's DiseaseParkinson Disease;Idiopathic Parkinson DiseaseDietary Supplement: N acetyl cysteine;Drug: [F-18] Fluorodopa Positron Emission TomographyThomas Jefferson UniversityNULLActive, not recruiting30 YearsN/AAll50Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT04167540
(ClinicalTrials.gov)
April 1, 20207/11/2019GDNF Gene Therapy for Parkinson's DiseaseOpen-Label Safety Study of Glial Cell Line-Derived Neurotrophic Factor Gene Transfer (AAV2- GDNF) in Parkinson's DiseaseParkinson's DiseaseBiological: AAV2-GDNFBrain Neurotherapy Bio, Inc.NULLRecruiting35 Years75 YearsAll12Phase 1United States
57NCT04182399
(ClinicalTrials.gov)
April 1, 202024/11/2019Role of Zonisamide in Advanced Parkinson's Disease (PD) in Egyptian Population: Pilot StudyRole of Zonisamide in Advanced Parkinson's Disease (PD) in Egyptian Population: Pilot StudyParkinson DiseaseDrug: Zonisamide CapsulesAin Shams UniversityNULLRecruiting18 YearsN/AAll90N/AEgypt
58NCT02967250
(ClinicalTrials.gov)
April 1, 202013/9/2016Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment7T Magnetic Resonance Spectroscopy Monitoring Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA TreatmentParkinson DiseaseDrug: ursodeoxycholic acidUniversity of MinnesotaNULLNot yet recruiting18 YearsN/AAll20Phase 1United States
59NCT04342273
(ClinicalTrials.gov)
March 31, 20208/4/2020A Through QT/QTc Study of KW-6356A Through QT/QTc Study of KW-6356 in Japanese Healthy AdultsParkinson's DiseaseDrug: KW-6356;Drug: Placebo;Drug: MoxifloxacinKyowa Kirin Co., Ltd.NULLCompleted20 Years54 YearsAll128Phase 1Japan
60NCT04269642
(ClinicalTrials.gov)
March 19, 202013/1/2020SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's DiseasePhase IIa Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients With Early Parkinson's DiseaseEarly Parkinson's DiseaseDrug: PT320 2.0mg Placebo;Drug: PT320 2.0 mg;Drug: PT320 2.5 mgPeptron, Inc.NULLRecruiting40 Years75 YearsAll99Phase 2Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2018-003941-41-AT
(EUCTR)
05/03/202019/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
62NCT04127695
(ClinicalTrials.gov)
March 3, 20209/10/2019A Study to Evaluate the Safety and Tolerability of ABBV-0805 in Patients With Parkinson's DiseaseA Randomized, Double-Blind, Placebo Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of ABBV-0805 in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: ABBV-0805;Drug: Placebo ABBV-0805AbbVieNULLWithdrawnN/A85 YearsAll0Phase 1United States;Puerto Rico
63NCT04353947
(ClinicalTrials.gov)
March 2, 202016/4/2020Induction and Recognition of EmotionsInduction and Recognition of Emotions in Healthy Older Adults, Alzheimer's Disease and Parkinson's DiseaseHealthy Older Adults;Alzheimer's Disease;Parkinson's DiseaseDiagnostic Test: Mini Cognitive Examination (MCE);Diagnostic Test: Beck Depression Inventory-II (BDI-II);Diagnostic Test: Global Deterioration Scale (GDS);Diagnostic Test: Memory alteration test (M@T);Diagnostic Test: Spanish-Complutense Verbal Learning Test (TAVEC);Diagnostic Test: Barcelona test (BT);Diagnostic Test: Rey-Osterrieth Complex Figure Test (ROCFT);Diagnostic Test: Frontal assessment battery (FAB);Diagnostic Test: Positive and Negative Affect Scale (PANAS);Diagnostic Test: Auto-Assessment Manikins (SAM)University of ValenciaAsociación Parkinson ValenciaRecruiting65 Years99 YearsAll60Spain
64NCT04260581
(ClinicalTrials.gov)
March 1, 20205/2/2020Is Long-term Use of Amantadine Effective in PD?Is Long-term Use of Amantadine Effective in Parkinson Disease?Parkinson DiseaseDrug: Determination of drug effects through amantadine cessationSeoul National University HospitalNULLNot yet recruiting40 YearsN/AAll32N/AKorea, Republic of
65NCT04154072
(ClinicalTrials.gov)
February 27, 20204/11/2019A Clinical Study of NLY01 in Patient's With Early Parkinson's DiseaseMulticenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-stage Parkinson's DiseaseParkinson DiseaseDrug: NLY01;Drug: VehicleNeuraly, Inc.NULLRecruiting30 Years80 YearsAll240Phase 2United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT04291859
(ClinicalTrials.gov)
February 26, 202028/2/2020Lu AF28996 in Patients With Parkinson's Disease (PD)Interventional, Open-label, Exploratory Study, Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AF28996 in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Lu AF28996H. Lundbeck A/SNULLRecruiting45 Years75 YearsAll10Phase 1Netherlands
67NCT04292223
(ClinicalTrials.gov)
February 10, 202028/2/2020Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease PsychosisA 16-Week Open-Label Study of the Effects of Treatment With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease PsychosisParkinson Disease PsychosisDrug: PimavanserinACADIA Pharmaceuticals Inc.NULLRecruiting40 YearsN/AAll53Phase 4United States
68NCT04251585
(ClinicalTrials.gov)
February 4, 202028/1/2020Intranasal Insulin in Parkinson's DiseaseSingle Center Safety and Tolerability Trial of Intranasal Insulin in Parkinson's DiseaseParkinson DiseaseDrug: Regular Novolin R;Drug: PlaceboHealthPartners InstituteNULLRecruiting41 Years89 YearsAll30Phase 2United States
69NCT04246437
(ClinicalTrials.gov)
February 4, 202025/1/2020[18F]F-DOPA Imaging in Patients With Autonomic Failure[18F]F-DOPA Imaging in Patients With Autonomic FailureAutonomic Failure;Pure Autonomic Failure;Parkinson Disease;Multiple System Atrophy;Dementia With Lewy BodiesDrug: [18F]FDOPA;Drug: Carbidopa 200mg oral dose;Drug: Entacapone 400mg oral doseDaniel ClaassenNULLRecruiting18 YearsN/AAll40Phase 1United States
70NCT04117178
(ClinicalTrials.gov)
February 4, 202030/9/2019Monitoring Anti-Dementia Drugs by Serum LevelsMonitoring Anti-Dementia Drugs by Serum Levels: Importance of Serum Levels, Drug-monitoring, Side-effects, Clinical Efficacy and Compliance (Translation of Official Danish Title)Dementia;Dementia With Lewy Bodies;Dementia in Parkinsons Disease;Dementia Alzheimers;Alzheimer DiseaseDrug: Donepezil;Drug: Memantine;Diagnostic Test: Measurement of serum level of anti-dementia drugZealand University HospitalEpilepsihospitalet FiladelfiaRecruiting18 YearsN/AAll110Phase 4Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT04428983
(ClinicalTrials.gov)
February 3, 202020/11/2019The Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's DiseaseThe Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's DiseaseParkinson DiseaseDietary Supplement: Hericium erinaceus myceliumNational Cheng-Kung University HospitalNULLRecruiting50 Years79 YearsAll80N/ATaiwan
72EUCTR2018-003941-41-PT
(EUCTR)
03/02/202021/08/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
MedDRA version: 20.0;Level: LLT;Classification code 10021102;Term: Hypotension orthostatic symptomatic;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
73NCT04322227
(ClinicalTrials.gov)
January 23, 202029/1/2020Study Investigating Effects of Foliglurax in Patients With Parkinson's Disease (PD) and Healthy SubjectsInterventional, Randomized, Double-blind, Placebo-controlled Three-way Crossover Study Investigating the Pharmacodynamic Effects of Two Doses of Foliglurax Using Electroencephalography in Patients With Parkinson's Disease and in Healthy SubjectsParkinson Disease;HealthyDrug: Foliglurax 10 mg (treatment A);Drug: Foliglurax 30 mg (treatment B);Drug: Placebo (treatment C)H. Lundbeck A/SNULLTerminated50 Years70 YearsAll6Phase 1France
74NCT04305002
(ClinicalTrials.gov)
January 21, 202020/2/2020Exenatide Treatment in Parkinson's DiseaseEffect of Exenatide on Disease Progression in Early Parkinson's DiseaseParkinson DiseaseDrug: Exenatide;Drug: PlaceboCenter for Neurology, StockholmKarolinska InstitutetRecruiting25 Years80 YearsAll60Phase 2Sweden
75NCT04220762
(ClinicalTrials.gov)
January 21, 202017/12/2019A Study to Determine the Dose of WIN-1001X by Evaluating Efficacy and Safety in Early Parkinson's Disease PatientsA Clinical Study to Determine the Optimal Dose of WIN-1001X by Evaluating Its Efficacy and Safety in Patients With Early Parkinson's Disease: Double-blind, Randomized, Placebo-controlled, Multicenter, Phase II StudyParkinson DiseaseDrug: WIN-1001X;Drug: PlaceboMedi Help LineNULLRecruiting30 YearsN/AAll188Phase 2Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT04232969
(ClinicalTrials.gov)
January 20, 202010/1/2020Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's DiseaseA Randomised, Double Blind, Parallel Group, Placebo Controlled, Phase 3 Trial of Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's DiseaseParkinson's DiseaseDrug: Exenatide extended release 2mg (Bydureon)University College, LondonNULLRecruiting25 Years80 YearsAll200Phase 3United Kingdom
77NCT04369430
(ClinicalTrials.gov)
January 16, 202013/4/2020Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic TreatmentA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic TreatmentParkinson DiseaseDrug: AKST4290;Drug: PlaceboAlkahest, Inc.NULLRecruiting50 Years80 YearsAll120Phase 2United States;Estonia;Germany;Poland;Slovakia;Hungary
78EUCTR2019-001657-42-SK
(EUCTR)
14/01/202001/10/2019A study to learn how well the drug AKST4290 works and how safeAKST4290 is in people who have Parkinson's disease that are takingdopamine based medication.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate theEfficacy and Safety of AKST4290 in Subjects with Parkinson's Disease onStable Dopaminergic Treatment. - N/A Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AKST4290
Product Code: AKST4290
INN or Proposed INN: AKST4290
Other descriptive name: 2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE
Alkahest, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Hungary;Estonia;Slovakia;Poland;Germany
79NCT04295642
(ClinicalTrials.gov)
January 8, 202024/1/2020A 2-Part Trial of CVL-751 in Subjects With Parkinson's DiseaseA 2-Part, Open Label, Adaptive, Single and/or Multiple Oral Dose, Safety, Tolerability, and Food Effect Trial of CVL-751 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: CVL-751Cerevel Therapeutics, LLCNULLRecruiting45 Years75 YearsAll33Phase 1United States
80NCT04223193
(ClinicalTrials.gov)
January 6, 20207/1/2020Flexible-Dose Trial in Early Parkinson's Disease (PD)A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO-2 Trial)Parkinson DiseaseDrug: Tavapadon;Drug: PlaceboCerevel Therapeutics, LLCNULLRecruiting40 Years80 YearsAll296Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT04127578
(ClinicalTrials.gov)
January 3, 202014/10/2019Phase 1/2a Clinical Trial of PR001A in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL)A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of PR001A in Patients With Parkinson's Disease With at Least One GBA1 MutationParkinson DiseaseBiological: PR001A;Drug: Methylprednisolone;Drug: Sirolimus;Drug: PrednisonePrevail TherapeuticsNULLRecruiting35 Years80 YearsAll12Phase 1;Phase 2United States
82NCT04226248
(ClinicalTrials.gov)
January 2, 20205/12/2019CHIEF PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease)CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease: A Phase 3 Randomised, Double-blind Placebo-controlled Trial of Rivastigmine to Prevent Falls in Parkinson's Disease.Parkinson DiseaseDrug: Rivastigmine Transdermal System;Other: Placebo Transdermal SystemUniversity of BristolRoyal United Hospitals Bath NHS Foundation TrustRecruiting18 YearsN/AAll600Phase 3United Kingdom
83NCT04301492
(ClinicalTrials.gov)
January 1, 202017/2/2020Tolerability, Safety and Efficacy of VortioxetineTolerability, Safety and Efficacy of Vortioxetine for Treatment od Depression in Parkinson's Disease: a 16 Week Open Label StudyDepressionDrug: VortioxetineIRCCS San RaffaeleNULLRecruiting30 Years80 YearsAll20Phase 4Italy
84NCT04152655
(ClinicalTrials.gov)
January 1, 20207/10/2019A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson DiseaseA Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease (SEASEiPPD)REM Sleep Behavior Disorder;Parkinson DiseaseDrug: Idebenone;Drug: Placebo oral tabletSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLRecruiting18 YearsN/AAll180Phase 2;Phase 3China
85NCT03808961
(ClinicalTrials.gov)
January 1, 202016/1/2019Niacin for Parkinsons DiseaseNAPS: Niacin for Parkinsons DiseaseParkinson's DiseaseDietary Supplement: Niacin;Dietary Supplement: Niacinamide;Other: PlaceboVA Office of Research and DevelopmentNULLRecruiting35 YearsN/AAll100N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT03446807
(ClinicalTrials.gov)
January 202020/2/2018Safety and Efficacy of Droxidopa for Fatigue in Patients With ParkinsonismSafety and Efficacy of Droxidopa for Fatigue in Patients With ParkinsonismParkinson Disease;Multiple System Atrophy;Progressive Supranuclear PalsyDrug: Droxidopa;Drug: Placebo Oral TabletLoma Linda UniversityH. Lundbeck A/SNot yet recruiting50 YearsN/AAll32Phase 2United States
87NCT04218968
(ClinicalTrials.gov)
December 30, 201926/12/2019Cardiac Changes in Early Parkinson's Disease: A Follow up StudyThe Effect of Adrenergic Blocker Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease: A Follow up StudyREM Sleep Behavior Disorder;Pre-motor Parkinson Disease;Symptomatic Parkinson DiseaseDrug: CarvedilolCedars-Sinai Medical CenterNULLEnrolling by invitation18 Years85 YearsAll15Phase 2United States
88NCT03815916
(ClinicalTrials.gov)
December 19, 201918/1/201931P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Parkinson's DiseaseA Phase 2, Pilot Open Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Parkinson's DiseaseParkinson's DiseaseDrug: Gold NanocrystalsClene NanomedicineUniversity of Texas Southwestern Medical CenterRecruiting30 Years80 YearsAll30Phase 2United States
89NCT04164121
(ClinicalTrials.gov)
December 17, 201912/11/2019A Clinical Study Trial of Phenlarmide in ChinaA Randomized, Double-blind, Placebo-controlled, Single-dose, Multiple-dose, Incremental Tolerance and Pharmacokinetics Study of Phenlarmide Tablets in Chinese Healthy Adult VolunteersParkinson DiseaseDrug: Phenlarmide Tablets;Drug: PlacebosYiling Pharmaceutical Inc.NULLRecruiting18 Years65 YearsAll36Phase 1China
90NCT04097080
(ClinicalTrials.gov)
December 15, 201918/9/2019Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's DiseaseComparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's DiseaseParkinson DiseaseDrug: NBTX-001;Drug: Standard of CareNobilis Therapeutics Inc.NULLRecruiting18 YearsN/AAll60Phase 1Russian Federation
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT04201093
(ClinicalTrials.gov)
December 13, 201913/12/2019Fixed-Dose Trial in Early Parkinson's Disease (PD)A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)Parkinson DiseaseDrug: Tavapadon;Drug: PlaceboCerevel Therapeutics, LLCNULLRecruiting40 Years80 YearsAll522Phase 3United States;Australia
92NCT04249544
(ClinicalTrials.gov)
December 3, 201928/1/2020Social Decision Making in Parkinson's DiseaseCognitive and Neural Mechanisms of Impaired Social Decision-Making in Parkinson's Patients Taking Dopamine AgonistsParkinson DiseaseDrug: Pramipexole;Drug: PlaceboVanderbilt University Medical CenterUnited States Department of DefenseRecruiting45 Years80 YearsAll60Phase 1United States
93NCT04183634
(ClinicalTrials.gov)
December 3, 201928/11/2019An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.Parkinson DiseaseDrug: Rotigotine TTS (Test);Drug: Neupro (Reference)SandozNULLTerminated18 Years80 YearsAll31Phase 1Germany
94NCT04191577
(ClinicalTrials.gov)
December 2, 201930/10/2019Study of CVN424 in Parkinson's Disease Patients With Motor FluctuationsA Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of CVN424 in Parkinson's Disease Patients With Motor FluctuationsParkinson DiseaseDrug: CVN424 Low Dose;Drug: CVN424 High Dose;Drug: PlaceboCerevance Beta, Inc.NULLRecruiting30 Years80 YearsAll66Phase 2United States
95NCT04044131
(ClinicalTrials.gov)
December 1, 201917/7/2019Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) and Parkinson's Disease (PD) PatientsA Phase 2, Randomized, Placebo Controlled Study to Evaluate the Efficacy, Tolerability and Safety of Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) And Parkinson's Disease (PD) PatientsAlzheimer Disease;Parkinson DiseaseDrug: Metabolic Cofactor Supplementation;Drug: SorbitolIstanbul Medipol University HospitalScandiBio Therapeutics AB;Alanya Alaaddin Keykubat University;Sahlgrenska University Hospital, Sweden;KTH Royal Institute of TechnologyRecruiting18 YearsN/AAll120Phase 2Turkey
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT03436953
(ClinicalTrials.gov)
December 20197/2/2018A Phase 2 Study of CX-8998 in Adults With Tremor Associated With Parkinson's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of CX-8998 for Tremor Associated With Parkinson's DiseaseParkinson's Disease;TremorDrug: CX-8998;Drug: PlaceboJazz PharmaceuticalsNULLNot yet recruiting40 Years80 YearsAll60Phase 2United States
97NCT03924414
(ClinicalTrials.gov)
November 15, 20192/4/2019Trial of Parkinson's And Zoledronic AcidTOPAZ: Trial of Parkinson's And Zoledronic Acid A Randomized Placebo-controlled Trial of Zoledronic Acid for the Prevention of Fractures in Patients With Parkinson's DiseaseParkinson Disease;Osteoporosis;ParkinsonismDrug: Zoledronic Acid 5Mg/Bag 100Ml Inj;Other: PlaceboCalifornia Pacific Medical Center Research InstituteNational Institute on Aging (NIA);University of California, San Francisco;Duke University;University of Pittsburgh;Parkinson's FoundationRecruiting60 YearsN/AAll3500Phase 4United States
98NCT04148391
(ClinicalTrials.gov)
November 14, 201930/10/2019A Study to Evaluate NYX-458 in Subjects With PD-MCIA Study to Evaluate NYX-458 in Subjects With Mild Cognitive Impairment Associated With Parkinson's DiseaseParkinson's Disease;Mild Cognitive ImpairmentDrug: Placebo Oral Capsule;Drug: NYX-458AptinyxCogState Ltd.;Worldwide Clinical TrialsActive, not recruiting50 Years80 YearsAll135Phase 2United States
99NCT04175132
(ClinicalTrials.gov)
November 12, 201912/11/2019Binding of Foliglurax to Regions in the Brain in Healthy Participants and in Patients With Parkinson's Disease (PD)Interventional, Open-label, Positron Emission Tomography (PET) Study With [11C]-PXT012253 Investigating the Brain mGlu4 Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of Foliglurax in Healthy Subjects and Patients With Parkinson's DiseaseHealthy;Parkinson DiseaseDrug: foligluraxH. Lundbeck A/SNULLTerminated50 Years70 YearsAll6Phase 1Sweden
100NCT03652870
(ClinicalTrials.gov)
November 1, 20198/8/2018Antidepressants Trial in Parkinson's DiseaseA Randomised Placebo-Controlled Trial of Escitalopram and Nortriptyline With Standard Psychological Care for Depression in Parkinson's DiseaseDepression;Parkinson DiseaseDrug: Nortriptyline;Drug: Escitalopram;Drug: PlaceboUniversity College, LondonLondon North West Healthcare NHS Trust;King's College London;University Hospital Plymouth NHS Trust;NHS LothianNot yet recruiting18 Years85 YearsAll408Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2018-003941-41-DK
(EUCTR)
29/10/201924/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Denmark;Australia;Bulgaria;Germany;New Zealand
102NCT04164758
(ClinicalTrials.gov)
October 23, 201913/11/2019Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose QuetiapineA Pilot Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose QuetiapineParkinson's DiseaseDrug: Pimavanserin;Other: Placebo;Drug: QuetiapineACADIA Pharmaceuticals Inc.NULLTerminated50 Years85 YearsAll11Phase 2United States
103EUCTR2019-001657-42-DE
(EUCTR)
22/10/201911/06/2019A study to learn how well the drug AKST4290 works and how safe AKST4290 is in people who have Parkinson's disease that are taking dopamine based medication.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects with Parkinson's Disease on Stable Dopaminergic Treatment - N/A Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AKST4290
Product Code: AKST4290
INN or Proposed INN: AKST4290
Other descriptive name: 2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE
Alkahest, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Estonia;Hungary;Slovakia;Poland;Germany
104ChiCTR1900026956
2019-10-212019-10-27Minimum alveolar concentration-awake of sevoflurane in patients with Parkinson's diseaseMinimum alveolar concentration-awake of sevoflurane in patients with Parkinson's disease Parkinson’s diseaseParkinson’s disease group:Sevoflurane induction;Non-Parkinson’s disease group:Sevoflurane induction;The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of ChinaNULLPending4064BothParkinson’s disease group:30;Non-Parkinson’s disease group:30;N/AChina
105NCT04273932
(ClinicalTrials.gov)
October 17, 201931/10/2019Effects of Lithium Therapy on Blood-based Therapeutic Targets in Parkinson's Disease.Effects of Lithium Therapy on Blood-based Therapeutic Targets in Parkinson's Disease.Parkinson DiseaseDrug: LithiumUniversity at BuffaloNULLRecruiting45 Years80 YearsAll20Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT04157933
(ClinicalTrials.gov)
October 16, 20191/11/2019Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's DiseaseA Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Profile of AZ-009 in Subjects With Established Parkinson's DiseaseParkinson's DiseaseDrug: 009-A1;Drug: 009-A2;Drug: 009-A3;Drug: 009-A0;Drug: 009-B1 (active --> placebo) crossover;Drug: 009-B2 (placebo --> active) crossoverAlexza Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll35Phase 1Netherlands
107NCT04146454
(ClinicalTrials.gov)
October 14, 201916/10/2019Smartphone-based Wearable TelerehabilitationA New Smartphone-based Wearable Telerehabilitation System for People With Parkinson's DiseaseParkinson DiseaseOther: Smartphone-based balance exercisesUniversity of HoustonEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Enrolling by invitation50 Years75 YearsAll44N/AUnited States
108NCT04165837
(ClinicalTrials.gov)
October 14, 201913/11/2019Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy SubjectsA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy SubjectsParkinson's DiseaseDrug: FB-101;Drug: Placebo1ST Biotherapeutics, Inc.NULLRecruiting19 Years55 YearsAll48Phase 1United States
109JPRN-jRCTs031190115
11/10/201911/10/2019PK & PD of coadministration of XOR inhibitor and inosinePharmacokinetics and pharmacodynamics study of coadministration of either allopurinol or febuxostat and inosine Parkinson's disease
neurodegenerative disease
Coadministration of allopurinol and inosine, or coadministration of febuxostat and inosineKamatani NaoyukiNULLRecruiting>= 20age old<= 40age oldMale28Phase 1Japan
110NCT04575259
(ClinicalTrials.gov)
October 10, 201929/9/2020OLE Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001Open Label Extension Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001Parkinson Disease DementiaDrug: ANAVEX2-73Anavex Life Sciences Corp.Anavex Australia Pty Ltd.;Anavex Germany GmbHRecruiting50 Years85 YearsAll120Phase 2Australia;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2018-003941-41-BG
(EUCTR)
10/10/201926/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
112NCT03987750
(ClinicalTrials.gov)
October 201912/6/2019Safinamide for Levodopa-induced Dyskinesia (PD-LID)A Phase 3, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of 2 Doses of Safinamide Compared to Placebo in the Treatment of LID in PD Patients With Motor FluctuationsDyskinesia, Drug-Induced;Parkinson DiseaseDrug: Safinamide Methanesulfonate 150mg;Drug: Safinamide Methanesulfonate 100mg;Drug: Safinamide Methanesulfonate matching placeboZambon SpANULLWithdrawn30 YearsN/AAll0Phase 3NULL
113NCT03905811
(ClinicalTrials.gov)
September 24, 20191/4/2019Terazosin for Parkinson's DiseaseA Pilot Study of Terazosin for Parkinson's DiseaseParkinson DiseaseDrug: Terazosin 5 MG;Drug: Placebo oral capsuleJordan SchultzUniversity of IowaEnrolling by invitation40 Years90 YearsAll20Phase 1;Phase 2United States
114NCT04477161
(ClinicalTrials.gov)
September 5, 201922/6/2020Effect of Ketone Esters in Parkinson's DiseaseEffect of Ketone Esters on Parkinson Disease: A Pilot, Prospective Trial.Parkinson Disease;KetosisDietary Supplement: Ketone Ester Elite endurance Nutrition Drink;Other: Stool SampleUniversity of FloridaNULLRecruiting40 Years75 YearsAll15N/AUnited States
115NCT04054960
(ClinicalTrials.gov)
September 20199/8/2019A Trial of tPCS on Parkinson's Disease OFF StateA Trial of tPCS on Parkinson's Disease OFF StateParkinson DiseaseDevice: Active tPCS;Device: Sham tPCS;Drug: Levodopa tabletWestern University, CanadaNULLNot yet recruiting40 Years80 YearsAll15N/ACanada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT03959540
(ClinicalTrials.gov)
September 201923/4/2019Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's DiseaseA Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's DiseaseParkinson DiseaseDrug: Opicapone;Drug: Levodopa (L-DOPA) + Standard careBial - Portela C S.A.NULLNot yet recruiting75 YearsN/AAll100NULL
117NCT04075318
(ClinicalTrials.gov)
August 29, 20195/8/2019Study of UB-312 in Healthy Participants and Parkinson's Disease PatientsA Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UBITh® PD Immunotherapeutic Vaccine (UB-312) in Healthy Participants and Participants With Parkinson's DiseaseParkinson Disease;ParkinsonismBiological: UB-312;Biological: PlaceboUnited Neuroscience Ltd.Centre for Human Drug Research, Netherlands;Worldwide Clinical TrialsActive, not recruiting40 Years85 YearsAll62Phase 1Netherlands
118NCT04006210
(ClinicalTrials.gov)
August 27, 201930/6/2019A Clinical Trial Investigating the Efficacy, Safety and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless).A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Clinical Trial, Investigating the Efficacy, Safety, and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless)Parkinson's DiseaseCombination Product: ND0612 Solution for SC infusion;Combination Product: Placebo for SC infusion;Drug: Carbidopa and Levodopa 25mg/100mg;Drug: Placebo for Carbidopa and Levodopa 25mg/100mgNeuroDerm Ltd.NULLRecruiting30 Years80 YearsAll380Phase 3United States;Austria;Belgium;Czechia;France;Hungary;Israel;Italy;Netherlands;Poland;Portugal;Russian Federation;Slovakia;Spain;Ukraine;United Kingdom
119EUCTR2018-003941-41-PL
(EUCTR)
23/08/201903/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
120NCT04062526
(ClinicalTrials.gov)
August 14, 201914/8/2019Evaluation of Neuroinflammation in Parkinson's Disease Using 18F-NOS PET/CTEvaluation of in Vivo Neuroinflammation in Parkinson's Disease Using 18F-NOS Positron Emission Tomography (PET/CT)Parkinson Disease;Healthy VolunteerDrug: [18F]NOSUniversity of PennsylvaniaNULLRecruiting18 Years75 YearsAll30Early Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2018-003941-41-ES
(EUCTR)
13/08/201911/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
122NCT03976349
(ClinicalTrials.gov)
August 12, 20194/6/2019A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's DiseaseA Phase 1 Single- and Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults With Parkinson's DiseaseParkinson's DiseaseDrug: BIIB094;Drug: PlaceboBiogenIonis Pharmaceuticals, Inc.Recruiting35 Years80 YearsAll82Phase 1United States;Canada;Israel;Norway;Spain;United Kingdom
123NCT04043338
(ClinicalTrials.gov)
August 11, 201924/7/2019Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult SubjectsA Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study Investigating the Safety, Tolerability, and Pharmacokinetics of XC130-A10H in Healthy Adult SubjectsParkinson's DiseaseDrug: XC130-A10H;Drug: PlaceboXoc PharmaceuticalsCelerionRecruiting18 Years75 YearsAll40Phase 1United States
124EUCTR2018-003941-41-GB
(EUCTR)
09/08/201916/05/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
125JPRN-UMIN000037421
2019/08/0101/08/2019A study on improvement of cognitive function by istradefylline for parkinson diseaseAn open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease - A study on improvement of cognitive function by istradefylline for parkinson disease Parkinson diseasePrescription istradefylline 20 mg for 1 month. If there are no side effects, We increase to 40 mg and prescribe for 2 months.
The assessments will be made in all patients participating the study, patients with MMSE scores of 26 or more, patients with MMSE score of less than 26.
Ichinomiya Nishi HospitalNULLRecruiting40years-old85years-oldMale and Female25Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT03881371
(ClinicalTrials.gov)
August 1, 201918/3/2019A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of LevodopaA Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of LevodopaParkinson DiseaseDrug: Safinamide;Other: PlaceboZambon SpANULLRecruiting18 YearsN/AAll306Phase 3China
127EUCTR2018-003941-41-HU
(EUCTR)
30/07/201901/08/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
128NCT04056689
(ClinicalTrials.gov)
July 23, 201912/8/2019Study to Evaluate DNL151 in Subjects With Parkinson's DiseaseA Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: DNL151;Drug: PlaceboDenali Therapeutics Inc.NULLActive, not recruiting30 Years75 YearsAll34Phase 1United States;Belgium;Netherlands;United Kingdom
129NCT03956979
(ClinicalTrials.gov)
July 22, 201917/5/2019A Study in Parkinson's Disease in paTients With mOderate to seveRe dyskInesiAA Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Parkinson's Disease Patients With Moderate to Severe Dyskinesia to Assess the Efficacy and Safety/Tolerability of Two Dose Combinations of JM-010DyskinesiasDrug: JM-010 group A;Drug: JM-010 group B;Drug: PlacebosContera PharmaBukwang PharmaceuticalRecruiting18 Years80 YearsAll81Phase 2Germany
130NCT03575195
(ClinicalTrials.gov)
July 15, 201921/6/2018Microbiota Intervention to Change the Response of Parkinson's DiseaseMicrobiota Intervention to Change the Response of Parkinson's DiseaseParkinson DiseaseDrug: Rifaximin;Other: PlaceboUniversity of California, San FranciscoNova Southeastern University;Gateway Institute for Brain ResearchRecruiting30 YearsN/AAll86Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2018-003941-41-EE
(EUCTR)
04/07/201929/05/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
132NCT03977441
(ClinicalTrials.gov)
July 201912/5/2019the Efficacy and Safety of Agomelatine in the Patients With Parkinson's DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled Study: Evaluation of the Efficacy and Safety of Agomelatine in the Treatment of Sleep Disorders and Depression in Patients With Parkinson's DiseaseParkinson Disease;Depression;Sleep Disorders;Circadian Rhythm DisordersDrug: Agomelatine or PIaceboSecond Affiliated Hospital of Soochow UniversityNULLNot yet recruiting30 Years75 YearsAll240Phase 4NULL
133NCT03938922
(ClinicalTrials.gov)
June 13, 201918/4/2019A Study to Evaluate ENT-01 for the Treatment of Parkinson's Disease DementiaA Multicenter, Open Label Study to Evaluate Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Dementia.Parkinson Disease;DementiaDrug: Active Investigational Treatment ENT-01Enterin Inc.NULLActive, not recruiting30 Years90 YearsAll40Phase 1United States
134NCT03939559
(ClinicalTrials.gov)
June 10, 20193/5/2019The Efficiency of Home Based Dual Task Training in Parkinson DiseaseThe Efficiency of Home Based Dual Task Training in Parkinson DiseaseParkinson DiseaseProcedure: Static, dynamic and functional balance exercises;Procedure: Static, dynamic and functional balance exercises with dual taskIstanbul University-CerrahpasaNULLNot yet recruiting30 Years80 YearsAll60N/ANULL
135NCT04389762
(ClinicalTrials.gov)
June 4, 201930/4/2020PS128 May Improve Off Duration on Parkinson's DiseaseLactobacillus Plantarum PS128 May Improve Off Duration in Parkinson's Disease: a Pilot StudyParkinson DiseaseDietary Supplement: daily ingestion of Lactobacillus plantarum PS128Professor Lu Neurological ClinicNULLCompleted40 Years80 YearsAll60N/ATaiwan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT04064294
(ClinicalTrials.gov)
June 1, 201919/8/2019Preventing Levodopa Induced Dyskinesia in Parkinson's Disease With HMG-CoA Reductase InhibitorsPreventing Levodopa Induced Dyskinesia in Parkinson?s Disease With StatinsParkinson Disease;Dyskinesia, Drug-InducedDrug: Intravenous InfusionVA Office of Research and DevelopmentOregon Health and Science UniversityRecruiting50 YearsN/AAll120United States
137JPRN-UMIN000036908
2019/05/3131/05/2019A dementia study by 11C-PiB, 18F-FDG PETA dementia study by 11C-PiB, 18F-FDG PET - A dementia study by 11C-PiB, 18F-FDG PET mild cognitive impairment, Alzheimer's disease, dementia with Lewy bodies, cerebrovascular dementia, frontotemporal degeneration, progressive supranuclear palsy, corticobasal degeneration, Parkinson's disease with dementia, other neurodegenerative diseases, normal pressure hydrocephalus, hypoxic encephalopathy, brain tumor, brain injury etc.11C-PiB, 18F-FDG PETNagoya City Rehabilitation AgencyNULLRecruiting20years-oldNot applicableMale and Female150Not applicableJapan
138NCT03971617
(ClinicalTrials.gov)
May 29, 201930/5/2019Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's DiseaseA Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability of Molecular Hydrogen in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Hydrogen;Drug: Placebo oral tabletStony Brook UniversityNULLRecruiting40 Years80 YearsAll70Phase 2;Phase 3United States
139NCT03693872
(ClinicalTrials.gov)
May 15, 20191/10/2018Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French HospitalsEvaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French HospitalsParkinson DiseaseDrug: Apomorphine;Drug: Dopaminergic Agonist + ApomorphineRennes University HospitalNULLRecruiting18 YearsN/AAll42N/AFrance
140NCT03671785
(ClinicalTrials.gov)
May 15, 201912/9/2018Study of the Fecal Microbiome in Patients With Parkinson's DiseaseA Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: PRIM-DJ2727;Drug: Placebo oral capsuleThe University of Texas Health Science Center, HoustonKelsey Research FoundationRecruiting55 Years75 YearsAll12Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT03552068
(ClinicalTrials.gov)
May 15, 201917/5/2018Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease:Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease: A Pilot Double Blind Randomized TrialParkinson's Disease;Mpulse Control DisordersDrug: placebo;Drug: ClonidineHospices Civils de LyonNULLRecruiting30 Years80 YearsAll38Phase 2France
142NCT04293159
(ClinicalTrials.gov)
May 14, 201919/2/2020Effect of Probiotic on Constipation in Patients With Parkinson's DiseaseEffect of Probiotic on Constipation and on Neuropsychological Performance in Patients With Parkinson's DiseaseParkinson Disease;ConstipationDietary Supplement: Lactobacillus casei DG (Enterolactis duo®)University of SalernoRoberto Erro;Maria Teresa Pellecchia;Antonella Santonicola;Carolina CiacciRecruiting18 Years75 YearsAll30N/AItaly
143NCT03970239
(ClinicalTrials.gov)
May 13, 20196/5/2019Serotonin in Impulse Control Disorders in Parkinson's DiseaseRole of the Serotoninergic System in Impulse Control Disorders in Parkinson's DiseaseParkinson Disease;Impulse Control DisordersDrug: Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin);Drug: Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin)Hospices Civils de LyonNULLRecruiting30 Years80 YearsAll45N/AFrance
144NCT03958708
(ClinicalTrials.gov)
May 13, 201914/5/2019Modulation of Gut Microbiota by Rifaximin in PD PatientsModulation of Gut Microbiota by Rifaximin in PD PatientsParkinson Disease;InflammationDrug: Rifaximin 550 MGTaipei Medical University Shuang Ho HospitalNULLRecruiting45 Years70 YearsAll20Phase 1;Phase 2Taiwan
145NCT04566341
(ClinicalTrials.gov)
May 4, 201911/8/2020Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's DiseaseStudy of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's DiseaseParkinson Disease;ParkinsonDevice: OCT - TCEMassachusetts General HospitalNULLRecruiting40 Years85 YearsAll20United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT03840837
(ClinicalTrials.gov)
May 2, 201911/2/2019Cholinergic Neurotransmission in Mobility and Cognition in Parkinson DiseaseCholinergic Neurotransmission - A Common Underlying Mechanism of Cognitive and Gait Impairment in Parkinson DiseaseParkinson DiseaseDrug: Rivastigmine transdermal patchUniversity of Maryland, BaltimoreNational Institute on Aging (NIA)Recruiting18 YearsN/AAll100Phase 4United States
147NCT03781167
(ClinicalTrials.gov)
April 29, 201918/12/2018A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's DiseaseParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLRecruiting30 YearsN/AAll130Phase 3United States;Australia;Belgium;Canada;Denmark;Germany;Italy;Japan;Netherlands;Russian Federation;Spain;Sweden;United Kingdom;France
148NCT03899324
(ClinicalTrials.gov)
April 26, 201929/3/2019Evaluation of the Efficacy and Safety of Bumetanide in Parkinson's DiseaseA Randomized Double-blind Placebo-controlled Multicenter Proof-of-concept Trial to Assess the Efficacy and Safety of Bumetanide in Parkinson's DiseaseParkinson DiseaseDrug: Bumetanide white, oblong, scored tablet;Drug: Placebo white, oblong, scored tabletB&A TherapeuticsNULLRecruiting40 Years80 YearsAll40Phase 2France
149NCT04420910
(ClinicalTrials.gov)
April 15, 20194/6/2020Non-motor Symptoms, Balance, Muscle Strength, and Functional Mobility in Patients With Parkinson's DiseaseInvestigation of Non-motor Symptoms, Balance, Muscle Strength, and Functional Mobility in Patients With Parkinson's DiseaseParkinson Disease;Balance;Muscle Strength;Mobility;Non-motor SymptomsOther: Non-Motor Symptoms;Other: Balance;Other: Lower Limb Strength;Other: Functional mobilityAnkara Yildirim Beyazit UniversityNULLCompleted50 Years65 YearsAll44Turkey
150NCT03661125
(ClinicalTrials.gov)
April 11, 20194/9/2018SRC Inhibition as a Potential Target for Parkinson's Disease PsychosisA Randomised, Balanced, Double-blind Two-way Crossover Design Study to Evaluate the Effects of SRC Kinase Inhibitor, Saracatinib, on Brain Activity Associated With Visual Processing in Patients With Parkinson's Disease Psychosis.Parkinson Disease PsychosisDrug: Saracatinib;Drug: Placebo Oral TabletKing's College LondonAstraZeneca;King's College Hospital NHS TrustRecruiting40 YearsN/AAll30Early Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT03841604
(ClinicalTrials.gov)
April 9, 201930/1/2019Effect of Safinamide on Parkinson's Disease Related Chronic PainA Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic PainIdiopathic Parkinson DiseaseDrug: Safinamide Methanesulfonate;Drug: Safinamide methanesulfonate matching placeboZambon SpANULLRecruiting30 YearsN/AAll177Phase 4Austria;France;Germany;Italy;Spain
152NCT03775096
(ClinicalTrials.gov)
April 4, 20199/12/2018Adrenergic Blockers for Cardiac Changes in Early Parkinson's DiseaseThe Effect of Adrenergic Blocker Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's DiseaseREM Sleep Behavior Disorder;Pre-motor Parkinson Disease;Symptomatic Parkinson DiseaseDrug: CarvedilolMichele Tagliati, MDNULLRecruiting30 Years75 YearsAll15Phase 2United States
153NCT03877510
(ClinicalTrials.gov)
April 3, 201912/3/2019Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor FluctuationsAn Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor FluctuationsParkinson DiseaseDrug: IPX203 140 mg;Drug: IPX203 210 mg;Drug: IPX203 280 mg;Drug: IPX203 350 mgImpax Laboratories, LLCNULLEnrolling by invitation40 YearsN/AAll300Phase 3United States;Czechia;France;Germany;Italy;Spain;United Kingdom
154NCT03858270
(ClinicalTrials.gov)
April 1, 20192/10/2018Inhibition of a-synuclein Cell-cell Transmission by NMDAR Blocker, MemantineInhibition of a-synuclein Cell-cell Transmission by NMDAR Blocker, MemantineParkinson DiseaseDrug: Memantine;Other: PlaceboWayne State UniversityNULLRecruiting45 Years85 YearsAll50Phase 3United States
155JPRN-jRCTs051180214
29/03/201927/03/2019The usefulness of flutemetamol for diagnostic imaging of neurogenerative diseaseThe usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease - The usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease Alzheimer's disease,Dementia with Lewy Bodies,Parkinson's syndrome,Frontotemporal lober degeneration
Alzheimer's disease, Dementia with Lewy Bodies, Parkinson's syndrome, Frontotemporal lober degeneration, Parkinson's disease, Mild cognitive impairment, Non-Alzheimer's disease, Progressive aphasia, Neurodegenerative disease, Cerebral corticobasal degeneration, Progressive supranuclear palsy
Amyloid PET: Given the flutemetamol (3mL) intravenously
FDG-PET:Given the FDG scanR (3mL) intravenously
Itoh YoshiakiNULLRecruitingAges 20 and overN/ABoth100N/AJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT03922711
(ClinicalTrials.gov)
March 26, 201917/4/2019A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's DiseaseA Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe)Parkinson DiseaseDrug: Pridopidine;Drug: PlaceboPrileniaNULLTerminated30 Years85 YearsAll23Phase 2United States
157NCT04064983
(ClinicalTrials.gov)
March 14, 201919/8/2019Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Parkinson's DiseaseIndividual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells (HB-adMSCs) for Parkinson's DiseaseParkinson DiseaseDrug: HB-adMSCsHope BiosciencesNULLNo longer available18 YearsN/AAllUnited States
158NCT03716570
(ClinicalTrials.gov)
March 12, 201922/10/2018A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's DiseaseA Multicenter, Blinded, Placebo-Controlled, Randomized, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: BIIB054;Drug: PlaceboBiogenNULLActive, not recruiting40 Years80 YearsAll24Phase 1Japan
159NCT03816020
(ClinicalTrials.gov)
March 9, 20197/12/2018NAD-supplementation in Drug naïve Parkinson's DiseaseNAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's DiseaseParkinson Disease;Neurodegenerative DiseasesDietary Supplement: Nicotinamide Riboside;Other: PlaceboHaukeland University HospitalNULLCompleted18 YearsN/AAll30N/ANorway
160NCT03887884
(ClinicalTrials.gov)
March 5, 20191/3/2019Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)Randomized, Multi-center, Open-label, Crossover Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) and an Oral Dose of Carbidopa/Levodopa CD/LD Under Fed Conditions in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: CVT-301;Drug: SinemetAcorda TherapeuticsNULLCompleted30 Years85 YearsAll23Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT03865121
(ClinicalTrials.gov)
March 4, 201926/2/2019Pilot Trial of Transnasal Nicotine in Parkinson DiseaseUncontrolled Pilot Trial of Transnasal Nicotine in Parkinson DiseaseParkinson DiseaseDrug: Nicotine Nasal Spray 10 MG/ML (0.5 MG/SPRAY)El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezHoward UniversityCompleted60 YearsN/AAll6Phase 2Mexico
162NCT03820037
(ClinicalTrials.gov)
March 201925/1/2019Relative Bioavailability and Bioequivalence of OpicaponeA Phase I, Open-Label, Randomised, Three-Period, Three-Sequence, Partial Replicate Crossover Study to Investigate the Relative Bioavailability and Bioequivalence of Opicapone Obtained From Two Different Sources, Under Fasting Conditions After Single-dose Administration in Healthy SubjectsParkinson DiseaseDrug: Ongentys;Drug: BIA 9-1067 (test)Bial - Portela C S.A.NULLNot yet recruiting18 Years55 YearsAll45Phase 1United Kingdom
163NCT03845387
(ClinicalTrials.gov)
February 26, 201915/2/2019A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.A Phase II Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.Parkinson DiseaseDrug: KDT-3594;Drug: PramipexoleKissei Pharmaceutical Co., Ltd.NULLActive, not recruiting20 Years79 YearsAll100Phase 2Japan
164NCT03655236
(ClinicalTrials.gov)
February 18, 201918/8/2018PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's DiseaseEarly Parkinson DiseaseDrug: K0706;Other: placeboSun Pharma Advanced Research Company LimitedNULLRecruiting50 YearsN/AAll504Phase 2United States;Hungary;Poland;Slovakia;Spain
165NCT03968744
(ClinicalTrials.gov)
February 18, 201919/4/2019Effect of Safinamide on Sleep Quality in Patients With Parkinson's DiseaseA Prospective, Open Label, Single Arm, Clinical Study to Evaluate the Effect of Safinamide on Sleep Quality and Polysomnographic Parameters in Patients With Parkinson's Disease: the Safe Sleep StudyIdiopathic Parkinson's Disease (at Later Stage)Drug: SafinamideAlain KaelinClinical Trial Unit Ente Ospedaliero CantonaleRecruiting18 YearsN/AAll23Phase 4Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166NCT03413384
(ClinicalTrials.gov)
February 15, 20198/1/2018To Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease DementiaA Randomized, Double Blinded, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease DementiaParkinson's Disease DementiaDrug: Ceftriaxone;Other: PlaceboBrainX CorporationNULLRecruiting50 Years80 YearsAll106Phase 2Taiwan
167NCT04510922
(ClinicalTrials.gov)
February 11, 20199/7/2020Lundbeck TOMs Orthostatic HypotensionTechnology-Based Objective Measures for Gait and Postural Assessment in Parkinson Disease Patients With Orthostatic Hypotension: Feasibility and Effect-Size Finding StudyOrthostatic Hypotension;Idiopathic Parkinson DiseaseDrug: Droxidopa 100 MG [Northera]Alberto Espay, MD, MScLundbeck LLCRecruiting30 Years80 YearsAll12Phase 4United States
168NCT03815071
(ClinicalTrials.gov)
February 1, 201921/1/2019A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem CellsClinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's DiseaseParkinson DiseaseDrug: Ips-nsc cellsAllife Medical Science and Technology Co., Ltd.The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital;Henan Provincial People's Hospital;Beijing HospitalNot yet recruiting18 Years60 YearsAll10Early Phase 1NULL
169NCT03790670
(ClinicalTrials.gov)
January 30, 201918/12/2018Biomarker Assessments of Leukine During Treatment of Parkinson's DiseaseSafety, Tolerability and Biomarker Assessments of Leukine (Sargramostim) During Extended Timed Treatment for Parkinson's Disease: A Phase I Pilot StudyParkinson DiseaseDrug: sargramostimUniversity of NebraskaNULLRecruiting35 Years85 YearsAll10Phase 1United States
170NCT03826134
(ClinicalTrials.gov)
January 17, 201930/1/2019A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy SubjectsInterventional, Phase I, Open-label, First in Human, Single-center Positron Emission Tomography (PET) Study Investigating Test-retest Properties of [11C]-PXT012253 as a Radiotracer in Healthy SubjectsParkinson DiseaseDrug: [11C]PXT012253H. Lundbeck A/SNULLCompleted20 Years50 YearsAll7Early Phase 1Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT04620863
(ClinicalTrials.gov)
January 15, 201926/10/2020TRANSCRANIAL DIRECT CURRENT STIMULATION (t-DCS) AS ADD-ON TO NEUROREHABILITATION OF PISA SYNDROME IN PARKINSON DISEASETRANSCRANIAL DIRECT CURRENT STIMULATION (t-DCS) AS ADD-ON TO NEUROREHABILITATION OF PISA SYNDROME IN PARKINSON DISEASE: A RANDOMIZED CONTROLLED TRIALParkinson Disease;Pisa SyndromeOther: t-DCS group;Other: Sham groupIRCCS National Neurological Institute C. Mondino FoundationNULLCompleted18 Years80 YearsAll30N/AItaly
172NCT03638479
(ClinicalTrials.gov)
January 8, 201913/8/2018Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement DisordersUtilizing Smart Devices to Identify New Phenotypical Characteristics in Movement DisordersParkinson Disease;Essential Tremor;Movement Disorders;Parkinson's Syndrome;Atypical ParkinsonismOther: Data CaptureWestfälische Wilhelms-Universität MünsterNULLRecruiting18 YearsN/AAll500Germany
173NCT03659682
(ClinicalTrials.gov)
January 2, 20193/9/2018GLP1R in Parkinson's DiseaseEffect of GLPIR Stimulation on Neuroprotection and Inflammation in Parkinson's DiseaseParkinson DiseaseDrug: SemaglutideOslo University HospitalNULLNot yet recruiting40 Years75 YearsAll120Phase 2NULL
174NCT03727295
(ClinicalTrials.gov)
January 1, 201930/10/2018Idebenone Treatment of Early Parkinson's DiseasesymptomsA Multicenter, Randomized, Double-blind, Placebo-controlled Study of Idebenone in the Treatment of Early-stage Parkinson's Disease With Motor and Non-motor SymptomsOxidative Stress is an Important Cause of Parkinson's DiseaseDrug: Idebenone/placeboSecond Affiliated Hospital of Soochow UniversityQilu Pharmaceutical Co., Ltd.Not yet recruiting30 Years80 YearsAll180Phase 4NULL
175NCT03391882
(ClinicalTrials.gov)
December 19, 20182/1/2018A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor FluctuationsMotor OFF Episodes Associated With Parkinson's DiseaseDrug: APL-130277;Drug: subcutaneous apomorphineSunovionNULLRecruiting18 YearsN/AAll106Phase 3Austria;France;Germany;Italy;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT03840005
(ClinicalTrials.gov)
December 18, 201811/2/2019Trial of Ursodeoxycholic Acid (UDCA) for Parkinson's Disease: The UP StudyA Phase II, Placebo Controlled, Double Blind, Randomised Clinical Trial To Assess The Safety And Tolerability Of 30mg/kg Daily Ursodeoxycholic Acid (UDCA) In Patients With Parkinson's Disease (PD)Parkinson's DiseaseDrug: UrsonormSheffield Teaching Hospitals NHS Foundation TrustJP Moulton Charitable Foundation;PRO.MED.CS Praha a.s.;Clinical Trials Research Unit, University of SheffieldActive, not recruiting18 Years75 YearsAll30Phase 2United Kingdom
177NCT03781791
(ClinicalTrials.gov)
December 10, 201827/11/2018Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease-Related Constipation (KARMET)Constipation;Parkinson DiseaseDrug: Active Investigational Treatment ENT-01;Drug: Placebo TreatmentEnterin Inc.NULLActive, not recruiting30 Years90 YearsAll152Phase 2United States
178NCT03710707
(ClinicalTrials.gov)
December 4, 201815/10/2018Study to Evaluate DNL201 in Subjects With Parkinson's DiseaseA Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: DNL201;Drug: PlaceboDenali Therapeutics Inc.NULLCompleted30 Years80 YearsAll29Phase 1United States
179NCT03944447
(ClinicalTrials.gov)
December 1, 20183/5/2019Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;CoronavirusDrug: Cannabis, MedicalOMNI Medical Services, LLCOMNI Medical Services IncRecruiting7 YearsN/AAll200000Phase 2United States
180NCT03639064
(ClinicalTrials.gov)
December 20184/7/2018Cannabis Oil for Pain in Parkinson's DiseaseA Phase II, Randomized, Open-label, Double-blind, Two-center Study to Evaluate the Tolerability, Safety and Dose-finding of Oil Cannabis Preparation for Pain in Parkinson's DiseaseParkinson DiseaseDrug: Cannabis OilUniversity Health Network, TorontoParkinson Society CanadaUnknown status18 YearsN/AAll15Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT03942172
(ClinicalTrials.gov)
November 27, 20186/5/2019Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance GlassesTreatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance GlassesParkinson DiseaseDevice: SpotOn balance glassesSpotOn Therapeutics Ltd.NULLSuspended30 YearsN/AAll50N/AIsrael
182NCT03822364
(ClinicalTrials.gov)
November 26, 201818/12/2018Staccato Apomorphine Single and Multi Dose PKA Randomized Study of the Safety, Tolerability, and Pharmacokinetics of AZ-009 (Staccato Apomorphine) in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZ-009 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: 009-1;Drug: active comparator;Drug: 009-0;Drug: 009-2;Drug: 009-3;Drug: 009-4;Drug: 009-5Alexza Pharmaceuticals, Inc.NULLCompleted18 Years60 YearsAll56Phase 1Netherlands
183NCT03823638
(ClinicalTrials.gov)
November 20, 201820/11/2018Safety, Tolerability and Effects of Mannitol in Parkinson's DiseaseA Phase II Single Center, Randomized, Double Blind and Placebo Controlled Study Assessing the Safety, Tolerability and Effects of Progressively Increased Dose of Oral Mannitol in Parkinson's DiseaseParkinson DiseaseDietary Supplement: Oral D-Mannitol of PlaceboHadassah Medical OrganizationNULLRecruiting40 Years75 YearsAll60Phase 2Israel
184NCT03713957
(ClinicalTrials.gov)
November 12, 201818/10/2018A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive ImpairmentA Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive ImpairmentParkinson DiseaseDrug: GRF6021;Other: PlaceboAlkahest, Inc.Michael J. Fox Foundation for Parkinson's ResearchCompleted40 Years85 YearsAll79Phase 2United States;Australia;France
185NCT03733561
(ClinicalTrials.gov)
November 9, 20186/11/2018A Study to Assess Pharmacokinetic Profiles of LY03003 and NeuproA Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy VolunteersParkinson DiseaseDrug: LY03003;Drug: Neupro 4Mg/24Hr Transdermal PatchLuye Pharma Group Ltd.NULLRecruiting18 Years45 YearsAll40Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT03667404
(ClinicalTrials.gov)
November 6, 201810/9/2018Resistant Maltodextrin for Gut Microbiome in Parkinson's Disease: Safety and Tolerability StudyGut Microbial Remodeling With Resistant Maltodextrin for Motor and Non-motor Symptoms in Parkinson's Disease: Safety and Tolerability StudyParkinson Disease;Intestinal Bacteria Flora Disturbance;Dietary ModificationDietary Supplement: Resistant maltodextrin;Dietary Supplement: maltodextrinNorthwestern UniversityUniversity of Illinois at ChicagoRecruiting60 YearsN/AAll30Phase 2United States
187NCT03670953
(ClinicalTrials.gov)
November 6, 201812/9/2018A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Patients With Motor FluctuationsA Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor FluctuationsParkinson's Disease (Disorder)Drug: IR CD-LD;Drug: IPX203 ER CD-LD;Other: IPX203 placebo;Other: IR CD-LD placeboImpax Laboratories, LLCNULLRecruiting40 YearsN/AAll510Phase 3United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom
188NCT04629404
(ClinicalTrials.gov)
November 5, 20185/11/2020A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD PatientsA Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of Multiple Intramuscular Doses of LY03003 in Patients With Early Parkinson's DiseaseParkinson DiseaseDrug: LY03003;Drug: PlaceboLuye Pharma Group Ltd.NULLCompleted30 YearsN/AAll32Phase 1China
189NCT03727139
(ClinicalTrials.gov)
November 1, 201830/10/2018Rasagiline Tablets Special Drug Use-Results Survey Survey on Long-term SafetyAZILECT Tablets Special Drug Use-Results Survey Survey on Long-term SafetyParkinson's DiseaseDrug: RasagilineTakedaNULLActive, not recruitingN/AN/AAll1021Japan
190NCT03069911
(ClinicalTrials.gov)
November 1, 201828/2/2017Trial of OnabotulinumtoxinA for Depression in Parkinson DiseaseRandomized Controlled Trial of OnabotulinumtoxinA for Depression in Parkinson DiseaseParkinson Disease;DepressionBiological: OnabotulinumtoxinA;Biological: ControlJohns Hopkins UniversityNULLTerminated18 Years95 YearsAll3Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191NCT03720418
(ClinicalTrials.gov)
October 17, 201816/10/2018Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's DiseaseA Phase I/II Safety and Dose Evaluation Study of OXB-102 in Patients With Bilateral Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: OXB-102;Other: Imitation Surgical Procedure (ISP)Axovant Sciences Ltd.Oxford BioMedicaRecruiting30 Years70 YearsAll30Phase 1;Phase 2France;United Kingdom
192NCT04048291
(ClinicalTrials.gov)
October 15, 20189/10/2018Efficacy of Brisk Walking in Parkinson's DiseaseEfficacy of Brisk Walking on Improving Balance and Gait Performance, and Functional Mobility in Parkinson's Disease - a Randomized Controlled TrialParkinson DiseaseBehavioral: Brisk walking and balance training;Behavioral: Upper limb exerciseThe Hong Kong Polytechnic UniversityNULLCompleted30 YearsN/AAll80N/AHong Kong
193NCT04451096
(ClinicalTrials.gov)
October 6, 201819/6/2020Probiotics-prebiotic Fiber Therapy in Parkinson's Disease Patients With ConstipationProbiotics-prebiotic Fiber Therapy Improved Bowel Opening Frequency and Whole Gut Transit Time in Parkinson's Disease Patients With Constipation: A Randomised Controlled StudyParkinson Disease;ConstipationDietary Supplement: Probiotics with prebiotic;Dietary Supplement: PlaceboNational University of MalaysiaNULLCompleted18 YearsN/AAll48Phase 3Malaysia
194NCT03703570
(ClinicalTrials.gov)
September 29, 20185/10/2018A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing PreparationsA Phase 2b Study of KW-6356 in Subjects With Parkinson's Disease on Treatment With Levodopa-containing PreparationsParkinson's DiseaseDrug: KW-6356;Drug: PlaceboKyowa Kirin Co., Ltd.NULLCompleted20 Years80 YearsAll502Phase 2Japan
195NCT03665454
(ClinicalTrials.gov)
September 24, 20181/8/2018PF 06412562 in Subjects With Advanced Stage Parkinson's DiseaseA Phase Ib Safety, Tolerability, and Efficacy Study of Two Days of Oral Split Dose (25/20 mg) Administration of PF 06412562 in Subjects With Advanced Stage Parkinson's DiseaseParkinson DiseaseDrug: PF-06412562;Drug: Standard of Care PlaceboMilton S. Hershey Medical CenterPfizerCompletedN/AN/AAll8Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196NCT03582137
(ClinicalTrials.gov)
September 17, 201817/4/2018A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's DiseaseA Randomized, Double Blind, Placebo-controlled Parallel Study of Tolerability and Efficacy of Cannabidiol (CBD) on Motor Symptoms in Parkinson's DiseaseParkinson DiseaseDrug: Cannabidiol;Other: PlaceboUniversity of Colorado, DenverColorado Department of Public Health and EnvironmentRecruiting40 Years85 YearsAll75Phase 2United States
197NCT04202757
(ClinicalTrials.gov)
September 14, 201821/9/2018Intravenous Plasma Treatment for Parkinson's DiseaseIntravenous Young Fresh Frozen Plasma (yFFP) Investigational Treatment for Parkinson's Disease - Randomized Controlled StudyIdiopathic Parkinson DiseaseBiological: [21CFR640.30] Plasma from 18 - 25 year old volunteer donors;Other: SalineThe Neurology CenterCarolina Longevity InstituteCompleted45 Years90 YearsAll18Phase 4United States
198NCT03648905
(ClinicalTrials.gov)
September 6, 201824/8/2018Clinical Laboratory Evaluation of Chronic Autonomic FailureClinical Laboratory Evaluation of Chronic Autonomic FailureParkinson's Disease;Multiple System Atrophy;Autonomic FailureDrug: 18F-Dopa;Drug: 11C-methylreboxetine;Drug: 13N-Ammonia;Drug: 18F-Dopamne;Drug: Desipramine (DMI)National Institute of Neurological Disorders and Stroke (NINDS)NULLRecruiting18 YearsN/AAll140Phase 1United States
199NCT03608371
(ClinicalTrials.gov)
August 31, 20189/5/2018BTRX-246040 Study in Subjects With Parkinson's Disease With Motor FluctuationsPhase 2A, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BTRX-246040 in Parkinson's Disease Subjects With Motor FluctuationsParkinson Disease;Motor DisorderDrug: BTRX-246040;Drug: PlaceboBlackThorn Therapeutics, Inc.NULLCompleted30 Years76 YearsAll24Phase 2United States
200NCT03229174
(ClinicalTrials.gov)
August 23, 201821/4/2017Brain Perfusion & Oxygenation in Parkinson's Disease With NOHEvaluation of Brain Perfusion and Oxygenation in PD Patients With Neurogenic Orthostatic Hypotension: 4 Week Comparison of Droxidopa Versus PlaceboParkinson Disease;Neurogenic Orthostatic HypotensionDrug: Droxidopa;Drug: PlaceboWilliam Ondo, MDLundbeck LLCRecruiting18 Years85 YearsAll28Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201NCT03621046
(ClinicalTrials.gov)
August 20, 20186/6/2018Use of Low-dose Zolpidem in Parkinson's DiseaseA Placebo Controlled Double Blind Randomised Controlled Proof of Concept Study of Zolpidem for the Treatment of Motor and Cognitive Deficits in Late-stage Parkinson'sParkinson DiseaseDrug: Zolpidem;Other: PlaceboAston UniversityUniversity Hospital Birmingham NHS Foundation TrustCompleted40 Years80 YearsAll28Phase 2United Kingdom
202NCT03567447
(ClinicalTrials.gov)
August 17, 201821/5/2018Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH)Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH)Parkinson Disease;Falls PatientDrug: Droxidopa;Other: PlaceboSt. Joseph's Hospital and Medical Center, PhoenixH. Lundbeck A/S;Arizona State UniversityRecruiting30 Years83 YearsAll10Phase 2United States
203NCT03675282
(ClinicalTrials.gov)
August 14, 20185/9/2018Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease (Stages I-IV, REM Sleep Behavior Disorder) and ControlsQuantitative Mapping of Substantia Nigra Iron in Parkinson's Disease and ControlsParkinson Disease;REM Sleep Behavior Disorder;HealthyDrug: (11C)PE2IWeill Medical College of Cornell UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Recruiting20 Years100 YearsAll100Phase 1;Phase 2United States
204NCT03773796
(ClinicalTrials.gov)
August 6, 201819/7/2018Nabilone for Non-motor Symptoms in Parkinson's DiseaseNabilone for Non-motor Symptoms in Parkinson's Disease: An Open-label Study to Evaluate Long-term Safety and EfficacyParkinson DiseaseDrug: Nabilone 0.25 mgMedical University InnsbruckNULLRecruiting30 Years100 YearsAll48Phase 3Austria
205NCT04455555
(ClinicalTrials.gov)
August 1, 201828/6/2020Efficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's DiseaseEfficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's DiseaseParkinson's DiseaseDrug: LY03003( the name of rotigotine);Other: PlaceboPeking University Third HospitalNULLCompleted18 YearsN/AAll294Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206NCT03599726
(ClinicalTrials.gov)
July 30, 201829/6/2018Improving Walking Automaticity in Parkinson's Disease: Levodopa or DonepezilImproving Walking Automaticity in Parkinson's Disease: Levodopa or DonepezilParkinson DiseaseDrug: Donepezil;Drug: PlaceboOregon Health and Science UniversityMedical Research Foundation, OregonCompleted50 Years90 YearsAll20Early Phase 1United States
207NCT03611569
(ClinicalTrials.gov)
July 25, 201826/7/2018Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's DiseaseInterventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Properties of Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's DiseaseHealthy;Parkinson DiseaseDrug: Lu AF82422;Drug: PlaceboH. Lundbeck A/SNULLRecruiting18 Years80 YearsAll84Phase 1United States
208NCT03587168
(ClinicalTrials.gov)
July 20, 20183/7/2018The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Parkinson's DiseaseThe Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Parkinson's DiseaseParkinson DiseaseOther: the timed 360° turn test;Other: Berg Balance Scale;Other: Four Square Step Test;Other: Functional Reach Test;Other: Trunk Impairment Scale;Other: Timed Up and Go Test;Other: Hoehn and Yahr Scale;Other: Unified Parkinson's Disease Rating ScaleGazi UniversityNULLCompleted40 YearsN/AAll86Turkey
209NCT03594656
(ClinicalTrials.gov)
July 15, 201811/7/2018Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's DiseaseEffects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled TrialParkinson DiseaseDrug: Ganoderma;Drug: PlacebosXuanwu Hospital, BeijingNULLRecruiting30 Years80 YearsAll288Phase 3China
210NCT03624920
(ClinicalTrials.gov)
July 12, 201810/7/2018Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime SleepinessSafety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime SleepinessParkinson DiseaseDrug: THN102 Dosage A;Drug: THN102 Dosage B;Drug: THN102 Dosage CTheranexusNULLCompleted18 Years80 YearsAll77Phase 2United States;Czechia;France;Germany;Hungary
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211NCT03774459
(ClinicalTrials.gov)
July 9, 20188/12/2018ANAVEX2-73 Study in Parkinson's Disease DementiaA Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Patients With Parkinson's Disease With DementiaParkinsons Disease With DementiaDrug: High dose ANAVEX2-73;Drug: Mid dose ANAVEX2-73;Drug: Placebo oral capsuleAnavex Life Sciences Corp.Anavex Germany GmbHCompleted50 Years85 YearsAll132Phase 2Australia;Spain
212NCT03775538
(ClinicalTrials.gov)
July 5, 201811/10/2018Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease. Extension to HP-CD-CL-2002 Clinical StudyA Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients With Idiopathic Parkinson's Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002Parkinson Disease;Movement Disorders;Neuro-Degenerative Disease;Nervous System Diseases;Brain DiseasesDrug: Cerebral Dopamine Neurotrophic Factor;Device: Renishaw Drug Delivery SystemHerantis Pharma Plc.Renishaw plc.Completed35 Years75 YearsAll15Phase 1;Phase 2Finland;Sweden
213NCT03146130
(ClinicalTrials.gov)
July 5, 20183/5/2017Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control DisordersStudy of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders (TCI) Induced by Dopaminergic Treatments in Parkinson's DiseaseImpulse Control Disorder;ParkinsonBiological: Variation of behaviors of Parkinson's diseaseCentre Hospitalier Universitaire, AmiensNULLUnknown status18 YearsN/AAll70Phase 3France
214NCT03521635
(ClinicalTrials.gov)
July 3, 201811/4/2018The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-DopaA Two- Stage Multicenter, Open-label, Randomized, Active Controlled Parallel Group Study Comparing the Efficacy and Safety of Pramipexole SR Versus Pramipexole IR Administered Orally Over an 18-week Treatment on Nocturnal Symptoms in L-Dopa+ Treated Patients With Advanced Parkinson's Disease (PD)Parkinson DiseaseDrug: Pramipexole SR;Drug: Pramipexole IRBoehringer IngelheimNULLCompleted30 YearsN/AAll98Phase 4China
215NCT03566589
(ClinicalTrials.gov)
July 2, 201812/6/2018Effects of PS128 on Parkinsonian SymptomsEffects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease: a Pilot StudyParkinson DiseaseDietary Supplement: Lactobacillus plantarum PS128Professor Lu Neurological ClinicNULLCompleted40 Years80 YearsAll30N/ATaiwan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216NCT03576638
(ClinicalTrials.gov)
July 201825/6/2018Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease PatientsAn Open Label Phase 2 Study to Assess the Pharmacokinetics of the Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Accordion Pill Carbidopa/Levodopa;Drug: Sinemet CR 25Mg-100Mg Extended-Release TabletIntec Pharma Ltd.NULLUnknown status30 YearsN/AAll12Phase 2NULL
217NCT03562494
(ClinicalTrials.gov)
June 28, 201816/5/2018VY-AADC02 for Parkinson's Disease With Motor Fluctuations (RESTORE-1)A Randomized, Sham Surgery Controlled, Double-blind, Multi-center, Phase 2 Clinical Trial, Evaluating the Efficacy and Safety of VY-AADC02 in Moderate to Advanced Parkinson's Disease Patients With Motor FluctuationsParkinson's DiseaseBiological: VY-AADC02;Other: Sham (Placebo) SurgeryNeurocrine BiosciencesVoyager TherapeuticsRecruiting40 Years75 YearsAll85Phase 2United States
218NCT03407378
(ClinicalTrials.gov)
June 26, 201815/1/2018A Study to Investigate a New Treatment in Patients With Parkinson's DiseaseA Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients With Parkinson's DiseaseParkinson DiseaseDrug: IPT803;Genetic: Optional pharmacogenetic assessment;Other: Questionnaires;Other: Optional Blood-Oxygen-level Dependent functionalMRI;Other: Motor Assessments before taking regular PD treatment;Other: Motor Assessments on regular PD treatmentTools4PatientNULLCompleted35 YearsN/AAll110Phase 1;Phase 2United States;Belgium;France
219NCT03439943
(ClinicalTrials.gov)
June 13, 201813/2/2018Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's DiseaseMulticenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's DiseaseParkinson DiseaseDrug: Lixisenatide;Drug: placeboUniversity Hospital, ToulouseCure Parkinson;Réseau NS-Park;EUCLID;SanofiActive, not recruiting40 Years75 YearsAll156Phase 2France
220NCT03456687
(ClinicalTrials.gov)
June 5, 20181/3/2018Effects of Exenatide on Motor Function and the BrainEffects of Exenatide on Motor Function and the BrainParkinson's DiseaseDrug: ExenatideUniversity of FloridaNational Institute of Neurological Disorders and Stroke (NINDS)Active, not recruiting40 Years77 YearsAll5Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221NCT03510572
(ClinicalTrials.gov)
June 4, 201817/4/2018Evaluation of [18F]PI-2620 as a Potential Positron Emission Computed Tomography Radioligand for Imaging Tau Protein in the BrainClinical Evaluation of [18F]PI-2620 Positron Emission Computed Tomography for Imaging Tau Protein in Patients With Tauopathies and Healthy Volunteers: Phase 0 StudyHealthy Volunteer;Alzheimer Disease;Frontotemporal Dementia;Parkinson DiseaseDrug: [18F]PI-2620Asan Medical CenterKorea Health Industry Development InstituteCompleted40 Years80 YearsAll20Early Phase 1Korea, Republic of
222NCT03532984
(ClinicalTrials.gov)
June 1, 201827/4/2018Beam Walking Across the Lifespan for Falls PredictionBeam Walking to Assess Dynamic Balance in Health and Disease: A Protocol for the 'BEAM' Multi-center Observational StudyAging;Parkinson Disease;Stroke;Dementia;Diagnoses Disease;Cognitive Impairment;Postural; DefectDiagnostic Test: Beam test to predict fallsUniversity Medical Center GroningenDokkyo Medical University;University of Potsdam;Somogy Megyei Kaposi Mór Teaching Hospital;University of Sao PauloUnknown status20 Years80 YearsAll432Brazil;Germany;Hungary;Japan;Netherlands
223NCT03891069
(ClinicalTrials.gov)
June 1, 201818/3/2019Feasibility of the AHA Exergame System in Parkinson's Disease PatientsFeasibility and Safety of the AHA Exergame System in Parkinson's Disease Patients: a Mixed Methods StudyParkinson DiseaseDevice: AHA Exergame SystemCampus Neurológico SéniorUniversity of LisbonCompleted40 Years80 YearsAll10N/APortugal
224NCT03684122
(ClinicalTrials.gov)
June 1, 201823/9/2018Use of Mesenchymal Stem Cells (MSCs) Differentiated Into Neural Stem Cells (NSCs) in People With Parkinson's (PD).A Safety and Efficacy Study of the Effects of Mesenchymal Stem Cells (MSCs) Differentiated Into Neural Stem Cells (NSCs) on the Motor and Non-motor Symptoms in People With Parkinson's Disease (PD).Parkinson DiseaseBiological: Injection of Umbilical cord derived MSCsUniversity of JordanNULLRecruiting20 Years75 YearsAll10Phase 1;Phase 2Jordan
225NCT03589066
(ClinicalTrials.gov)
May 15, 20188/6/2018Pharmacokinetic Study of LY03003 in Patients With Parkinson's DiseaseAn Open-label, Randomized, Parallel-group Trial to Evaluate the Pharmacokinetics of Two Formulations of LY03003 After a Single Intramuscular Injection Administered to Patients With Parkinson's DiseaseParkinson DiseaseDrug: LY03003Luye Pharma Group Ltd.NULLCompleted18 YearsN/AAll24Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226NCT03541356
(ClinicalTrials.gov)
May 8, 20185/4/2018Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off ReversalA Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Ascending Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of DCI to L-dopa Responsive Parkinson's Disease PatientsParkinson's DiseaseCombination Product: Placebo;Combination Product: L-dopa 35 mg;Combination Product: L-dopa 70mg;Combination Product: L-dopa 140 mg;Combination Product: L-dopa 70mg/carbidopa 7mgImpel NeuroPharma Inc.NULLCompleted40 Years80 YearsAll32Phase 2Australia
227NCT03587649
(ClinicalTrials.gov)
May 7, 20183/7/2018Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density LossEvaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss in the Brain of Patients With Probable Alzheimer's Disease, Probable Parkinson's Disease (PD) Subjects as Compared to Healthy Volunteers (HV).Alzheimer Disease;Parkinson Disease;Healthy VolunteersDrug: [18F]MNI-1126InvicroNULLCompleted18 Years55 YearsAll12Phase 1United States
228NCT04228887
(ClinicalTrials.gov)
May 4, 20185/8/2019Effects of Inspiratory Muscle Training in Patients With Parkinson's DiseaseEffects of Inspiratory Muscle Training on Postural Stability, Mobility, Activities of Daily Living, Quality of Life and Respiratory Function in Patients With Parkinson's DiseaseParkinson DiseaseDiagnostic Test: Respiratory Muscle Strength;Device: Balance Training;Device: Inspiratory Muscle TrainingBezmialem Vakif UniversityNULLCompleted60 Years85 YearsAll30N/ATurkey
229NCT03843944
(ClinicalTrials.gov)
May 1, 201812/2/2019Overnight Switch From Rasagiline To SafinamideOvernight Switch From Rasagiline To Safinamide In Fluctuating Patients With Parkinson's Disease: A Tolerability And Safety StudyParkinson DiseaseDrug: SafinamideIRCCS San RaffaeleNULLCompleted30 Years80 YearsAll20Phase 4Italy
230NCT03230526
(ClinicalTrials.gov)
April 20, 201818/7/2017Identification of a Biomarker Predictive of Evolution of Parkinson DiseaseBrain Microglial Activation in the Early Stage of the Parkinson's Disease: a Predictive Biomarker of the Evolution?Parkinson DiseaseDrug: [18F]DPA-714 PET scanNantes University HospitalNULLRecruiting40 Years67 YearsAll64Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231NCT03374917
(ClinicalTrials.gov)
April 18, 20188/12/2017A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient EnvironmentAn Open-Label Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient EnvironmentParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLCompleted30 Years85 YearsAll20Phase 1United States
232NCT03368170
(ClinicalTrials.gov)
April 12, 20185/12/2017Efficacy and Tolerability of IRL790 in Parkinson's Disease DyskinesiaA Randomized, Placebo-controlled, Phase IIa Study Evaluating the Efficacy and Tolerability of IRL790 in Parkinson's Disease DyskinesiaParkinson DiseaseDrug: Mesdopetam (IRL790)Integrative Research Laboratories ABThe Clinical Trial CompanyCompleted18 Years79 YearsAll75Phase 2Sweden;United Kingdom
233EUCTR2017-002707-10-DK
(EUCTR)
10/04/201803/11/2017Measurements of drug concentration in the blood for anti-dementia drugs, in order to improve efficacy and reduce side-effectsSerum-monitoring of anti-dementia drugs, and the relevance to side-effects, clinical efficacy and compliance Dementia in Alzheimers Disease, Parkinsons Disease and Dementia with Lewy Bodies
MedDRA version: 20.0;Level: PT;Classification code 10012271;Term: Dementia Alzheimer's type;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease;Classification code 10067889;Term: Dementia with Lewy bodies;Classification code 10075174;Term: Mixed dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Memantin Orion
INN or Proposed INN: MEMANTINE
Product Name: Donepezil Sandoz
Product Code: 25330
INN or Proposed INN: DONEPEZIL
Regional Dementia Research Centre, Dept of NeurologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 4Denmark
234NCT03827746
(ClinicalTrials.gov)
April 1, 201831/1/2019The Effect of Kinesiophobia on Physical Activity, Balance and Falling in Parkinson's Disease PatientsThe Effect of Kinesiophobia on Physical Activity, Balance and Falling in Parkinson's Disease PatientsParkinson Disease;Kinesiophobia;Physical Activity;Balance;FallingOther: Tampa Kinesiophobia Scale, Berg-Balance Test, International Physical Activity Questionnaire-Short Form, Falls Efficacy ScaleIstanbul Kültür UniversityMarmara University;Istanbul University-Cerrahpasa;Koç UniversityCompleted40 Years85 YearsAll60Turkey
235NCT03648671
(ClinicalTrials.gov)
March 28, 201826/6/2018Pain in Parkinson's Disease With Motor Fluctuations.Spontaneous and Evoked Pain in Parkinson's Disease With Motor Fluctuations: an Observational, Prospective, Clinical and Neurophysiological Study in Patients Under L-dopa Add on Therapies.Parkinson DiseaseDrug: safinamide metansolfonato (12 weeks);Drug: rasagilina mesilato (12 weeks)Universita di VeronaAzienda Ospedaliera Universitaria Integrata VeronaUnknown status18 Years80 YearsAll48Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236NCT03301272
(ClinicalTrials.gov)
March 22, 201813/9/2017Effectiveness of Botox on Reducing Rest Tremor in Parkinson's DiseaseEffectiveness of Onabotulinumtoxin A on Reduction of Rest Tremor in Parkinson's Disease: a Pilot StudyParkinson DiseaseDrug: Onabotulinumtoxin A Injection;Other: PlaceboUniversity of North Carolina, Chapel HillNULLCompleted45 Years80 YearsAll16Phase 2United States
237NCT03457493
(ClinicalTrials.gov)
March 22, 201823/2/2018TSPO-PET for Neuroinflammation in Parkinson's DiseaseUAB Neuroinflammation in Parkinson's Disease - TSPO-PET SubstudyParkinson DiseaseDrug: DPA-714-PET/MRIUniversity of Alabama at BirminghamNULLRecruiting30 YearsN/AAll20Phase 1;Phase 2United States
238NCT03462641
(ClinicalTrials.gov)
March 9, 20186/3/2018Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil ArmModulation of GABA-A Receptors and Axial Motor Impairments in Parkinson Disease-Flumazenil ArmParkinson DiseaseDrug: Flumazenil;Drug: PlaceboUniversity of MichiganNational Institute of Neurological Disorders and Stroke (NINDS)Recruiting50 Years99 YearsAll30Phase 1;Phase 2United States
239NCT03482882
(ClinicalTrials.gov)
March 9, 201823/3/2018Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and DepressionAn Open-label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults With Parkinson's Disease and DepressionTreatment of Depression in Adults With Parkinson's Disease (PD)Drug: PimavanserinACADIA Pharmaceuticals Inc.NULLCompleted50 YearsN/AAll47Phase 2United States
240NCT03149809
(ClinicalTrials.gov)
March 1, 20189/5/2017Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson DiseaseBehavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson DiseaseOveractive Bladder;Parkinson DiseaseDrug: solifenacin;Behavioral: Pelvic floor muscle exercise-based behavioral therapyVA Office of Research and DevelopmentNULLRecruitingN/AN/AAll90Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241NCT04265027
(ClinicalTrials.gov)
February 20, 20187/2/2020Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC)An Open Label, Randomised, Two Period, Crossover Study to Assess Bioavailability, Bioequivalence and S COMT Activity Between Two Active Pharmaceutical Ingredient Sources of Opicapone at Two Different Dosage Strengths (50 mg and 25 mg) After Single and Multiple Dose Administrations Under Fasting Conditions in Healthy Volunteers.Parkinson DiseaseDrug: 50 mg BIA 9 1067;Drug: 25 mg BIA9 1067;Drug: 50 mg Ongentys;Drug: 25 mg OngentysBial - Portela C S.A.NULLCompleted18 Years55 YearsAll72Phase 1United Kingdom
242NCT03419806
(ClinicalTrials.gov)
February 16, 201810/1/2018Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa in Patients With Parkinson's DiseaseLevodopa Pharmacokinetics in Patients With Parkinson's Disease and Symptom Fluctuation: A Phase I, Open-label, Randomized, Multicentre, Crossover Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal DuodopaParkinson DiseaseDrug: Infudopa i.v.;Drug: Infudopa s.c.;Drug: LCIG (Duodopa)Vastra Gotaland RegionThe Swedish Research Council;Dizlin Medical Design AB;Göteborg UniversityCompleted30 YearsN/AAll25Phase 1Sweden
243NCT03882398
(ClinicalTrials.gov)
February 15, 201811/3/2019Effects of a High-intensity Progressive-cycle Program on Quality of Life and Motor Symptomatology in Parkinson's DiseaseEffects of a High-intensity Progressive-cycle Program on Quality of Life and Motor Symptomatology in Parkinson's Disease Population: a Pilot Randomized Controlled TrialParkinson Disease;Exercise;Physical Activity;Quality of LifeOther: Balance;Other: EnduranceUniversity of VigoNULLCompleted60 Years80 YearsAll14N/ASpain
244NCT03496870
(ClinicalTrials.gov)
February 8, 20181/3/2018A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.A Phase 1, Open-Label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Repeated Doses of Opicapone, and Effect on Levodopa Pharmacokinetics in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: Opicapone;Drug: Carbidopa LevodopaNeurocrine BiosciencesNULLCompleted18 Years85 YearsAll16Phase 1United States
245NCT03189563
(ClinicalTrials.gov)
February 6, 201812/6/2017Safety and Efficacy of DA-9805 for Parkinson's DiseaseA Phase IIa, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of DA-9805 in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: DA-9805 45mg;Drug: DA-9805 90mg;Other: PlaceboDong-A ST Co., Ltd.NULLCompleted30 Years79 YearsAll60Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246NCT03440112
(ClinicalTrials.gov)
January 29, 201826/1/2018Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil ArmModulation of GABA-A Receptors and Axial Motor Impairments in ParkinsonParkinson DiseaseDrug: Clarithromycin (Not used as of 4/2020);Drug: Placebo (Not used as of 4/2020);Drug: Transdermal flumazenil (Added 4/2020);Drug: Placebo (Added 4/2020)Nicolaas Bohnen, MD, PhDNational Institute of Neurological Disorders and Stroke (NINDS)Recruiting50 YearsN/AAll30Phase 1;Phase 2United States
247NCT03329508
(ClinicalTrials.gov)
January 29, 201830/10/2017A Phase 3 Study With P2B001 in Subjects With Early Parkinson'sA Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.Parkinson DiseaseDrug: P2B001;Drug: Rasagiline;Drug: Pramipexole;Drug: Pramipexole ERPharma Two B Ltd.NULLRecruiting35 Years80 YearsAll525Phase 3United States;Canada;Germany;Spain
248NCT03531086
(ClinicalTrials.gov)
January 19, 20188/5/2018Idiopathic Parkinson's Progression and Dopamine Transporter SPECTExploring Dopamine Transporter Single-photon Emission Computer Tomography Quantification as a Measure of Disease Progression in Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: Ioflupane I 123Julie GurwellNULLActive, not recruiting40 Years75 YearsAll12United States
249NCT03331848
(ClinicalTrials.gov)
January 15, 20181/11/2017Study to Evaluate the Efficacy, Safety, and Tolerability of PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED)A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety, and Tolerability of 8-week Oral Treatment With PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED)Parkinson DiseaseDrug: Placebo oral capsule;Drug: PXT002331 - 20mgPrexton TherapeuticsNULLWithdrawn35 Years85 YearsAll0Phase 2NULL
250NCT03318523
(ClinicalTrials.gov)
January 10, 201819/10/2017Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: Placebo;Drug: BIIB054BiogenNULLActive, not recruiting40 Years80 YearsAll357Phase 2United States;Austria;Canada;France;Germany;Israel;Italy;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251NCT03550183
(ClinicalTrials.gov)
January 10, 201811/5/2018Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Parkinson's DiseaseSafety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem CellsParkinson's DiseaseBiological: mesenchymal stem cellsHebei Newtherapy BIo-Pharma technology Co., Ltd.NULLEnrolling by invitation40 Years80 YearsAll20Phase 1China
252EUCTR2017-000087-15-DE
(EUCTR)
21/12/201717/05/2017A Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants with Early Parkinson’s Disease with a 6 -Year all-Participants-on Treatment Extension (Pasadena)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: aSyn Mab
Product Code: RO7046015
INN or Proposed INN: N/A
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;France;Spain;Austria;Germany
253NCT03321019
(ClinicalTrials.gov)
December 12, 201720/10/2017Airway Protective Mechanisms in PD (R01)Mechanisms of Airway Protection Dysfunction in Parkinson's DiseaseParkinson DiseaseDrug: Capsaicin;Device: Resistive respiratory loads;Other: Event-related evoked potential using electroencephalography (EEG).;Procedure: Fluoroscopic swallow evaluationUniversity of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Recruiting45 Years85 YearsAll260United States
254NCT03377322
(ClinicalTrials.gov)
December 1, 20177/12/2017Trial of Probiotics for Constipation in Parkinson's DiseaseA Randomized Double-Blinded Placebo-Controlled Trial of Probiotics for Constipation in Parkinson's DiseaseParkinson DiseaseDrug: Probiotic Capsule;Drug: Placebo CapsuleUniversity of MalayaNULLCompleted40 Years85 YearsAll72N/AMalaysia
255NCT03944785
(ClinicalTrials.gov)
November 30, 20171/5/2019Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)A Prospective, Observational Study to Evaluate Changes in Non-Motor Symptoms and Other Clinical Outcome Assessments of Parkinson's Disease Patients Treated With XADAGO (Safinamide)TabletsIdiopathic Parkinson DiseaseDrug: XADAGO (safinamide)US WorldMeds LLCNULLCompleted30 Years80 YearsAll209United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256NCT03194217
(ClinicalTrials.gov)
November 10, 201719/6/2017BEN-2001 in Parkinson Disease Patients With Excessive Daytime SleepinessDose Finding Phase IIb Study of Bavisant to Evaluate Its Safety and effiCacy in treAtment of exceSsive Daytime sleePiness (EDS) in PARkinson's Disease (PD).Excessive Daytime Sleepiness;Parkinson DiseaseDrug: BEN-2001;Drug: PlaceboBenevolentAI BioNULLCompleted50 Years80 YearsAll244Phase 2United States
257NCT03305809
(ClinicalTrials.gov)
November 9, 20174/10/2017A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)Effect of LY3154207 on Cognition in Mild-to-Moderate Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)Lewy Body DementiaDrug: LY3154207;Drug: PlaceboEli Lilly and CompanyNULLCompleted40 Years85 YearsAll344Phase 2United States;Canada;Puerto Rico;China
258NCT03232996
(ClinicalTrials.gov)
November 1, 201724/7/2017Evaluation of a Computer Game Based Rehabilitation System for Assessment and Treatment of Balance and Gait Impairments in Individuals With Parkinson's Disease.Evaluation of a Computer Game Based Rehabilitation System for Assessment and Treatment of Balance and Gait Impairments in Individuals With Parkinson's Disease.Parkinson Disease;ParkinsonOther: Computer game based balance and walking rehabilitation for individuals with Parkinson's DiseaseUniversity of ManitobaNULLCompleted55 Years70 YearsAll30N/ACanada
259NCT02611167
(ClinicalTrials.gov)
November 1, 201711/11/2015Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's DiseasePilot Phase I Study of Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's DiseaseParkinson's DiseaseBiological: Allogeneic bone marrow-derived MSCs (1 x 10 6 MSC/kg);Biological: Allogeneic bone marrow-derived MSCs (3 x 10 6 MSC/kg);Biological: Allogeneic bone marrow-derived MSCs (6 x 10 6 MSC/kg);Biological: Allogeneic bone marrow-derived MSCs (10 x 10 6 MSC/kg)The University of Texas Health Science Center, HoustonNULLCompleted45 Years70 YearsAll20Phase 1United States
260NCT03205956
(ClinicalTrials.gov)
October 19, 201729/6/2017Measuring Parkinson's Disease ProgressionDopamine Buffering Capacity Measured by phMRI as a Novel Biomarker of Disease Progression in PDParkinson's DiseaseDrug: LevodopaKevin J. Black, MDThe Michael J. Fox Foundation for Parkinson's ResearchCompleted40 Years79 YearsAll31Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261NCT03272165
(ClinicalTrials.gov)
October 17, 201729/6/2017Single Ascending Dose Study of MEDI1341 in Healthy VolunteersA Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI1341 in Healthy Male and Female Volunteers.Parkinson's DiseaseDrug: MEDI1341;Drug: PlaceboAstraZenecaCovance;MMS Holdings, Inc;CatalentRecruiting18 Years80 YearsAll48Phase 1United States;United Kingdom
262NCT03205488
(ClinicalTrials.gov)
October 16, 201728/6/2017Nilotinib in Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants With Parkinson's DiseaseParkinson DiseaseDrug: Cohort 1:Nilotinib Oral Capsules (150mg or 300mg);Drug: Cohort 2: Nilotinib Oral Capsules (dose to be determined from Cohort 1);Drug: PlaceboNorthwestern UniversityUniversity of Rochester;University of Iowa;Michael J. Fox Foundation for Parkinson's ResearchCompleted40 Years79 YearsAll76Phase 2United States
263NCT03250117
(ClinicalTrials.gov)
October 10, 201711/8/2017Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral RopiniroleAn Open-Label, Relative Bioavailability Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ropinirole Implants in Patients With Parkinson's Disease Switched From Oral Immediate-Release Ropinirole While on L-DopaParkinson DiseaseDrug: Ropinirole oral product;Drug: Ropinirole ImplantTitan PharmaceuticalsNULLTerminated30 Years80 YearsAll3Phase 1;Phase 2United States
264NCT04045678
(ClinicalTrials.gov)
October 10, 201730/7/2019A Multiple Ascending Dose Study With LY03003 in Patients With Early-stage Parkinson's DiseaseA Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular InjectionsParkinson DiseaseDrug: LY03003 ( Rotigotine, extended-release microspheres);Drug: Placebo, extended-release microspheresLuye Pharma Group Ltd.Beijing Bozhiyin T&S Co., Ltd.Completed18 Years75 YearsAll30Phase 1China
265NCT03769896
(ClinicalTrials.gov)
October 3, 20176/12/2018Nabilone for Non-motor Symptoms in Parkinson's DiseaseNabilone for Non-motor Symptoms in Parkinson's Disease: A Randomized Placebo-controlled, Double-blind, Parallel-group, Enriched Enrolment Randomized Withdrawal StudyParkinson DiseaseDrug: Nabilone 0.25 mg;Drug: PlaceboMedical University InnsbruckNULLCompleted30 Years100 YearsAll48Phase 2Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266NCT03257046
(ClinicalTrials.gov)
September 28, 201714/8/2017Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's DiseaseA Randomized, Placebo-Controlled, Double-Blind Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ITI-214 in Patients With Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: ITI-214;Other: PlaceboIntra-Cellular Therapies, Inc.NULLCompleted50 YearsN/AAll40Phase 1;Phase 2United States
267NCT03295786
(ClinicalTrials.gov)
September 26, 201714/9/2017Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's DiseasePhase 1-2, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Via an Investigational Drug Delivery System to Patients With Parkinson's DiseaseParkinson Disease;Movement Disorders;Neurodegenerative Diseases;Nervous System Diseases;Brain DiseasesDrug: Cerebral Dopamine Neurotrophic Factor;Device: Renishaw Drug Delivery SystemHerantis Pharma Plc.Renishaw plc.Completed35 Years75 YearsAll17Phase 1;Phase 2Finland;Sweden
268NCT03104725
(ClinicalTrials.gov)
September 25, 20174/4/2017Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease?Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease?Parkinson Disease;Cerebrospinal FluidDrug: N-Acetylcysteine;Procedure: Lumbar Puncture;Radiation: FluoroscopyNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted18 YearsN/AAll6Phase 1United States
269NCT03306329
(ClinicalTrials.gov)
September 13, 201725/9/2017DNS-7801 vs. Placebo in Parkinson's DiseaseA Phase 2a, Double-Blind, Placebo-Controlled Two-Part Study To Investigate the Safety and Efficacy of Increasing Doses Of DNS-7801 In Parkinson's Disease (PD) Subjects With Motor FluctuationsParkinson's DiseaseDrug: DNS-7801 (low-dose);Drug: DNS-7801 (high dose);Drug: PlaceboDart NeuroScience, LLCNULLTerminated30 YearsN/AAll5Phase 2United States
270NCT03272230
(ClinicalTrials.gov)
September 6, 20173/8/2017Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based SystemAssessment of Apathy in a Real-life Situation, With a Video and Sensors-based System in Healthy Subject and Patient With Cerebral DiseaseApathy;Frontotemporal Dementia;Parkinson Disease;Depressive SymptomsBehavioral: ECOCAPTURE;Behavioral: Cognitive and Behavioral experimental tasks;Diagnostic Test: Neuropsychological assessment;Behavioral: ICM_APATHY_TASKS;Other: MRI;Biological: Neurohormonal mechanisms;Diagnostic Test: Supplementary Neuropsychological Assessment - Parkinson's DiseaseInstitut National de la Santé Et de la Recherche Médicale, FranceNULLRecruiting40 Years85 YearsAll135N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271ChiCTR-INR-17012013
2017-09-012017-07-17Clinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's diseaseClinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's disease Parkinson‘s disease, DepressionBTX-A:BOTOX Allergan;Placebo:0.9% Sodium Chloride Injection;Shanghai Tongji Hospital, Tongji UniversityNULLPending1880BothBTX-A:40;Placebo:40;China
272NCT03292016
(ClinicalTrials.gov)
August 22, 201711/9/2017A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by OFF EpisodesA Comparative Bioavailability Study to Evaluate the Single Dose Pharmacokinetic Properties of APL-130277 With Two Different Formulations of Subcutaneous Apomorphine in a Randomized, 3-Period Crossover Design in Subjects With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)Parkinson DiseaseDrug: APL-130277;Drug: APO-go;Drug: ApokynSunovionNULLCompleted18 YearsN/AAll8Phase 2United States
273EUCTR2017-000087-15-AT
(EUCTR)
17/08/201718/05/2017A Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab(PRX002) in Participants with Early Parkinson's Disease with A 6-Year all-Participants-on-Treatment Extension (Pasadena)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: aSyn Mab
Product Code: RO7046015
INN or Proposed INN: N/A
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2France;United States;Spain;Austria;Germany
274NCT04162275
(ClinicalTrials.gov)
August 15, 201722/9/2019A Single-dose Study to Investigate the Tolerance and Pharmacokinetics of Finamine Tablets in ChinaA Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Tolerance and Pharmacokinetics Study of Oral Taking Finamine Tablets in Chinese Healthy-adult SubjectsParkinson DiseaseDrug: Finamine tablets;Drug: Placebo tabletsYiling Pharmaceutical Inc.NULLActive, not recruiting18 Years65 YearsAll34Phase 1China
275NCT03204929
(ClinicalTrials.gov)
August 14, 201728/6/2017Dose Escalation Study of Cu(II)ATSM in Parkinson's DiseaseA Phase 1 Dose Escalation Study of Cu(II)ATSM Administered Orally to Patients With Early Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: Cu(II)ATSMCollaborative Medicinal Development Pty LimitedNULLCompleted30 YearsN/AAll31Phase 1Australia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276NCT03187301
(ClinicalTrials.gov)
August 3, 20177/6/2017A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations OFF EpisodesA Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)Parkinson's Disease;Off Episodes of Parkinson DiseaseDrug: APL-130277;Drug: Placebo;Drug: MoxifloxacinSunovionNULLCompleted18 YearsN/AAll48Phase 2United States;Italy
277EUCTR2017-000087-15-FR
(EUCTR)
27/07/201730/10/2017A Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants with Early Parkinson’s Disease with A 52-Week Blinded Extension (Pasadena)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: aSyn Mab
Product Code: RO7046015
INN or Proposed INN: N/A
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;France;Spain;Austria;Germany
278EUCTR2017-000087-15-ES
(EUCTR)
26/07/201708/06/2017A Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants with Early Parkinson’s Disease with A 52-Week Blinded Extension (Pasadena)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: aSyn Mab
Product Code: RO7046015
INN or Proposed INN: N/A
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2France;United States;Spain;Austria;Germany
279NCT03178786
(ClinicalTrials.gov)
July 18, 20175/6/2017Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's DiseaseVisual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's DiseaseParkinson DiseaseBehavioral: PAT sessionsNYU Langone HealthNULLRecruiting40 Years75 YearsAll40N/AUnited States
280NCT03412513
(ClinicalTrials.gov)
July 17, 201721/1/2018Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's DiseaseMirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease: a Double-blind, Randomized Placebo-controlled TrialOveractive Bladder;Parkinson DiseaseDrug: Mirabegron;Drug: PlaceboSeoul National University HospitalNULLUnknown status40 Years80 YearsAll144Phase 4Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281NCT03026231
(ClinicalTrials.gov)
July 15, 201711/1/2017Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease PatientsA Prospective, Randomized Placebo Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Weekly Administration of Lyophilized PRIM-DJ2727 Given Orally in Subjects With Parkinson's DiseaseParkinson's DiseaseBiological: PRIM-DJ2727;Drug: Placebo (for PRIM-DJ2727)The University of Texas Health Science Center, HoustonKelsey Research FoundationWithdrawn45 Years70 YearsAll0Phase 1;Phase 2United States
282NCT03555292
(ClinicalTrials.gov)
July 12, 201724/4/201811C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia SyndromesSafety and Diagnostic Performance of 11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia SyndromesParkinson DiseaseDrug: 11C-PiBOriental Neurosurgery Evidence-Based-Study TeamNULLRecruiting18 YearsN/AAll200Phase 2China
283EUCTR2017-000135-14-ES
(EUCTR)
07/07/201709/06/2017A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug LevodopaA Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Prexton Therapeutics B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 2Spain;Austria;Germany
284NCT03185481
(ClinicalTrials.gov)
July 6, 20179/6/2017Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor FluctuationsA PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASEParkinson's Disease With Motor FluctuationsDrug: 1 mg QD to 15 mg QD PF-06649751;Drug: 3 mg QD to 15 mg QD PF-06649751;Drug: 7 mg QD to 15 mg QD PF-06649751;Drug: 15 mg QD PF-06649751;Drug: 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study);Drug: 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QDPfizerNULLTerminated40 Years87 YearsAll5Phase 2United States
285NCT03162874
(ClinicalTrials.gov)
July 4, 201719/5/2017Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's PatientsA Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED)Parkinson DiseaseDrug: Placebo oral capsule;Drug: PXT002331 - dose 1;Drug: PXT002331 - dose 2Prexton TherapeuticsNULLCompleted35 Years85 YearsAll157Phase 2Austria;France;Germany;Italy;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286NCT04146519
(ClinicalTrials.gov)
July 1, 201718/10/2019Parkinson's Disease Therapy Using Cell TechnologyDevelopent and Implement a Method of Parkinson's Disease Therapy Using Cell TechnologyTransplantation:Mesenchymal Stem Cell TransplantationBiological: Autologous mesenchymal stem cellsBelarusian Medical Academy of Post-Graduate EducationNULLActive, not recruiting18 YearsN/AAll12Phase 2Belarus
287NCT03288155
(ClinicalTrials.gov)
July 1, 201715/9/2017Can a Flavonoid-rich Pure Cocoa Reduce Fatigue in People With Parkinson's (PD)A Study to Determine Whether the Daily Consumption of Flavonoid-rich Pure Cocoa Can Reduce Fatigue in People With Parkinson's (PD)Parkinson Disease;FatigueDietary Supplement: CocoaOxford Brookes UniversityEuropean Parkinson Therapy CentreCompleted18 YearsN/AAll30N/AItaly
288NCT03042416
(ClinicalTrials.gov)
June 29, 20171/2/201718F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety18F-DOPA PET Imaging: an Evaluation of Biodistribution and SafetyCongenital Hyperinsulinism;Neuroblastoma;Neuroendocrine Tumors;Parkinson Disease;Brain GliomaDrug: 18F-DOPAUniversity of AlbertaAlberta Health ServicesActive, not recruitingN/AN/AAll400Phase 3Canada
289NCT04223245
(ClinicalTrials.gov)
June 29, 20172/12/2019A Home Program Using Multimodal Sensory Feedback for People With Parkinson DiseaseA Comparison Of Home Exercises With Multimodal Real-time Sensory Feedback To The Same Exercise Program With No Enhanced Feedback on Walking Automaticity in People With Parkinson Disease.Parkinson DiseaseBehavioral: exercise+multi-modal sensory feedback (MMSF);Behavioral: Exercise onlyRegis UniversityNULLCompleted21 YearsN/AAll26N/AUnited States
290NCT04403399
(ClinicalTrials.gov)
June 29, 201721/5/2020Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease Exp. 3 - Proj#3 (UdallP3)Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease Exp. 3 - Proj#3Parkinson's DiseaseDrug: Varenicline;Other: Evaluation by Investigator;Other: PlaceboUniversity of MichiganNULLCompleted45 YearsN/AAll33Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291NCT03100149
(ClinicalTrials.gov)
June 27, 201729/3/2017A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants With Early Parkinson's Disease With a 6-Year All-Participants-on-Treatment ExtensionParkinson's DiseaseDrug: RO7046015;Drug: PlaceboHoffmann-La RocheProthena Biosciences LimitedActive, not recruiting40 Years80 YearsAll316Phase 2United States;Austria;France;Germany;Spain
292NCT03195231
(ClinicalTrials.gov)
June 25, 201720/6/2017Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's DiseaseWuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease: a Randomised, Double-blind, Placebo-controlled Trial.Antidepressive AgentsDrug: Wuling Powder;Drug: PlaceboBeijing HospitalTongji Hospital;Shanghai Tong Ren Hospital;The First Hospital of Hebei Medical UniversityNot yet recruiting40 YearsN/AAll120Phase 4NULL
293NCT03116295
(ClinicalTrials.gov)
June 20, 201712/4/2017Bioavailability and Bioequivalence Study of Two Different Sources of OpicaponeA Comparative, Randomized, Open-label, Fasted, Single-dose, 2-way Crossover Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone in Healthy SubjectsParkinson DiseaseDrug: Opicapone (OPC)Bial - Portela C S.A.NULLCompleted18 Years55 YearsAll56Phase 1Germany
294EUCTR2017-000135-14-GB
(EUCTR)
15/06/201717/03/2017A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug LevodopaA Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Prexton Therapeutics B.V.NULLNot RecruitingFemale: yes
Male: yes
165Phase 2Spain;Austria;Germany;United Kingdom
295NCT03083132
(ClinicalTrials.gov)
June 13, 20177/3/2017Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD)Modafinil as a Novel Therapy for the Treatment of Freezing of Gait in Parkinson's DiseaseParkinson DiseaseDrug: modafinil 50mg;Drug: Placebo oral capsuleUniversity of ArkansasNULLCompleted50 Years90 YearsAll23Early Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296NCT03973502
(ClinicalTrials.gov)
June 12, 201730/5/2019Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) With HCV and PDApplication of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) in Research of the Association Between HCV Infection and Parkinson's Disease.Hepatitis C;Hepatitis B;Parkinson DiseaseDrug: 18F-DOPA PETNational Taiwan University HospitalNULLRecruiting20 YearsN/AAll230N/ATaiwan
297EUCTR2017-000135-14-DE
(EUCTR)
06/06/201710/03/2017A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug LevodopaA Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Prexton Therapeutics B.V.NULLNot RecruitingFemale: yes
Male: yes
165Phase 2Spain;Austria;Germany;Italy;United Kingdom
298EUCTR2017-000135-14-IT
(EUCTR)
30/05/201704/11/2020A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug LevodopaStudio di fase IIa, multicentrico, in doppio cieco, randomizzato, controllato verso placebo, a gruppi paralleli per valutare l'efficacia, la sicurezza e la tollerabilit¿ del trattamento orale con PXT002331 (foliglurax) della durata di 28 giorni nella riduzione delle complicazioni motorie dovute alla terapia con levodopa nei pazienti affetti da malattia di Parkinson che manifestano deterioramento da fine dose e discinesia indotta da levodopa (AMBLED) - AMBLED Study Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
PREXTON THERAPEUTICS B.V.NULLNot RecruitingFemale: yes
Male: yes
165Phase 2France;Spain;Austria;Germany;United Kingdom;Italy
299EUCTR2017-000135-14-AT
(EUCTR)
26/05/201708/03/2017A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug LevodopaA Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Prexton Therapeutics B.V.NULLNot RecruitingFemale: yes
Male: yes
165Phase 2Spain;Austria;Germany;United Kingdom
300NCT03111485
(ClinicalTrials.gov)
May 24, 201728/3/2017Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's DiseaseEffect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's DiseaseParkinson's Disease;Obstructive Sleep ApneaDrug: Sinemet CR;Drug: Placebo oral capsuleMcGill University Health Centre/Research Institute of the McGill University Health CentreWeston Brain InstituteRecruiting18 YearsN/AAll42Phase 4Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301NCT03033498
(ClinicalTrials.gov)
May 17, 201725/1/2017A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's DiseaseA Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 24 Hour and 72 Hour Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's DiseaseParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLCompleted45 Years85 YearsAll29Phase 1United States
302NCT03174938
(ClinicalTrials.gov)
May 15, 201728/5/2017The Swedish BioFINDER 2 StudyThe Swedish BioFINDER 2 StudyDementia;Alzheimer Disease;Parkinson Disease;Lewy Body Disease;Parkinson-Dementia Syndrome;Frontotemporal Degeneration;Semantic Dementia;Progressive Nonfluent Aphasia;Progressive Supranuclear Palsy;Corticobasal Degeneration;Multiple System Atrophy;Mild Cognitive ImpairmentDiagnostic Test: Flutemetamol F18 Injection;Diagnostic Test: [18F]-RO6958948;Diagnostic Test: Elecsys (Roche) Abeta42, Ttau and Ptau;Diagnostic Test: Lumipulse (Fujirebio) Abeta42, Ttau and PtauSkane University HospitalLund UniversityRecruiting20 Years100 YearsAll1505N/ASweden
303NCT03242499
(ClinicalTrials.gov)
May 15, 20171/8/2017Lovastatin as a Neuroprotective Treatment for Early Stage Parkinson's DiseaseLovastatin as a Neuroprotective Treatment for Early Stage Parkinson's Disease: a Single-center, Double-blind, Placebo-controlled Randomized TrialParkinson DiseaseDrug: Lovastatin;Drug: PlaceboNational Taiwan University HospitalNULLRecruiting30 Years90 YearsAll80Phase 2Taiwan
304NCT03047629
(ClinicalTrials.gov)
May 11, 20173/2/2017Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related ConstipationA Multi-Center, Single-Dose, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Related ConstipationParkinson's Disease;ConstipationDrug: ENT-01;Other: PlaceboEnterin Inc.NULLCompleted30 Years86 YearsAll50Phase 1;Phase 2United States
305NCT03065192
(ClinicalTrials.gov)
May 11, 201710/2/2017Safety and Efficacy Study of VY-AADC01 for Advanced Parkinson's DiseaseAn Open-label Safety and Efficacy Study of VY-AADC01 Administered by MRI-Guided Convective Infusion Using a Posterior Trajectory Into the Putamen of Participants With Parkinson's Disease With Fluctuating Responses to LevodopaIdiopathic Parkinson's Disease;Parkinson's Disease;Basal Ganglia Disease;Brain Diseases;Central Nervous System Diseases;Movement Disorders;Nervous System Diseases;Neurodegenerative Diseases;Parkinsonian DisordersDrug: VY-AADC01Neurocrine BiosciencesVoyager TherapeuticsActive, not recruiting40 Years75 YearsAll16Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306NCT02982512
(ClinicalTrials.gov)
May 1, 201728/11/2016Dexmedetomidine on Basal Ganglia Neuronal Activity in Parkinson's DiseaseEffects of Different Concentrations of Dexmedetomidine on Basal Ganglia Neuronal Activity (Local Field Potentials) in Parkinson's DiseaseDexmedetomidine;Deep Brain Stimulation;Parkinson DiseaseDrug: DexmedetomidineClinica Universidad de Navarra, Universidad de NavarraNULLUnknown status18 YearsN/AAll12Phase 4Spain
307NCT03119636
(ClinicalTrials.gov)
May 20176/4/2017Safety and Efficacy Study of Human ESC-derived Neural Precursor Cells in the Treatment of Parkinson's DiseaseA Phase I/II, Open-Label Study to Assess the Safety and Efficacy of Striatum Transplantation of Human Embryonic Stem Cells-derived Neural Precursor Cells in Patients With Parkinson's DiseaseParkinson's DiseaseBiological: NPC transplantation;Drug: LevodopaChinese Academy of SciencesThe First Affiliated Hospital of Zhengzhou UniversityRecruiting50 Years80 YearsAll50Phase 1;Phase 2China
308NCT02702076
(ClinicalTrials.gov)
May 20172/3/2016Apomorphine in Parkinson's Disease Patients With Visual HallucinationsRandomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Continuous Subcutaneous Infusion in Parkinson's Disease Patients With Refractory Visual HallucinationsParkinson's Disease;Hallucinations, VisualDrug: Apomorphine;Drug: PlaceboUniversity Medical Center GroningenNULLRecruiting30 YearsN/AAll35Phase 2Netherlands
309NCT03425877
(ClinicalTrials.gov)
April 22, 201710/1/2018Arousal Response Tool for Neurological DiseaseArousal Response Tool for Neurological DiseaseParkinson Disease;Stroke;HealthyDevice: MS Band 2;Behavioral: Emotion Assessment;Behavioral: Single Task;Behavioral: Dual Task;Behavioral: RestIRCCS San Camillo, Venezia, ItalyUniversità Politecnica delle Marche;University of PadovaUnknown status25 YearsN/AAll45N/AItaly
310NCT03115827
(ClinicalTrials.gov)
April 18, 20179/3/2017Norepinephrine-targeted Therapy for Action Control in Parkinson DiseaseNorepinephrine-targeted Therapy for Action Control in Parkinson DiseaseParkinson DiseaseDrug: Droxidopa;Drug: CarbidopaVanderbilt University Medical CenterH. Lundbeck A/S;American Academy of NeurologyCompleted18 YearsN/AAll15Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311NCT03128450
(ClinicalTrials.gov)
April 15, 20179/2/2017A Study To Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease PatientA Single Arm, Open-Label,Pilot Study to Evaluate the Safety and Efficacy of Human Neural Stem Cells Injection (ANGE-S003) Through Nasal Way Delivery to Patients With Parkinson's DiseaseParkinson DiseaseBiological: human neural stem cellSecond Affiliated Hospital of Soochow UniversityNULLEnrolling by invitation35 Years70 YearsAll12Phase 2;Phase 3China
312NCT03011476
(ClinicalTrials.gov)
April 11, 201727/12/2016Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson DiseaseEffect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease Characterized by Postural Instability and Gait DisturbanceParkinson DiseaseDrug: Donepezil;Drug: PlacebosKyung Hee University HospitalNULLUnknown status40 Years75 YearsAll20Phase 4Korea, Republic of
313NCT03051607
(ClinicalTrials.gov)
April 10, 20179/2/2017Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-OffIdiopathic Parkinson DiseaseDrug: TozadenantBiotie Therapies Inc.Acorda TherapeuticsTerminated30 Years80 YearsAll66Phase 3United States;Canada;United Kingdom
314JPRN-jRCTs051180185
07/04/201726/03/2019APISJ StudyIntervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease - APISJ Study Parkinson's disease
Parkinson's disease
In this research, the duration of evaluation will be 24 weeks.
Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by Istradefylline.
Takahashi MakioKyowa Kirin Co., Ltd.Not Recruiting>= 30age oldNot applicableBoth30N/AJapan
315NCT02953665
(ClinicalTrials.gov)
April 3, 201721/10/2016Safety and Efficacy of Liraglutide in Parkinson's DiseaseA Phase II, Randomized, Double-blinded, Placebo-controlled Trial of Liraglutide in Parkinson's DiseaseParkinson DiseaseDrug: Liraglutide;Drug: PlaceboCedars-Sinai Medical CenterThe Cure Parkinson's Trust;Novo Nordisk A/SActive, not recruiting25 Years85 YearsAll63Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316NCT02970019
(ClinicalTrials.gov)
March 30, 201718/11/2016Safety and Tolerability Study of K0706 in Subjects With Parkinson's DiseaseA Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.Parkinson DiseaseDrug: K0706;Drug: PlaceboSun Pharma Advanced Research Company LimitedNULLCompleted18 Years65 YearsAll60Phase 1United States
317JPRN-UMIN000026492
2017/03/1515/03/2017Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's DiseaseIntervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease - Intervention Study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease. Parkinson's diseaseIn this research, the duration of evaluation will be 24 weeks.
Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by istradefylline.
Osaka Red Cross HospitalClinical Research Center, Wakayama Medical UniversityComplete: follow-up complete30years-oldNot applicableMale and Female30Not selectedJapan
318NCT02864004
(ClinicalTrials.gov)
March 3, 201715/7/2016Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP)Apomorphine Pump in Early Stage of Parkinson's DiseaseParkinson's DiseaseDrug: Apomorphine;Other: Best Medical TreatmentRennes University HospitalNULLRecruiting18 Years65 YearsAll192Phase 3France
319NCT03068481
(ClinicalTrials.gov)
February 20, 201726/2/2017Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's DiseaseA Phase I Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's DiseaseParkinson DiseaseDrug: KDT-3594;Drug: PlaceboKissei Pharmaceutical Co., Ltd.NULLCompleted20 Years74 YearsAll36Phase 1Japan
320NCT02799381
(ClinicalTrials.gov)
February 9, 201710/6/2016A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER)An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease DYSCOVER (DYSkinesia COmparative Interventional Trial on Duodopa VERsus Oral Medication)Parkinson's Disease (PD)Drug: Optimized antiparkinsonian treatment;Drug: Levodopa-Carbidopa Intestinal Gel (LCIG);Device: CADD-Legacy ambulatory infusion pump;Device: Percutaneous endoscopic gastrostomy tube;Device: Jejunal extension tubeAbbVieNULLCompleted30 YearsN/AAll63Phase 3United States;Finland;Greece;Hungary;Italy;Slovakia;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
321NCT03330470
(ClinicalTrials.gov)
January 1, 201717/10/2017Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative DiseaseMolecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative DiseaseSubjective Cognitive Impairment;Mild Cognitive Impairment;Parkinson Disease;Healthy VolunteersBehavioral: exercise;Dietary Supplement: carnosine supplementation;Behavioral: stretching;Dietary Supplement: supplementation with placeboSlovak Academy of SciencesComenius University;University Hospital Bratislava;National Cheng Kung UniversityRecruiting55 Years80 YearsAll100N/ASlovakia;Taiwan
322NCT02954978
(ClinicalTrials.gov)
January 20171/11/2016Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's DiseaseA Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Low Doses of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's DiseaseParkinson Disease;Parkinsons Disease With DementiaDrug: Placebo Oral Capsule;Drug: Nilotinib 150mg oral capsule [Tasigna];Drug: Nilotinib 300mg oral capsule [Tasigna]Georgetown UniversityNULLActive, not recruiting40 Years90 YearsAll75Phase 2United States
323NCT03037203
(ClinicalTrials.gov)
January 201723/1/2017A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive SleepinessA 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive SleepinessExcessive Sleepiness;Parkinson DiseaseDrug: JZP-110;Other: PlaceboJazz PharmaceuticalsNULLCompleted35 Years80 YearsAll66Phase 2United States
324NCT03034564
(ClinicalTrials.gov)
January 201725/1/2017A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's DiseaseParkinson Disease;Fatigue;ParkinsonismDrug: Northera;Drug: Placebo Oral TabletThe Cooper Health SystemNULLRecruiting18 YearsN/AAll70Phase 4United States
325NCT02969369
(ClinicalTrials.gov)
December 31, 201617/11/2016A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease PsychosisA Multicenter Randomized Double-blind Followed by an Open-label Extension Study to Evaluate the Efficacy, Safety, and Tolerability of SEP-363856 in Subjects With Parkinson's Disease PsychosisParkinson Disease PsychosisDrug: SEP-363856;Drug: Placebo capsuleSunovionNULLCompleted55 Years105 YearsAll39Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
326NCT02906020
(ClinicalTrials.gov)
December 15, 201614/9/2016A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients With Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant.Parkinson's DiseaseDrug: GZ/SAR402671;Drug: PlaceboGenzyme, a Sanofi CompanyNULLActive, not recruiting18 Years80 YearsAll270Phase 2United States;Austria;Canada;France;Germany;Greece;Israel;Italy;Japan;Norway;Portugal;Singapore;Spain;Sweden;Taiwan;United Kingdom
327NCT02879136
(ClinicalTrials.gov)
December 201623/6/2016TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's DiseaseTAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease: A Single Center, Randomized Pilot StudyParkinson's Disease, IdiopathicDrug: Methylphenidate;Other: Physical Therapy;Drug: AtomoxetineHubert FernandezNULLRecruiting18 Years90 YearsAll42Early Phase 1United States
328NCT02941822
(ClinicalTrials.gov)
December 20165/9/2016Ambroxol in Disease Modification in Parkinson DiseaseA Phase IIA Prospective, Single-Centre, Open Label Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of Ambroxol in Patients With Parkinson Disease: Ambroxol in Disease Modification in Parkinson DiseaseParkinson DiseaseDrug: AmbroxolUniversity College, LondonThe Cure Parkinson's TrustCompleted40 Years80 YearsAll23Phase 2United Kingdom
329NCT02789020
(ClinicalTrials.gov)
December 201620/5/2016Image Parkinson's Disease Progression StudyImage Parkinson's Disease Progression StudyParkinson's DiseaseDrug: Rasagiline;Other: Placebo;Device: Magnetic Resonance Imaging;Device: functional Magnetic Resonance Imaging;Other: Physical Function Performance TestUniversity of FloridaNational Institute of Neurological Disorders and Stroke (NINDS)Active, not recruiting40 Years77 YearsAll96Phase 2United States
330NCT03000569
(ClinicalTrials.gov)
November 30, 201628/11/2016A Study to Evaluate SAGE-217 in Participants With Parkinson's DiseaseA Phase 2, Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: SAGE-217;Drug: Levodopa;Drug: Antiparkinsonian Agent(s)Sage TherapeuticsNULLCompleted40 Years75 YearsAll29Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
331NCT02847442
(ClinicalTrials.gov)
November 23, 201621/7/2016Efficacy and Safety of Opicapone in Clinical PracticeEfficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor FluctuationsParkinson's Disease With Wearing-off Motor FluctuationsDrug: BIA 9-1067;Drug: levodopa/dopa decarboxylase inhibitorBial - Portela C S.A.NULLCompleted30 YearsN/AAll518Phase 4Germany
332NCT03007888
(ClinicalTrials.gov)
November 14, 20166/12/2016A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's DiseaseA Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's DiseaseAdvanced Parkinson's DiseaseDrug: IR CD-LD;Drug: ER CD-LDImpax Laboratories, LLCNULLCompleted40 Years100 YearsAll28Phase 2United States
333NCT03531060
(ClinicalTrials.gov)
November 8, 201610/4/2018A Clinical Study of IRL790 in Patients With Parkinson's Disease Experiencing Levodopa Induced DyskinesiaA Randomised, Double-blind, Placebo-controlled, Phase Ib Study Evaluating the Safety and Tolerability of IRL790 in Patients With Parkinson's Disease (PD) Experiencing Levodopa (L-Dopa) Induced Dyskinesia (LID).Parkinson DiseaseDrug: IRL790;Drug: PlaceboIntegrative Research Laboratories ABNULLCompleted50 Years85 YearsAll15Phase 1;Phase 2NULL
334EUCTR2016-001762-29-IT
(EUCTR)
08/11/201625/05/2017A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes)A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes) - CTH-201 Parkinson's Disease (PD)
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: APL-130277
Product Code: APL-130277
INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate
Other descriptive name: Apomorphine Hydrocloride
Product Name: APL-130277
Product Code: APL-130277
INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate
Other descriptive name: Apomorphine Hydrocloride
Product Name: APL-130277
Product Code: APL-130277
INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate
Other descriptive name: Apomorphine Hydrocloride
Product Name: APL-130277
Product Code: APL-130277
INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate
Other descriptive name: Apomorphine Hydrocloride
Product Name: APL-130277
Product Code: APL-130277
INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate
Other descriptive name: Apomorphine Hydrocloride
Trade Name: AVALOX - 400 MG COMPRESSE RIVESTITE CON FILM 5 COMPRESSE IN BLISTER PP/AL
Product Name: Avalox
Product Code: n.a.
INN or Proposed INN: MOXIFLOXACINA CLORIDRATO
SUNOVION PHARMACEUTICALSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Italy
335NCT03022799
(ClinicalTrials.gov)
November 201627/12/2016Phase I, KM-819 in Healthy Subjects for Parkinson's DiseaseA First in Human, Randomized, Double-blind, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following Single and Multiple Oral Doses of KM-819 in Healthy Young Adult and Elderly SubjectsParkinson's DiseaseDrug: KM-819;Drug: PlaceboKainos Medicine Inc.NULLCompleted19 Years45 YearsAll88Phase 1Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336NCT02857244
(ClinicalTrials.gov)
November 201625/7/2016A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson PatientsA Multidisciplinary Approach to Manage Gait Difficulty in Parkinson PatientsParkinson's DiseaseDrug: Duloxetine;Drug: Donepezil;Drug: ModafinilUniversity of ChicagoNULLWithdrawn18 Years100 YearsAll0Phase 2United States
337NCT02968433
(ClinicalTrials.gov)
November 201614/11/2016The Stanford Parkinson's Disease Plasma StudyThe Stanford Parkinson's Disease Plasma (SPDP) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Moderate Parkinson's DiseaseParkinson Disease(PD)Drug: Infusions of young plasmaStanford UniversityNULLActive, not recruiting50 Years80 YearsAll15Phase 1United States
338NCT02871427
(ClinicalTrials.gov)
October 20, 201615/8/2016Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior DisorderAn Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior DisorderLewy Body Dementia;Dementia With Lewy Bodies;Parkinson's Disease Dementia;Visual Hallucinations;REM Sleep Behavior DisorderDrug: NelotanserinAxovant Sciences Ltd.NULLTerminated50 YearsN/AAll80Phase 2United States
339NCT02847650
(ClinicalTrials.gov)
October 17, 201625/7/2016Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the DiseaseA 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON'S DISEASEParkinson DiseaseDrug: Placebo;Drug: PF-06649751PfizerNULLTerminated45 Years80 YearsAll57Phase 2United States;France;Germany;Israel
340NCT02728843
(ClinicalTrials.gov)
October 12, 201631/3/2016Study of Parkinson's Early Stage With DeferiproneA Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: Deferiprone;Drug: PlaceboApoPharmaNULLCompleted18 Years80 YearsAll140Phase 2Canada;France;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341EUCTR2016-002391-27-GB
(EUCTR)
07/10/201604/08/2016Opicapone in clinical practice (OPTIPARK)This action will amend the information submitted in this data field for all relevant applications. Please refer to the guidance under the Amendment tab and consider whether further notification to review bodies is required. - Opicapone in clinical practice (OPTIPARK)_V1 Parkinson's disease (PD) patients with wearing-off motor fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
BIAL - Portela & Ca, S.A.NULLNot Recruiting Female: yes
Male: yes
550Phase 4Germany;United Kingdom
342NCT02935842
(ClinicalTrials.gov)
October 1, 201618/8/2016Evaluation of Intensive Language TherapyEffectiveness of High-frequency Specific Speech Therapy on Verbal Fluency Decline and/ or Verbal Apraxia in Patients With Parkinson's Disease With and Without Deep Brain Stimulation (DBS) - a Randomized Controlled Single-blinded TrialParkinson's DiseaseOther: Specific SL-therapy;Other: Rhythmic Balance-Movement Training (rBMT)University Hospital, Basel, SwitzerlandNULLCompleted45 Years80 YearsAll38N/ASwitzerland
343NCT02818777
(ClinicalTrials.gov)
October 20166/5/2016A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's DiseaseA Randomized, Double Blind, Placebo-controlled Crossover Study of Tolerability and Efficacy of Cannabidiol (CBD) on Tremor in Parkinson's DiseaseParkinson's DiseaseDrug: cannabidiolUniversity of Colorado, DenverColorado Department of Public Health and Environment;GW Research LtdCompleted40 Years80 YearsAll13Phase 2United States
344NCT02803749
(ClinicalTrials.gov)
October 201614/6/2016Buspirone in Parkinson's DiseaseThe Tolerability of Buspirone for the Treatment of Anxiety in Parkinson's DiseaseParkinson Disease;AnxietyDrug: Buspirone;Drug: PlaceboUniversity of RochesterMichael J. Fox Foundation for Parkinson's ResearchCompleted18 YearsN/AAll21Phase 2United States
345NCT02538315
(ClinicalTrials.gov)
October 201625/8/2015Using [18F]FDOPA PET/CT to Monitor the Effectiveness of Fetal Dopaminergic Grafts in Parkinson Disease PatientsUsing 3,4-dihydroxy-6-[18F]-Fluoro-l-phenylalanine ( [18F]FDOPA) PET/CT to Monitor the Effectiveness of Fetal Dopaminergic Grafts in Parkinson Disease PatientsParkinson`s DiseaseDrug: [18F]FDOPA PET/CTUniversity of SaskatchewanUniversity of ManitobaRecruiting18 YearsN/AAll30N/ACanada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
346NCT02940912
(ClinicalTrials.gov)
October 201614/10/2016Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's DiseaseDouble Bind Randomized Placebo-controlled Cross-over Study to Evaluate Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's DiseaseParkinson DiseaseDrug: Apomorphine;Drug: PlaceboClinique Beau SoleilNULLRecruiting35 Years90 YearsAll45Phase 4France
347NCT02910102
(ClinicalTrials.gov)
October 201616/9/2016Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With DementiaA Phase 2, Double-blind, Randomized, Placebo-controlled Crossover Study Evaluating the Effect of RVT-101 on Gait and Balance in Subjects With Alzheimer's Disease, Dementia With Lewy Bodies, or Parkinson's Disease DementiaAlzheimer's Disease;Dementia With Lewy Bodies;Parkinson's Disease DementiaDrug: RVT-101 35 mg;Drug: PlaceboAxovant Sciences Ltd.NULLCompleted50 Years89 YearsAll38Phase 2United States
348NCT03462680
(ClinicalTrials.gov)
September 28, 201622/2/2018GPR109A and Parkinson's Disease: Role of Niacin in Outcome MeasuresGPR109A and Parkinson's Disease: Role of Niacin in Outcome MeasuresParkinson's DiseaseDietary Supplement: niacin;Other: placeboVA Office of Research and DevelopmentNULLCompleted35 YearsN/AAll47N/AUnited States
349JPRN-UMIN000024312
2016/09/2025/05/2017Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosisTreatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeksTsukuba International Clinical Pharmacology ClinicNULLComplete: follow-up complete20years-old80years-oldMale and Female12Not selectedJapan
350NCT02688465
(ClinicalTrials.gov)
September 5, 201618/2/2016Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).Parkinson's DiseaseDrug: ApomorphineFondation Ophtalmologique Adolphe de RothschildNULLTerminated18 YearsN/AAll15Phase 4France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
351NCT02815800
(ClinicalTrials.gov)
September 2, 201613/6/2016Efficacy of Ethnodyne Visio in Parkinson's DiseaseParkinson's DiseaseDietary Supplement: ETHNODYNE VISIOUniversity Hospital, Strasbourg, FranceETHNODYNECompleted40 Years75 YearsAll24N/AFrance
352NCT02897063
(ClinicalTrials.gov)
September 20167/9/2016Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic FailureThe Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure Aim 2 of RDCRN (Rare Diseases Clinical Research Network) Project 2Autonomic Failure;Pure Autonomic Failure;Multiple System Atrophy;Parkinson Disease;Orthostatic HypotensionDrug: Droxidopa;Drug: Midodrine;Drug: PlaceboVanderbilt University Medical CenterNULLRecruiting40 Years80 YearsAll34Phase 1United States
353NCT03192046
(ClinicalTrials.gov)
September 201613/6/2017Bracing for Walking in Parkinson's DiseaseImpact of Carbon Fiber AFOs on Gait and Resulting Changes in Quality of Life Across Time in Persons With PDGait Disorders, Neurologic;Parkinson DiseaseDevice: Carbon Fiber Ankle Foot Orthosis (AFO)University of Texas Southwestern Medical CenterAmerican Orthotic and Prosthetic AssociationRecruiting30 Years85 YearsAll16N/AUnited States
354NCT02385500
(ClinicalTrials.gov)
September 20164/3/2015Fesoterodine on Urgency Episodes in Parkinson's Disease PopulationRandomized Cross-Over Study of Fesoterodine on Urgency Episodes in Parkinson's Disease PopulationUrinary Bladder, Overactive;Parkinson DiseaseDrug: Fesoterodine;Drug: PlaceboSir Mortimer B. Davis - Jewish General HospitalNULLTerminated50 Years85 YearsAll5Phase 4Canada
355NCT02939391
(ClinicalTrials.gov)
September 201617/10/2016A Study of KW-6356 in Subjects With Early Parkinson's DiseaseAn Early Phase 2 Study of KW-6356 in Subject With Early Parkinson's DiseaseParkinson's DiseaseDrug: KW-6356;Drug: PlaceboKyowa Kirin Co., Ltd.NULLCompleted20 Years80 YearsAll175Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
356NCT02601586
(ClinicalTrials.gov)
September 201617/8/2015Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's DiseaseEvaluation of the Analgesic Effects of Prolonged-release Oxycodone and of Levodopa, Versus Placebo, on Central Neuropathic Pain in Parkinson's Disease: OXYDOPA TrialParkinson DiseaseDrug: PR Oxycodone;Drug: Levodopa;Drug: Oxycodone Placebo;Drug: Levodopa placeboUniversity Hospital, ToulouseNULLRecruiting40 Years75 YearsAll84Phase 2;Phase 3France
357NCT02782481
(ClinicalTrials.gov)
August 201622/5/2016A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor FluctuationsA Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor FluctuationsParkinson's DiseaseDrug: ND0612;Drug: PlaceboNeuroDerm Ltd.NULLWithdrawn30 Years80 YearsAll0Phase 3Israel
358NCT02365870
(ClinicalTrials.gov)
August 201611/2/2015Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational TreatmentAnxiety in Parkinson's: Use of Quantitative Methods to Guide Rational TreatmentAnxiety Disorders;Parkinson DiseaseDrug: rotigotine transdermal patch;Drug: placeboJohns Hopkins UniversityNational Institute on Aging (NIA)Terminated21 Years89 YearsAll4Phase 4United States
359NCT02452723
(ClinicalTrials.gov)
July 201618/5/2015A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's DiseaseA Single Arm, Open-Label Phase 1 Study to Evaluate the Safety and Tolerability of ISC-hpNSC Injected Into the Striatum and Substantia Nigra of Patients With Parkinson's DiseaseParkinson DiseaseBiological: ISC-hpNSCCyto Therapeutics Pty LimitedNULLActive, not recruiting30 Years70 YearsAll12Phase 1Australia
360NCT02382198
(ClinicalTrials.gov)
July 201621/1/2015Study of Glycopyrrolate for Moderate-to-severe Sialorrhea in Parkinson's DiseaseA Randomized, Placebo-controlled, 2-arm Parallel-group Superiority Phase II Study of GLYCOpyrrolate for Moderate-to-severe Sialorrhea in PARkinson's DiseaseSialorrhea;Parkinson's DiseaseDrug: Glycopyrrolate;Drug: PlaceboOttawa Hospital Research InstituteNULLUnknown status30 YearsN/AAll28Phase 2Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
361NCT02615873
(ClinicalTrials.gov)
July 201623/11/2015A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004An Open-Label,Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects Who Completed Study IN 11 004Parkinson's DiseaseDrug: Accordion Pill™ Carbidopa/LevodopaIntec Pharma Ltd.NULLUnknown status30 Years100 YearsAll460Phase 3United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom
362NCT02785978
(ClinicalTrials.gov)
June 201611/5/2016Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy VolunteersPilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy VolunteersParkinson Disease;Healthy VolunteersDrug: Levodopa acute challenge;Other: Controlled environment tests (series of tasks of everyday life);Other: Standardized scales: MDS-UPDRS (Part II to IV) and RDRS;Device: ActiMyo recording;Other: Diary completionInstitut de Myologie, FranceNULLCompleted18 YearsN/AAll30N/AFrance
363NCT02642393
(ClinicalTrials.gov)
June 201619/12/2015Study of Urate Elevation in Parkinson's Disease, Phase 3A Randomized, Double-blind, Placebo-controlled Trial of Urate-elevating Inosine Treatment to Slow Clinical Decline in Early Parkinson's DiseaseParkinson's DiseaseDrug: Inosine;Drug: PlaceboMichael Alan SchwarzschildThe Parkinson Study Group;Michael J. Fox Foundation for Parkinson's Research;University of Rochester;National Institute of Neurological Disorders and Stroke (NINDS)Completed30 YearsN/AAll298Phase 3United States;Puerto Rico
364NCT02807675
(ClinicalTrials.gov)
June 201617/6/2016A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder)A Phase 1 Study of the Safety and Tolerability of a Single Dose Administration of CVT- 301 (Levodopa Inhalation Powder) When Administered for Early Morning OFF Symptoms in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: CVT-301, LIP;Other: PlaceboAcorda TherapeuticsNULLCompleted30 Years85 YearsAll36Phase 1United States
365NCT02838797
(ClinicalTrials.gov)
June 201616/6/2016RQ-00000010 for Gastroparesis and Constipation in Parkinson's DiseaseRQ-00000010 for Gastroparesis and Constipation in Parkinson's DiseaseParkinson's Disease;Gastroparesis;ConstipationDrug: RQ-00000010;Drug: PlaceboVirginia Commonwealth UniversityMichael J. Fox Foundation for Parkinson's Research;RaQualia Pharma Inc.Completed18 YearsN/AAll51Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
366NCT02762591
(ClinicalTrials.gov)
May 3, 20163/5/2016Expanded Access of Pimavanserin for Patients With PD PsychosisExpanded Access Program of Pimavanserin in Patients With Parkinson's Disease PsychosisParkinson's Disease PsychosisDrug: Pimavanserin tartrateACADIA Pharmaceuticals Inc.NULLApproved for marketing40 YearsN/AAllN/ANULL
367NCT02812147
(ClinicalTrials.gov)
May 201625/5/2016Effect of L-Dihydoxyphenylserine on Locomotion, Postural Stability, and Fall Risk Reduction in Parkinson DiseaseEffect of L-Dihydoxyphenylserine (L-DOPS, Northera) a Central and Peripheral Norepinephrine Agent on Locomotion, Postural Stability (Balance), and Fall Risk Reduction in Parkinson Disease (PD)Parkinson DiseaseDrug: L-DOPS;Drug: PlaceboSt. Joseph's Hospital and Medical Center, PhoenixArizona State University, TempeActive, not recruiting30 Years83 YearsAll20Phase 2United States
368NCT02726386
(ClinicalTrials.gov)
May 201629/3/2016A Clinical Study in Advanced Parkinson's Disease Investigating the Long Term Safety of ND0612 Administered as a Continuous SC InfusionA Multicenter, International, Open-label, Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's DiseaseParkinson's DiseaseDrug: ND0612NeuroDerm Ltd.NULLActive, not recruiting30 YearsN/AAll210Phase 2United States;Austria;Czechia;France;Germany;Israel;Italy;Poland;Spain
369NCT02705755
(ClinicalTrials.gov)
May 20167/3/2016TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)A Phase 2 Study to Assess the Effect of TD-9855 in Subjects With Neurogenic Orthostatic HypotensionNeurogenic Orthostatic Hypotension;Multiple System Atrophy (MSA) With Orthostatic Hypotension;Pure Autonomic Failure;Parkinson Disease;Hypotension, Orthostatic;Orthostatic Hypotension;Pure Autonomic Failure With Orthostatic Hypotension;Parkinson Disease With Orthostatic HypotensionDrug: TD-9855;Drug: PlaceboTheravance BiopharmaNULLCompleted40 YearsN/AAll34Phase 2United States
370NCT02784145
(ClinicalTrials.gov)
May 201617/5/2016Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson DiseaseEffects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson DiseaseParkinson DiseaseDietary Supplement: Resistant starch;Other: Recommendation with regard to nutritionSaarland UniversityNULLCompleted18 YearsN/AAll95N/AGermany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
371NCT03034538
(ClinicalTrials.gov)
April 8, 201625/1/2017An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's DiseaseAn Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's DiseaseParkinson Disease;Parkinsonism;DyskinesiasDrug: ZonegranThe Cooper Health SystemNULLRecruiting18 YearsN/AAll20Phase 4United States
372NCT02764125
(ClinicalTrials.gov)
April 8, 201613/1/2016Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC)Efficacy and Safety of ODM-104 Compared to a Standard Combination (Stalevo®); a Randomized Double-blind, Crossover Proof-of-concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-offParkinson's DiseaseDrug: Stalevo;Drug: levodopa MROrion Corporation, Orion PharmaNULLCompleted30 YearsN/AAll84Phase 2Finland;Germany;Hungary;Latvia
373NCT02775591
(ClinicalTrials.gov)
April 20169/5/2016Effect of Short-term Motilitone Therapy on Health-related Quality of Life in PD Patients With Gastrointestinal SymptomsEffect of Short-term Motilitone Therapy on Health-related Quality of Life in Parkinson's Disease Patients With Gastrointestinal Symptoms: a Multicenter, Double-blind Randomized, Placebo-controlled TrialParkinson Disease;DyspepsiaDrug: DA-9701;Drug: DA-9701 placeboSeoul National University HospitalSamsung Medical Center;Korea University Guro Hospital;Hanyang University;Seoul Veterans Hospital;SMG-SNU Boramae Medical CenterCompleted50 Years80 YearsAll147Phase 4Korea, Republic of
374NCT02729714
(ClinicalTrials.gov)
April 201626/1/2016A Pilot Study of Suvorexant for Insomnia in Parkinson DiseaseA Randomized, Double-Blind, Placebo-Controlled Pilot Study of Suvorexant for Insomnia in Parkinson DiseaseInsomniaDrug: Suvorexant;Drug: PlaceboBurdick, Daniel, M.D.Merck Sharp & Dohme Corp.Recruiting30 Years80 YearsAll20Phase 4United States
375NCT04470037
(ClinicalTrials.gov)
April 201626/5/2020Multidisciplinary Study of Novel NMDA Modulation for Neurodegenerative DisorderMultidisciplinary Study of Novel NMDA Modulation for Neurodegenerative DisorderParkinson's Disease With DementiaDrug: DAAOI-P;Drug: PlaceboChina Medical University HospitalMinistry of Science and Technology, TaiwanRecruiting50 Years90 YearsAll60Phase 2Taiwan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
376NCT03173781
(ClinicalTrials.gov)
April 201610/8/2016Effects of Droxidopa When Measuring Gait Speed, Kyphosis, and Functional Reach in Parkinson's DiseaseEffects of Droxidopa When Measuring Gait Speed, Kyphosis, and Functional Reach in Parkinson's DiseaseParkinson's DiseaseDrug: droxidopa;Drug: PlaceboColorado Springs Neurological AssociatesH. Lundbeck A/SCompleted18 YearsN/AAll21N/AUnited States
377NCT02719496
(ClinicalTrials.gov)
April 201615/3/2016Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's DiseaseProve of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's DiseaseGastrointestinal Disorders in Parkinson's DiseaseDrug: IBEROGASTNantes University HospitalNULLCompleted30 Years80 YearsAll45Phase 2France
378NCT02462603
(ClinicalTrials.gov)
March 31, 201620/5/2015Safety and Biomarker Study of EPI-589 in Parkinson's DiseaseA Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson's Disease SubjectsParkinson's DiseaseDrug: EPI-589PTC TherapeuticsNULLCompleted21 Years75 YearsAll44Phase 2United States;Germany;United Kingdom
379NCT02787590
(ClinicalTrials.gov)
March 21, 201626/5/2016Simvastatin as a Neuroprotective Treatment for Moderate Parkinson's DiseaseSimvastatin as a Neuroprotective Treatment for Parkinson's Disease: a Double-blind, Randomised, Placebo Controlled Futility Study in Patients of Moderate Severity.Parkinson DiseaseDrug: Simvastatin;Drug: Matched Placebo (for Simvastatin)University Hospital Plymouth NHS TrustUniversity of PlymouthActive, not recruiting40 Years90 YearsAll235Phase 2United Kingdom
380NCT02687542
(ClinicalTrials.gov)
March 3, 201629/1/2016Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor FluctuationsA 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASEParkinson DiseaseDrug: Placebo;Drug: PF-06649751 low dose (1 mg QD);Drug: PF-06649751 middle dose 1 (3 mg QD);Drug: PF-06649751 middle dose 2 (7 mg QD);Drug: PF-06649751 high dose (15 mg QD)PfizerNULLTerminated40 Years85 YearsAll108Phase 2United States;Canada;France;Germany;Japan;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
381NCT02994719
(ClinicalTrials.gov)
March 1, 201621/12/2015Gait Analysis in Neurological DiseaseGait Pattern Analysis in Neurological DiseaseParkinson's Disease;Parkinsonian Disorders;Atypical Parkinson Disease;Progressive Supranuclear Palsy;Multiple System Atrophy;Corticobasal Degeneration;Gait, Frontal;Huntington DiseaseDrug: Anti-Parkinson medication;Device: Deep Brain StimulationBeth Israel Deaconess Medical CenterNULLActive, not recruiting18 Years85 YearsAll120United States
382JPRN-UMIN000021236
2016/03/0101/03/2016Investigation in effect of aroma therapy using magnetoencepharography Normal volunteer, Epilepsy patients, Parkinson disease patientsaroma 1
Trans-nasal administration of lavender essence
Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes
After the administration, MEG signals will be recorded for 4 minutes
Also, the subjects were evaluated their moods and awareness.
aroma 2
Trans-nasal administration of grapefruit essence
Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes
After the administration, MEG signals will be recorded for 4 minutes
Also, the subjects were evaluated their moods and awareness.
fragrant
Trans-nasal administration of fragrant
Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes
After the administration, MEG signals will be recorded for 4 minutes
Also, the subjects were evaluated their moods and awareness.
Osaka University Graduate School of Medicine Department of NeurosurgeryNULLComplete: follow-up continuing20years-old80years-oldMale and Female10Phase 1Japan
383NCT02605434
(ClinicalTrials.gov)
March 20165/11/2015A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's PatientsPhase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's PatientsParkinson's DiseaseDrug: Accordion Pill™ Carbidopa/Levodopa;Drug: Sinemet®;Drug: Placebo -AP-CD/LD;Drug: Placebo- SinemetIntec Pharma Ltd.NULLUnknown status30 YearsN/AAll420Phase 3United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom;Hungary
384NCT02708186
(ClinicalTrials.gov)
March 201610/3/2016Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)A Phase 2, Double-blind, Randomized, Placebo-controlled Study of Nelotanserin Versus Placebo in Subjects With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) Who Have REM Sleep Behavior Disorder (RBD)Dementia With Lewy Bodies;REM Sleep Behavior Disorder;Parkinson's Disease DementiaDrug: Nelotanserin;Drug: PlaceboAxovant Sciences Ltd.NULLCompleted50 YearsN/AAll34Phase 2United States
385NCT02668497
(ClinicalTrials.gov)
March 201626/1/2016Kinematic-based BoNT-A Bilateral Upper Limb PD TherapyKinematic Characterization of Upper Limb Parkinson's Disease Tremor for Optimized Botulinum Toxin Type A TherapyParkinson's DiseaseDrug: Botulinum Toxin Type AWestern University, CanadaNULLActive, not recruiting18 Years80 YearsAll50Phase 2Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
386NCT04569656
(ClinicalTrials.gov)
February 2, 201624/9/2020Treatment of Chronic Constipation in Parkinson's DiseasePilot Study for the Evaluation of the Parameters of Activity of a Preparation of PHGG and Sodium Hyaluronate in Chronic Constipation in Patients With Parkinson's DiseaseParkinson DiseaseDrug: hydrolyzed guar gumIRCCS San RaffaeleNULLCompleted18 YearsN/AAll34Phase 2Italy
387NCT02618941
(ClinicalTrials.gov)
February 2, 201625/11/2015Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)Phase IB Follow-up, Controlled, Parallel Group, Single-center Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological and Clinical Activity in Patients Who Have Participated in the AFF008 ProgramParkinson's DiseaseBiological: AFFITOPE® PD01AAffiris AGNULLCompleted40 Years68 YearsAll26Phase 1Austria
388JPRN-UMIN000020288
2016/02/0128/12/2015Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease. Parkinson's diseaseIn this research, the duration of evaluation will be 12 weeks.
Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by istradefylline.
Juntendo University Shizuoka HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female30Not selectedJapan
389NCT02683629
(ClinicalTrials.gov)
February 20168/2/2016Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's DiseaseA Phase IIb, Randomised, Double-blind, Placebo-controlled, Dose-range Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's DiseaseParkinson's DiseaseBiological: NTCELL Implantation;Other: Sham SurgeryLiving Cell TechnologiesStatistecol Consultants LimitedCompleted40 Years65 YearsAll18Phase 2New Zealand
390NCT02641054
(ClinicalTrials.gov)
February 20167/12/2015Efficacy Phase IIa Study of CVXL-0107 in Advanced Parkinson's DiseaseDouble-Blind Randomized Placebo-Controlled Cross-Over Phase IIa Trial to Evaluate Efficacy of CVXL-0107 on Parkinson-Related Symptoms and Levodopa-Induced Dyskinesia in Advanced Parkinson's Disease Patients Using a Levodopa Challenge TestIdiopathic Parkinson DiseaseDrug: CVXL-0107;Drug: Placebo;Drug: LevodopaCleveXel PharmaNULLCompleted40 Years75 YearsAll21Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
391NCT02524405
(ClinicalTrials.gov)
February 201613/8/2015BEAM: Brain-Eye Amyloid Memory StudyThe Brain Eye Amyloid Memory (BEAM) Study: Validation of Ocular Measures as Potential Biomarkers for Early Detection of Brain Amyloid and NeurodegenerationAlzheimer's Disease;Mild Cognitive Impairment;Vascular Cognitive Impairment;Parkinson's Disease;Lewy Body DiseaseOther: Pittsburgh Compound B [11C]-PIBSunnybrook Health Sciences CentreBrain Canada;Weston Brain Institute;GE Healthcare;University Health Network, Toronto;Centre for Addiction and Mental Health;Baycrest;St. Michael's Hospital, Toronto;Kensington Eye InstituteRecruiting50 Years90 YearsAll345Canada
392NCT02655315
(ClinicalTrials.gov)
February 20167/1/2016Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's DiseaseConservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease. European Multicentre, Parallel-group, Placebo-controlled, Randomized Clinical Trial of DeferiproneParkinson DiseaseDrug: Deferiprone;Drug: PlaceboUniversity Hospital, LilleEuropean Commission;ApoPharmaActive, not recruitingN/A80 YearsAll372Phase 2Austria;Czechia;France;Germany;Netherlands;Portugal;Spain;United Kingdom;Czech Republic
393NCT03258294
(ClinicalTrials.gov)
January 13, 201620/8/2017Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's DiseaseEffect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled TrialParkinson's DiseaseDrug: Melatonin(Circadin®);Drug: Placebo Oral TabletKIMJisunKuhnil Pharmaceutical Co., Ltd.Enrolling by invitation55 YearsN/AAll82Phase 4NULL
394NCT02549573
(ClinicalTrials.gov)
January 20169/9/2015Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN®Outpatient Physical Therapy Intervention in Subjects With Parkinson's DiseaseCurrently Using APOKYN®: A Phase IV Study of Outcome Assessments of Physical Therapy in Subjects in an On Versus End-of-Dose-Off Motor StateParkinson's Disease;Motor SymptomsDrug: APOKYN;Behavioral: Physical TherapyUS WorldMeds LLCNULLTerminated18 Years78 YearsAll13Phase 4United States
395NCT02589340
(ClinicalTrials.gov)
January 201623/10/2015Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced DyskinesiaBuspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced DyskinesiaParkinson's Disease;Dyskinesias;Movement DisordersDrug: Buspirone;Drug: PlaceboOregon Health and Science UniversityPortland VA Medical CenterActive, not recruiting18 Years99 YearsAll15Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
396NCT02579473
(ClinicalTrials.gov)
January 201613/10/2015A Study of Weekly Subcutaneous Injections of SER-214 in Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetic (PK) Profile of SER-214A Multi-center, Open-label, Multiple Ascending Dosage-ranging Cohort (MAD) Study in Early, Untreated or Stably Treated Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetics (PK) of Injections of SER-214 Administered Subcutaneously Once a Week for Two Weeks After 0-2 Weeks of Dose TitrationParkinson's DiseaseDrug: SER-214Serina TherapeuticsNULLActive, not recruiting40 Years80 YearsAll20Phase 1United States
397NCT02649608
(ClinicalTrials.gov)
January 20166/1/2016An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease PatientsInterventional, Open-label, Exploratory Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AE04621 and the Active Metabolite Lu AA40326 After Ascending Oral Doses of Lu AE04621 to Patients With Parkinson's DiseaseParkinson DiseaseDrug: 0.04 mg Lu AE04621;Drug: 0.08 mg Lu AE04621;Drug: 0.2 mg Lu AE04621;Drug: 0.4 mg Lu AE04621;Drug: 0.6 mg Lu AE04621;Drug: 0.8 mg Lu AE04621;Drug: 1.0 mg Lu AE04621;Drug: 1.2 mg Lu AE04621H. Lundbeck A/SNULLCompleted45 Years75 YearsAll15Phase 1United States
398NCT02610231
(ClinicalTrials.gov)
December 201513/11/2015Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's DiseaseA Phase 3, Long-term, Open-label Study of Istradefylline in Subjects With Moderate to Severe Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: Istradefylline 20 mg or 40 mgKyowa Hakko Kirin Pharma, Inc.Kyowa Kirin Co., Ltd.Completed30 YearsN/AAll239Phase 3United States;Canada;Czechia;Germany;Israel;Italy;Poland;Serbia;Czech Republic
399NCT02470780
(ClinicalTrials.gov)
December 20154/6/2015Treating Bacterial Overgrowth in Parkinson's DiseaseTreating Bacterial Overgrowth in Parkinson's DiseaseParkinson's Disease;Small Intestinal Bacterial OvergrowthDrug: Rifaximin;Drug: PlaceboUniversity of CincinnatiNULLCompleted18 YearsN/AAll24Phase 2;Phase 3United States
400NCT02616120
(ClinicalTrials.gov)
December 201520/11/2015Effect of SQJZ Herbal Mixtures on Non-motor Symptoms of Parkinson's DiseaseEfficacy and Safety of SQJZ Herbal Mixtures on Non-motor Symptoms in Parkinson's Disease PatientsParkinson's DiseaseDrug: SQJZ herbal mixtures;Drug: PlaceboDongzhimen Hospital, BeijingNULLRecruiting18 Years80 YearsAll240Phase 2China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
401NCT02702102
(ClinicalTrials.gov)
December 20153/3/2016Imaging Inflammation in Patients With Parkinson's Disease Dementia or Dementia With Lewy BodiesImaging Inflammation in Patients With Diffuse Lewy Body DiseaseDiffuse Lewy Body Disease;Dementia With Lewy Bodies;Parkinson's Disease DementiaDrug: 11C-PBR28William Charles KreislNational Institute on Aging (NIA)Completed60 YearsN/AAll5Phase 2United States
402NCT02536976
(ClinicalTrials.gov)
December 201528/8/2015Mirabegron in Parkinson Disease and Impaired CognitionA Clinical Trial of Mirabegron for Overactive Bladder Symptoms in Patients With Parkinson Disease and Impaired CognitionParkinson Disease;Overactive Bladder;Impaired CognitionDrug: mirabegron;Drug: PlaceboHealthPartners InstituteNULLCompleted25 Years80 YearsAll7Phase 4United States
403NCT02565628
(ClinicalTrials.gov)
November 16, 201528/9/2015PF-06669571 In Subjects With Idiopathic Parkinson's DiseaseA Phase 1b, Double Blind, Sponsor Open, Randomized, Parallel, Group Multiple Dose Study Examining The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06669571 In Subjects With Idiopathic Parkinson's Disease.Idiopathic Parkinson's DiseaseDrug: PF-06669571;Drug: PlaceboPfizerNULLCompletedN/AN/AAll20Phase 1United States
404JPRN-jRCTs041180070
04/11/201507/03/2019Trerief Impact in PD PET StudyRandomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - TIPPS Parkinson's disease
Parkinson's disease;D010300
[1] Zonisamide treatment group
Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms.
[2] Zonisamide non-treatment group
Only levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms.
Ouchi YasuomiNULLNot RecruitingNot applicable< 80age oldBoth20N/AJapan
405NCT04110678
(ClinicalTrials.gov)
November 1, 201518/9/2019Tolerance to NeuroEPO in Parkinson DiseaseNasal Administration of the NeuroEPO in Parkinson Disease: Short-term Tolerance Physician Lead TrialParkinson DiseaseDrug: NeuroEPOInternational Center for Neurological Restoration, CubaCenter of Molecular Immunology, Cuba;University of Electronic Science and Technology of ChinaCompleted40 Years70 YearsAll26Phase 1;Phase 2Cuba
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
406NCT02914366
(ClinicalTrials.gov)
November 20158/9/2016Ambroxol as a Treatment for Parkinson's Disease DementiaAmbroxol as a Novel Disease Modifying Treatment for Parkinson's Disease DementiaParkinson's Disease DementiaDrug: Ambroxol;Other: PlaceboLawson Health Research InstituteWeston Brain Institute;University of Western Ontario, Canada;London Health Sciences CentreRecruiting50 YearsN/AAll75Phase 2Canada
407NCT02271503
(ClinicalTrials.gov)
November 201513/10/2014A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's DiseaseA Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's DiseaseParkinson's DiseaseDrug: CD-LD IR;Drug: IPX203 180 mg;Drug: IPX203 270 mg;Drug: Rytary 195 mg;Drug: Rytary 145 mgImpax Laboratories, LLCNULLCompleted40 YearsN/AAll26Phase 2United States
408NCT02758730
(ClinicalTrials.gov)
November 201526/4/2016Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A in PD-GBA PatientsA Randomized, Placebo-controlled, Parallel Group, Patient-blind, Single-center Phase I Pilot Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A, a New Vaccine Against Alpha-synuclein, in Patients With PD-GBAParkinson's DiseaseBiological: AFFITOPE® PD01A + Adjuvant;Biological: Adjuvant without active componentAffiris AGUniversity Hospital TuebingenWithdrawn40 Years80 YearsBoth0Phase 1Germany
409NCT02577523
(ClinicalTrials.gov)
November 20156/10/2015A Clinical Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of ND0612H, a Solution of Levodopa/Carbidopa Administered as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's DiseaseA Multicenter, Parallel-group, Rater-blinded, Randomized Clinical Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of 2 Dosing Regimens of ND0612H, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's DiseaseParkinson's DiseaseDrug: ND0612 (Levodopa/Carbidopa solution)NeuroDerm Ltd.NULLCompleted30 Years80 YearsAll38Phase 2United States;Austria;Israel;Italy
410NCT02632279
(ClinicalTrials.gov)
November 201526/11/2015Tryptophan Depletion in PD Patients Treated With STN DBSTryptophan Depletion in Parkinson's Disease Patients Treated With Deep Brain Stimulation of the Subthalamic Nucleus: Effects on Mood and Motor FunctionsParkinson's DiseaseDietary Supplement: Tryptophan (TRP) depletion;Dietary Supplement: Placebo;Device: Stimulator ON;Device: Stimulator OFFMaastricht University Medical CenterNetherlands Brain FoundationTerminatedN/AN/AAll7N/ANetherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
411NCT02933372
(ClinicalTrials.gov)
October 5, 20156/4/2016Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease Experiments 1 & 2 - Proj #3Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease Experiments 1 & 2 - Projects #3Parkinson's DiseaseDrug: Varenicline;Radiation: [18-Fluorine] Flubatine PET Scan;Other: Evaluation by InvestigatorUniversity of MichiganNULLCompleted45 YearsN/AAll25Phase 2NULL
412JPRN-UMIN000019524
2015/10/0128/10/2015Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) imagesRandomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - Trerief Impact in PD PET Study (TIPPS) Parkinson's DiseaseZonisamide treatment group:

Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms.
Zonisamide non-treatment group:

Only Levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms.
Hamamatsu University School of MedicineNULLComplete: follow-up completeNot applicable80years-oldMale and Female20Not applicableJapan
413NCT02572713
(ClinicalTrials.gov)
October 20157/10/2015Systemic Synuclein Sampling Study (S4)Systemic Synuclein Sampling Study (S4)Parkinson's DiseaseProcedure: Biofluid samplings;Procedure: Tissue samplings;Drug: DaTSCAN™Michael J. Fox Foundation for Parkinson's ResearchIndiana University;University of Iowa;Banner Health;Paracelsus Elena KlinikCompleted40 YearsN/AAll80N/AUnited States;Canada
414NCT02562768
(ClinicalTrials.gov)
September 30, 201528/9/2015A Study of LY3154207 in Healthy Participants and Participants With Parkinson's DiseaseMultiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3154207 in Healthy Subjects and Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: LY3154207;Drug: PlaceboEli Lilly and CompanyNULLCompleted20 YearsN/AAll80Phase 1United States
415NCT02549092
(ClinicalTrials.gov)
September 9, 201511/9/2015A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) THerapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects With Advanced Parkinson's Disease - INSIGHTS StudyAdvanced Parkinson's DiseaseDrug: ABT-SLV187AbbVieNULLActive, not recruiting30 Years99 YearsAll89Phase 3United States;Australia;Canada;Germany;Greece;Italy;Korea, Republic of;Spain;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
416NCT02542696
(ClinicalTrials.gov)
August 31, 20153/9/2015Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's DiseaseAn Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)Parkinson DiseaseDrug: APL-130277SunovionNULLRecruiting18 YearsN/AAll226Phase 3United States;Austria;Canada;France;Germany;Italy;Spain;United Kingdom
417NCT02599753
(ClinicalTrials.gov)
August 20151/11/2015Investigating the Microstructural and Functional Alterations of Brain in Parkinson's Disease PatientsInvestigating the Microstructural and Functional Alterations of Brain in Parkinson's Disease Patients With Neuropsychiatric Disorders by Multimodal NeuroimagingParkinson's DiseaseDrug: 18-FDTBZChang Gung Memorial HospitalNULLCompleted20 Years80 YearsAll35Phase 2Taiwan
418NCT02337751
(ClinicalTrials.gov)
July 10, 20159/1/2015A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease ParticipantsA Multicenter, Open-label, Long-term, Extension, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With LevodopaParkinson's DiseaseDrug: TVP-1012 1mgTakedaNULLCompleted30 Years79 YearsAll198Phase 3Japan
419NCT02459886
(ClinicalTrials.gov)
July 1, 201529/5/2015Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's DiseaseA Phase 1 Randomized, Double-Blinded, Placebo-Controlled Single-Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB054 in Healthy Subjects and Subjects With Early Parkinson's DiseaseParkinson's Disease;HealthyDrug: BIIB054;Drug: PlaceboBiogenNULLCompleted40 Years80 YearsAll66Phase 1United States
420NCT02488265
(ClinicalTrials.gov)
July 1, 201521/5/2015Protocol: Balance Training in Parkinson's DiseaseRandomized Controlled Trial Protocol: Balance Training With Rhythmical Cues to Improve and Maintain Balance Control in Parkinson's DiseaseParkinson DiseaseOther: Balance Training;Other: Screening to prevent fallsUniversity of Sao Paulo General HospitalNULLCompleted50 Years70 YearsAll150N/ABrazil
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
421NCT02453386
(ClinicalTrials.gov)
July 201521/5/2015Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's PatientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-Off (TOZ-PD)Idiopathic Parkinson's DiseaseDrug: tozadenant;Drug: placeboBiotie Therapies Inc.NULLTerminated30 Years80 YearsAll449Phase 3United States;Austria;Canada;Czechia;Germany;Italy;Spain;Czech Republic
422NCT02469090
(ClinicalTrials.gov)
June 18, 20159/6/2015Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's DiseaseRandomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)Parkinson Disease, Off EpisodesDrug: APL-130277;Drug: PlaceboSunovionNULLCompleted18 YearsN/AAll141Phase 3United States;Canada;United Kingdom
423NCT02769793
(ClinicalTrials.gov)
June 20159/5/2016Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ONEfficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in Parkinson's Disease Patients With Delayed ON: a Multicenter Randomized Open-label Cross-over TrialParkinson DiseaseDrug: Levodopa dispersible;Drug: LevodopaSeoul National University HospitalSMG-SNU Boramae Medical Center;Samsung Medical CenterUnknown status31 Years80 YearsAll40Phase 4Korea, Republic of
424NCT02450786
(ClinicalTrials.gov)
June 201514/5/2015Effect of Donepezil on Cognition in Parkinson's Disease With Mild Cognitive Impairment (PD-MCI)Parkinson's DiseaseDrug: DonepezilYonsei UniversityNULLActive, not recruiting40 YearsN/AAll80Phase 2Korea, Republic of
425NCT02230930
(ClinicalTrials.gov)
June 201529/8/2014Treatment of Apomorphine-induced Skin Reactions: a Pilot StudyOpen-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin ReactionsParkinson's Disease;Apomorphine-induced Skin ReactionsDrug: Apomorphine 0.25% (2.5mg/ml);Device: Massage with a spiky ball;Drug: Hydrocortisone cream 1%;Drug: Subcutaneous hydrocortisone 10mgUniversity Medical Center GroningenNULLRecruiting30 YearsN/AAll20Phase 2Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
426JPRN-jRCTs061180028
11/05/201526/02/2019Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetineA double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine Parkinson's disease;D010300The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule.Ando RinaNULLComplete20 years oldNoneBoth50Phase 2Japan
427NCT02448914
(ClinicalTrials.gov)
May 201512/5/2015A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD PatientsA Single Centre, Two-period, Open Label, Randomised, Cross-over Study to Assess Plasma Levodopa, Carbidopa and Entacapone Concentrations After Continuous Infusion of TRIGEL or Duodopa in Patients With Advanced Parkinson´s DiseaseParkinson's DiseaseDrug: TRIGEL;Drug: DuodopaLobSor Pharmaceuticals ABTFS Trial Form SupportCompleted30 YearsN/AAll11Phase 1Sweden
428NCT02452125
(ClinicalTrials.gov)
May 201520/5/2015The Effects of Nicotine Chewing Gum in Parkinson's DiseaseThe Effects of Nicotine Chewing Gum on Acute Low Blood Pressure in Parkinson's DiseaseLow Blood Pressure;Parkinsons DiseaseDietary Supplement: Nicotine gumNew York Institute of TechnologyNULLCompletedN/AN/AAll10N/AUnited States
429NCT02604914
(ClinicalTrials.gov)
May 20153/11/2015A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects1) To Identify the Concentration of CD That Provides Optimal Bioavailability of a Concomitant Fixed Concentration of LD Infused SC Continuously; 2) To Compare the Bioavailability of the Optimal LD/CD Solution to That of LD/CD Intestinal GelParkinson's DiseaseDrug: ND0612;Drug: LCIGNeuroDerm Ltd.Quotient ClinicalCompleted30 Years65 YearsAll36Phase 1United Kingdom
430NCT02390089
(ClinicalTrials.gov)
April 201519/2/2015Cough According to Stimulus Type in PDAirway Protection Deficits According to Stimulus Type in Parkinson's DiseaseParkinson's DiseaseDrug: Capsaicin vapor;Other: fog;Radiation: Videofluoroscopic swallow evaluation;Device: NebulizerUniversity of FloridaNational Institute on Deafness and Other Communication Disorders (NIDCD)Completed50 Years80 YearsAll158Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
431NCT02393027
(ClinicalTrials.gov)
March 20156/3/2015Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999Idiopathic Parkinson DiseaseDrug: [18F] LBT-999 PETUniversity Hospital, ToursNULLTerminated45 Years75 YearsAll16Early Phase 1France
432NCT02242487
(ClinicalTrials.gov)
March 201515/9/2014Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF EpisodesA 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)Idiopathic Parkinson's DiseaseDrug: CVT-301Acorda TherapeuticsNULLCompleted30 Years86 YearsAll325Phase 3United States;Canada;Czechia;Poland;Spain;Czech Republic
433NCT02373072
(ClinicalTrials.gov)
March 201520/2/2015A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's DiseaseA Phase 1, Double Blind, Sponsor Open, Randomized, Placebo-controlled, Single Ascending Dose Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson DiseaseDrug: PF-06649751;Drug: Trimethobenzamide Hydrochloride;Drug: PlaceboPfizerNULLCompletedN/AN/AAll18Phase 1United States;Belgium
434NCT02352363
(ClinicalTrials.gov)
March 201526/1/2015Randomized Safety Study of CVT-301 Compared to an Observational Control GroupA Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort ControlIdiopathic Parkinson's DiseaseDrug: CVT-301;Other: Observational cohortAcorda TherapeuticsNULLCompleted30 Years85 YearsAll408Phase 3United States;Austria;Belgium;Czechia;France;Germany;Hungary;Israel;Netherlands;Poland;Romania;Serbia;Spain;United Kingdom;Czech Republic;Italy
435NCT02696603
(ClinicalTrials.gov)
March 201523/2/2016Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower)Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower)Parkinson Disease;Neurodegenerative Diseases;Movement Disorders;Central Nervous System Diseases;Brain Diseases;Basal Ganglia Diseases;Parkinsonian DisordersBehavioral: Participant self-assessment surveys;Behavioral: Phonation;Behavioral: Gait and balance;Behavioral: Memory;Behavioral: Dexterity;Behavioral: Participant open-response writing;Other: Parkinson mPower mobile applicationSage BionetworksRobert Wood Johnson FoundationRecruiting18 YearsN/AAll20000N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
436NCT02337725
(ClinicalTrials.gov)
February 7, 20159/1/2015A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease PatientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With LevodopaParkinson's DiseaseDrug: TVP-1012;Drug: PlaceboTakedaNULLCompleted30 Years80 YearsAll244Phase 3Japan
437NCT02337764
(ClinicalTrials.gov)
February 3, 20159/1/2015A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease ParticipantsA Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease PatientsParkinson's DiseaseDrug: TVP-1012 1mgTakedaNULLCompleted30 Years79 YearsAll222Phase 3Japan
438NCT02339064
(ClinicalTrials.gov)
February 201531/3/2014Infusion of Apomorphine: Long-term Safety StudyA Phase 3, Open-Label Study of the Safety, Efficacy and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients With Unsatisfactory Control on Available TherapyIdiopathic Parkinson's DiseaseDrug: apomorphine infusionUS WorldMeds LLCNULLActive, not recruiting30 YearsN/AAll99Phase 3United States
439NCT02337738
(ClinicalTrials.gov)
January 27, 20159/1/2015A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease ParticipantsA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients With Wearing OffParkinson's DiseaseDrug: TVP-1012 1mg;Drug: TVP-1012 0.5mg;Drug: PlaceboTakedaNULLCompleted30 Years79 YearsAll404Phase 2;Phase 3Japan
440NCT02258152
(ClinicalTrials.gov)
December 22, 20143/10/2014SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)Parkinson's Disease Dementia (PDD)Drug: SYN120;Drug: PlaceboBiotie Therapies Inc.Michael J. Fox Foundation for Parkinson's Research;Massachusetts General Hospital;Acorda TherapeuticsCompleted50 YearsN/AAll82Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
441NCT02480803
(ClinicalTrials.gov)
December 20144/5/2015INfusion VErsus STimulation in Parkinson's DiseaseTreatment in Advanced Parkinson's Disease: Continuous Intrajejunal Levodopa INfusion VErsus Deep Brain STimulationParkinson's DiseaseDrug: Continuous intrajejunal infusion of levodopa-carbidopa;Device: deep brain stimulationAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)ZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruiting18 YearsN/AAll66Phase 4Netherlands
442NCT03116308
(ClinicalTrials.gov)
November 21, 201412/4/2017Effect of Food on OpicaponeEffect of Food on Opicapone Bioavailability and Pharmacodynamics in Healthy SubjectsParkinson DiseaseDrug: Opicapone (OPC)Bial - Portela C S.A.NULLCompleted18 Years45 YearsAll28Phase 1NULL
443ChiCTR-DDD-17010794
2014-11-082017-03-05The study on early diagnosis of Parkinson 's disease by transcranial ultrasonographythe study on early diagnosis of Parkinson 's disease by transcranial ultrasonography Parkinson's DiseaseGold Standard:Diagnosis of Parkinson disease needs to meet 3 or more: unilateral onset;resting tremor;progressive course; long term asymmetry, the most obvious symptoms is the onset side; a good response to levodopa (70% ~ 100%); levodopa induced chorea; a reaction of levodopa lasts 5 years or more; clinical course last;Index test:Laboratory apparatus
As shown in Figure 1, The ultrasound equipment, Philips IE33-BOMJH1 color Doppler ultrasonography, Model IE-ELite, with 2-4MHz phased array probe (S5-1 probe) was used for TCS to examine SN in our study.
Transcranial ultrasound study
Ultrasonography through temporal window, alon;
Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union HospitalNULLCompleted3684BothTarget condition:135;Difficult condition:0China
444NCT02278588
(ClinicalTrials.gov)
November 201428/10/2014Effect of 2.5 Years of Rasagiline Therapy on Progression of Cognitive Biomarkers Assessed by MRI in Parkinson's Disease.Effect of 2.5 Years of Rasagiline Therapy on Progression of Cognitive Biomarkers Assessed by MRI in Parkinson's Disease.Parkinson's DiseaseDrug: RasagilineThomas GuttusoNULLCompletedN/AN/AAll45United States
445NCT02240030
(ClinicalTrials.gov)
November 201411/9/2014Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF EpisodesA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)Idiopathic Parkinson's DiseaseDrug: CVT-301 Low Dose;Drug: CVT-301 High Dose;Other: PlaceboAcorda TherapeuticsNULLCompleted30 Years85 YearsAll351Phase 3United States;Canada;Czechia;Poland;Spain;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
446NCT02168842
(ClinicalTrials.gov)
November 201418/6/2014Efficacy of Isradipine in Early Parkinson DiseasePhase 3 Double-blind Placebo-controlled Parallel Group Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson DiseaseParkinson DiseaseDrug: Isradipine;Drug: Placebo (for Isradipine)University of RochesterNational Institute of Neurological Disorders and Stroke (NINDS);Michael J. Fox Foundation for Parkinson's Research;The Parkinson Study GroupCompleted30 YearsN/AAll336Phase 3United States;Canada
447NCT02274766
(ClinicalTrials.gov)
October 201422/10/2014Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced DyskinesiaADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)Dyskinesia;Levodopa-Induced Dyskinesia (LID);Parkinson's Disease (PD)Drug: ADS-5102;Other: PlaceboAdamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll77Phase 3United States;Austria;France;Germany;Spain
448NCT02224664
(ClinicalTrials.gov)
October 201415/8/2014Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson`s DiseaseA Phase 1b, 2-period, Open Label, Multicenter, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Parkinson`s Disease And Motor FluctuationsParkinson`s DiseaseDrug: PF-06649751PfizerNULLCompleted30 Years80 YearsAll50Phase 1United States;Belgium
449NCT02183519
(ClinicalTrials.gov)
October 20142/7/2014Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's DiseaseRespiratory Kinematics of Reflex and Voluntary Cough in Healthy Older Adults and Parkinson's DiseaseCough;Parkinson's DiseaseDrug: Capsaicin;Other: Voluntary cough testUniversity of FloridaNULLCompleted55 Years85 YearsAll44Phase 1;Phase 2United States
450JPRN-UMIN000016893
2014/09/2201/04/2015A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression.A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression. - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine. PD patientsThe treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule.
The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule.
Ehime University HospitalDept. of Clinical pharmacology and NeurologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female50Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
451NCT02236260
(ClinicalTrials.gov)
September 3, 201429/8/2014Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain StimulationEvaluation of the Benefit Provided by the Addition of Acupunctural Analgesia With Electrostimulation to Conventional Local Anesthesia Compared to Conventional Local Anesthesia Alone in Surgery of Deep Brain Stimulation for Movement Disorders.Parkinson's DiseaseProcedure: Electroacupuncture;Drug: Local Anesthesia (lidocaine hydrochloride)Nantes University HospitalNULLCompleted18 Years74 YearsAll20N/AFrance
452NCT03151460
(ClinicalTrials.gov)
September 20149/5/2017Dopaminergic Modulation of Declarative MemoryDopaminergic Modulation of Declarative MemoryParkinson's DiseaseDrug: Dopamine AgentI.R.C.C.S. Fondazione Santa LuciaNULLCompletedN/AN/AAll40Phase 4Italy
453NCT02212678
(ClinicalTrials.gov)
September 20144/8/2014Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's DiseaseRepeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's DiseaseParkinson DiseaseDrug: N-acetylcysteine capsuleUniversity of MinnesotaParkinson's Disease Society of the United KingdomCompleted18 YearsN/AAll8Phase 2United States
454NCT02230904
(ClinicalTrials.gov)
September 201429/8/2014A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's DiseaseA Multicenter, Randomized, Double-blind, 2-way Cross-over Study to Compare the Adhesiveness of 2 Different Rotigotine Patch Formulations in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: Rotigotine (Test product PR 2.3.1);Drug: Rotigotine (Reference product PR 2.1.1)UCB BIOSCIENCES GmbHPharmaceutical Health Sciences;Bracket GlobalCompleted18 YearsN/AAll57Phase 1Germany
455NCT02228590
(ClinicalTrials.gov)
August 31, 201426/8/2014A Study to Examine APL-130277 in Patients With Parkinson's DiseaseA Phase 2 Study to Examine the Safety, Tolerability and Efficacy of APL-130277 in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: APL-130277SunovionNULLCompleted18 Years80 YearsAll20Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
456NCT02153645
(ClinicalTrials.gov)
August 18, 201430/5/2014Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID.A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced DyskinesiasParkinson's Disease;Levodopa Induced Dyskinesias (LID)Drug: 240mg Amantadine HCl ER tablets;Drug: Placebo tablets;Drug: 320mg Amantadine HCl ER tabletsOsmotica Pharmaceutical US LLCNULLTerminated30 Years85 YearsAll87Phase 3United States;Canada;France;Germany;Spain
457NCT02096601
(ClinicalTrials.gov)
August 201418/3/2014A Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease PatientsA Phase I/II Pharmacokinetic (PK) Study of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD), Delivered as a Continuous Subcutaneous in Parkinson's Disease (PD) Patients Treated With LDParkinson's DiseaseDrug: Levodopa and carbidopa SC solution;Drug: Oral levodopa and carbidopaNeuroDerm Ltd.Michael J. Fox Foundation for Parkinson's ResearchCompleted30 Years80 YearsAll16Phase 1;Phase 2United States;Israel
458NCT02236065
(ClinicalTrials.gov)
August 20148/9/2014Combination Therapy of Cord Blood and G-CSF for Patients With Brain Injury or Neurodegenerative DisordersA Pilot Study of Combination Therapy of Allogeneic Umbilical Cord Blood and Granulocyte-colony Stimulating Factor for Patients With Brain Injury or Neurodegenerative DisordersBrain Injury;Cerebral Palsy;Amyotrophic Lateral Sclerosis;Parkinson's DiseaseProcedure: Umbilical cord blood therapy;Biological: FilgrastimMinYoung Kim, M.D.NULLCompleted19 Years75 YearsAll10N/AKorea, Republic of
459NCT02153632
(ClinicalTrials.gov)
July 30, 201430/5/2014Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LIDA Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced DyskinesiasParkinson's Disease;Levodopa Induced Dyskinesia (LID)Drug: amantadine HCl ER;Drug: PlaceboOsmotica Pharmaceutical US LLCNULLTerminated30 Years85 YearsAll135Phase 3United States;Canada;France;Germany;Spain
460NCT02206620
(ClinicalTrials.gov)
July 201429/7/2014Effects of Cholinergic Augmentation on Measures of Balance and GaitEffects of Cholinergic Augmentation on Measures of Balance and GaitParkinson's DiseaseDrug: DonepezilOregon Health and Science UniversityMichael J. Fox Foundation for Parkinson's ResearchCompleted30 YearsN/AAll49Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
461NCT02202551
(ClinicalTrials.gov)
July 201425/7/2014Open-Label Safety Study of ADS-5102 in PD Patients With LIDOpen-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)Dyskinesia;Levodopa Induced Dyskinesia (LID);Parkinson's Disease (PD)Drug: ADS-5102Adamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll223Phase 3United States;Austria;Canada;France;Germany;Spain
462NCT02136914
(ClinicalTrials.gov)
May 20149/5/2014ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)Efficacy and Safety of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease Patients (EASE LID Study)Dyskinesia;Levodopa Induced Dyskinesia (LID);Parkinson's DiseaseDrug: ADS-5102;Other: PlaceboAdamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll126Phase 3United States;Canada
463NCT02780895
(ClinicalTrials.gov)
May 201412/5/2016Parkinsonian Brain Repair Using Human Stem CellsHuman OK99 Allogeneic Stem Cell Transplantation for Patients With Severe Parkinson's DiseaseIdiopathic Parkinson DiseaseDrug: Human Stem CellsCelavie Bioscences, LLCHospital Angeles del PedregalActive, not recruiting18 Years75 YearsBoth8Phase 1Mexico
464NCT02046447
(ClinicalTrials.gov)
May 201423/1/2014Neuroimaging of DystoniaNeuroimaging of Dystonia: The Bachmann-Strauss Dystonia and Parkinson Disease Center of Excellence at the University of FloridaPrimary Cervical Dystonia;DYT 1 DystoniaDrug: Primary Cervical Dystonia (Trihexyphenidyl);Other: Controls Primary Cervical Dystonia (Trihexyphenidyl);Other: DYT 1 Dystonia (Healthy Control);Other: DYT 1 DystoniaUniversity of FloridaBachmann Strauss Dystonia & Parkinson Foundation, Inc.Completed7 Years70 YearsAll20N/AUnited States
465NCT03314597
(ClinicalTrials.gov)
April 2, 201415/10/2017Instrumental or Physical-Exercise Rehabilitation of Balance in Parkinson's Disease? (IPER-PD)Instrumental or Physical-exercise Rehabilitation of Balance Improve Both Balance and Gait in Parkinson's Disease.Parkinson's Disease;RehabilitationOther: Balance exercise;Other: Mobile platform exerciseUniversity of PaviaFondazione Salvatore MaugeriCompleted50 Years85 YearsAll38N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
466NCT01738178
(ClinicalTrials.gov)
April 201428/11/2012Caffeine as a Therapy for Parkinson's DiseaseCaffeine as a Therapeutic Agent in Parkinson's DiseaseParkinson's DiseaseDrug: Caffeine;Drug: PlaceboMcGill University Health CenterPontifícia Universidade Católica do Paraná;University of Calgary;University of Newfoundland and Eastern Health;University Health Network, Toronto;UBC Hospital;Movement Disorder Clinic - Deer Lodge Centre;The Ottawa HospitalCompleted45 Years75 YearsAll119Phase 3Brazil;Canada
467NCT02111122
(ClinicalTrials.gov)
April 20148/4/2014Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's DiseaseA Phase II, Prospective, Randomized, Double-blind, Crossover Placebo-controlled Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's DiseaseSleep-wake Disturbances in Motor-phase Parkinson's DiseaseDrug: Sodium Oxybate;Drug: PlaceboChristian BaumannNULLCompleted18 Years90 YearsAll16Phase 2Switzerland
468NCT02091739
(ClinicalTrials.gov)
April 201418/3/2014Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological ConditionsProspective, Randomized, Double-blind, Placebo-controlled, Parallel-group Multicenter Study, With an Extension Period of Dose-blinded Active Treatment, to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 in Treating Chronic Troublesome Sialorrhea in Various Neurological ConditionsChronic Troublesome Sialorrhea;Parkinson's Disease;Post-stroke;Traumatic Brain InjuryDrug: IncobotulinumtoxinA (100 Units);Drug: IncobotulinumtoxinA (75 Units);Drug: PlaceboMerz Pharmaceuticals GmbHNULLCompleted18 Years80 YearsAll184Phase 3Germany;Poland;United States
469NCT02082249
(ClinicalTrials.gov)
March 10, 201414/2/2014An Extension Study to Assess the Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian MedicationsAn Open-Label Three-Part Extension Study Assessing Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian MedicationsAdvanced Parkinson's DiseaseDrug: ABT-SLV187AbbVieNULLCompleted30 Years99 YearsAll23Phase 3Japan;Korea, Republic of;Taiwan
470NCT02006121
(ClinicalTrials.gov)
March 3, 201422/11/2013Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's DiseaseMulticentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical TreatmentParkinson's DiseaseDrug: Apomorphine hydrochloride;Drug: PlaceboBritannia Pharmaceuticals Ltd.NULLCompleted30 YearsN/AAll107Phase 3Austria;Denmark;France;Germany;Netherlands;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
471NCT02445651
(ClinicalTrials.gov)
March 201423/1/2015Physiological Effects of Nutritional Support in Patients With Parkinson's DiseasePhysiological Effects of Nutritional Support in Patients With Parkinson's DiseaseParkinson Disease;Idiopathic Parkinson DiseaseDietary Supplement: Intravenous and Oral n-acetyl cysteineThomas Jefferson UniversityNULLActive, not recruiting30 Years80 YearsAll65N/AUnited States
472NCT02305017
(ClinicalTrials.gov)
March 201428/11/2014Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy VolunteersEffect of Paracetamol on Opicapone Pharmacokinetics in Healthy VolunteersParkinson's DiseaseDrug: BIA 9-1067;Drug: ParacetamolBial - Portela C S.A.NULLCompleted18 Years45 YearsAll28Phase 1NULL
473NCT02092181
(ClinicalTrials.gov)
March 20147/3/2014A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO)A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease. (MAESTRO)Parkinsons DiseaseDrug: Mirabegron;Drug: PlaceboDaniel Burdick, MDAstellas Pharma US, Inc.Completed30 Years85 YearsAll30Phase 4United States
474NCT02103894
(ClinicalTrials.gov)
February 201412/2/2014Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy SubjectsEvaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Clinically Diagnosed Tauopathies in Comparison to Healthy SubjectsAlzheimer's Disease (AD);Parkinson's Disease (PD);Chronic Traumatic Encephalopathy (CTE);Progressive Supranuclear Palsy (PSP);Frontal Temporal Dementia (FTD);Pick's Disease;TauopathiesDrug: [18F]T807 ([18F]MNI-777)Molecular NeuroImagingInstitute for Neurodegenerative DisordersCompleted18 Years85 YearsBoth16Phase 1United States
475NCT02305316
(ClinicalTrials.gov)
February 201428/11/2014Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of OpicaponeSingle-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone in Healthy VolunteersParkinson DiseaseDrug: BIA 9-1067 non-micronized;Drug: BIA 9-1067 micronizedBial - Portela C S.A.NULLCompleted18 Years45 YearsAll28Phase 1NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
476NCT02064166
(ClinicalTrials.gov)
February 201413/2/2014Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.A Double-blinded Placebo-controlled Single-center Study to Evaluate the Efficacy of Intranasal Insulin 40 International Units Day as Treatment for Subjects With Parkinson Disease and Multiple System AtrophyParkinson Disease;Multiple System AtrophyDrug: Intranasal InsulinPeter NovakNULLCompleted18 YearsN/AAll15Phase 2United States
477NCT02046434
(ClinicalTrials.gov)
January 201423/1/2014Phenylbutyrate Response as a Biomarker for Alpha-synuclein Clearance From the BrainPhenylbutyrate Response As a Biomarker for Alpha-Synuclein Clearance From BrainParkinson's DiseaseDrug: Glycerol PhenylbutyrateUniversity of Colorado, DenverNULLActive, not recruiting21 Years80 YearsAll40Phase 1United States
478NCT02018406
(ClinicalTrials.gov)
December 201330/10/2013Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain InjuryNeurological Diseases;Ischemic Stroke;Hemorrhagic Stroke;Cerebral Palsy;Atypical Parkinson DiseaseDrug: Combination injection of EPO and G-CSF;Drug: Injection of normal salineYonsei UniversityNULLActive, not recruiting20 YearsN/AAll16Phase 1;Phase 2Korea, Republic of
479NCT01968460
(ClinicalTrials.gov)
December 201315/10/2013Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's DiseaseA Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's DiseaseParkinson's DiseaseDrug: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),;Drug: Placebo;Drug: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),Pharma Two B Ltd.NULLCompleted35 Years75 YearsAll149Phase 2;Phase 3United States;Israel
480NCT02108704
(ClinicalTrials.gov)
December 20134/4/2014Helicobacter Pylori Eradication Study in Parkinson's DiseaseHelicobacter Pylori Eradication in Parkinson's Disease: A Double-blind Randomised Placebo Controlled TrialParkinson's Disease;Helicobacter Pylori InfectionDrug: Helicobacter pylori eradication therapy;Drug: PlaceboUniversity of MalayaNULLCompleted18 YearsN/AAll75N/AMalaysia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
481NCT04044547
(ClinicalTrials.gov)
November 22, 201330/7/2019A Study of LY03003 in Patients With Early-stage Parkinson's DiseaseA Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular InjectionsParkinson DiseaseDrug: Rotigotine, extended-release microspheres;Drug: Placebo, extended-release microspheresLuye Pharma Group Ltd.Beijing Bozhiyin T&S Co., Ltd.Completed18 Years75 YearsAll60Phase 1NULL
482NCT01927055
(ClinicalTrials.gov)
November 201316/8/2013A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa TherapyA Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa TherapySymptomatic Neurogenic Orthostatic Hypotension;Parkinson's Disease;Multiple Systems Atrophy;Pure Autonomic Failure;Dopamine Beta Hydroxylase DeficiencyDrug: Droxidopa;Drug: PlaceboChelsea TherapeuticsNULLTerminated18 YearsN/AAll61Phase 3United States
483NCT01856738
(ClinicalTrials.gov)
November 201314/5/2013Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson&Apos;s DiseaseCholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson's Disease:a Multi-center Placebo-controlled Trial.Parkinson's DiseaseDrug: Rivastigmine;Drug: Placebo (for rivastigmine)VU University Medical CenterAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA);Atrium Medical Center;University Medical Center Groningen;Leiden University Medical Center;University Medical Center Nijmegen;International Parkinson Fonds Germany GmbH;ZonMw: The Netherlands Organisation for Health Research and DevelopmentTerminated40 YearsN/AAll91Phase 4Netherlands
484NCT01973543
(ClinicalTrials.gov)
October 201325/10/2013Safety Study of AADC Gene Therapy (VY-AADC01) for Parkinson's DiseaseAn Open-label Safety and Efficacy Study of VY-AADC01 Administered by MRI-Guided Convective Infusion Into the Putamen of Subjects With Parkinson's Disease With Fluctuating Responses to LevodopaParkinson's DiseaseBiological: VY-AADC01Neurocrine BiosciencesUniversity of California, San Francisco;Veristat, Inc.;Feinstein Institute for Medical Research;Oregon Health and Science University;Voyager TherapeuticsCompleted40 Years70 YearsAll15Phase 1United States
485NCT01960842
(ClinicalTrials.gov)
October 20139/10/2013A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian MedicationsAn Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian MedicationAdvanced Parkinson's DiseaseDrug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVieNULLCompleted30 YearsN/AAll31Phase 3Japan;Korea, Republic of;Taiwan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
486NCT01968031
(ClinicalTrials.gov)
October 201318/10/2013A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's DiseaseA Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: Istradefylline 40 mg;Drug: Istradefylline 20 mg;Drug: PlaceboKyowa Hakko Kirin Pharma, Inc.Kyowa Kirin Co., Ltd.Completed30 YearsN/AAll613Phase 3United States;Canada;Czechia;Germany;Israel;Italy;Poland;Serbia;Czech Republic
487NCT01882010
(ClinicalTrials.gov)
September 201313/6/2013Leukine (Sargramostim) for Parkinson's DiseaseLeukine (Sargramostim) for Parkinson's DiseaseParkinson's DiseaseProcedure: blood draw;Procedure: physical exam and UPDRS part III assessment;Procedure: MEG;Drug: sargramostim;Drug: placebo;Behavioral: physical exam and UPDRS part III assessment;Procedure: Motion AnalysisHoward Gendelman, MDSanofi;National Institute of Neurological Disorders and Stroke (NINDS);UNeMed;Nebraska Neuroscience AllianceCompleted35 Years85 YearsBoth37Phase 1United States
488NCT01929317
(ClinicalTrials.gov)
August 28, 201322/8/2013A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients.A Study ROP116991, Clinical Evaluation of 18 to 24mg/Day Ropinirole CR for Parkinson's Disease.Parkinson DiseaseDrug: Ropinirole CR 2mg tablet;Drug: Ropinirole CR 8mg tablet;Drug: Ropinirole CR matching Placebo tabletGlaxoSmithKlineNULLTerminated20 YearsN/AAll81Phase 3Japan
489JPRN-UMIN000011111
2013/07/1615/07/2013Spinal blood flow and metabolism in neurological diseases motor neuron disease including ALS, multiple sclerosis, stroke, Parkinson disease, spinocerebellar degeneration, multiple system atrophyPET scan study with 11C-flumazenil
PET scan study with 18F- FDG
PET scan study with 15O-H2O
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesNULLRecruiting20years-oldNot applicableMale and Female70Not applicableJapan
490NCT01767129
(ClinicalTrials.gov)
July 20139/1/2013Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease PatientsA Phase 2a, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients.Dyskinesia;Parkinson's DiseaseDrug: AVP-923-45;Drug: PlaceboAvanir PharmaceuticalsMichael J. Fox Foundation for Parkinson's ResearchCompleted30 Years80 YearsAll14Phase 2United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
491NCT02263235
(ClinicalTrials.gov)
June 201318/9/2014In Vivo Alzheimer ProteomicsUse of Targeted Quantitative Proteomics and Metabolic Labelling With Stable Isotopes for the Diagnosis and the Investigation of Neurological Disorders and in Particular Alzheimer DiseaseProbable Alzheimer Disease;Parkinson Disease;Neurological Disease Without Cognitive Degradation;Brain Trauma;Acute HydrocephalyBiological: administration of stable isotope-labelled leucine-;Other: collection of CSF, blood, urine, salivaUniversity Hospital, MontpellierAssistance Publique - Hôpitaux de Paris;University Hospital, Clermont-Ferrand;International Atomic Energy AgencyRecruiting55 Years85 YearsBoth110N/AFrance
492NCT01850381
(ClinicalTrials.gov)
June 20137/5/2013Phase 2A Study of GM 608 in Mild to Moderate Parkinson DiseaseGM 608 in A Phase IIA Pilot Double-blinded, Randomized, Placebo Controlled Trial in Mild to Moderate Parkinson DiseaseParkinson's DiseaseDrug: GM608;Drug: Placebo ComparatorGenervon Biopharmaceuticals, LLCColumbia UniversityCompleted30 YearsN/AAll6Phase 2United States
493JPRN-UMIN000010752
2013/05/1717/05/2013A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia. Parkinson's diseasedonepezilKansai Medical UniversityNULLComplete: follow-up completeNot applicableNot applicableMale and Female50Not selectedJapan
494NCT03022201
(ClinicalTrials.gov)
May 201323/11/2016Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's DiseaseTherapeutic Efficacy of DA-9701 on Gastric Motility in Patients With Parkinson's Disease Evaluated by Magnetic Resonance Imaging: A Randomized Controlled, Double-Blind, Non-Inferiority TrialParkinson's Disease,IdiopathicDrug: DA-9701;Drug: Domperidone;Drug: Placebo domperidone;Drug: Placebo DA-9701Seoul National University HospitalNULLCompleted20 Years80 YearsAll40Phase 4Korea, Republic of
495NCT02473562
(ClinicalTrials.gov)
May 201312/6/2015Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's DiseaseVarenicline, a Partial Nicotinic Receptor Agonist for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease: a Placebo-controlled Cross-over Pilot StudyParkinson's DiseaseDrug: Varenicline;Drug: Placebo (for varenicline)VU University Medical CenterCentre for Human Drug Research, NetherlandsTerminatedN/AN/AAll22Phase 4Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
496NCT01851850
(ClinicalTrials.gov)
May 20131/5/2013Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical TrialContinue Providing Care for Patient Who Participated in the BIA 9-1067-302 Clinical TrialParkinson DiseaseDrug: OpicaponeRabin Medical CenterNULLCompleted30 Years80 YearsAll1Phase 3Israel
497NCT01777555
(ClinicalTrials.gov)
April 201323/1/2013Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF EpisodesA Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)Idiopathic Parkinson's DiseaseDrug: CVT-301;Drug: PlaceboAcorda TherapeuticsNULLCompleted30 Years80 YearsAll89Phase 2United States;Italy;Serbia;United Kingdom
498NCT02005029
(ClinicalTrials.gov)
April 201318/9/2013Erythromycin in Parkinson's DiseaseErythromycin in Parkinson's Disease: A Pilot Study of Its Effects on Levodopa Pharmacokinetics and PharmacodynamicsParkinson's Disease;LevodopaDrug: Erythromycin;Drug: placeboVirginia Commonwealth UniversityNULLCompleted18 Years80 YearsAll18N/AUnited States
499NCT04627155
(ClinicalTrials.gov)
March 15, 20135/11/2020A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Human Tolerance and Kinetics of LY03003 By Single Intramuscular InjectionParkinson DiseaseDrug: LY03003Luye Pharma Group Ltd.NULLCompleted18 Years45 YearsAll20Phase 1NULL
500NCT01736176
(ClinicalTrials.gov)
March 201327/11/2012A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's DiseaseAn Open-Label, Two Part, Multicenter Study to Assess the Safety and Efficacy of Levodopa-Carbidopa Intestinal Gel (LCIG) for the Treatment of Non-Motor Symptoms in Subjects With Advanced Parkinson's DiseaseAdvanced Parkinson's DiseaseDrug: Levodopa-Carbidopa Intestinal Gel;Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J);Drug: Levodopa-carbidopa Immediate Release (LC-IR) TabletsAbbVie (prior sponsor, Abbott)NULLCompleted30 YearsN/AAll39Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
501NCT01789047
(ClinicalTrials.gov)
March 20137/2/2013Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's DiseaseTopiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's DiseaseIdiopathic Parkinson's Disease;Drug Induced DyskinesiaDrug: Topiramate;Drug: Placebo;Drug: AmantadineRush University Medical CenterMichael J. Fox Foundation for Parkinson's ResearchTerminated30 Years90 YearsAll42Phase 2United States
502NCT02059733
(ClinicalTrials.gov)
February 20137/2/2014Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and ParkinsonismDeveloping a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism by 18F-DTBZ PETParkinson's DiseaseDrug: 18F-DTBZChang Gung Memorial HospitalNULLCompleted20 Years80 YearsAll72Phase 2Taiwan
503NCT01782222
(ClinicalTrials.gov)
February 201330/1/2013Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And ApathyA Multicenter, Multinational, Double-Blind, Placebo-Controlled, 3-Arm, Phase 4 Study To Evaluate The Efficacy Of Rotigotine On Parkinson's Disease-Associated Apathy, Motor Symptoms, And MoodIdiopathic Parkinson's DiseaseDrug: Rotigotine;Other: PlaceboUCB BIOSCIENCES GmbHNULLCompleted18 YearsN/AAll122Phase 4United States;Austria;Hungary;Poland;Slovakia;Slovenia;Spain
504NCT03651856
(ClinicalTrials.gov)
January 20132/7/2018Atomoxetine for Freezing of Gait in Parkinson's DiseaseA Pilot Study of Atomoxetine for Freezing of Gait in Parkinson's DiseaseParkinson's Disease;Freezing of GaitDrug: ATM FOG in PDMedical University of South CarolinaNULLCompleted18 Years80 YearsAll10Phase 3United States
505NCT01014858
(ClinicalTrials.gov)
January 201316/11/2009Multi-centre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated With Parkinson's DiseaseMulti-centre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated With Parkinson's DiseaseParkinson's DiseaseDrug: DonepezilNewcastle-upon-Tyne Hospitals NHS TrustUniversity of Newcastle Upon-Tyne;University of Cambridge;University of Manchester;University of Birmingham;Bangor University;London School of Economics and Political Science;University College, London;Lancashire Care NHS Foundation Trust;Newcastle University;King's College LondonTerminated18 YearsN/AAll64Phase 3United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
506NCT01770145
(ClinicalTrials.gov)
December 20127/1/2013Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT)A Phase 4, Open-Label, Efficacy and Safety Study of Apokyn® for Rapid and Reliable Improvement of Motor Symptoms in Parkinson Disease Subjects With Delayed Onset of L-Dopa ActionParkinson's Disease;Motor Symptoms;Akinesia;Hypomobility;Delayed Levodopa OnsetDrug: APOKYN;Drug: L-dopa;Drug: TrimethobenzamideUS WorldMeds LLCNULLCompleted18 YearsN/AAll127Phase 4United States
507NCT01741701
(ClinicalTrials.gov)
December 20121/12/2012A Pilot Study of Oxaloacetate in Subjects With Treated PDA Pilot Double-Blind, Parallel Group, Placebo Controlled Study of Oxaloacetate in Subjects With Treated Parkinson's Disease (PD)Parkinson's DiseaseDrug: Oxaloacetate (OAA);Drug: PlaceboUniversity of Kansas Medical CenterTerra Biological LLCCompleted30 YearsN/AAll33Phase 2;Phase 3United States
508NCT01738191
(ClinicalTrials.gov)
November 201228/11/2012Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)Parkinson's Disease;Cognitive ImpairmentDrug: Atomoxetine;Drug: PlaceboMedical University of South CarolinaMichael J. Fox Foundation for Parkinson's ResearchCompleted35 Years75 YearsAll30Phase 2United States
509NCT01721460
(ClinicalTrials.gov)
November 201230/10/2012Effects of Dexmedetomidine on Activity in the Subthalamic NucleusEffects of Dexmedetomidine on Neuronal Activity in the Subthalamic Nucleus During Deep Brain Stimulation (DBS) Electrode Implantation SurgeryParkinson's Disease;Deep Brain Stimulation SurgeryDrug: DexmedetomidineUniversity of Wisconsin, MadisonNULLCompleted18 Years85 YearsAll6Phase 4United States
510NCT01723228
(ClinicalTrials.gov)
November 20125/11/2012Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's DiseaseA 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: Rasagiline;Drug: PlaceboTeva Branded Pharmaceutical Products, R&D Inc.NULLCompleted45 Years80 YearsAll170Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
511NCT01744496
(ClinicalTrials.gov)
November 20125/12/2012Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated PainA Multicenter, Multinational, Double-Blind, Placebo-Controlled, 2-Arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated PainAdvanced Idiopathic Parkinson's DiseaseDrug: Rotigotine;Drug: PlaceboUCB BIOSCIENCES GmbHNULLCompleted18 YearsN/AAll68Phase 4United States;Germany;Poland;Slovakia;Hungary;Korea, Republic of
512NCT01683253
(ClinicalTrials.gov)
November 20127/9/2012Remission of ICD by Switching Dopamine Agonist to Levodopa/CarbidopaThe REmission of the Impulse Control Disorder and the Changes of the Neuropsychiatric Characteristics After Switching Into Levodopa/Carbidopa in Patients With Parkinson's Disease Who Have Developed Impulse Control Disorders Due to the Dopamine Replacement TherapyImpulse Control DisorderDrug: Levodopa/Carbidopa(200mg/50mg);Drug: Dopaminergic AgonistsSandozNULLCompleted30 Years80 YearsAll150Phase 4NULL
513NCT03652363
(ClinicalTrials.gov)
October 25, 201221/8/2018GDNF in ideopathicParkinsons DiseaseA Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal (GDNF) Infusions Administered Via Convection Enhanced Delivery (CED) in Subjects With Parkinson&Apos;s DiseaseIdiopathic Parkinson DiseaseDrug: glial cell line-derived neurotrophic factorNorth Bristol NHS TrustNULLCompleted35 Years75 YearsAll42Phase 2NULL
514NCT01796483
(ClinicalTrials.gov)
October 201213/2/2013EEG and Pharmacological Exploration of Executive Dysfunctions Induced by STN-DBS in PDExploration électroencéphalographie et Pharmacologique Des Dysfonctionnements exécutifs Induits Par la Stimulation cérébrale Profonde du Noyau Sous-thalamique Dans la Maladie de ParkinsonParkinson DiseaseDevice: Clonidine (Catapressan);Device: Placebo 90 minutes before EEGHospices Civils de LyonNULLCompleted40 Years70 YearsAll37N/AFrance
515NCT01723904
(ClinicalTrials.gov)
October 20126/11/2012A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's DiseaseAn Open-Label Study to Investigate the Safety and Efficacy of Rotigotine Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease Phase 3BAdvanced Parkinson's DiseaseDrug: RotigotineUCB BIOSCIENCES GmbHOtsuka Pharmaceutical Co., Ltd.Completed30 Years80 YearsAll90Phase 3Australia;Korea, Republic of;Malaysia;Singapore;Taiwan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
516NCT01563913
(ClinicalTrials.gov)
October 201216/3/2012Reducing Dyskinesia in Parkinson's Disease With Omega-3 Fatty AcidsReducing Dyskinesia in Parkinson Disease With Omega-3 Fatty AcidsParkinson's DiseaseDrug: Docosahexaenoic Acid (DHA);Drug: PlaceboVA Office of Research and DevelopmentOregon Health and Science UniversityCompleted21 Years99 YearsAll33Phase 1United States
517NCT01662791
(ClinicalTrials.gov)
September 20127/8/2012Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial OvergrowthWeight Loss in Parkinson's Disease and the Potential Role of Small Bowel Bacterial OvergrowthParkinson's DiseaseDrug: RifaximinMayo ClinicNULLCompleted18 YearsN/AAll49Phase 3United States
518NCT01711866
(ClinicalTrials.gov)
September 201218/10/2012A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's DiseaseAn Open-Label, Multicenter, Multinational Study to Assess the Feasibility of Switching Therapy From Pramipexole or Ropinirole to the Rotigotine Transdermal System and Its Effect on Motor and Non-Motor Symptoms in Subjects With Advanced Idiopathic Parkinson's Disease Phase 4Advanced Idiopathic Parkinson's DiseaseDrug: RotigotineUCB BIOSCIENCES GmbHOtsuka Pharmaceutical Co., Ltd.Completed30 Years80 YearsAll87Phase 4United States;Korea, Republic of;Malaysia;Singapore;Taiwan
519NCT01684475
(ClinicalTrials.gov)
September 201211/9/2012A STUDY TO EVALUATE THE EFFICACY OF CJH1 (CLR4001) IN PARKINSON'S DISEASEA STUDY TO EVALUATE THE EFFICACY OF CJH1 [CLR4001] IN THE TREATMENT OF PARKINSON'S DISEASEParkinson's DiseaseDrug: CJH1 (CLR4001)Alexandra Marine and General HospitalNULLRecruiting40 Years85 YearsBoth21Phase 1;Phase 2Canada
520NCT02419313
(ClinicalTrials.gov)
August 201227/1/2014Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Tremor: A Customized ApproachInvestigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Disease Tremor: A Customized ApproachParkinson;TremorDrug: incobotulinumtoxinA;Drug: SalineYale UniversityNULLCompleted18 YearsN/AAll33Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
521NCT01491022
(ClinicalTrials.gov)
July 20128/12/2011A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's DiseaseA Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's DiseaseParkinson's DiseaseDrug: Ampyra first, then Placebo;Drug: placebo first, then AmpyraUniversity of MiamiAcorda TherapeuticsCompleted45 Years80 YearsAll22Phase 1;Phase 2United States
522NCT01646255
(ClinicalTrials.gov)
July 201218/7/2012Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease PatientsA Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of The Efficacy And Safety of Rotigotine Transdermal Patch In Chinese Subjects With Advanced-stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled On LevodopaIdiopathic Parkinson's DiseaseDrug: Rotigotine;Drug: Placebo Patch;Drug: L-dopaUCB PharmaUCB Trading (Shanghai) Co. Ltd.Completed30 YearsN/AAll346Phase 3China
523NCT01646268
(ClinicalTrials.gov)
July 201218/7/2012Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease PatientsA Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Of The Efficacy And Safety Of The Rotigotine Transdermal Patch In Chinese Subjects With Early-stage Idiopathic Parkinson's DiseaseIDIOPATHIC PARKINSON'S DISEASEDrug: Rotigotine;Drug: Placebo PatchUCB PharmaNULLCompleted30 YearsN/AAll249Phase 3China
524NCT01602549
(ClinicalTrials.gov)
July 201217/5/2012A Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric EmptyingA Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric EmptyingGastroparesisDrug: GSK962040 (25 mg tablet);Drug: PlaceboGlaxoSmithKlineNULLCompleted40 Years80 YearsAll58Phase 2Australia;Germany;Sweden;United Kingdom
525NCT01398748
(ClinicalTrials.gov)
July 201219/7/2011Intranasal Glutathione in Parkinson's DiseaseA Phase 1 Study of Intranasal Reduced Glutathione in Parkinson's DiseaseParkinson's Disease (PD)Drug: Intranasal glutathione - (in)GSH;Drug: Saline Intranasal DeliveryBastyr UniversityNational Center for Complementary and Integrative Health (NCCIH)Completed21 Years100 YearsAll34Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
526NCT02786667
(ClinicalTrials.gov)
June 201218/5/2016Non Motors Aspects in De Novo Parkinson's DiseaseNon Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.Parkinson Disease;ApathyDrug: Rotigotine;Drug: PlaceboUniversity Hospital, GrenobleNULLActive, not recruiting30 Years72 YearsAll199Phase 3France
527NCT01993680
(ClinicalTrials.gov)
June 201227/4/2012Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease -TreatmentA Monocentric Randomized, Controlled, Double Blind, Crossover Phase II Trial to Show Non-inferiority of the Effect of Pyridostigmine Bromide vs. Fludrocortisone on Symptoms of Autonomic Dysregulation in Parkinson's DiseaseAutonomic Disturbances in Parkinson's DiseaseDrug: Pyridostigmine bromide;Drug: fludrocortisoneChristian BaumannNULLCompleted50 Years80 YearsAll18Phase 2Switzerland
528JPRN-UMIN000007896
2012/05/0107/05/2012Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes Parkinson's disease and other parkinsonian syndromesThe patients are given domperidone 30 mg/day for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day lactose powder is given to the patients and levodopa (250 mg)/carbidopa (25 mg) is given on the fifth day in a double-blind manner. On fourth and fifth day, motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug.
The patients are given domperidone 30 mg/day (standard dose in Japan) for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day levodopa (250 mg)/carbidopa (25 mg) is given to the patients and lactose powder is given on the fifth day in a double-blind manner. Motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug.
Kansai Medical UniversityNULLRecruitingNot applicableNot applicableMale and Female100Not selectedJapan
529NCT01617135
(ClinicalTrials.gov)
May 20127/5/2012Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and Off EpisodesA Randomized, Placebo-Controlled, Phase 2 Study of the Safety, Pharmacokinetics and Pharmacodynamics of CVT-310 (Levodopa Inhalation Powder) in Patients With Parkinson's Disease and Motor Response Fluctuations (Off Episodes)Idiopathic Parkinson's DiseaseDrug: CVT-301;Drug: Placebo;Drug: Sinemet (carbidopa/levodopa)Acorda TherapeuticsMichael J. Fox Foundation for Parkinson's ResearchCompleted30 YearsN/AAll25Phase 2Israel;Serbia;United Kingdom
530NCT01494532
(ClinicalTrials.gov)
April 2, 20121/12/2011A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's DiseaseA Fixed Dose, Dose-response Study of Ropinirole Prolonged Release (PR) as Adjunctive Treatment to L-dopa in Patients With Advanced Parkinson's DiseaseParkinson DiseaseDrug: ropinirole/L-dopa;Drug: placebo/L-dopaGlaxoSmithKlineNULLCompleted30 YearsN/AAll352Phase 4United States;Argentina;Chile;Estonia;Korea, Republic of;Russian Federation;Slovakia;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
531NCT01550484
(ClinicalTrials.gov)
April 20126/3/2012A Trial of 18F-AV-133 Positron Emission Tomography (PET) Imaging to Differentiate Subjects With Parkinson's Disease (PD) From Other Movement DisordersAn Open Label, Multicenter Study, Evaluating the Safety and Efficacy of 18F-AV-133 PET Imaging to Identify Subjects With Dopaminergic Degeneration Among Subjects Presenting to a Movement Disorders Specialty Clinic With an Uncertain DiagnosisParkinson's Disease;Primary Parkinsonism;Lewy Body Parkinson's DiseaseDrug: 18F-AV-133Avid RadiopharmaceuticalsNULLCompleted40 YearsN/AAll170Phase 2;Phase 3United States;Australia
532NCT01556165
(ClinicalTrials.gov)
April 201213/3/2012Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in ChinaRandomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in ChinaParkinson's DiseaseDrug: rasagiline;Drug: placeboH. Lundbeck A/SNULLCompleted35 YearsN/AAll130Phase 3China
533NCT01523301
(ClinicalTrials.gov)
April 201227/1/2012Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease PatientsDouble Blind, Placebo-controlled, Parallel, Multicenter, Randomized Interventional Phase IV Study to Evaluate the Efficacy of Rotigotine on Depressive Symptoms in Idiopathic Parkinson's Disease PatientsIdiopathic Parkinson's DiseaseDrug: Rotigotine;Drug: PlaceboUCB Korea Co., Ltd.NULLCompleted20 YearsN/AAll380Phase 4Korea, Republic of
534NCT01491529
(ClinicalTrials.gov)
April 201212/12/2011Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of Modified Release AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's DiseaseDyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia AgentsDrug: AFQ056;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted30 Years80 YearsAll154Phase 2United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey
535NCT01653132
(ClinicalTrials.gov)
March 201225/7/2012Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/ParkinsonismRandomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/ParkinsonismSialorrheaDrug: Incobotulinum Toxin A;Drug: PlaceboBeth Israel Deaconess Medical CenterNULLCompleted18 Years90 YearsAll10Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
536NCT01519882
(ClinicalTrials.gov)
March 201224/1/2012Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's DiseaseA Multi-Centre, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of Rotigotine on Sleep Efficiency in Patients With Advanced Parkinson's Disease.Advanced Idiopathic Parkinson's DiseaseOther: Placebo;Other: RotigotineUCB Pharma SANULLTerminated18 YearsN/AAll1Phase 4United Kingdom
537NCT01491932
(ClinicalTrials.gov)
March 20121/12/2011Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasDyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia AgentsDrug: AFQ056Novartis PharmaceuticalsNULLCompletedN/AN/AAll129Phase 2United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey
538NCT01565395
(ClinicalTrials.gov)
March 201226/3/2012Incobotulinum Toxin A for Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS)Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS)Parkinson Disease;Amyotrophic Lateral SclerosisDrug: Incobotulinum Toxin A;Drug: placeboBeth Israel Deaconess Medical CenterMerz PharmaceuticalsWithdrawn20 Years80 YearsAll0Phase 2United States
539NCT03061513
(ClinicalTrials.gov)
February 28, 201213/2/2017Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial BiomarkersUbiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial BiomarkersParkinson DiseaseDrug: Ubiquinol;Dietary Supplement: PlaceboWeill Medical College of Cornell UniversityNULLCompleted40 Years75 YearsAll11Phase 2NULL
540NCT01525641
(ClinicalTrials.gov)
February 20121/2/2012Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's DiseaseSpecial Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Mirapex LABoehringer IngelheimNULLCompletedN/AN/AAll615N/AJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
541NCT01673724
(ClinicalTrials.gov)
February 201223/8/2012Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's DiseaseEffect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized StudyParkinson's DiseaseDrug: pramipexole;Drug: BromocriptineSandozNULLCompleted30 YearsN/AAll121Phase 4Korea, Republic of
542NCT01539837
(ClinicalTrials.gov)
February 201222/2/2012A Pilot Clinical Trial With the Iron Chelator Deferiprone in Parkinson's DiseaseA Pilot Clinical Trial With the Iron Chelator Deferiprone in Parkinson's DiseaseParkinson's DiseaseDrug: Deferiprone 20mg;Drug: Placebo;Drug: Deferiprone 30mgImperial College LondonNULLCompleted50 Years75 YearsAll22Phase 2United Kingdom
543NCT01485172
(ClinicalTrials.gov)
January 31, 20121/12/2011A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's DiseaseA Fixed Dose, Dose Response Study for Ropinirole Prolonged Release (PR) in Patients With Early Stage Parkinson's DiseaseParkinson DiseaseDrug: ropinirole monotherapy;Drug: placebo monotherapyGlaxoSmithKlineNULLCompleted30 YearsN/AAll186Phase 4United States;Estonia;Korea, Republic of;Russian Federation;Slovakia;Poland
544NCT01470027
(ClinicalTrials.gov)
January 20124/11/2011N-Acetylcysteine for Neuroprotection in Parkinson's DiseaseN-Acetylcysteine for Neuroprotection in Parkinson's DiseaseParkinson DiseaseDrug: N-acetylcysteine;Drug: PlaceboWeill Medical College of Cornell UniversityNational Institute on Aging (NIA)Completed50 Years75 YearsAll50Phase 1;Phase 2United States
545NCT01536015
(ClinicalTrials.gov)
January 201215/2/2012Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal DysfunctionA Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease With Motor Fluctuations and Symptoms of Gastrointestinal DysfunctionAdvanced Parkinson's DiseaseDrug: Rotigotine;Drug: PlaceboUCB PharmaNULLTerminated30 YearsN/AAll25Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
546NCT01515410
(ClinicalTrials.gov)
January 201211/1/2012Study in Advanced Parkinson's Disease Patients With Predictable Motor FluctuationsA Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor FluctuationsParkinson's Disease;Motor FluctuationsDrug: DM-1992;Drug: Sinemet IRDepomedNULLCompleted30 YearsN/AAll34Phase 2United States
547NCT01519271
(ClinicalTrials.gov)
December 201110/1/2012Mild Cognitive Impairment in Parkinson's DiseaseA Phase IV Randomized, Double-Blind, Placebo-Controlled, Crossover Single Site Study Of Exelon® Patch (Rivastigmine Transdermal System) For Mild Cognitive Impairment In Parkinson's DiseaseParkinson's Disease;Mild Cognitive ImpairmentDrug: Exelon Patch (rivastigmine transdermal system);Drug: Placebo PatchesUniversity of PennsylvaniaNULLCompleted40 Years85 YearsAll28Phase 4United States
548NCT01470859
(ClinicalTrials.gov)
December 20119/11/2011The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Diseasea Pilot Follow-up Study of Investigating the Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Chinese Patients With Early Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: pramipexole;Drug: Sinemet CRHuashan HospitalBoehringer IngelheimCompleted30 Years75 YearsAll30N/AChina
549NCT01479530
(ClinicalTrials.gov)
December 201122/11/2011Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in ChinaRandomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in ChinaParkinson's DiseaseDrug: Placebo;Drug: Azilect®H. Lundbeck A/SNULLCompleted30 YearsN/AAll321Phase 3China
550NCT02302144
(ClinicalTrials.gov)
December 201124/11/2014A Multifactorial Exercise Program to Reduce Falls in People With Parkinson DiseaseA Multifactorial Exercise Program to Reduce Falls in People With Parkinson DiseaseParkinson DiseaseBehavioral: Balance & Strengthening ExercisesBoston University Charles River CampusNULLCompleted18 YearsN/AAll32N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
551NCT01457807
(ClinicalTrials.gov)
November 201110/10/2011To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy VolunteersA Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) After Administration of Multiple Doses in Healthy Male and Female VolunteersParkinson's DiseaseDrug: AZD3241 ER formulation 1;Drug: Placebo;Drug: AZD3241 Alternative titration scheme with formulation 1 or 2AstraZenecaNULLCompleted30 Years65 YearsBoth24Phase 1United Kingdom
552NCT01556100
(ClinicalTrials.gov)
November 20116/3/2012Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease ProgressionLong-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease ProgressionParkinson DiseaseDrug: 18F-DTBZ AV-133Chang Gung Memorial HospitalNULLCompleted20 YearsN/AAll40Phase 2NULL
553NCT01479127
(ClinicalTrials.gov)
October 201126/9/2011Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's DiseaseAn Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Explore the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's DiseaseAdvanced Parkinson's DiseaseDrug: ABT-SLV187;Drug: Oral Levodopa/Carbidopa;Device: Infusion Pump: CADD-Legacy® 1400 Pump;Device: NJ-Tube: Silicon ED Tube;Device: Adaptor: Hakko AdaptorAbbVie (prior sponsor, Abbott)Abbott Japan Co.,LtdCompleted30 Years99 YearsAll8Phase 2Japan
554NCT02427646
(ClinicalTrials.gov)
October 201122/4/2015Kinematic-guided BoNT-A Treatment for ET and PD TremorUse of Kinematic Assessment of Hand Tremor Pre- and Post- Treatment With Botulinum Toxin Type A in Essential Tremor and Parkinson DiseaseTremorDrug: BoNT-AWestern University, CanadaNULLActive, not recruiting18 Years80 YearsAll54Phase 2NULL
555NCT01474421
(ClinicalTrials.gov)
September 15, 20115/10/2011Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's DiseaseA Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy, Safety and Tolerability of AQW051 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Moderate to Severe L-dopa Induced DyskinesiasDyskinesias;Drug-inducedDrug: AQW051;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted30 Years85 YearsAll71Phase 2United States;France;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
556NCT01545856
(ClinicalTrials.gov)
September 20112/2/2012Cardiovascular Events in Parkinson's Disease PatientsBackground Incidence of Cardiovascular Ischaemic Events in Treated Parkinson's Disease Patients in the Impact DatabaseCardiovascular Event;Parkinson DiseaseDrug: levodopaGlaxoSmithKlineNULLCompleted20 YearsN/AAll1N/ANULL
557NCT02170376
(ClinicalTrials.gov)
September 201119/6/2014The Effect of BIA 9-1067 at Steady-state on the Levodopa PharmacokineticsThe Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics When Administered With Immediate-release 100/25 mg Levodopa/Carbidopa in Healthy SubjectsParkinson's Disease (PD)Drug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa/carbidopaBial - Portela C S.A.NULLCompleted18 Years45 YearsAll80Phase 1France
558EUCTR2010-020299-42-DE
(EUCTR)
30/08/201126/04/2011A study in U.S. and Germany to show if patients with an early stage of Parkinson's disease could be treated with a nicotine patch. In this study the nicotine patch is being compared to a placebo patch. The placebo patch is identical in appearance to the nicotine patch but does not contain any active ingredients.A randomized, placebo-controlled, double-blind, multi-center trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA (NIC-PD) - NIC-PD Early PD subjects within 18 months of diagnosis and not expected to require dopamine agonist or levodopa therapy for 1 year, with Hoehn and Yahr stage <2, with stable (>2 months) MAO-B inhibitor therapy allowed
MedDRA version: 16.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Nicotinell 17,5 mg/24-Stunden-Pflaster
Product Name: Nicotinell
Other descriptive name: NICOTINE
Trade Name: Nicotinell 35 mg/24-Stunden-Pflaster
Product Name: Nicotinell
Other descriptive name: NICOTINE
Philipps-University MarburgNULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;Germany
559NCT01411137
(ClinicalTrials.gov)
August 20114/8/2011Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety StudyAn Open Label Conversion Study of Carbidopa-Levodopa (CD-LD) Extended-Release Taken Alone or in Combination With CD-LD Immediate Release to IPX066 Followed by an Open-Label Extension Safety Study of IPX066 in Advanced PDParkinson's DiseaseDrug: IPX066Impax Laboratories, LLCMichael J. Fox Foundation for Parkinson's ResearchCompleted30 YearsN/AAll43Phase 3United States
560NCT01461109
(ClinicalTrials.gov)
August 201127/9/2011Research Involving Subjects With Parkinson's Disease, Alzheimer Disease and Healthy ControlsEvaluation of [18F] CFPyPB PET as a Marker of Glycine Transporter-1 (GlyT1) Receptor in Subjects With Parkinson Disease, Alzheimer Disease and Healthy SubjectsParkinson Disease;Alzheimer DiseaseDrug: [18F] CFPyPBInstitute for Neurodegenerative DisordersNULLCompleted18 Years90 YearsBoth4Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
561NCT01427517
(ClinicalTrials.gov)
July 201130/8/2011Intravenous N-acetylcysteine for the Treatment of Gaucher's Disease and Parkinson's DiseaseIntravenous N-acetylcysteine for the Treatment of Gaucher's Disease and Parkinson's DiseaseParkinson's Disease;Gaucher's DiseaseDrug: N-acetylcysteineUniversity of MinnesotaRare Diseases Clinical Research Network;National Center for Advancing Translational Science (NCATS);National Institute of Neurological Disorders and Stroke (NINDS);National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 YearsN/AAll9Phase 1United States
562NCT01397422
(ClinicalTrials.gov)
July 201118/7/2011Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)Dyskinesia;Levodopa Induced Dyskinesia;Parkinson's DiseaseDrug: ADS-5102 (extended release amantadine HCl)Adamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll83Phase 2;Phase 3United States
563NCT01528592
(ClinicalTrials.gov)
June 201131/1/2012PharmacoMRI of Parkinson DiseaseA Pilot Study of the Drug Effects on Brain Connectivity of Parkinson's DiseaseParkinson's DiseaseDrug: Carbidopa-LevodopaNorthwestern UniversityNULLCompleted30 YearsN/AAll18N/AUnited States
564NCT01652534
(ClinicalTrials.gov)
June 201115/8/2011Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's DiseaseEfficacy of Amantadine for Gait Dysfunction and Gait Freezing in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: Amantadine;Drug: PlaceboNorthwestern UniversityNULLTerminated18 Years85 YearsAll3Phase 3United States
565NCT01520987
(ClinicalTrials.gov)
May 201126/1/2012Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian SubjectsRandomized, Double-Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Compare the Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian SubjectsParkinson DiseaseDrug: BIA 9-1067;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years65 YearsAll105Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
566NCT01361009
(ClinicalTrials.gov)
May 201123/5/2011a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease PatientsSafety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing SurveillanceParkinson DiseaseDrug: pramipexoleBoehringer IngelheimNULLCompleted30 Years75 YearsAll2017N/AChina
567NCT01856439
(ClinicalTrials.gov)
May 201114/5/2013Long Term Safety and Efficacy Study of ProSavin in Parkinson's DiseaseA Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease.Parkinson's DiseaseDrug: ProSavinAxovant Sciences Ltd.Oxford BioMedicaActive, not recruitingN/AN/AAll15Phase 1;Phase 2France;United Kingdom
568NCT01119131
(ClinicalTrials.gov)
May 201123/4/2010Effects of Vitamin D in Parkinson's Disease (PD)The Effects of Vitamin D on Balance in Persons With PDParkinson Disease;Accidental FallsDrug: Vitamin D3;Dietary Supplement: calcium;Other: PlaceboVA Office of Research and DevelopmentOregon Health and Science UniversityCompleted50 Years99 YearsAll101Phase 2United States
569NCT01504178
(ClinicalTrials.gov)
May 201130/12/2011Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's DiseaseEvaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's DiseaseParkinson's DiseaseDrug: duloxetine;Drug: placebo of duloxetine;Drug: injection of apomorphine;Drug: injection of placebo of apomorphine;Drug: L-Dopa;Drug: injection of placebo of L-DopaUniversity Hospital, ToulouseFrench Parkinson AssociationCompleted30 Years70 YearsAll28Phase 3France
570NCT01323855
(ClinicalTrials.gov)
March 28, 201124/3/2011A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)A Study to Assess Pharmacokinetics of Preladenant in Subjects With Chronic Renal ImpairmentParkinson DiseaseDrug: PreladenantMerck Sharp & Dohme Corp.NULLCompleted18 Years75 YearsAll46Phase 1Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
571NCT01283594
(ClinicalTrials.gov)
March 201124/1/2011Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing OffA Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of SYN115 as Adjunctive Therapy in Levodopa-treated Parkinson's Subjects With End of Dose Wearing OffParkinson's DiseaseDrug: Tozadenant (SYN115) 60 mg BID;Drug: Placebo;Drug: Levodopa (L-dopa);Drug: Tozadenant (SYN115) 120 mg BID;Drug: Tozadenant (SYN115) 180 mg BID;Drug: Tozadenant (SYN115) 240 mg BIDBiotie Therapies Inc.NULLCompleted30 Years80 YearsAll420Phase 2;Phase 3United States;Argentina;Canada;Chile;Romania;Ukraine
572NCT01568073
(ClinicalTrials.gov)
March 201129/3/2012Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off PhenomenonEfficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo- and Active-controlled, Parallel-group, Multicentre Clinical StudyParkinson's DiseaseDrug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: BenserazideBial - Portela C S.A.NULLCompleted30 Years83 YearsAll600Phase 3Portugal;Austria
573NCT01330290
(ClinicalTrials.gov)
March 201118/3/2011Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver SupportA Multi-site, Non-interventional, Cross-sectional Evaluation of the Caregivers' and the Physicians' Preferred Route of Administration and the Physicians' Rationale for the Choice of Neupro® in Patients With Parkinson Requiring Caregiver SupportIdiopathic Parkinson's DiseaseDrug: Neupro®UCB PharmaNULLCompleted18 YearsN/AAll148N/AGermany
574NCT01264861
(ClinicalTrials.gov)
March 201120/12/2010A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain ImagingOpen-Label Escalating Dose Study Using [123|]ß-CIT SPECT Single Photon Emission Computerized Tomography (SPECT) to Evaluate Dopamine and Serotonin Transporter Occupancy by Safinamide in Parkinson Disease PatientsParkinson DiseaseDrug: SafinamideNewronNULLTerminated40 Years80 YearsAll5Phase 2United States
575NCT01280123
(ClinicalTrials.gov)
March 20113/12/2010Pioglitazone in Early Parkinson's DiseaseA Multi-Center, Double-Blind, Placebo-Controlled Phase II Study of Pioglitazone in Early Parkinson's DiseaseParkinson's DiseaseDrug: Pioglitazone;Drug: placeboUniversity of RochesterNational Institute of Neurological Disorders and Stroke (NINDS);Michael J. Fox Foundation for Parkinson's ResearchCompleted30 YearsN/AAll210Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
576NCT01227655
(ClinicalTrials.gov)
March 201122/10/2010Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Study.Parkinson's DiseaseDrug: BIA 9-1067;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: BenserazideBial - Portela C S.A.NULLCompleted30 Years83 YearsAll427Phase 3Portugal
577NCT01294800
(ClinicalTrials.gov)
February 25, 201110/2/2011A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402)A Phase 2, 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Preladenant in Japanese Subjects With Moderate to Severe Parkinson's Disease. (Phase 2; Protocol No. P06402)Parkinson's DiseaseDrug: Preladenant;Drug: Placebo tablet to match PreladenantMerck Sharp & Dohme Corp.NULLCompleted30 Years85 YearsAll450Phase 2Japan
578NCT01300819
(ClinicalTrials.gov)
February 201118/2/2011Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor SymptomsMulticenter, Double-blind, Placebo-controlled, Parallel-group, Phase IV Study to Assess the Effect of Rotigotine on Non-motor Symptoms in Patients With Idiopathic Parkinson's DiseaseIdiopathic Parkinson's DiseaseOther: Placebo;Drug: RotigotineUCB PharmaNULLCompleted18 YearsN/AAll349Phase 4Austria;Belgium;Bulgaria;Czech Republic;France;Germany;Hungary;Italy;Romania;Slovakia;Spain;Switzerland
579NCT02880033
(ClinicalTrials.gov)
February 20113/8/2016Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating LymphocytesModulation of Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes of Patients With Parkinson's Disease or Amyotrophic Lateral SclerosisParkinson's Disease;Amyotrophic Lateral Sclerosis;Oxidative Stress;Iron OverloadDrug: deferiprone;Drug: placeboUniversity Hospital, LilleNULLCompleted18 Years80 YearsAll90N/AFrance
580EUCTR2010-021860-13-ES
(EUCTR)
24/01/201127/10/2010EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY IEFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY I Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations.Adjunto a levodopa/inhibidor dopa descarboxilasa para pacientes con enfermedad de Parkinson y fluctuaciones motoras de fin de dosis
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Trade Name: Comtan®
Product Name: Over-encapsulated Entacapone Tablets
Product Code: Over-encapsulated Entacapone Tablets
INN or Proposed INN: ENTACAPONE
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
BIAL - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
550Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
581NCT01340885
(ClinicalTrials.gov)
January 201119/4/2011Cognitive Decline in Non-demented PDCognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot StudyParkinson's DiseaseDrug: Strattera;Drug: Exelon;Other: PlaceboOregon Health and Science UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed18 YearsN/AAll9Phase 4United States
582NCT01268891
(ClinicalTrials.gov)
January 201130/12/2010Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in KoreaRandomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in KoreaParkinson's DiseaseDrug: Placebo;Drug: Azilect®H. Lundbeck A/SNULLCompleted30 YearsN/AAll132Phase 3Korea, Republic of
583NCT01341080
(ClinicalTrials.gov)
December 28, 201021/4/2011Varenicline for Gait and Balance Impairment in Parkinson DiseaseVarenicline for the Treatment of Postural and Gait Dysfunction in Parkinson DiseaseParkinson DiseaseDrug: Varenicline;Drug: Sugar pillRush University Medical CenterNULLCompleted40 Years90 YearsAll40Phase 2United States
584EUCTR2010-020109-34-ES
(EUCTR)
29/11/201023/09/2010Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment.Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment. Cognition in non-demented patients with idiopathic Parkinson's disease Cognición en sujetos no dementes con Enfermedad de Parkinson idiopática
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamida
Product Code: NW-1015
Other descriptive name: Safinamida
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Spain;Italy
585NCT01227265
(ClinicalTrials.gov)
November 19, 201022/10/2010Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)A Phase 3, 12 Week, Double-blind, Placebo-controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease.Parkinson Disease;Idiopathic Parkinson Disease;Idiopathic Parkinson's DiseaseDrug: Preladenant;Drug: PlaceboMerck Sharp & Dohme Corp.NULLCompleted30 Years85 YearsAll476Phase 3Argentina;Chile;Colombia;Croatia;Latvia;Lithuania;Mexico;Russian Federation;Serbia;South Africa;Ukraine;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
586NCT01215227
(ClinicalTrials.gov)
November 18, 20104/10/2010An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3, Protocol No. P06153)Parkinson Disease;Idiopathic Parkinson DiseaseDrug: Preladenant;Drug: Rasagiline;Drug: Placebo to preladenant;Drug: Placebo to rasagilineMerck Sharp & Dohme Corp.NULLTerminated30 Years85 YearsAll839Phase 3Argentina;Austria;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Finland;France;India;Israel;Italy;Latvia;Lithuania;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Serbia;South Africa;Spain;Sweden;Ukraine;United Kingdom;United States
587NCT01270711
(ClinicalTrials.gov)
November 20109/12/2010Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)Study on Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)Parkinson's Disease;HyperprolactinemiaDrug: Study DrugPfizerNULLCompletedN/AN/AAll22014N/ANULL
588NCT01192529
(ClinicalTrials.gov)
October 201030/8/2010Evaluation of a Diet in Patients With Senile DementiaClinical Evaluation of an Specific Diet for People With Dementia DiseaseAlzheimer's Disease;Parkinson's Disease;Senile DementiaDietary Supplement: Supressi. T-Diet plus Range;Dietary Supplement: High Protein. T-Diet plus RangeVegenat, S.A.NULLRecruiting70 YearsN/ABoth184N/ASpain
589NCT01173731
(ClinicalTrials.gov)
October 201028/7/2010Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasParkinson Disease;Dyskinesia, Drug-Induced;LevodopaDrug: AFQ056Novartis PharmaceuticalsNULLCompletedN/AN/AAll66Phase 2United States;Australia;Canada;France;Germany;Italy;Finland;Spain
590NCT01536574
(ClinicalTrials.gov)
September 2, 201019/1/2012Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528An Open Label Extension Study With REQUIP PR for Subjects From Study ROP111528Parkinson DiseaseDrug: Requip PRGlaxoSmithKlineNULLCompleted30 YearsN/AAll295Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
591NCT01191944
(ClinicalTrials.gov)
August 201030/8/2010Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) PatientsA Double-blind, Double-dummy, Randomised, Parallel-group Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release Versus Pramipexole Immediate Release Administered Orally for 18 Weeks in Chinese Parkinson's Disease (PD) Patients Who Can be Concomitantly Treated With LevodopaParkinson DiseaseDrug: pramipexole immediate release tablet;Drug: pramipexole extended release tabletBoehringer IngelheimNULLCompleted30 YearsN/AAll475Phase 3China
592NCT01190735
(ClinicalTrials.gov)
August 201026/8/2010Caffeine for Motor Manifestations of Parkinson's DiseaseCaffeine for Motor Manifestations of Parkinson's Disease: An Open-Label Dose-Response Study.Parkinson's DiseaseDrug: Caffeine alkaloidRon PostumaCanadian Institutes of Health Research (CIHR)Completed18 YearsN/ABoth28Phase 2Canada
593NCT01785628
(ClinicalTrials.gov)
August 201024/6/2011The Impact of Pharmacological and Electric Modulation of NMDA Pathway on the Cognitive Flexibility and Volitional Movement Preparation in Patients With Parkinson's DiseaseParkinson's Disease With DementiaDietary Supplement: Sarcosine Capsule;Dietary Supplement: Placebo CapsuleChina Medical University HospitalNational Science Council, TaiwanCompletedN/AN/AAll30N/ATaiwan
594NCT01155466
(ClinicalTrials.gov)
July 14, 201030/6/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3;Protocol No. P04938)Parkinson DiseaseDrug: Preladenant 2 mg tablet;Drug: Preladenant 5 mg tablet;Drug: Preladenant 10 mg tablet;Drug: Placebo to Preladenant Tablet;Drug: Rasagiline 1 mg capsule;Drug: Placebo to Rasagiline capsuleMerck Sharp & Dohme Corp.NULLCompleted30 Years85 YearsAll778Phase 3Austria;Brazil;Bulgaria;Canada;Czech Republic;Finland;France;Germany;India;Israel;Italy;Japan;Netherlands;Peru;Poland;Portugal;Russian Federation;Spain;Sweden;Turkey;United Kingdom;United States
595EUCTR2010-018650-12-FR
(EUCTR)
13/07/201006/05/2010Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOXEvaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOX maladie de Parkinson
MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: CYMBALTA
Product Name: duloxetine
Trade Name: APOKINON
Product Name: apomorphine
Trade Name: MODOPAR
Product Name: levodopa
Trade Name: MOTILIUM
Product Name: dompéridone
CHU de ToulouseNULLNot RecruitingFemale: yes
Male: yes
Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
596NCT01155479
(ClinicalTrials.gov)
July 6, 201030/6/2010A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's DiseaseParkinson DiseaseDrug: Preladenant 2 mg tablet;Drug: Preladenant 5 mg tablet;Drug: Preladenant 10 mg tablet;Drug: Rasagiline 1 mg capsule;Drug: Placebo for Rasagiline 1 mg capsule;Drug: Placebo for PreladenantMerck Sharp & Dohme Corp.NULLTerminated30 Years85 YearsAll1022Phase 3Argentina;Bulgaria;Canada;Chile;Colombia;Czech Republic;Finland;France;Germany;Hungary;India;Israel;Italy;Mexico;Peru;Poland;Russian Federation;Spain;Sweden;Turkey;United Kingdom;United States
597NCT01174004
(ClinicalTrials.gov)
July 201030/7/2010A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease PsychosisA Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's DiseaseParkinson's Disease PsychosisDrug: pimavanserin tartrate;Drug: placeboACADIA Pharmaceuticals Inc.NULLCompleted40 YearsN/AAll199Phase 3United States;Canada
598NCT01435915
(ClinicalTrials.gov)
June 28, 20101/9/2011Ropinirole PR Pharmacokinetics Study Among Chinese Healthy SubjectsA Single Dose and Repeat Dose Study to Investigate the Pharmacokinetics of Ropinirole After Single and Multiple Doses of a PR-formulation in Chinese Healthy Male and Female SubjectsParkinson DiseaseDrug: RopiniroleGlaxoSmithKlineNULLCompleted18 Years45 YearsAll24Phase 1China
599NCT01176240
(ClinicalTrials.gov)
June 201030/7/2010A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's DiseaseA Multi-center, Double-blind, Randomized, Parallel-Group, Placebo-Controlled Study to Assess the Clinical Effect of Droxidopa in the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients With Parkinson's DiseaseOrthostatic Hypotension;Parkinson's DiseaseDrug: Droxidopa;Other: PlaceboChelsea TherapeuticsNULLCompleted18 YearsN/AAll225Phase 3United States
600NCT01141023
(ClinicalTrials.gov)
June 20108/6/2010Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease ProgressionThe Parkinson's Progression Markers Initiative (PPMI)Parkinson DiseaseDrug: DaTscanKen Marek, MDInstitute for Neurodegenerative DisordersActive, not recruiting30 YearsN/AAll1100Phase 2United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Norway;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
601NCT01227681
(ClinicalTrials.gov)
June 201022/10/2010Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's DiseaseA Double-Blind, Placebo-Control, Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's DiseaseParkinson DiseaseDrug: G-CSF;Drug: PlaceboBuddhist Tzu Chi General HospitalNULLTerminated40 Years65 YearsAll4Phase 2Taiwan
602NCT01130493
(ClinicalTrials.gov)
May 201024/5/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's DiseaseParkinson's DiseaseDrug: IPX066;Drug: CLEImpax Laboratories, LLCNULLCompleted30 YearsN/AAll110Phase 3United States;France;Germany;Italy
603NCT00988117
(ClinicalTrials.gov)
April 201029/9/2009The Effects of the Rivastigmine Patch on Parkinson's Disease With Memory and/or Thinking ProblemsThe Effects of the Rivastigmine Patch on Attention and Behavior in Parkinson's Disease With Dementia (PDD)Parkinsons Disease With Dementia;Parkinsons Disease With Mild to Moderate Memory and/or Thinking ProblemsDrug: Rivastigmine Patch 9.5 cm2University of California, San FranciscoNovartisCompleted55 YearsN/AAll15Phase 4United States
604NCT01484990
(ClinicalTrials.gov)
April 201028/7/2011A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's DiseaseA Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's DiseaseParkinson DiseaseDrug: Levodopa-CarbidopaAbbVieQuintiles, Inc.Completed30 Years99 YearsAll19Phase 1Germany;Sweden
605NCT01092065
(ClinicalTrials.gov)
March 201022/3/2010Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced DyskinesiaA 6-week, Double-blind, Placebo-controlled, Randomized, Multicenter Study to Explore the Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With OFF Time and Moderate-severe L-dopa Induced DyskinesiaParkinson's DiseaseDrug: AFQ056 with L-dopa;Drug: PlaceboNovartisNULLCompleted30 Years80 YearsAll23Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
606NCT01096186
(ClinicalTrials.gov)
March 201025/3/2010An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's DiseaseAn Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: IPX066 95 mg;Drug: IPX066 145 mg;Drug: IPX066 195 mg;Drug: IPX066 245 mgImpax Laboratories, LLCNULLCompleted30 YearsN/AAll617Phase 3United States;Canada;Estonia;Germany;Latvia;Lithuania;Poland;Romania;Spain;Ukraine
607NCT01055379
(ClinicalTrials.gov)
March 201022/1/2010Rasagiline in Cognitive-impairment Related Depression: AzileCt in COgnitive-impairment Related DepressiOnA Randomised, Double-blind, Placebo-controlled Study to Evaluate if Rasagiline Can Improve Depressive Symptoms and Cognitive Function in Non-demented, Idiopathic Parkinson's Disease Patients: ACCORDO StudyDepressive Symptoms;Parkinson's DiseaseDrug: Rasagiline;Drug: PlaceboLundbeck Italia S.p.A.Teva Pharmaceutical IndustriesCompleted40 Years80 YearsAll121Phase 4Italy
608NCT02101190
(ClinicalTrials.gov)
March 201020/1/2012Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic ImpairmentOpen-label, Single-dose, Multi-center Study, Investigating the Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic ImpairmentParkinson's DiseaseDrug: BIA 9-1067Bial - Portela C S.A.NULLCompleted18 Years65 YearsAll16Phase 1France;Russian Federation
609NCT01503944
(ClinicalTrials.gov)
March 201014/7/2010A Trial of 18F-AV-133 and 18F-AV-45 Positron Emission Tomography (PET)Detection of Striatal Dopaminergic Degeneration and Neocortical Amyloid Pathology in Patients With Dementia With Lewy Bodies, Alzheimer's Disease, Parkinson's Disease, and Healthy Elderly VolunteersDementia With Lewy Bodies;Alzheimer's Disease;Parkinson's DiseaseDrug: 18F-AV-133;Drug: 18F-AV-45Avid RadiopharmaceuticalsNULLCompleted50 YearsN/ABoth30Phase 1;Phase 2United States
610NCT01097421
(ClinicalTrials.gov)
March 201025/3/2010Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s DiseaseInfluence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's DiseaseParkinson DiseaseDrug: Pramipexole Extended ReleaseBoehringer IngelheimNULLCompleted30 YearsN/AAll329N/ASweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
611NCT01154166
(ClinicalTrials.gov)
February 15, 201029/6/2010A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-DopaA Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-DopaParkinson DiseaseDrug: ReQuip PR;Drug: PlaceboGlaxoSmithKlineNULLCompleted30 YearsN/AAll347Phase 3China
612EUCTR2009-016360-37-SE
(EUCTR)
06/02/201004/12/2009TREATMENT OF DYSKINESIAS IN PARKINSON’S DISEASE WITH OSU6162 – A PILOT STUDYTREATMENT OF DYSKINESIAS IN PARKINSON’S DISEASE WITH OSU6162 – A PILOT STUDY Parkinsons disease is complicated by dyskinesias and dystonia. Due stabilizing properties, we believe (-)-OSU6162 may alleviate dyskinesias, without causing parkinsonism. Aim: To evaluate in a double-blind cross over pilot study whether OSU6162 attenuates dyskinesias without worsening parkinsonism in PD patients with motor complications using clinical examination and patient diaries.Björn HolmbergNULLNot Recruiting Female: yes
Male: yes
20Phase 1;Phase 2Sweden
613NCT01568047
(ClinicalTrials.gov)
February 201029/3/2012Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) PatientsMulticentre, Double-blind, Randomised, Placebo-controlled Study in Four Parallel Groups of PD Patients Treated With Standard-release Levodopa/Carbidopa 100/25 mg (Sinemet®) or Levodopa/Benserazide 100/25 mg (Madopar®/Restex®) and With Motor Fluctuations (Wearing-off Phenomenon)Parkinson's DiseaseDrug: Placebo;Drug: BIA 9-1067;Drug: Levodopa/Carbidopa;Drug: Levodopa/BenzerazideBial - Portela C S.A.NULLCompleted30 YearsN/AAll40Phase 2Romania;Ukraine
614NCT02169414
(ClinicalTrials.gov)
February 201024/1/2012Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa PharmacokineticsEffect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics of a Single-dose of Immediate Release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy SubjectsParkinson's Disease (PD)Drug: BIA 9-1067 5 mg;Drug: BIA 9-1067 25 mg;Drug: levodopa/carbidopa 100/25;Drug: Placebo;Drug: levodopa/benserazide 100/25 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsAll74Phase 1France
615NCT01058291
(ClinicalTrials.gov)
January 201027/1/2010Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500Phase 3 Study of KW-6500 (Placebo-Controlled Double-Blind Crossover Comparative Study in Patients With Parkinson's Disease)Parkinson's DiseaseDrug: KW-6500;Drug: KW-6500 PlaceboKyowa Hakko Kirin Co., LtdNULLCompleted20 YearsN/AAll31Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
616NCT01071395
(ClinicalTrials.gov)
January 201017/2/2010Validation of Dyskinesia Rating ScalesValidation of Dyskinesia Rating ScalesParkinson's DiseaseDrug: Amantadine;Drug: PlaceboRush University Medical CenterMichael J. Fox Foundation for Parkinson's ResearchCompleted30 Years90 YearsAll68Phase 4United States;Austria;Canada;France
617NCT01018264
(ClinicalTrials.gov)
January 201019/11/2009Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's DiseaseURGE-PD: A Multi-site, Double-blind, Randomized, Placebo Controlled Trial of Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's DiseaseOveractive Bladder in Parkinson's DiseaseDrug: solifenacin succinate (VESIcare);Drug: placeboUniversity of South FloridaNULLCompleted40 Years80 YearsAll23Phase 4United States
618NCT01063621
(ClinicalTrials.gov)
January 20104/2/2010Extended Long-Term Safety Study of KW-6500Phase 3 Study of KW-6500 (Safety Study for Extended Long-Term Self-Injection at Home in Patients With Parkinson's Disease)Parkinson's DiseaseDrug: KW-6500Kyowa Hakko Kirin Co., LtdNULLCompleted20 YearsN/AAll27Phase 3Japan
619NCT01417598
(ClinicalTrials.gov)
January 201015/8/2011BETA Study: Improving Balance Function in Elderly by Progressive and Specific Training and Physical ActivityImproving Balance Function in Elderly by Progressive and Specific Training and Physical Activity- a Randomized Controlled Study.Elderly;Parkinsons Disease;OsteoporosisOther: Gait and balance group training;Other: Nordic walking (only osteoporosis group)Karolinska InstitutetThe Swedish Research CouncilActive, not recruiting60 YearsN/AAll200N/ASweden
620NCT01168596
(ClinicalTrials.gov)
December 200919/2/2010Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's DiseaseRasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease: A Bi-Center, Placebo-Controlled Study (The REST Fatigue Trial)Parkinson's DiseaseDrug: Rasagiline;Drug: PlaceboUniversity of FloridaNULLCompleted40 Years85 YearsAll30Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
621NCT01049984
(ClinicalTrials.gov)
December 200913/1/2010Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's DiseaseA Double-blind, Placebo Controlled, Randomized, Multicenter Study to Assess the Safety and Clinical Benefit of Rasagiline as an Add on Therapy to Stable Dose of Dopamine Agonists in the Treatment of Early Parkinson's DiseaseParkinson's DiseaseDrug: Rasagiline;Drug: PlaceboTeva Neuroscience, Inc.H. Lundbeck A/SCompleted30 YearsN/AAll328Phase 4United States
622NCT00660387
(ClinicalTrials.gov)
December 200915/4/2008Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's SubjectsA Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor FluctuationsAdvanced Parkinson's DiseaseDrug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo Gel;Drug: Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVie (prior sponsor, Abbott)Quintiles, Inc.Completed30 YearsN/AAll35Phase 3United States;New Zealand
623NCT00660673
(ClinicalTrials.gov)
November 13, 200915/4/2008Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PDOpen-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous StudiesAdvanced Parkinson's DiseaseDrug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pumpAbbVie (prior sponsor, Abbott)Quintiles, Inc.Active, not recruiting30 Years99 YearsAll262Phase 3United States;Australia;Canada;Czechia;Israel;New Zealand;Poland;Portugal;Russian Federation;Thailand;United Kingdom;Czech Republic
624EUCTR2009-013885-14-ES
(EUCTR)
12/11/200923/09/2009A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas.A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas. Excessive daytime sleepiness in Parkinson?s DiseaseSomnolencia diurna excesiva en la enfermedad de Parkinson.
MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness
MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism
Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant
BIOPROJETNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
246France;Spain
625NCT01052831
(ClinicalTrials.gov)
November 200915/1/2010Naltrexone for Impulse Control Disorders in Parkinson's DiseaseRandomized, Double-blind, Placebo-controlled Study of Naltrexone for Impulse Control Disorders in Parkinson's DiseaseImpulse Control Disorder;Parkinson DiseaseDrug: Naltrexone;Drug: PlaceboUniversity of PennsylvaniaMichael J. Fox Foundation for Parkinson's ResearchCompleted18 Years85 YearsAll50Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
626NCT01532128
(ClinicalTrials.gov)
November 200923/1/2012Effect of BIA 9-1067 on Rasagiline PharmacokineticsEffect of BIA 9-1067 on Rasagiline Pharmacokinetics in Healthy SubjectsParkinson DiseaseDrug: rasagiline;Drug: BIA 9-1067Bial - Portela C S.A.NULLCompleted18 Years45 YearsAll24Phase 1France
627NCT01028209
(ClinicalTrials.gov)
November 20098/12/2009Evaluation of [18F] PBR06 and PET as a Marker of Inflammation in Subjects With Neurological ConditionsAlzheimer Disease;Parkinson Disease;Multiple SclerosisDrug: [18F] PBR06Institute for Neurodegenerative DisordersNULLTerminated18 YearsN/AAll12Phase 1United States
628NCT01532141
(ClinicalTrials.gov)
November 200923/1/2012Effect of Rasagiline on BIA 9-1067 PharmacokineticsEffect of Rasagiline on BIA 9-1067 Pharmacokinetics in Healthy SubjectsParkinson DiseaseDrug: BIA 9-1067;Drug: RasagilineBial - Portela C S.A.NULLCompleted18 Years45 YearsAll25Phase 1France
629NCT01519284
(ClinicalTrials.gov)
November 200923/1/2012Study of BIA 9-1067 to Investigate Its Effect on Levodopa PharmacokineticA Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy SubjectsParkinson DiseaseDrug: BIA 9-1067 5 mg;Drug: Entacapone;Drug: Placebo;Drug: levodopa/carbidopa;Drug: BIA 9-1067 15 mg;Drug: BIA 9-1067 30 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsAll82Phase 1Portugal
630NCT00985517
(ClinicalTrials.gov)
October 29, 200925/9/2009Safety and Efficacy of CERE-120 in Subjects With Parkinson's DiseaseA Phase 1/2 Trial Assessing the Safety and Efficacy of Bilateral Intraputaminal and Intranigral Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) in Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson's DiseaseBiological: CERE-120: Adeno-Associated Virus Delivery of Neurturin;Procedure: Sham SurgerySangamo TherapeuticsNULLCompleted35 Years70 YearsAll57Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
631NCT01016470
(ClinicalTrials.gov)
October 200928/9/2009Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson`s DiseaseEfficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson`s DiseaseParkinson`s DiseaseDietary Supplement: VIUSID/ALZER;Dietary Supplement: PlaceboCatalysis SLNULLCompleted20 Years90 YearsBoth100Phase 3Cuba
632NCT01631825
(ClinicalTrials.gov)
October 200925/6/2012A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease PatientsAn Open-label Long-term Extension Trial From Phase III of SPM962 (243-08-002) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopaParkinson's DiseaseDrug: SPM 962Otsuka Pharmaceutical Co., Ltd.NULLCompletedN/AN/AAll321Phase 3Japan
633NCT01371682
(ClinicalTrials.gov)
September 18, 200910/6/2010A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and ArandaAn Open Label Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets (Ropinirole XL, Marketed as REQUIP-MODUTAB™, REQUIP XL™ at 2 mg) Manufactured at Crawley and ArandaParkinson DiseaseDrug: Ropinirole XLGlaxoSmithKlineNULLCompleted18 Years50 YearsAll50Phase 1Belgium
634NCT00794313
(ClinicalTrials.gov)
September 200919/11/2008Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's DiseaseQuantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's DiseaseParkinson's DiseaseDrug: Amantadine 300 mg;Drug: Topiramate;Drug: Sugar PillOregon Health and Science UniversityNULLTerminated21 YearsN/AAll3N/AUnited States
635NCT00974974
(ClinicalTrials.gov)
September 200910/9/2009A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's DiseaseParkinson's DiseaseDrug: IPX066;Drug: IR CD-LDImpax Laboratories, LLCNULLCompleted30 YearsN/AAll471Phase 3United States;Canada;France;Germany;Poland;Romania;Spain;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
636NCT00986245
(ClinicalTrials.gov)
September 200924/9/2009Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-dailyAn Open-label, Multi-center, Crossover Study to Compare the Effect of Once-daily Ropinirole PR and Twice-daily Ropinirole PR in Patients With Parkinson DiseaseParkinson DiseaseDrug: Ropinirole Prolonged releaseSeoul National University HospitalNULLCompleted30 Years80 YearsAll82Phase 4Korea, Republic of
637NCT00986414
(ClinicalTrials.gov)
September 200929/9/2009Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's DiseaseParkinson Disease;DyskinesiasDrug: AFQ056;Drug: PlaceboNovartisNULLCompleted30 Years80 YearsAll260Phase 2Australia;Canada;Finland;France;Germany;Italy;Japan;Spain
638NCT03316365
(ClinicalTrials.gov)
August 200916/10/2017Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's DiseaseLong-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's DiseaseContinuous Rhythmic Auditory Stimulation;Intermittent Rhythmic Auditory StimulationOther: Rhythmic Auditory Stimulation (RAS)University of TorontoPoudre Valley Health System Fort Collins CO;Colorado State UniversityCompleted18 YearsN/AAll60N/ANULL
639NCT00970333
(ClinicalTrials.gov)
August 200931/8/2009Evaluation of [18F] FEPPA and PET Imaging as a Marker of Inflammation in Subjects With Neurological ConditionsEvaluation of [18F] FEPPA and PET as a Marker of Inflammation in Subjects With Neurological ConditionsAlzheimer Disease;Parkinson Disease;Multiple SclerosisDrug: [18F]-FEPPAInstitute for Neurodegenerative DisordersNULLCompleted18 YearsN/ABoth3Phase 1United States
640NCT00970229
(ClinicalTrials.gov)
July 200931/8/2009Evaluation of [123I]MNI-420 and SPECT as a Marker of the Adenosine A2a Receptor in PD, HD and Healthy Subjects.Evaluation of [123I]MNI-420 and SPECT as a Marker of the Adenosine A2a Receptor in Subjects With Parkinson Disease, Huntington Disease, and Healthy ControlsParkinson Disease;Huntington DiseaseDrug: [123I]MNI-420Institute for Neurodegenerative DisordersNULLCompleted18 YearsN/AAll19Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
641NCT00955604
(ClinicalTrials.gov)
July 20096/8/2009Azilect + Antidepressant Chart ReviewInvestigation of the Occurrence of Serotonin Toxicity in Parkinson's Disease (PD) Patients Treated Concomitantly With Rasagiline and Antidepressants, Using Retrospective Chart ReviewSerotonin SyndromeDrug: Group R+AD Rasagiline + Antidepressant;Drug: Group R Rasagiline;Drug: Group AD Anti-PD + AntidepressantTeva Pharmaceutical IndustriesNULLCompletedN/AN/AAll1500N/AUnited States
642NCT00955318
(ClinicalTrials.gov)
July 20097/8/2009Long-Term Safety Study of KW-6500 in Patients With Parkinson's DiseasePhase 3 Study of KW-6500 (Safety Study for Long-Term Self-Administration at Home in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: KW-6500Kyowa Hakko Kirin Co., LtdNULLCompleted20 YearsN/AAll58Phase 3Japan
643NCT00909545
(ClinicalTrials.gov)
July 200926/5/2009Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson DiseaseA Pilot Phase II Double-Blind, Placebo-Controlled, Tolerability and Dosage Finding Study of Isradipine CR as a Disease Modifying Agent in Patients With Early Parkinson DiseaseParkinson DiseaseDrug: Isradipine CR 5mg;Drug: Isradipine CR 10mg;Drug: Isradipine CR 20mg;Drug: PlaceboNorthwestern UniversityMichael J. Fox Foundation for Parkinson's Research;Northwestern University Dixon Fund;The Parkinson Study GroupCompleted30 YearsN/AAll99Phase 2United States;Canada
644EUCTR2008-004146-88-ES
(EUCTR)
16/06/200916/04/2009A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono SA - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
498Phase 3Portugal;Finland;Germany;Czech Republic;Bulgaria;Spain;Italy;Poland
645NCT00921128
(ClinicalTrials.gov)
June 2, 200913/6/2009Convection-Enhanced Delivery to Study the Pathophysiology Underlying the Clinical Features of Parkinson s DiseaseConvection Enhanced Delivery of Muscimol to Study the Pathophysiology Underlying the Clinical Features of Parkinson's DiseaseParkinson's DiseaseDrug: MuscimolNational Institute of Neurological Disorders and Stroke (NINDS)NULLWithdrawn18 YearsN/AAll0Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
646NCT01628926
(ClinicalTrials.gov)
June 200924/6/2012A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease PatientsA Double-Blind, 3-Arm, Parallel Group, Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopaParkinson's DiseaseDrug: SPM 962;Drug: Ropinirole;Drug: PlaceboOtsuka Pharmaceutical Co., Ltd.NULLCompleted30 Years79 YearsAll420Phase 3Japan
647NCT00360568
(ClinicalTrials.gov)
June 20093/8/2006Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's SubjectsOpen-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease SubjectsDyskinesias;Parkinson's Disease;Severe Motor FluctuationsDrug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVie (prior sponsor, Abbott)Quintiles, Inc.Completed30 YearsN/AAll62Phase 3United States;Germany;New Zealand
648NCT00833690
(ClinicalTrials.gov)
June 200927/1/2009Safety of Urate Elevation in Parkinson's DiseaseA Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial of Oral Inosine to Assess Safety and Ability to Elevate Urate in Early Parkinson's DiseaseParkinson DiseaseDrug: Placebo;Drug: inosineThe Parkinson Study GroupMassachusetts General Hospital;Harvard School of Public Health;University of Rochester;Michael J. Fox Foundation for Parkinson's ResearchCompleted30 YearsN/AAll75Phase 2United States
649NCT00669461
(ClinicalTrials.gov)
June 200928/4/2008Lubiprostone as a Treatment for Constipation in Parkinson's DiseaseLubiprostone as a Treatment for Constipation in Parkinson's DiseaseConstipation;Parkinson's DiseaseDrug: LubiprostoneUniversity of ArkansasTakedaTerminated50 Years85 YearsAll1N/AUnited States
650NCT02169440
(ClinicalTrials.gov)
June 200924/1/2012Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of WarfarinEffect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy VolunteersParkinson's Disease (PD)Drug: BIA 9-1067;Drug: WarfarinBial - Portela C S.A.NULLCompleted18 Years45 YearsAll20Phase 1Portugal
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
651NCT01536366
(ClinicalTrials.gov)
June 200923/1/2012Effect of BIA 9-1067 on the Pharmacokinetics of RepaglinideEffect of BIA 9-1067 on the Pharmacokinetics of Repaglinide in Healthy VolunteersParkinson DiseaseDrug: BIA 9-1067;Drug: RepaglinideBial - Portela C S.A.NULLCompleted18 Years45 YearsAll27Phase 1Portugal
652NCT00845000
(ClinicalTrials.gov)
April 21, 200913/2/2009Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550)Acute Effects of SCH 420814 on Dyskinesia and Parkinsonism in Levodopa Treated PatientsParkinson DiseaseDrug: SCH 420814 10 mg;Drug: SCH 420814 100 mg;Drug: Placebo;Drug: Levodopa;Drug: CarbidopaMerck Sharp & Dohme Corp.Oregon Health and Science UniversityCompleted18 YearsN/AAll12Phase 1United States
653NCT00880620
(ClinicalTrials.gov)
April 20093/4/2009A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's DiseaseA Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: Placebo;Drug: IPX066 95 mg LD;Drug: IPX066 145 mg LD;Drug: IPX066 195 mg LD;Drug: IPX066 245 mg LDImpax Laboratories, LLCNULLCompleted30 YearsN/AAll381Phase 3United States;Canada;Estonia;Latvia;Lithuania;Romania;Ukraine
654NCT00865579
(ClinicalTrials.gov)
April 200910/3/2009Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease PatientsParkinson's DiseaseDrug: SafinamideNewronNULLTerminated30 YearsN/AAll964Phase 3Romania
655NCT01568034
(ClinicalTrials.gov)
April 200929/3/2012A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067A Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 on the Levodopa Pharmacokinetics, Motor Response, and Erythrocyte Soluble Catechol-O-methyltransferase Activity in Parkinson's Disease Patients Concomitantly Treated With Levodopa/Dopa-decarboxylase InhibitorParkinson's DiseaseDrug: BIA 9-1067;Drug: Placebo;Drug: Levodopa/Carbidopa;Drug: Levodopa/BenzerazideBial - Portela C S.A.NULLCompleted30 Years75 YearsAll10Phase 2Portugal;Romania;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
656NCT01533077
(ClinicalTrials.gov)
March 200924/1/2012Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/CarbidopaPharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa in Healthy SubjectsParkinson DiseaseDrug: BIA 9-1067;Drug: Sinemet® 100/25 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsAll18Phase 1Canada
657NCT01399905
(ClinicalTrials.gov)
March 200921/7/2011High and Low Dose Carbidopa Treatment of Parkinson's DiseaseA Randomized Controlled Trial of Four Week Outpatient Treatment of Parkinson's Disease Comparing High and Low Dose Carbidopa.Parkinson's DiseaseDrug: carbidopaOregon Health and Science UniversityNULLCompleted35 Years85 YearsAll14Phase 2United States
658NCT00823836
(ClinicalTrials.gov)
March 200915/1/2009Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's DiseaseClinical Evaluation of Ropinirole PR/XR Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's DiseaseParkinson DiseaseDrug: ropinirole PR/XR;Drug: ropinirole IRGlaxoSmithKlineNULLCompleted20 YearsN/AAll302Phase 3Japan
659NCT00940914
(ClinicalTrials.gov)
March 200916/7/2009Dopaminergic Loss and Pain in Parkinson's DiseaseEvaluation of Radioligand Uptake (FP-CIT) of Dopamine Transporters in Patients Suffering From Parkinson's Disease With or Without PainParkinson's Disease;PainDrug: ioflupane 123I (DATSCAN®)University Hospital, ToulouseNULLCompleted30 Years70 YearsAll20Phase 2France
660NCT00870974
(ClinicalTrials.gov)
March 200926/3/2009A PET Brain Imaging Study of mGluR5 in Subjects With Neuropsychiatric ConditionsEvaluation of [18F]PEB and Positron Emission Tomography (PET) as a Marker of mGluR5 in Subjects w/ Neuropsychiatric ConditionsParkinson Disease;Huntington Disease;Autistic Spectrum Disorders;Fragile X Syndrome;Alzheimer Disease;Mild Cognitive ImpairmentDrug: [18F]FPEBInstitute for Neurodegenerative DisordersNULLCompleted18 Years85 YearsAll48Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
661NCT01533116
(ClinicalTrials.gov)
March 200924/1/2012Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/BenserazideEffect of BIA 9-1067 at Steady-state on the Pharmacokinetics of a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy SubjectsParkinson DiseaseDrug: BIA 9-1067;Drug: Placebo;Drug: levodopa/carbidopa;Drug: levodopa/benserazideBial - Portela C S.A.NULLCompleted25 Years45 YearsAll52Phase 1Canada
662NCT00758368
(ClinicalTrials.gov)
March 200923/9/2008Comparison of Continuous and Pulsatile Apomorphine in Parkinson's DiseaseComparison of Continuous and Pulsatile Apomorphine Administration in Parkinson's Disease Complicated by Levodopa-induced DyskinesiaParkinson's DiseaseDrug: ApomorphineOregon Health and Science UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Withdrawn21 YearsN/AAll0Phase 2United States
663NCT01421719
(ClinicalTrials.gov)
February 200919/8/2011Safety and Efficacy of botulinumA Toxin (BotoxA) for Treatment of Neurogenic Bladder of Parkinson's DiseaseOnabotulinum Toxin Type A (BTX-A) For Treatment of Neurogenic Overactive Bladder Due to Parkinson's Disease: Safety and EfficacyParkinson's Disease;Neurogenic Bladder;Urinary Incontinence;Clostridium Botulinum Toxin Adverse ReactionDrug: Cystoscopic injection of Botox into the urinary bladderStanford UniversityAllerganCompleted50 Years85 YearsAll20Phase 4United States
664NCT00908076
(ClinicalTrials.gov)
February 200921/5/2009Amitiza in Constipation Associated With PD (Parkinson's Disease)Randomized Double-Blind Placebo-Controlled Trial of Lubiprostone in the Treatment of Constipation Associated With Parkinson's DiseaseParkinson's DiseaseDrug: LUBIPROSTONEBaylor College of MedicineUniversity of South FloridaCompleted18 Years85 YearsAll78Phase 4United States
665NCT01039090
(ClinicalTrials.gov)
February 200922/12/2009Efficacy of Continuous Apomorphine Infusion on Cognitive and Neuropsychological Functions in Parkinson's DiseaseProspective, Randomised, Comparative Study Comparing Efficacy of Continuous Apomorphine Infusion Versus Usual Dopaminergic Per os Treatment on Cognitive and Neuropsychological Functions in Parkinson's Disease: a Clinical and PET-scan StudyParkinsons's DiseaseDrug: Continuous Apomorphine infusion;Drug: Usual dopaminergic per os treatmentRennes University HospitalNULLCompleted18 YearsN/AAll21Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
666NCT00357994
(ClinicalTrials.gov)
January 200927/7/2006Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's SubjectsA Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor FluctuationsAdvanced Parkinson's DiseaseDrug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo gel;Drug: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVie (prior sponsor, Abbott)Quintiles, Inc.Completed30 YearsN/AAll36Phase 3United States;Germany
667NCT00857532
(ClinicalTrials.gov)
January 20095/3/2009Florbetapir F 18 PET Imaging of Beta-amyloid in Parkinson's Disease PatientsA Phase 2 Trial of Florbetapir F18 PET Imaging of ß-amyloid in Parkinson's Disease Patients With Cognitive ImpairmentParkinson's DiseaseDrug: florbetapir F 18Avid RadiopharmaceuticalsNational Institutes of Health (NIH);National Institute of Neurological Disorders and Stroke (NINDS)Completed60 YearsN/AAll31Phase 2United States
668NCT00740714
(ClinicalTrials.gov)
December 200822/8/2008Effects of Coenzyme Q10 (CoQ) in Parkinson DiseaseEffects of Coenzyme Q10 in Parkinson Disease - Phase IIIParkinson DiseaseDrug: Coenzyme Q10 with vitamin E;Drug: placebo with vitamin EWeill Medical College of Cornell UniversityNational Institute of Neurological Disorders and Stroke (NINDS);University of RochesterTerminated30 YearsN/AAll600Phase 3United States;Canada
669EUCTR2007-006721-27-GB
(EUCTR)
11/11/200825/02/2009A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease.A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease. idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: CERE-120
Product Code: CERE-120
Ceregene Inc.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United Kingdom
670NCT00869791
(ClinicalTrials.gov)
November 200824/3/2009A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-LevodopaA Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-LevodopaParkinson's DiseaseDrug: IPX066;Drug: IR CD-LDImpax Laboratories, LLCNULLCompleted30 YearsN/AAll27Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
671EUCTR2007-006721-27-AT
(EUCTR)
20/10/200815/09/2008A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease.A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease. idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: CERE-120
Product Code: CERE-120
Ceregene Inc.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2Austria;United Kingdom
672EUCTR2008-003225-16-FI
(EUCTR)
10/09/200830/05/2008Aivostimulaattorin ja levodopainfuusion vaikutus elämänlaatuun ja autonomisen hermoston toimintaan Parkinsonin tautia sairastavilla potilaillaAivostimulaattorin ja levodopainfuusion vaikutus elämänlaatuun ja autonomisen hermoston toimintaan Parkinsonin tautia sairastavilla potilailla Vaikeahoitoinen Parkinsonin tauti potilailla, joille on aiemmin asetettu aivostimulaattori, tai on päädytty päivittäisten oireiden vuoksi aloittamaan Duodopa-infuusio.
MedDRA version: 9.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS
Trade Name: DuodopaOrganisation name was not enteredNULLNot RecruitingFemale: yes
Male: yes
Finland
673NCT01010802
(ClinicalTrials.gov)
August 20088/11/2009Safety Study of Erythropoietin (EPO) in Parkinson's DiseasePhase 1 Study of Recombinant Human Erythropoietin (rhEPO) in Parkinson's Disease (PD)Parkinson DiseaseDrug: Erythropoietin human recombinant (EPOrh)International Center for Neurological Restoration, CubaCentro de Immunologia Molecular, CubaCompleted45 Years75 YearsAll10Phase 1Cuba
674NCT00753636
(ClinicalTrials.gov)
April 200813/9/2008Parkinson's Disease Isradipine Safety StudyPhase II Safety and Tolerability of Isradipine (A Potential Neuroprotective Agent) in Patients With Parkinson's Disease- Stage IIParkinson's DiseaseDrug: Dynacirc CR (Isradipine)Northwestern UniversityNorthwestern Memorial HospitalCompleted30 Years75 YearsAll31Phase 2United States
675NCT00651183
(ClinicalTrials.gov)
April 200831/3/2008Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole TreatmentNon-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole TreatmentParkinson DiseaseDrug: Pramipexole immediate releaseBoehringer IngelheimNULLCompleted18 YearsN/AAll286Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
676NCT00605553
(ClinicalTrials.gov)
April 200815/1/2008Study to Evaluate SYN115 in Parkinson's DiseaseA Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Study to Explore the Effects of 7 Days of Dosing With SYN115 20 mg p.o. BID or 60 mg p.o. BID on Clinical and fMRI Response to Intravenous Levodopa in Patients With Mild to Moderate Parkinson's DiseaseParkinson's DiseaseDrug: Placebo;Drug: TozadenantBiotie Therapies Inc.NULLCompleted40 Years75 YearsAll30Phase 2United States
677NCT00761137
(ClinicalTrials.gov)
March 200825/9/2008Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease PatientsA Two-Phase, Double Blind, Placebo-Controlled, Randomized, Crossover Study of the Safety and Efficacy of Intra-Oral NH004 Films for the Short-Term Relief of Sialorrhea Symptoms in Parkinson's Disease PatientsSialorrhea Secondary to Parkinson's DiseaseDrug: 0.3 mg tropicamide;Drug: 1 mg tropicamide;Drug: 3 mg tropicamide;Drug: 0 mg tropicamideNeuroHealing Pharmaceuticals Inc.Michael J. Fox Foundation for Parkinson's ResearchCompleted50 Years80 YearsAll19Phase 2Argentina
678NCT00658567
(ClinicalTrials.gov)
March 200810/4/2008A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease PsychosisParkinson's Disease PsychosisDrug: Pimavanserin tartrate (ACP-103)ACADIA Pharmaceuticals Inc.NULLCompleted40 YearsN/AAll123Phase 3United States;Austria;Belgium;Italy;Poland;Portugal;Serbia;Spain;Sweden
679NCT00642356
(ClinicalTrials.gov)
March 200819/3/2008Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing OffAn 8-week, Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing OffParkinson's DiseaseDrug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopaNovartisNULLTerminated30 Years85 YearsAll14Phase 4United States
680NCT00607451
(ClinicalTrials.gov)
March 200822/1/2008Safety, Tolerability, PK and PD Study of Neu-120 in the Treatment of Levodopa-induced DyskinesiaA Double-blind, Placebo Controlled, Crossover, Ascending Single Dose Safety Tolerability, Pharmacokinetic and Pharmacodynamic Study of Neu-120 in Patients With Advanced Phase Idiopathic Parkinson's Disease With Levodopa Induced DyskinesiaLevodopa-induced DyskinesiaDrug: Neu-120Neurim Pharmaceuticals Ltd.NULLTerminated30 Years80 YearsAll8Phase 1;Phase 2Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
681EUCTR2007-002964-90-ES
(EUCTR)
18/01/200830/11/2007A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopaA phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopa Ideopathic Parkinson's Disease Enfermedad de Parkinson Idiopática
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono International S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1121Phase 3Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria
682EUCTR2007-002963-28-ES
(EUCTR)
17/01/200816/11/2007A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonistA phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonist Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono International S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1036Phase 3Portugal;Finland;Germany;Czech Republic;Bulgaria;Spain;Italy;Poland
683NCT00601523
(ClinicalTrials.gov)
January 200815/1/2008Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).Parkinson DiseaseDrug: Placebo;Drug: PramipexoleBoehringer IngelheimNULLCompleted30 YearsN/AAll511Phase 3United States;Austria;Czech Republic;Finland;France;Germany;Hungary;India;Japan;Malaysia;Netherlands;Russian Federation;Slovakia;Taiwan;Ukraine;Argentina
684NCT00335153
(ClinicalTrials.gov)
January 20088/6/2006Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's DiseaseAn Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor Fluctuations Despite Optimized Treatment With Available Parkinson's Disease MedicationsAdvanced Parkinson's DiseaseDrug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVie (prior sponsor, Abbott)Quintiles, Inc.Completed30 YearsN/AAll354Phase 3United States;Australia;Canada;Czech Republic;Finland;Germany;Israel;Italy;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Spain;Thailand;United Kingdom;Greece
685NCT01628965
(ClinicalTrials.gov)
January 200825/6/2012A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease PatientsAn Open-label Long-term Extension Trial From Phase II/III of SPM962 (243-07-001) in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopaParkinson's DiseaseDrug: SPM 962Otsuka Pharmaceutical Co., Ltd.NULLCompletedN/AN/AAll143Phase 2;Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
686NCT00623103
(ClinicalTrials.gov)
January 200814/2/2008Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD)Parkinson's Disease DementiaDrug: Rivastigmine capsule;Drug: Rivastigmine transdermal patchNovartisNULLCompleted50 Years85 YearsAll583Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Turkey;United Kingdom
687NCT00612872
(ClinicalTrials.gov)
January 200816/1/2008Evaluation of [123I]CLINDE and SPECT as a Marker of Inflammation in Subjects With PD or AD and in Healthy SubjectsEvaluation of [123I]CLINDE and SPECT as a Marker of Inflammation in Subjects With Parkinson Disease or Alzheimer Disease and in Healthy SubjectsParkinson Disease;Alzheimer Disease;Healthy Controls;Multiple SclerosisDrug: [123I]CLINDEInstitute for Neurodegenerative DisordersNULLTerminated30 Years50 YearsAll46Phase 1United States
688NCT00526630
(ClinicalTrials.gov)
December 20075/9/2007Methylphenidate for the Treatment of Gait Impairment in Parkinson's DiseaseMethylphenidate for the Treatment of Gain Impairment in Parkinson's Disease: a Randomized Double-Blind, Placebo-Controlled, Cross-over StudyParkinson's Disease;Gait ImpairmentDrug: Methylphenidate (MPD);Drug: PlaceboUniversity of CincinnatiMichael J. Fox Foundation for Parkinson's ResearchCompleted35 Years85 YearsAll23Phase 4United States
689NCT00577460
(ClinicalTrials.gov)
December 200719/12/2007Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PDLong-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD)Parkinson DiseaseDrug: Pramipexole;Drug: PlaceboBoehringer IngelheimNULLCompleted32 YearsN/AAll391Phase 3Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom
690NCT00584025
(ClinicalTrials.gov)
December 200721/12/2007Keppra IV for the Treatment of Motor Fluctuations in Parkinson's DiseaseParkinson's DiseaseDrug: levetiracetam;Drug: PlaceboUniversity of South FloridaNULLWithdrawn30 Years80 YearsAll0Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
691NCT00537017
(ClinicalTrials.gov)
November 23, 200727/9/2007Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 (Preladenant) 5 mg BID (P05175)Parkinson Disease;Neurodegenerative Diseases;Central Nervous System Diseases;Movement Disorders;Brain DiseasesDrug: Preladenant;Drug: L-dopa;Drug: Other Parkinson's Disease treatmentsMerck Sharp & Dohme Corp.NULLCompleted30 YearsN/AAll140Phase 2Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Singapore;Spain;United States
692NCT00560508
(ClinicalTrials.gov)
November 200716/11/2007A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment PeriodA Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With Parkinson's Disease (PD) on L-dopa Therapy, Followed by a 52-week Open-label Long-term Treatment Period to Evaluate the Long-term Safety and Efficacy of Pramipexole ERParkinson DiseaseDrug: Pramipexole Immediate Release;Drug: Pramipexole Extended ReleaseBoehringer IngelheimNULLCompleted1 YearN/AAll112Phase 2;Phase 3Japan
693NCT00610103
(ClinicalTrials.gov)
November 200722/1/2008Phase 2 Clinical Study of KW-6500 in Parkinson's Disease Patients With Motor Response Complication on Levodopa TherapyA Phase 2 Clinical Study of KW-6500 (Apomorphine Hydrochloride) in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: apomorphine hydrochlorideKyowa Kirin Co., Ltd.NULLCompleted20 YearsN/AAll16Phase 2Japan
694EUCTR2005-005791-32-SE
(EUCTR)
04/10/200730/07/2007Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease.Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney.
MedDRA version: 9.1;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes)
Product Name: HF0220
Product Code: HF0220
Other descriptive name: 7-beta-hydroxyepiandrosterone
Hunter-Fleming LtdNULLNot RecruitingFemale: yes
Male: yes
40United Kingdom;Sweden
695NCT00566462
(ClinicalTrials.gov)
October 200729/11/2007Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECTAssessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECTParkinson's DiseaseDrug: perampanel;Drug: placeboEisai Inc.NULLTerminated30 YearsN/AAll1Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
696NCT00547911
(ClinicalTrials.gov)
October 200719/10/2007Augmenting Effects of L-DOPS With Carbidopa and EntacaponeL-Dihydroxyphenylserine (L-DOPS) for Norepinephrine Deficiency: Interactions With Carbidopa and EntacaponeParkinson Disease;Multiple System Atrophy;Autonomic Nervous System DiseasesDrug: Droxidopa;Drug: Carbidopa;Drug: EntacaponeNational Institute of Neurological Disorders and Stroke (NINDS)NULLTerminated18 YearsN/AAll14Phase 1;Phase 2United States
697NCT00558025
(ClinicalTrials.gov)
October 200712/11/2007Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson DiseaseA Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IRParkinson DiseaseDrug: Pramipexole Extended Release;Drug: Pramipexole Immediate ReleaseBoehringer IngelheimNULLCompleted30 YearsN/AAll156Phase 3France;Germany;Netherlands
698NCT00537485
(ClinicalTrials.gov)
September 200727/9/2007A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease PatientsA Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopaEarly Parkinson's DiseaseDrug: SPM 962;Drug: placeboOtsuka Pharmaceutical Co., Ltd.NULLCompleted30 Years79 YearsAll180Phase 2;Phase 3Japan
699NCT00594464
(ClinicalTrials.gov)
September 200721/12/2007A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing SurgeryAn Explorative, Multicenter, Open-label Pilot Trial With Neupro® (Rotigotine Transdermal Patch) Once Daily Treatment Administered Perioperatively in Patients With Idiopathic Parkinson's DiseaseParkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted18 Years80 YearsAll14Phase 4Germany
700NCT00407095
(ClinicalTrials.gov)
August 200730/11/2006An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.Advanced Stage Parkinson's DiseaseDrug: PardoprunoxSolvay PharmaceuticalsNULLCompleted30 YearsN/ABoth140Phase 3United States;Albania;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Latvia;Lithuania;Peru;Russian Federation;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
701NCT00593606
(ClinicalTrials.gov)
July 200721/12/2007Safety and Tolerability Trial of Switching From Ropinirole to RotigotineA Phase 3b, Open-Label, Multicenter Trial to Assess the Safety and Tolerability of Switching Korean Subjects From Ropinirole to the Rotigotine Transdermal System and Its Effect on Symptoms in Idiopathic Parkinson's DiseaseParkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted18 YearsN/AAll124Phase 3NULL
702NCT00515437
(ClinicalTrials.gov)
July 200710/8/2007A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease PatientsA Multi-Center, Randomized, Double-blind, Placebo-Controlled,Sequential Dose Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease PatientsDroolingBiological: Botulinum Toxin Type B (Myobloc);Biological: Matched placebo to MyoblocSolstice NeurosciencesNULLCompleted18 Years85 YearsAll54Phase 2United States
703NCT00505622
(ClinicalTrials.gov)
July 20079/7/2007Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor FluctuationsParkinson's DiseaseDrug: PerampanelEisai LimitedNULLTerminated30 YearsN/AAll328Phase 3France
704NCT00550238
(ClinicalTrials.gov)
July 200726/10/2007A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease PsychosisA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's DiseaseParkinson's Disease PsychosisDrug: Pimavanserin tartrate (ACP-103)ACADIA Pharmaceuticals Inc.NULLCompleted40 YearsN/AAll459Phase 3United States;Austria;Belgium;Canada;France;India;Italy;Poland;Portugal;Russian Federation;Serbia;Sweden;Ukraine;United Kingdom
705NCT00522379
(ClinicalTrials.gov)
July 200728/8/2007Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal PatchA Multicenter, Randomized, Double-blind, Placebo-controlled, 5-arm, Parallel-group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-stage Parkinson's DiseaseParkinson's DiseaseDrug: Rotigotine;Other: PlaceboUCB PharmaNULLCompleted30 YearsN/AAll514Phase 3United States;Chile;India;Mexico;Peru
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
706NCT00519532
(ClinicalTrials.gov)
July 200721/8/2007Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's DiseaseA Multicenter, Multinational, Phase 3b, Open-label Extension Trial to Evaluate the Long-term Effect of the 24-hour Transdermal Delivery of Rotigotine on Motor Function, Sleep Quality, and Nocturnal and Non-motor Symptoms in Subjects With Idiopathic Parkinson's DiseaseParkinson's DiseaseDrug: RotigotineUCB PharmaNULLTerminated18 YearsN/AAll84Phase 3United States;Australia;Finland;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom;Austria
707NCT00485069
(ClinicalTrials.gov)
June 200711/6/2007REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 StudyPost-Marketing Clinical Study of REQUIP (Ropinirole Hydrochloride) Tablets in Patients With Parkinson's Disease- Evaluation of Long-Term Efficacy and Safety -Parkinson Disease;Parkinson's DiseaseDrug: ROP;Drug: ROP+L-DopaGlaxoSmithKlineNULLCompleted20 YearsN/AAll123Phase 4Japan
708NCT00477672
(ClinicalTrials.gov)
June 200722/5/2007A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease PsychosisA Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's DiseaseParkinson's Disease PsychosisDrug: Pimavanserin tartrate (ACP-103);Drug: PlaceboACADIA Pharmaceuticals Inc.NULLCompleted40 YearsN/AAll298Phase 3United States;Bulgaria;France;India;Russian Federation;Ukraine;United Kingdom
709NCT00571285
(ClinicalTrials.gov)
June 20077/12/2007Clinical Effects of Vitamin D Repletion in Patients With Parkinson's DiseaseClinical Effects of Vitamin D Repletion in Patients With Parkinson's DiseaseParkinson's DiseaseDietary Supplement: Vitamin D3;Dietary Supplement: Vitamin D3 - high dose;Dietary Supplement: PlaceboEmory UniversityNULLTerminated18 Years89 YearsAll31Phase 4United States
710EUCTR2007-000074-23-ES
(EUCTR)
29/05/200702/03/2010A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).Estudio aleatorizado, doble ciego, doble simulación, controlado con placebo de tres grupos paralelos que compara la eficacia, la seguridad y la tolerabilidad de pramipexol ER frente a placebo y frente a pramipexol IR administrados por vía oral durante una fase de mantenimiento de 26 semanas de duración en pacientes con enfermedad de Parkinson (EP) avanzada tratados con L-Dopa+.A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).Estudio aleatorizado, doble ciego, doble simulación, controlado con placebo de tres grupos paralelos que compara la eficacia, la seguridad y la tolerabilidad de pramipexol ER frente a placebo y frente a pramipexol IR administrados por vía oral durante una fase de mantenimiento de 26 semanas de duración en pacientes con enfermedad de Parkinson (EP) avanzada tratados con L-Dopa+. Pacientes varones o mujeres, diagnosticados de enfermedad de Parkinson idiopática, al menos dos años antes, con 30 años o más de edad en el momento del diagnóstico, con un estadío entre 2 y 4 en la escala modificada de Hoehn y Yahr en el periodo on.Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Trade Name: SIFROL
INN or Proposed INN: Pramipexole
Boehringer Ingelheim España, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
516Phase 1Hungary;United Kingdom;Spain;Italy;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
711EUCTR2006-006752-35-ES
(EUCTR)
27/05/200727/03/2007RECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - RecoverRECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Recover Enfermedad de Parkinson(Parkinson's disease)
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Neupro 2mg/24 h transdermal patch
Product Code: ND1587
INN or Proposed INN: Rotigotine
Trade Name: Neupro 4mg/24 h transdermal patch
Product Code: ND1589
INN or Proposed INN: Rotigotine
Trade Name: Neupro 6mg/24 h transdermal patch
Product Code: ND1590
INN or Proposed INN: Rotigotine
Trade Name: Neupro 8 mg/24 h transdermal patch
Product Code: ND1702
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3BHungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
712NCT00474058
(ClinicalTrials.gov)
May 200714/5/2007Randomized Evaluation of the 24-Hour Coverage: Efficacy of RotigotinePhase 3B, Multicenter, Multinational, Double-Blind, Placebo Controlled, 2-Arm Trial to Evaluate the Effect of the 24-Hour Transdermal Delivery of Rotigotine on the Control of Early Morning Motor Function, Sleep Quality, Nocturnal Symptoms, and Non-Motor Symptoms in Subjects With Idiopathic Parkinson's DiseaseParkinson's DiseaseDrug: Rotigotine;Other: PlaceboUCB PharmaNULLCompleted18 YearsN/AAll287Phase 3United States;Australia;Austria;Finland;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom
713NCT00477802
(ClinicalTrials.gov)
May 200722/5/2007Botulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's DiseaseBotulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's Disease: A Double-Blind, Randomized, Placebo Controlled, Cross-Over Design StudyParkinson DiseaseBiological: Botulinum Toxin Type A;Biological: PlaceboUniversity of CincinnatiAllerganTerminated35 Years75 YearsBoth8Phase 4United States
714NCT00489255
(ClinicalTrials.gov)
May 200720/6/2007Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and TreatmentA Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Trimethobenzamide (Tigan®) in the Control of Nausea and Vomiting During Initiation and Continued Treatment With Subcutaneous Apomorphine (Apokyn®) in Apomorphine-naïve Subjects With Parkinson's Disease Suffering From Acute Intermittent Off Episodes, With Phased Withdrawal of Subjects From Tigan® to PlaceboParkinson's DiseaseDrug: Tigan®;Drug: PlaceboIpsenINC Research LimitedCompleted18 YearsN/AAll117Phase 4United States
715NCT00479401
(ClinicalTrials.gov)
May 200725/5/2007Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD PatientsA Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD).Early Parkinson Disease (Early PD)Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: PlaceboBoehringer IngelheimNULLCompleted30 YearsN/AAll539Phase 3United States;Argentina;Austria;Czech Republic;Finland;Germany;Hungary;India;Japan;Malaysia;Russian Federation;Slovakia;Taiwan;Ukraine;Brazil
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
716EUCTR2006-000577-29-DE
(EUCTR)
27/04/200712/10/2006Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s SubjectsA Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s Subjects Receiving Optimized Treatments with Parkinson Medicinal Products who Continue toExperience Persistent Motor Fluctuations Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: DUODOPA®Intestinal Gel
INN or Proposed INN: Levodopa
Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate
Trade Name: Sinemet®25-100
INN or Proposed INN: Levodopa
Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate
Abbott Products, Inc (Abbott Products Inc. is part of the parent company, Abbott Laboratories)NULLNot RecruitingFemale: yes
Male: yes
31United States;Germany
717EUCTR2007-000307-15-IT
(EUCTR)
24/04/200723/08/2007Safety and Efficacy of Melperone in the Treatment of Patients with Psychosis Associated with Parkinson's Disease.Safety and Efficacy of Melperone in the Treatment of Patients with Psychosis Associated with Parkinson's Disease. Psicosi associata al morbo di Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: Melperon
INN or Proposed INN: melperon
OVATION PHARMACEUTICALS INCNULLNot RecruitingFemale: yes
Male: yes
90Italy
718NCT00434304
(ClinicalTrials.gov)
April 9, 20079/2/2007Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study -Parkinson DiseaseDrug: Ropinirole prolonged release/extended release(PR/XR)GlaxoSmithKlineNULLCompleted20 YearsN/AAll62Phase 2Japan
719NCT00438607
(ClinicalTrials.gov)
April 200720/2/2007Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects With Moderate to Late Stage Parkinson's Disease Who Are Also Receiving Treatment With LevodopaParkinson's DiseaseDrug: BIIB014;Drug: PlaceboBiogen IdecNULLCompleted30 YearsN/ABoth83Phase 2India;Israel;United Kingdom
720NCT00466167
(ClinicalTrials.gov)
April 200725/4/2007Pivotal Study in Advanced Parkinsons Disease PatientsA Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).Parkinson DiseaseDrug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: PlaceboBoehringer IngelheimNULLCompleted32 YearsN/AAll517Phase 3Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
721NCT00437125
(ClinicalTrials.gov)
March 200716/2/2007Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's DiseaseAn Open Label Pilot Study on the Tolerability of Duloxetine in the Treatment of Depressed Patients With Parkinson's DiseaseMajor Depressive Disorder;Idiopathic Parkinson DiseaseDrug: Duloxetine hydrochlorideEli Lilly and CompanyNULLCompleted30 Years75 YearsAll151Phase 4Italy
722NCT00449865
(ClinicalTrials.gov)
March 200720/3/2007NET-PD LS-1 Creatine in Parkinson's DiseaseA Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Subjects With Treated Parkinson's Disease (PD) Long Term Study (LS-1)Parkinson's DiseaseDrug: creatine;Other: placeboUniversity of RochesterNational Institute of Neurological Disorders and Stroke (NINDS)TerminatedN/AN/AAll1741Phase 3United States;Canada
723NCT00443872
(ClinicalTrials.gov)
March 20073/3/2007Efficacy of Orally Disintegrating Selegiline in Parkinson's Patients Experiencing Adverse Effects With Dopamine AgonistsAdding Orally Disintegrating Selegiline (Zelapar) to Patients Taking Dopamine Agonists and Experiencing ComplicationsParkinson's DiseaseDrug: orally disintegrating selegiline (Zelapar)Parkinson's Disease and Movement Disorder Center of Boca RatonValeant Pharmaceuticals International, Inc.Completed30 Years90 YearsAll77Phase 4United States
724NCT00427011
(ClinicalTrials.gov)
February 200724/1/2007A Study of E2007 In Patients With Parkinson's DiseaseA Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing-Off Motor FluctuationsParkinson's DiseaseDrug: E2007Eisai Inc.NULLTerminated18 YearsN/AAll25Phase 2United States
725NCT00480701
(ClinicalTrials.gov)
February 200730/5/2007Evaluation of 123-I Iodobenzovesamicol (IBVM) and SPECT Imaging of Healthy Subjects and Patients With Alzheimer DiseaseEvaluation of 123-I Iodobenzovesamicol (IBVM) and SPECT as a Marker of Acetylcholine Transporter Density in the Brain of Healthy Subjects and Patients With Alzheimer DiseaseAlzheimer Disease;Parkinson DiseaseDrug: [123I]-IBVMInstitute for Neurodegenerative DisordersNULLCompleted50 YearsN/ABoth26Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
726EUCTR2006-003490-27-GB
(EUCTR)
19/12/200629/09/2006A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects with Moderate to Late Stage Parkinson’s Disease Who Are Also Receiving Treatment with LevodopaA Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects with Moderate to Late Stage Parkinson’s Disease Who Are Also Receiving Treatment with Levodopa Parkinson's disease
MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease
BIOGEN IDEC LTDNULLNot Recruiting Female: yes
Male: yes
137Phase 2United Kingdom
727NCT01631812
(ClinicalTrials.gov)
December 200625/6/2012A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease PatientsAn Open-label Long-term Extension Trial From Late Phase II of SPM962 (243-05-001) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopaParkinson's DiseaseDrug: SPM 962Otsuka Pharmaceutical Co., Ltd.NULLCompletedN/AN/AAll130Phase 2Japan
728NCT00406029
(ClinicalTrials.gov)
November 20, 200630/11/2006Dyskinesia in Parkinson's Disease (Study P04501)A Phase 2, 12-Week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and DyskinesiasParkinson Disease;Movement Disorders;Central Nervous System Diseases;Neurodegenerative Diseases;Brain DiseasesDrug: Preladenant;Drug: Placebo;Drug: L-dopa;Drug: Other Parkinson's Disease treatmentsMerck Sharp & Dohme Corp.NULLCompleted30 YearsN/AAll253Phase 2Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Italy;New Zealand;Peru;Singapore;South Africa;Spain;United States
729EUCTR2006-001793-24-PT
(EUCTR)
07/11/200631/07/2006A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not availableA MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI.
MedDRA version: 7;Level: LLT;Classification code 10061536
Product Name: Nebicapone
Product Code: BIA 3-202
Trade Name: COMTAN®
Product Name: Entacapone
INN or Proposed INN: Entacapone
Product Name: Nebicapone
Product Code: BIA 3-202
Product Name: Nebicapone
Product Code: BIA 3-202
BIAL - Portela & Cª, SANULLNot RecruitingFemale: yes
Male: yes
250Portugal;Austria
730NCT00404170
(ClinicalTrials.gov)
November 200622/11/2006Assessing Imaging as a Tool in Monitoring and Predicting the Progression of Parkinson DiseaseAssessing the Determinants of PD Progression - Long-term Dopamine Transporter Imaging in the PRECEPT CohortParkinson DiseaseDrug: B-CIT and SPECT imagingInstitute for Neurodegenerative DisordersUnited States Department of DefenseCompleted30 YearsN/AAll396Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
731NCT00387075
(ClinicalTrials.gov)
November 200610/10/2006A Study Evaluating Potential Screening Tools for Detecting Parkinson DiseaseParkinson Associated Risk Factor Study (PARS): Evaluating Potential Screening Tools for Parkinson DiseaseParkinson DiseaseProcedure: [123I]ß-CIT and SPECT imaging;Drug: [123I]ß-CITInstitute for Neurodegenerative DisordersUnited States Department of Defense;Molecular NeuroImagingActive, not recruiting50 YearsN/AAll3000Phase 2United States
732NCT00397228
(ClinicalTrials.gov)
November 20066/11/2006ALTROPANE® SPECT Imaging in Patients With Parkinson DiseaseOptimizing the Performance of ALTROPANE® SPECT Imaging in Patients With Parkinson DiseaseParkinson DiseaseDrug: ALTROPANE®Molecular NeuroImagingInstitute for Neurodegenerative DisordersCompleted30 YearsN/ABoth27Phase 2United States
733NCT00402233
(ClinicalTrials.gov)
November 200619/11/2006A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) PatientsA Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Efficacy Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over a 12-week Treatment Phase in Early Parkinson's Disease Patients (PramiBID)Parkinson DiseaseDrug: Pramipexole;Drug: PlaceboBoehringer IngelheimNULLCompleted31 YearsN/AAll312Phase 4United States
734NCT00360308
(ClinicalTrials.gov)
November 20062/8/2006Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo and Entacapone Controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsParkinson's DiseaseDrug: Placebo;Drug: E2007Eisai LimitedNULLTerminated30 YearsN/AAll723Phase 3France
735NCT00400634
(ClinicalTrials.gov)
November 200615/11/2006Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's DiseaseMulticenter, Randomized, Double-Blind, Sham Surgery-Controlled Study of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) to Assess the Efficacy and Safety of Bilateral Intraputaminal (IPu) Delivery in Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]);Procedure: Sham SurgeryCeregeneNULLCompleted35 Years75 YearsAll58Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
736NCT00399477
(ClinicalTrials.gov)
October 200610/11/2006A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's DiseaseOpen-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD)Parkinson's DiseaseDrug: rasagiline mesylate;Drug: Rasagiline mesylate plus Mirapex;Drug: Rasagiline mesylate with Levodopa;Drug: Rasagiline mesylate with RequipTeva Neuroscience, Inc.NULLCompleted30 YearsN/ABoth200Phase 4United States
737NCT00391898
(ClinicalTrials.gov)
October 200624/10/2006Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-offA 3-month, Multi-center, Double-blind, Randomized Study to Evaluate the Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Impairment of Activities of Daily Living and Early Wearing-off With LevodopaParkinson's DiseaseDrug: Levodopa/carbidopa/entacapone;Drug: Levodopa/carbidopaNovartisNULLCompleted30 Years80 YearsAll95Phase 4Spain
738NCT03103399
(ClinicalTrials.gov)
September 26, 200628/3/2017Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff PhenomenonA Multicentre, Double-blind, Randomised, Active- and Placebo-controlled Trial to Investigate the Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff Phenomenon Treated With Levodopa/Carbidopa or Levodopa/BenserazideParkinson DiseaseDrug: Comtan®;Drug: Nebicapone;Drug: Levodopa/DDCI;Drug: PlaceboBial - Portela C S.A.NULLCompleted30 Years80 YearsAll254Phase 2NULL
739EUCTR2005-001006-12-CZ
(EUCTR)
06/09/200624/08/2006Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSODouble-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.
MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated
Product Name: Lisparin
INN or Proposed INN: Lisuride Hydrogenmaleate
Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea
Axxonis Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Germany;Czech Republic;Italy;Austria
740NCT00368108
(ClinicalTrials.gov)
August 200622/8/2006Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsA Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsParkinson's DiseaseDrug: 2 mg perampanel;Drug: 4 mg perampanel;Drug: placebo comparatorEisai Inc.NULLCompleted30 YearsN/AAll752Phase 3United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
741NCT01628848
(ClinicalTrials.gov)
August 200624/6/2012A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease PatientsA Placebo-controlled Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopaParkinson's DiseaseDrug: SPM 962;Drug: PlaceboOtsuka Pharmaceutical Co., Ltd.NULLCompleted30 Years79 YearsAll174Phase 2Japan
742EUCTR2006-001793-24-AT
(EUCTR)
31/07/200624/07/2006A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not availableA MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI.
MedDRA version: 7;Level: LLT;Classification code 10061536
Product Name: Nebicapone
Product Code: BIA 3-202
Product Name: Entacapone
INN or Proposed INN: Entacapone
Product Name: Nebicapone
Product Code: BIA 3-202
Product Name: Nebicapone
Product Code: BIA 3-202
BIAL - Portela & Cª, SANULLNot RecruitingFemale: yes
Male: yes
250Portugal;Austria
743EUCTR2006-000391-32-NL
(EUCTR)
18/07/200610/05/2006A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's DiseaseA 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Apomorphine Nasal Powder
Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate
Britannia Pharmaceuticals LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Germany;United Kingdom;Netherlands
744NCT03097211
(ClinicalTrials.gov)
July 17, 200627/3/2017Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mgA Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mgParkinson DiseaseDrug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: NebicaponeBial - Portela C S.A.NULLCompleted18 Years45 YearsAll38Phase 1Portugal
745EUCTR2006-000680-28-ES
(EUCTR)
07/07/200622/05/2006Estudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBIEstudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBI Enfermedad de Parkinson (Parkinson Disease)Trade Name: Stalevo 100
Product Name: Stalevo (levodopa/carbidopa/entacapona)
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: ENTACAPONA
Trade Name: Sinemet plus
Product Name: Sinemet plus (levodopa/carbidopa)
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Trade Name: Stalevo 150
Product Name: Stalevo (levodopa/carbidopa/entacapona)
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: ENTACAPONA
NOVARTIS FARMACEUTICA, S.ANULLNot RecruitingFemale: yes
Male: yes
200Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
746EUCTR2006-000391-32-DE
(EUCTR)
04/07/200627/04/2006A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's DiseaseA 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease Alleviation of acute episodes of motor symptoms associated with Parkinson's DiseaseProduct Name: Apomorphine Nasal Powder
Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
130United Kingdom;Germany;Netherlands
747NCT00354133
(ClinicalTrials.gov)
July 200619/7/2006Controlled Trial With Deep Brain Stimulation in Patients With Early Parkinson's DiseaseThe Effect of Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) on Quality of Life in Comparison to Best Medical Treatment in Patients With Complicated Parkinson's Disease and Preserved Psychosocial Competence (EARLYSTIM-study)Parkinson DiseaseDevice: Kinetra and Soletra (neurostimulator, Medtronic);Drug: Best Medical TreatmentGerman Parkinson Study Group (GPS)University Hospital Schleswig-Holstein;Assistance Publique - Hôpitaux de Paris;KKS NetzwerkActive, not recruiting18 Years60 YearsAll251Phase 4France;Germany
748NCT00346827
(ClinicalTrials.gov)
July 200629/6/2006Apomorphine Nasal Powder in the Treatment of Parkinson's Disease Off Periods.Parkinson's DiseaseDrug: Apomorphine Nasal PowderBritannia Pharmaceuticals Ltd.NULLCompleted18 Years85 YearsAll36Phase 2;Phase 3NULL
749NCT00331149
(ClinicalTrials.gov)
June 20, 200626/5/2006A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson'sA Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment With Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468) in Advanced Stage Parkinson's Disease Subjects Who Are Not Adequately Controlled on L-dopa.Parkinson DiseaseDrug: Ropinirole prolonged release;Drug: ropinirole immediate releaseGlaxoSmithKlineNULLCompleted30 YearsN/AAll343Phase 3Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic
750EUCTR2006-000391-32-GB
(EUCTR)
06/06/200621/04/2006A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's DiseaseA 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Apomorphine Nasal Powder
Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
130Phase 3Netherlands;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
751EUCTR2005-004949-34-ES
(EUCTR)
29/05/200621/04/2006A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start StudyA randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start Study Parkinson's disease
MedDRA version: 6.1;Level: pref;Classification code 10061536
Trade Name: Sifrol, Mirapexin
Product Name: Sifrol, Mirapexin
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol, Mirapexin
Product Name: Sifrol, Mirapexin
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol, Mirapexin
Product Name: Sifrol, Mirapexin
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
500Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
752NCT00321854
(ClinicalTrials.gov)
May 20063/5/2006Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease.Parkinson DiseaseDrug: pramipexoleBoehringer IngelheimNULLCompleted30 Years79 YearsAll535Phase 4United States;Austria;Finland;France;Germany;Italy;Japan;Spain;Sweden;United Kingdom
753NCT00324896
(ClinicalTrials.gov)
May 20069/5/2006Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of EszopicloneTreatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of EszopicloneParkinson's Disease;InsomniaDrug: eszopiclone;Other: placeboUniversity of Medicine and Dentistry of New JerseySunovionCompleted35 Years85 YearsAll30Phase 3United States
754NCT03094156
(ClinicalTrials.gov)
April 26, 200623/3/2017Effect of BIA 6-512 at Steady-state on the Levodopa PharmacokineticsA Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Entacapone 200 mgParkinson DiseaseDrug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: Comtan®Bial - Portela C S.A.NULLCompleted18 Years45 YearsAll39Phase 1Portugal
755EUCTR2005-005791-32-GB
(EUCTR)
24/04/200617/02/2006Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease.Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney.
MedDRA version: 9.1;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes)
Hunter-Fleming LtdNULLNot Recruiting Female: yes
Male: yes
40Phase 2United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
756EUCTR2005-001006-12-AT
(EUCTR)
02/04/200628/02/2006Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSODouble-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.Product Name: Lisparin
INN or Proposed INN: Lisuride Hydrogenmaleate
Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate
Trade Name: Sifrol, 0,35 mg Tablette
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Trade Name: Sifrol, 0,70 mg Tablette
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Trade Name: Cabaseril, 1,0 mg Tablette
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea
Trade Name: Cabaseril, 2,0 mg Tablette
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]-
Axxonis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Germany;Czech Republic;Italy;Austria
757NCT00294554
(ClinicalTrials.gov)
April 200621/2/2006Memantine for Treatment of Cognitive Impairment in Patients With Parkinson's Disease and DementiaDouble-Blind Placebo-Controlled Trial of Memantine for Treatment of Cognitive Impairment in Patients With Parkinson's Disease and DementiaParkinson's Disease;Cognitive Impairment;DementiaDrug: Memantine;Drug: Placebo Oral TabletJohns Hopkins UniversityForest LaboratoriesCompleted50 YearsN/AAll20N/AUnited States
758NCT00467597
(ClinicalTrials.gov)
April 200627/4/2007Developing Objective Measures of Levodopa Induced Dyskinesia: (Study 1)Quantification of Levodopa Induced Dyskinesia in Parkinson Disease: Developing Objective Measures of Levodopa Induced Dyskinesia (Study One)Dyskinesias;Movement Disorders;Parkinson DiseaseDrug: Levodopa (delivered intravenously)VA Office of Research and DevelopmentOregon Health and Science UniversityCompleted21 YearsN/AAll36N/AUnited States
759EUCTR2005-001006-12-DE
(EUCTR)
09/03/200605/09/2006Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSODouble-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.
MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated
Product Name: Lisparin
INN or Proposed INN: Lisuride Hydrogenmaleate
Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea
Axxonis Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Germany;Italy;Austria
760NCT00297778
(ClinicalTrials.gov)
March 200628/2/2006Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive SymptomsA Randomized, Double-blind, Placebo-controlled, Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinson's Disease Patients With Stable Motor Function and Depressive SymptomsParkinson Disease;DepressionDrug: Pramipexole;Other: PlaceboBoehringer IngelheimNULLCompleted30 Years80 YearsAll296Phase 4Austria;Finland;France;Germany;Italy;Netherlands;Norway;Romania;Russian Federation;South Africa;Spain;Sweden;Ukraine;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
761NCT00141518
(ClinicalTrials.gov)
March 200630/8/2005Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic ImpactA Long-term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/DyskinesiaAdvanced Idiopathic Parkinson's DiseaseDrug: Levodopa-carbidopa intestinal gel (LCIG);Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: percutaneous endoscopic gastrostomy tube (PEG tube);Device: jejunal extension tube (J-tube)AbbVie (prior sponsor, Abbott)NULLCompleted18 Years99 YearsAll77Phase 4Norway;Sweden
762NCT00282152
(ClinicalTrials.gov)
March 200623/1/2006Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)Safety and Tolerability of Neurostimulation in Early Stage Parkinson's DiseaseParkinson's DiseaseDevice: B-STN DBS;Drug: Optimal drug therapyVanderbilt University Medical CenterNULLCompleted50 Years75 YearsAll37N/AUnited States
763EUCTR2005-003788-22-ES
(EUCTR)
09/02/200628/12/2005A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivosA randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivos A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptomsTrade Name: Mirapexin / Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Mirapexin/Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Mirapexin/Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Mirapexin/Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim España S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 1Finland;Germany;United Kingdom;Spain;Italy;Sweden
764NCT00296192
(ClinicalTrials.gov)
February 200622/2/2006Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson SymptomsA Double-Blind, Placebo-Controlled, Parallel-Group, Proof of Concept Trial to Assess the Tolerability, Safety, and Efficacy of Rotigotine Nasal Spray for the Acute Treatment of OFF Symptoms in Subjects With Advanced-Stage, Idiopathic Parkinson DiseaseParkinson's DiseaseDrug: Rotigotine nasal spray;Other: PlaceboUCB PharmaNULLCompleted30 YearsN/AAll82Phase 2Germany
765NCT03095105
(ClinicalTrials.gov)
January 24, 200623/3/2017Pharmacokinetic Profile of BIA 6-512 in Healthy Elderly Subjects Versus Healthy Young SubjectsAn Open-label, Parallel-group Study to Compare the Pharmacokinetic Profile in Healthy Elderly Subjects Versus Healthy Young Subjects After Single and Repeated Oral Administration of BIA 6-512 (Trans-resveratrol)Parkinson DiseaseDrug: 200 mg BIA 6-512Bial - Portela C S.A.NULLCompleted18 YearsN/AAll25Phase 1Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
766NCT00292227
(ClinicalTrials.gov)
January 200614/2/2006Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's DiseaseDouble-blind, Randomized, Placebo- and Positive-controlled, Parallel-group Trial to Assess the Potential Electrocardiographic Effects of Rotigotine Transdermal System up to 120 cm2/54.0 mg/Day in Subjects With Advanced-stage Idiopathic Parkinson's Disease: A Thorough QT/QTc Trial.Parkinson's DiseaseDrug: Rotigotine;Other: Placebo;Drug: Moxifloxacin infusion;Other: Placebo infusionUCB PharmaNULLCompleted18 YearsN/AAll130Phase 1South Africa
767NCT00275275
(ClinicalTrials.gov)
January 20069/1/2006Pramipexole Conversion to Ropinirole Controlled Release (CR)An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease.Parkinson DiseaseDrug: Requip PR;Drug: MirapexRajesh Pahwa, MDGlaxoSmithKlineCompleted18 YearsN/AAll61Phase 3United States
768NCT00279825
(ClinicalTrials.gov)
January 200618/1/2006Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet in Subjects With Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: IPX054 200 mg;Drug: IPX054 250 mg;Drug: CD-LD IR;Drug: CD-LD CR;Drug: IPX054 200 mg Placebo;Drug: IPX054 250 mg Placebo;Drug: CD-LD IR Placebo;Drug: CD-LD CR PlaceboImpax Laboratories, LLCNULLCompleted30 YearsN/AAll16Phase 2United States
769NCT00253084
(ClinicalTrials.gov)
November 200511/11/2005Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's DiseaseA Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: IPX054 200 mg;Drug: CD-LD IR;Drug: IPX054 Placebo;Drug: CD-LD IR PlaceboImpax Laboratories, LLCNULLCompleted30 YearsN/AAll12Phase 2United States
770NCT00256204
(ClinicalTrials.gov)
November 200516/11/2005A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's DiseaseA Multi Center, Double Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease SubjectsParkinson's DiseaseDrug: Rasagiline Mesylate;Other: PlaceboTeva Pharmaceutical IndustriesNULLCompleted30 Years80 YearsAll1174Phase 3Argentina;Austria;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Romania;Spain;United Kingdom;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
771NCT00912808
(ClinicalTrials.gov)
October 20052/6/2009Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's DiseaseA Study of Cholinergic Augmentation in Frequently Falling Subjects With Parkinson'sParkinson's DiseaseDrug: Donepezil;Drug: Sugar Pill (placebo)Oregon Health and Science UniversityNULLCompleted21 YearsN/AAll23N/ANULL
772NCT00199381
(ClinicalTrials.gov)
October 200512/9/2005An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001An Open-Label Multicenter Study of the Continued Safety of Istradefylline (KW-6002) In Subjects With Parkinson's Disease Who Have Recently Completed One Year of Treatment With Istradefylline.Parkinson's DiseaseDrug: IstradefyllineKyowa Kirin Pharmaceutical Development, Inc.NULLTerminated30 YearsN/AAll504Phase 3United States
773NCT00239564
(ClinicalTrials.gov)
October 200513/10/2005Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's DiseaseAn Open-Label Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: IPX054 100 mg;Drug: IPX054 150 mg;Drug: IPX054 200 mg;Drug: IPX054 250 mg;Drug: IPX054 300 mgImpax Laboratories, LLCNULLCompleted30 YearsN/AAll12Phase 1;Phase 2United States
774NCT00472355
(ClinicalTrials.gov)
October 200510/5/2007Low Dose Apomorphine and ParkinsonismDoes Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?Parkinson's DiseaseDrug: apomorphineOregon Health and Science UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Withdrawn35 Years85 YearsAll0Phase 2United States
775NCT00165789
(ClinicalTrials.gov)
September 200512/9/2005A Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor FluctuationsA Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor FluctuationsParkinson's DiseaseDrug: E2007Eisai Inc.NULLCompleted18 YearsN/AAll75Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
776NCT00134966
(ClinicalTrials.gov)
August 200523/8/2005A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/LevodopaA 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 mg t.i.d. vs. Immediate Release Carbidopa/Levodopa 25/100 mg (t.i.d.) in Parkinson's Disease Patients Requiring LevodopaParkinson's DiseaseDrug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)NovartisNULLCompleted30 Years80 YearsAll493Phase 3United States;Canada;Czechia;Israel;Italy;Poland;Portugal;Turkey;Czech Republic
777NCT00143026
(ClinicalTrials.gov)
July 200531/8/2005Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United StatesStudy to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease.Parkinson's DiseaseDrug: carbidopa, levodopa, entacaponeNovartisNULLCompleted30 YearsN/AAll184Phase 4Australia;Philippines;Taiwan;Thailand
778NCT00125138
(ClinicalTrials.gov)
July 200527/7/2005Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's DiseaseSafety and Efficacy of Melperone in the Treatment of Patients With Psychosis Associated With Parkinson's DiseaseParkinson's Disease;Psychotic DisordersDrug: Melperone HCl;Drug: PlaceboLundbeck LLCNULLCompletedN/AN/AAll90Phase 2United States;India;Italy
779NCT00086190
(ClinicalTrials.gov)
June 200528/6/2004Study of Antidepressants in Parkinson's DiseaseStudy of Antidepressants in Parkinson's DiseaseParkinson Disease;DepressionDrug: paroxetine;Drug: venlafaxine;Other: placeboUniversity of RochesterNational Institute of Neurological Disorders and Stroke (NINDS)Completed30 YearsN/AAll115Phase 3United States;Canada;Puerto Rico
780NCT03095092
(ClinicalTrials.gov)
May 23, 200523/3/2017Effect of Food on BIA 6-512 (Trans-resveratrol)The Effect of Food on the Pharmacokinetics of a Single 400 mg Oral Dose of BIA 6-512 (Trans-resveratrol) in Healthy SubjectsParkinson DiseaseDrug: BIA 6-512 400 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsAll24Phase 1Portugal
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
781NCT03093389
(ClinicalTrials.gov)
May 11, 200522/3/2017Tolerability and Steady-state Pharmacokinetics of BIA 6-512A Double-blind, Randomised, Placebo-controlled, Rising Multiple-dose Study to Investigate the Tolerability and Steady-state Pharmacokinetics of BIA 6-512 (Trans-resveratrol) in Healthy VolunteersParkinson DiseaseDrug: BIA 6-512;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years45 YearsAll40Phase 1Portugal
782NCT00505687
(ClinicalTrials.gov)
February 200520/7/2007An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's DiseaseA Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted31 YearsN/AAll186Phase 3United States;Austria;Germany;Israel;Italy;South Africa;Spain;United Kingdom
783NCT00286949
(ClinicalTrials.gov)
January 6, 20053/2/2006Treatment of Executive Dysfunction in Parkinson's DiseaseAtomoxetine for the Treatment of Executive Dysfunction in Patients With Parkinson's Disease: A Pilot Open-label StudyParkinson's DiseaseDrug: AtomoxetineJohns Hopkins UniversityEli Lilly and CompanyCompleted21 Years65 YearsAll12N/AUnited States
784NCT00219284
(ClinicalTrials.gov)
January 200530/6/2005Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's DiseaseA Prospective, Multi-center, Randomized, Open-label Study With Blinded Raters to Evaluate the Effects of Immediate Versus Delayed Switch to Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease With End-of-dose Wearing OffParkinson's Disease With End of Dose Wearing OffDrug: Carbidopa/levodopa/entacaponeNovartis PharmaceuticalsNULLCompleted30 Years85 YearsAll359Phase 4United States;Puerto Rico
785NCT00144300
(ClinicalTrials.gov)
January 20052/9/2005Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) PatientsA Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease PatientsParkinson DiseaseDrug: Mirapex;Drug: RequipBoehringer IngelheimNULLCompleted30 YearsN/AAll246Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
786NCT01634243
(ClinicalTrials.gov)
January 200527/6/2012A Dose-ranging Study for SPM 962 in Parkinson's Disease PatientsA Open-label Dose-ranging Study for SPM 962 in Parkinson's Disease PatientsParkinson's DiseaseDrug: SPM 962Otsuka Pharmaceutical Co., Ltd.NULLCompleted30 Years79 YearsAll64Phase 2Japan
787NCT01518309
(ClinicalTrials.gov)
November 17, 200416/12/2008An Open-label Safety Study of Pimavanserin in Parkinson's Disease PatientsAn Open-Label Safety Study of Pimavanserin in Parkinson's Disease PatientsParkinson's Disease PsychosisDrug: pimavanserin tartrate (ACP-103)ACADIA Pharmaceuticals Inc.NULLCompletedN/AN/AAll39Phase 2United States
788NCT03091868
(ClinicalTrials.gov)
November 3, 200421/3/2017Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa PharmacokineticsA Double-blind, Randomised, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability and Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Carbidopa 100/25 mg or With a Single-dose of Levodopa/Carbidopa 100/25 mg Plus a Single-dose of Entacapone 200 mgParkinson DiseaseDrug: Placebo oral capsule;Drug: Sinemet® 100/25;Drug: Comtan®;Drug: BIA 6-512 25 mg;Drug: BIA 6-512 100 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsAll80Phase 1Portugal
789NCT00296946
(ClinicalTrials.gov)
November 200423/2/2006Ipratropium Spray for Drooling Saliva in Parkinson's DiseasePhase II Clinical Trial of Ipratropium Bromide Spray as a Treatment for Sialorrhea in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: ipratropium bromide (drug)University Health Network, TorontoParkinson's Disease FoundationCompleted30 YearsN/AAll20Phase 2Canada
790NCT01634360
(ClinicalTrials.gov)
November 20043/7/2012Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor FluctuationsA 48-month Open Label Multi-centered Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 in Patients With Parkinson's Disease With Wearing Off Motor Fluctuations and on Period DyskinesiasParkinson's DiseaseDrug: PerampanelEisai Inc.NULLTerminatedN/AN/AAll185Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
791NCT00105508
(ClinicalTrials.gov)
September 30, 200415/3/2005Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated DyskinesiaA Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated DyskinesiaParkinson's Disease;DyskinesiaDrug: Sarizotan;Drug: PlaceboEMD SeronoNULLCompleted30 YearsN/AAll506Phase 3United States
792NCT00105521
(ClinicalTrials.gov)
September 200415/3/2005Sarizotan HCl in Patients With Parkinson's Disease Suffering From Treatment-Associated DyskinesiaA Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated DyskinesiaParkinson's Disease;DyskinesiaDrug: Sarizotan HC1EMD SeronoNULLCompleted30 YearsN/AAll594Phase 3United States
793NCT00099268
(ClinicalTrials.gov)
September 200410/12/2004Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa TherapyA Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa TherapyParkinson's DiseaseDrug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopaNovartis PharmaceuticalsOrion Corporation, Orion PharmaCompleted30 Years70 YearsAll747Phase 3United States;Austria;Belgium;Canada;Finland;France;Germany;Greece;Italy;Spain;Sweden;Switzerland;Turkey;United Kingdom
794NCT00089622
(ClinicalTrials.gov)
August 4, 20046/8/2004Lisuride Patch to Treat Parkinson's DiseaseTranscutaneous Lisuride Therapy of Parkinson's DiseaseParkinson DiseaseDrug: Intravenous Levodopa;Drug: Lisuride Transdermal SystemNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted40 Years80 YearsAll40Phase 2United States
795NCT00501969
(ClinicalTrials.gov)
August 200416/7/2007An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's DiseaseAn Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-DopaAdvanced Stage Parkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted31 YearsN/AAll395Phase 3Australia;Austria;Croatia;Czech Republic;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Poland;South Africa;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
796NCT00304161
(ClinicalTrials.gov)
July 200415/3/2006Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's DiseaseDepression Diagnosis and Treatment in Parkinson DiseaseDepressive Disorder;Parkinson DiseaseDrug: Atomoxetine;Drug: PlaceboUniversity of PennsylvaniaNational Institute of Mental Health (NIMH)Completed30 Years79 YearsAll55Phase 4United States
797NCT00359723
(ClinicalTrials.gov)
July 200431/7/2006Methylphenidate and Parkinson's DiseaseSubacute Trial of Methylphenidate in Parkinson's DiseaseParkinson's DiseaseDrug: methylphenidateOregon Health and Science UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed21 YearsN/AAll13Phase 2United States
798NCT00086294
(ClinicalTrials.gov)
June 25, 200429/6/2004ACP-103 to Treat Parkinson's Disease5HT2A/C Serotonin Blockade in Parkinson's DiseaseParkinson's Disease;DyskinesiasDrug: Intravenous Levodopa;Drug: ACP-103National Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted30 Years80 YearsAll40Phase 2United States
799NCT03091543
(ClinicalTrials.gov)
May 4, 200421/3/2017Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa PharmacokineticsA Double-blind, Randomised, Crossover, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 100/25 mgParkinson DiseaseDrug: Madopar® HBS 125;Drug: Placebo;Drug: BIA 6-512 25 mg dose;Drug: BIA 6-512 50 mg dose;Drug: BIA 6-512 100 mg dose;Drug: BIA 6-512 200 mg doseBial - Portela C S.A.NULLCompleted18 Years45 YearsAll20Phase 1Portugal
800NCT00632736
(ClinicalTrials.gov)
February 20044/3/2008An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s DiseaseAn Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169Parkinson Disease;Parkinson's DiseaseDrug: Ropinirole XL (formerly CR)GlaxoSmithKlineNULLCompleted30 YearsN/AAll419Phase 3United States;Belgium;Czech Republic;France;Hungary;Italy;Poland;Spain;United Kingdom;Germany;Philippines
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
801NCT00674310
(ClinicalTrials.gov)
February 20045/5/2008A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed ConditionsA Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed ConditionsParkinson's Disease;Restless Leg SyndromeDrug: Ropinirole HydrochlorideRoxane LaboratoriesNULLCompleted18 Years45 YearsAll29N/ANULL
802NCT00673088
(ClinicalTrials.gov)
February 20045/5/2008A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted ConditionsA Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted ConditionsParkinson's Disease;Restless Leg SyndromeDrug: Ropinirole HydrochlorideRoxane LaboratoriesNULLCompleted18 Years45 YearsAll30N/ANULL
803NCT00363727
(ClinicalTrials.gov)
December 20037/8/2006Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson'sA Two Year Phase IIIb Randomised, Multicenter, Double-blind, SINEMET Controlled, Parallel Group, Flexible Dose Study, to Assess the Effectiveness of Controlled Release Ropinirole add-on Therapy to L-dopa at Increasing the Time to Onset of Dyskinesia in Parkinson's Disease Subjects.Parkinson's Disease;Parkinson Disease;DyskinesiasDrug: ropinirole controlled-release (REQUIP CR) for RLSGlaxoSmithKlineNULLCompleted30 Years70 YearsAll209Phase 3United States
804NCT00615472
(ClinicalTrials.gov)
October 20039/1/2008Intravenous Versus Inhalational Anesthesia in Parkinson's DiseaseIntravenous General Anesthesia Versus Inhalational General Anesthesia in Parkinson's DiseaseParkinson's DiseaseDrug: Isoflurane;Drug: Remifentanil;Drug: PropofolColumbia UniversityNULLTerminated18 YearsN/AAll58N/AUnited States
805NCT00070941
(ClinicalTrials.gov)
July 20039/10/2003SAM-e for the Treatment of Depression in Patients With Parkinson's DiseaseSAM-e Treatment of Depression in Parkinson's Disease.Parkinson's Disease;DepressionDrug: SAM-e;Drug: oral escitalopram;Drug: placeboNew York University School of MedicineNational Center for Complementary and Integrative Health (NCCIH);Office of Dietary Supplements (ODS)Completed30 Years80 YearsAll29Phase 2;Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
806NCT00062738
(ClinicalTrials.gov)
June 200312/6/2003Treatment of Depression in Parkinson's Disease TrialTreatment of Depression in Patients With Parkinson's DiseaseParkinson Disease;DepressionDrug: paroxetine;Drug: Nortriptyline;Other: placeboRutgers, The State University of New JerseyGlaxoSmithKlineCompleted35 Years80 YearsAll52Phase 2United States
807NCT00381472
(ClinicalTrials.gov)
June 200326/9/2006Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopaA Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole CR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-dopaParkinson DiseaseDrug: RopiniroleGlaxoSmithKlineNULLCompleted30 YearsN/AAll393Phase 3United States;Belgium;Czech Republic;France;Germany;Hungary;Italy;Poland;Spain
808NCT00056524
(ClinicalTrials.gov)
February 200315/3/2003Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter)An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.Alzheimer's Disease;Stroke;Parkinson's Disease;Traumatic Brain InjuryDrug: AVP-923Avanir PharmaceuticalsNULLCompleted18 Years80 YearsBoth600Phase 3United States
809NCT00237263
(ClinicalTrials.gov)
February 20037/10/2005An Extension Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off. This Study is Not Recruiting in the United StatesAn Extension Study to Phase IIb Dose-finding Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-offParkinson's DiseaseDrug: EntacaponeNovartisNULLCompleted20 YearsN/AAll285Phase 2United States
810NCT00594386
(ClinicalTrials.gov)
August 200224/12/2007An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's DiseaseAn Open-Label Extension to the Double-Blind SP650 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease.Parkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted31 YearsN/AAll258Phase 3United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
811NCT00599196
(ClinicalTrials.gov)
August 200224/12/2007An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's DiseaseAn Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's DiseaseEarly Stage Parkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted30 YearsN/AAll381Phase 3Australia;Austria;Belgium;Croatia;Czech Republic;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;South Africa;Spain;Sweden;Switzerland;United Kingdom
812NCT00314288
(ClinicalTrials.gov)
July 200212/4/2006Sarizotan in Parkinson Patients With L-dopa-induced DyskinesiaA Multicenter, Multinational, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Investigate the Anti-dyskinetic Efficacy and Safety of Sarizotan in Parkinson Patients With L-dopa-induced DyskinesiaParkinson's Disease;DyskinesiaDrug: Sarizotan HClEMD SeronoNULLCompleted30 YearsN/AAll360Phase 2United States;Belgium;Bulgaria;Canada;France;Germany;Hungary;Portugal;Romania;South Africa;United Kingdom
813NCT00040209
(ClinicalTrials.gov)
June 200221/6/2002JP-1730 to Treat Parkinson's DiseaseAlpha-2 Adrenergic Antagonist Treatment of Parkinson's DiseaseParkinson DiseaseDrug: JP 1730;Drug: IV Levodopa;Drug: IV ApomorphineNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth30Phase 2United States
814NCT00594165
(ClinicalTrials.gov)
June 200224/12/2007An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease.An Open-Label Extension to the Double-Blind SP512 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease.Early-Stage Parkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted31 YearsN/AAll217Phase 3United States;Canada
815NCT00650104
(ClinicalTrials.gov)
May 200227/3/2008Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164101648/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients With Parkinson's Disease Who Completed the Previous Ropinirole CR Studies 167 or 164Parkinson DiseaseDrug: Ropinirole XL (formerly CR)GlaxoSmithKlineNULLCompleted30 YearsN/AAll76Phase 3United States;Belgium;France;Netherlands;Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
816NCT02162979
(ClinicalTrials.gov)
February 200226/12/2007Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's DiseaseA Double-Blind, Placebo-Controlled, Cross-Over Study of Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's DiseaseParkinson's DiseaseDrug: sildenafil;Drug: PlaceboLoma Linda UniversityNULLTerminated18 Years80 YearsAll2Phase 2United States
817NCT00117819
(ClinicalTrials.gov)
March 200130/6/2005A Study of Brain Imaging With Nuclear Medicine Technology in Individuals With and at Risk for Parkinson's DiseaseDynamic SPECT Imaging With [123I] B-CIT in Individuals With Parkinsonian Syndrome (PS) and in Individuals at Risk for Parkinsonian SyndromeParkinsonian SyndromeDrug: [123I]ß CIT and SPECT imagingInstitute for Neurodegenerative DisordersIndiana University;Albany Medical CollegeCompleted22 YearsN/ABoth232Phase 2United States
818NCT00070928
(ClinicalTrials.gov)
September 20009/10/2003Valerian to Improve Sleep in Patients With Parkinson's DiseasePolysomnographic Assessment of Alternative Treatments for Sleep Disturbance in Parkinson's DiseaseInsomnia;Parkinson's DiseaseDrug: valerianNational Center for Complementary and Integrative Health (NCCIH)NULLCompleted30 Years80 YearsBoth80Phase 2United States
819NCT00134784
(ClinicalTrials.gov)
April 200023/8/2005Long-Term Dopamine Transporter Imaging and Clinical Assessment of Parkinson's Disease Progression[123I]ß-CIT and SPECT in Vivo Three Year Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinson's Disease Participating in Earlier vs. Later Levodopa in Parkinson's DiseaseParkinson DiseaseDrug: [123I]B-CIT SPECT imagingInstitute for Neurodegenerative DisordersUnited States Department of DefenseCompleted22 YearsN/AAll142Phase 2NULL
820NCT00037830
(ClinicalTrials.gov)
November 199922/5/2002GM1 Ganglioside Effects on Parkinson's DiseaseThe Study of GM1 Ganglioside, A Potential New Parkinson's Disease MedicationParkinson DiseaseDrug: GM1 ganglioside;Drug: PlaceboThomas Jefferson UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed39 Years85 YearsAll94Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
821NCT00132626
(ClinicalTrials.gov)
September 199218/8/2005Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian SyndromeDynamic SPECT Imaging With [123I]ß-CIT in Patients With ParkinsonismParkinson's Disease;Parkinsonian SyndromeDrug: [123I]ß-CIT and SPECT imagingInstitute for Neurodegenerative DisordersMolecular NeuroImaging;National Institutes of Health (NIH)Completed35 YearsN/AAll500Phase 2NULL

7. 大脳皮質基底核変性症 [臨床試験数:16,薬物数:33(DrugBank:11),標的遺伝子数:6,標的パスウェイ数:13
Searched query = "Corticobasal degeneration", "Corticobasal syndrome", "CBD"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
13 / 16 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000036908
2019/05/3131/05/2019A dementia study by 11C-PiB, 18F-FDG PETA dementia study by 11C-PiB, 18F-FDG PET - A dementia study by 11C-PiB, 18F-FDG PET mild cognitive impairment, Alzheimer's disease, dementia with Lewy bodies, cerebrovascular dementia, frontotemporal degeneration, progressive supranuclear palsy, corticobasal degeneration, Parkinson's disease with dementia, other neurodegenerative diseases, normal pressure hydrocephalus, hypoxic encephalopathy, brain tumor, brain injury etc.11C-PiB, 18F-FDG PETNagoya City Rehabilitation AgencyNULLRecruiting20years-oldNot applicableMale and Female150Not applicableJapan
2JPRN-jRCTs051180214
29/03/201927/03/2019The usefulness of flutemetamol for diagnostic imaging of neurogenerative diseaseThe usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease - The usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease Alzheimer's disease,Dementia with Lewy Bodies,Parkinson's syndrome,Frontotemporal lober degeneration
Alzheimer's disease, Dementia with Lewy Bodies, Parkinson's syndrome, Frontotemporal lober degeneration, Parkinson's disease, Mild cognitive impairment, Non-Alzheimer's disease, Progressive aphasia, Neurodegenerative disease, Cerebral corticobasal degeneration, Progressive supranuclear palsy
Amyloid PET: Given the flutemetamol (3mL) intravenously
FDG-PET:Given the FDG scanR (3mL) intravenously
Itoh YoshiakiNULLRecruitingAges 20 and overN/ABoth100N/AJapan
3NCT03744546
(ClinicalTrials.gov)
November 26, 201814/11/2018Expanded Access to ABBV-8E12Expanded Access to ABBV-8E12Primary Tauopathy Corticobasal Degeneration Syndrome (CBD)Drug: ABBV-8E12AbbVieNULLNo longer available40 YearsN/AAllNULL
4NCT03658135
(ClinicalTrials.gov)
September 12, 201813/8/2018BIIB092 in Primary Tauopathies: CBS, nfvPPA, sMAPT, and TESA Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel Cohort Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Intravenously Infused BIIB092 in Patients With Four Different Primary Tauopathy SyndromesPrimary Tauopathies;Corticobasal Degeneration Syndrome;Frontotemporal Lobar Degeneration With Tau Inclusions;MAPT Mutation Carriers, Symptomatic;Traumatic Encephalopathy Syndrome;Nonfluent Aphasia, ProgressiveDrug: BIIB092;Other: PlaceboUniversity of California, San FranciscoNULLTerminated35 Years80 YearsAll22Phase 1United States
5NCT03545126
(ClinicalTrials.gov)
August 21, 201712/3/2018Human CNS Tau Kinetics in TauopathiesHuman CNS Tau Kinetics in TauopathiesProgressive Supranuclear Palsy (PSP);Corticobasal Degeneration (CBD);Frontotemporal Dementia (FTD MAPT Mutation)Other: 13C6 LeucineWashington University School of MedicineAssociation of Frontotemporal Degeneration;Tau ConsortiumRecruiting18 YearsN/AAll32United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03174938
(ClinicalTrials.gov)
May 15, 201728/5/2017The Swedish BioFINDER 2 StudyThe Swedish BioFINDER 2 StudyDementia;Alzheimer Disease;Parkinson Disease;Lewy Body Disease;Parkinson-Dementia Syndrome;Frontotemporal Degeneration;Semantic Dementia;Progressive Nonfluent Aphasia;Progressive Supranuclear Palsy;Corticobasal Degeneration;Multiple System Atrophy;Mild Cognitive ImpairmentDiagnostic Test: Flutemetamol F18 Injection;Diagnostic Test: [18F]-RO6958948;Diagnostic Test: Elecsys (Roche) Abeta42, Ttau and Ptau;Diagnostic Test: Lumipulse (Fujirebio) Abeta42, Ttau and PtauSkane University HospitalLund UniversityRecruiting20 Years100 YearsAll1505N/ASweden
7EUCTR2017-000094-36-SE
(EUCTR)
31/03/201730/01/2017The BioFINDER 2 study - improved diagnostics and increased understanding of the underlying mechanisms of cognitive disordersThe BioFINDER 2 study - improved diagnostics and increased understanding of the pathophysiology of cognitive disorders Neurodegenerative disorders with Tau-pathology; including, but not limited to, Alzheimers disease, progressive supranuclear palsy,frontotemporal dementia, corticobasal degeneration and mild cognitive impairment.
MedDRA version: 19.1;Level: PT;Classification code 10053643;Term: Neurodegenerative disorder;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.1;Classification code 10012267;Term: Dementia;Classification code 10067889;Term: Dementia with Lewy bodies;Level: HLGT;Classification code 10028037;Term: Movement disorders (incl parkinsonism);Classification code 10012271;Term: Dementia Alzheimer's type;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes);Level: LLT;Classification code 10009846;Term: Cognitive impairment;Classification code 10048598;Term: Cognitive disorders;Classification code 10001896;Term: Alzheimer's disease;Classification code 10012285;Term: Dementia due to Pick's disease;Classification code 10036813;Term: Progressive supranuclear palsy;Classification code 10074616;Term: Prodromal Alzheimer's;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Product Name: 18F-RO6958948
Trade Name: Vizamyl (flutemetamol(F-18))
Product Name: Vizamyl
Skåne University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Sweden
8NCT02994719
(ClinicalTrials.gov)
March 1, 201621/12/2015Gait Analysis in Neurological DiseaseGait Pattern Analysis in Neurological DiseaseParkinson's Disease;Parkinsonian Disorders;Atypical Parkinson Disease;Progressive Supranuclear Palsy;Multiple System Atrophy;Corticobasal Degeneration;Gait, Frontal;Huntington DiseaseDrug: Anti-Parkinson medication;Device: Deep Brain StimulationBeth Israel Deaconess Medical CenterNULLActive, not recruiting18 Years85 YearsAll120United States
9EUCTR2014-000422-38-SE
(EUCTR)
19/09/201405/08/2014A study evaluating the diagnostic accuracy of [18F]-AV-1451 PET to detect and distinguish neurodegenerative disorders characterized by cerebral accumulation of the protein tauAn open-label study evaluating the diagnostic accuracy of [18F]-AV-1451 PET to detect and distinguish neurodegenerative disorders characterized by cerebral accumulation of tau Neurodegenerative disorders with Tau-pathology; including Alzheimer's disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration and important differential diagnostic conditions.
MedDRA version: 17.0;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes);System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0;Level: PT;Classification code 10053643;Term: Neurodegenerative disorder;Level: LLT;Classification code 10009846;Term: Cognitive impairment;Classification code 10001896;Term: Alzheimer's disease;Classification code 10012285;Term: Dementia due to Pick's disease;Classification code 10012267;Term: Dementia;Classification code 10067889;Term: Dementia with Lewy bodies;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Product Name: 18F-AV-1451Skåne University Hospital, Region SkåneNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Sweden
10NCT02167594
(ClinicalTrials.gov)
August 12, 201417/6/2014Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers18F-AV-1451 Injection for Brain Imaging of Tau in Subjects With Progressive Supranuclear Palsy (PSP), Subjects With Corticobasal Degeneration (CBD) and Healthy VolunteersProgressive Supranuclear Palsy;Corticobasal DegenerationDrug: Flortaucipir F18;Procedure: Brain PET scanAvid RadiopharmaceuticalsNULLCompleted50 Years85 YearsAll29Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT02133846
(ClinicalTrials.gov)
May 20146/5/2014Safety Study of TPI-287 to Treat CBS and PSPA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohort, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TPI 287 in Patients With Primary Four Repeat Tauopathies: Corticobasal Syndrome or Progressive Supranuclear PalsyPrimary Four Repeat Tauopathies (4RT);Corticobasal Syndrome (CBS);Progressive Supranuclear Palsy (PSP);Corticobasal Degeneration (CBD)Drug: TPI 287 2 mg/m2;Drug: TPI-287 20 mg/m2;Drug: Placebo;Drug: TPI-287 6.3 mg/m2University of California, San FranciscoCBD Solutions;Tau ConsortiumCompleted50 Years85 YearsAll44Phase 1United States
12NCT01056965
(ClinicalTrials.gov)
January 201021/1/2010Davunetide (AL-108) in Predicted Tauopathies - Pilot StudyA 12 Week Randomized, Double Blind, Placebo-Controlled Pilot Study of Davunetide (NAP, AL-108) in Predicted TauopathiesPredicted Tauopathies, Including;Progressive Supranuclear Palsy;Frontotemporal Dementia With Parkinsonism Linked to Chromosome 17;Corticobasal Degeneration Syndrome;Progressive Nonfluent AphasiaDrug: davunetide (AL-108, NAP);Drug: Placebo nasal sprayUniversity of California, San FranciscoNULLCompleted40 Years85 YearsAll12Phase 1United States
13NCT00703677
(ClinicalTrials.gov)
September 200820/6/2008A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal DegenerationA Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal DegenerationProgressive Supranuclear Palsy;Corticobasal DegenerationDrug: LithiumWestatNational Institute of Neurological Disorders and Stroke (NINDS)Completed40 Years80 YearsAll17Phase 1;Phase 2United States;United Kingdom

28. 全身性アミロイドーシス [臨床試験数:212,薬物数:234(DrugBank:72),標的遺伝子数:54,標的パスウェイ数:170
Searched query = "Systemic amyloidosis", "AL amyloidosis", "Immunoglobulin light chain amyloidosis", "Amyloid light-chain amyloidosis", "Familial amyloidosis", "Familial amyloid polyneuropathy", "Senile transthyretin amyloidosis", "Senile TTR amyloidosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
154 / 212 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-000713-32-DE
(EUCTR)
23/12/202009/09/2020A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis.A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis stage IIIa cardiac AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CAEL-101
INN or Proposed INN: Not assigned
Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4
Caelum Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
267Phase 3United States;Greece;Spain;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan
2EUCTR2019-004254-28-DE
(EUCTR)
23/12/202009/09/2020A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis.A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis stage IIIb cardiac AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CAEL-101
INN or Proposed INN: Not assigned
Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4
Caelum Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
111Phase 3United States;Greece;Spain;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan
3NCT04617925
(ClinicalTrials.gov)
December 202020/10/2020A Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL AmyloidosisA Phase 2 Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL AmyloidosisAL AmyloidosisDrug: Belantamab mafodotinEuropean Myeloma NetworkGlaxoSmithKlineNot yet recruiting18 YearsN/AAll35Phase 2Greece
4EUCTR2019-004254-28-GB
(EUCTR)
30/11/202010/09/2020A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis.A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis Stage IIIb cardiac AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CAEL-101
INN or Proposed INN: Not assigned
Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4
Caelum Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
111Phase 3United States;Greece;Spain;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Japan
5EUCTR2020-000713-32-GR
(EUCTR)
27/11/202005/10/2020A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis.A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis stage IIIa cardiac AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CAEL-101
INN or Proposed INN: Not assigned
Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4
Caelum Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
267Phase 3United States;Greece;Spain;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-004254-28-GR
(EUCTR)
27/11/202005/10/2020A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis.A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis stage IIIb cardiac AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CAEL-101
INN or Proposed INN: Not assigned
Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4
Caelum Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
111Phase 3United States;Greece;Spain;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan
7NCT04316442
(ClinicalTrials.gov)
November 13, 202016/3/2020Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL AmyloidosisA Phase 1, Open-Label, Dose-Escalation Study of the Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Systemic AL AmyloidosisLight Chain (AL) AmyloidosisBiological: STI-6129Sorrento Therapeutics, Inc.NULLRecruiting18 YearsN/AAll60Phase 1United States
8NCT04270175
(ClinicalTrials.gov)
November 202012/2/2020Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to DaratumumabDaratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to DaratumumabAmyloid;AL Amyloidosis;Refractory AL AmyloidosisDrug: Daratumumab;Drug: Pomalidomide;Drug: DexamethasoneWeill Medical College of Cornell UniversityJanssen Scientific Affairs, LLCNot yet recruiting18 YearsN/AAll21Phase 2United States
9NCT04418024
(ClinicalTrials.gov)
October 21, 202022/5/2020Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid PolyneurophathyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects With Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial)Transthyretin-Related (ATTR) Familial Amyloid PolyneuropathyDrug: AG10;Drug: PlaceboEidos TherapeuticsNULLRecruiting18 Years90 YearsAll145Phase 3United States;Canada;Spain
10NCT04512235
(ClinicalTrials.gov)
August 25, 202010/8/2020A Study to Evaluate the Effectiveness and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL AmyloidosisA Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL AmyloidosisAL AmyloidosisDrug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and dexamethasone (CyBorD)Caelum BiosciencesIQVIA BiotechRecruiting18 YearsN/AAll267Phase 3United States;Australia;Belgium;Canada;France;Germany;Greece;Israel;Italy;Japan;Poland;Russian Federation;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04504825
(ClinicalTrials.gov)
August 25, 202020/7/2020A Study to Evaluate the Effectiveness and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL AmyloidosisA Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL AmyloidosisAL AmyloidosisDrug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD)Caelum BiosciencesIQVIA BiotechRecruiting18 YearsN/AAll111Phase 3United States;Australia;Belgium;Canada;France;Germany;Greece;Israel;Italy;Japan;Poland;Russian Federation;Spain;United Kingdom
12NCT04115956
(ClinicalTrials.gov)
August 6, 202029/8/2019A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) AmyloidosisAn Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients With AL Amyloidosis Following at Least One Prior Line of TherapyAL AmyloidosisDrug: Melphalan-Flufenamide (Melflufen);Drug: DexamethasoneOncopeptides ABPRA Health SciencesRecruiting18 YearsN/AAll46Phase 1;Phase 2United States;Czechia;France;Germany;Greece;Israel;Italy;Norway;Poland;Spain;United Kingdom
13NCT04392960
(ClinicalTrials.gov)
July 22, 202027/2/2020Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL AmyloidosisMolecular, Magnetic Resonance, and Echocardiographic Imaging Combined With Biomarkers of Cardiac and Clonal Disease to Predict Survival and Assess Response to Therapy in Cardiac AL AmyloidosisAL AmyloidosisDrug: [18F]FlorbetabenIRCCS Policlinico S. MatteoNULLRecruiting18 YearsN/AAll69N/AItaly
14NCT04304144
(ClinicalTrials.gov)
March 18, 202028/2/2020A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL AmyloidosisCAEL101-203: A Phase 2, Open-label, Multicenter Dose Selection Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL AmyloidosisAL AmyloidosisDrug: CAEL-101Caelum BiosciencesNULLEnrolling by invitation18 YearsN/AAll25Phase 2United States
15EUCTR2018-002761-19-ES
(EUCTR)
05/02/202009/08/2019It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL Amyloidosis.Patients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Melflufen
INN or Proposed INN: melphalan fulfenamide hydrochloride
Other descriptive name: MELFLUFEN
Trade Name: Dexamethasone 4 mg JENAPHARM
Product Name: Dexamethasone
Product Code: H02AB02
INN or Proposed INN: DEXAMETHASONE
Oncopeptides ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 1;Phase 2United States;France;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
16EUCTR2018-004333-33-FR
(EUCTR)
23/01/202002/12/2019Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis Patients with newly diagnosed stage 3B AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Velcade
Product Name: Bortezomib
Product Code: 26866138
INN or Proposed INN: BORTEZOMIB
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
INN or Proposed INN: Recombinant human hyaluronidase PH20
Other descriptive name: PEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20
European Myeloma NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;Greece;Netherlands;Italy
17NCT04612582
(ClinicalTrials.gov)
January 1, 202015/6/2020Comparison of BTD and BCD Based Regimens in the Treatment of AL AmyloidosisA Comparative Study of Bortezomib-Thalidomide-Dexamethason and Bortezomib-Cyclophosphamide-Dexamethason in the Treatment of Monoclonal Immunoglobulin Light Chain Amyloidosis: A Prospective Randomized Controlled Trial(BTD-CHINA-TRIAL)Immunoglobulin Light-Chain AmyloidosisDrug: Thalidomide;Drug: CyclophosphamideGuangdong Provincial People's HospitalNULLRecruiting18 Years80 YearsAll70Phase 4China
18EUCTR2018-002761-19-GR
(EUCTR)
03/12/201915/11/2019 It is an early clinical trial to assess a new drug (Melflufen) when given together with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL Amyloidosis Patients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Oncopeptides ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
46Phase 2France;United States;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;Italy;United Kingdom
19EUCTR2018-002761-19-NO
(EUCTR)
15/11/201901/08/2019It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Melflufen
INN or Proposed INN: melphalan fulfenamide hydrochloride
Other descriptive name: MELFLUFEN
Trade Name: Dexamethasone 4 mg JENAPHARM
Product Name: Dexamethasone
Product Code: H02AB02
INN or Proposed INN: DEXAMETHASONE
Oncopeptides ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 2United States;France;Czech Republic;Greece;Spain;Poland;Israel;Germany;Norway;United Kingdom;Italy
20EUCTR2018-002761-19-PL
(EUCTR)
24/10/201907/08/2019It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Melflufen
INN or Proposed INN: melphalan fulfenamide hydrochloride
Other descriptive name: MELFLUFEN
Trade Name: Dexamethasone 4 mg JENAPHARM
Product Name: Dexamethasone
Product Code: H02AB02
INN or Proposed INN: DEXAMETHASONE
Oncopeptides ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 2United States;France;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2018-002761-19-CZ
(EUCTR)
21/10/201931/07/2019It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Melflufen
INN or Proposed INN: melphalan fulfenamide hydrochloride
Other descriptive name: MELFLUFEN
Trade Name: Dexamethasone 4 mg JENAPHARM
Product Name: Dexamethasone
Product Code: H02AB02
INN or Proposed INN: DEXAMETHASONE
Oncopeptides ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 2France;United States;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;Italy;United Kingdom
22EUCTR2018-004333-33-IT
(EUCTR)
01/08/201928/04/2020Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis - EMN22/54767414AMY2005 Patients with newly diagnosed stage 3B AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Darzalex
Product Name: Daratumumab
Product Code: JNJ-54767414
INN or Proposed INN: DARATUMUMAB
Trade Name: Velcade
Product Name: Bortezomib
Product Code: 26866138
INN or Proposed INN: BORTEZOMIB
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
INN or Proposed INN: Recombinant human hyaluronidase PH20
Other descriptive name: PEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20
Product Name: Decadron
Product Code: H02AB02 Desametasone
INN or Proposed INN: DEXAMETHASONE
Other descriptive name: Dexamethasone
European Myeloma NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;Greece;Netherlands;Italy
23EUCTR2018-004333-33-NL
(EUCTR)
24/07/201908/07/2019Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis Patients with newly diagnosed stage 3B AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
European Myeloma NetworkNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40Phase 2Greece;Netherlands;Italy
24EUCTR2018-004333-33-GR
(EUCTR)
08/07/201905/06/2019Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis Patients with newly diagnosed stage 3B AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Darzalex
Product Name: Daratumumab
Product Code: JNJ-54767414
INN or Proposed INN: DARATUMUMAB
Trade Name: Velcade
Product Name: Bortezomib
Product Code: 26866138
INN or Proposed INN: BORTEZOMIB
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
INN or Proposed INN: Recombinant human hyaluronidase PH20
Other descriptive name: PEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20
European Myeloma NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Greece;Netherlands;Italy
25EUCTR2017-002210-31-DE
(EUCTR)
31/05/201924/01/2019An allocation by random phase II/III trial of doxycycline in comparison to standard therapy in newly-diagnosed cardiac AL amyloidosis patients with bortezomib-based therapyA randomized phase II/III trial of doxycycline vs. standard supportive therapy in newly-diagnosed cardiac AL amyloidosis patients undergoing bortezomib-based therapy - ReDox Light chain (AL) amyloidosis is a protein conformational disease, caused by a small bone marrow plasma cell clone producing light chains (LCs) that undergo conformational changes, aggregate and deposit in tissues in the form of amyloid fibrils. This process causes dysfunction of the organs involved and leads to death if not effectively treated.;Therapeutic area: Not possible to specifyAmyloid Center - Biotechnology Research Laboratories Policlinico San MatteoNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120Phase 2;Phase 3Canada;Turkey;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT04298372
(ClinicalTrials.gov)
February 20, 20193/12/2019Frontline Lenalidomide for AL Amyloidosis Involving MyocardiumFrontline Lenalidomide for AL Amyloidosis Involving Myocardium: Investigation of Organ Reversing Capacity of LenalidomideAmyloidosis CardiacDrug: Lenalidomide 25mgSeoul National University HospitalNULLRecruiting19 Years99 YearsAll30Phase 3Korea, Republic of
27NCT03474458
(ClinicalTrials.gov)
February 11, 201916/3/2018A Trial of Doxycycline vs. Standard Supportive Therapy in Newly-diagnosed Cardiac AL Amyloidosis Patients Undergoing Bortezomib-based TherapyA Randomized Phase II/III Trial of Doxycycline vs. Standard Supportive Therapy in Newly-diagnosed Cardiac AL Amyloidosis Patients Undergoing Bortezomib-based TherapyCardiac AL AmyloidosisDrug: Doxycycline;Drug: Standard of care therapyIRCCS Policlinico S. MatteoNULLRecruiting18 YearsN/AAll120Phase 2;Phase 3Canada;France;Germany;Greece;Italy;Spain;Turkey;United Kingdom
28EUCTR2016-001737-27-GB
(EUCTR)
08/10/201811/01/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
29NCT03678259
(ClinicalTrials.gov)
October 1, 201830/7/2018124I-p5+14 Injection Safety in Subjects With Systemic AmyloidosisEvaluation of 124I-p5+14 Injection as an Imaging Agent for the Detection of Systemic AmyloidosisSystemic AmyloidosisDrug: 124I-p5+14 InjectionUniversity of Tennessee Graduate School of MedicineNULLRecruiting18 YearsN/AAll43Phase 1United States
30EUCTR2016-001737-27-PL
(EUCTR)
06/09/201816/07/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2016-001737-27-DK
(EUCTR)
22/08/201804/06/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Australia;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
32NCT03618537
(ClinicalTrials.gov)
August 2, 20182/8/2018Ixazomib Maintenance Study in Patients With AL AmyloidosisIxazomib Maintenance Following Initial Therapy in Patients With Immunoglobulin Light Chain (AL) AmyloidosisAL AmyloidosisDrug: Ixazomib;Drug: DexamethasoneMemorial Sloan Kettering Cancer CenterTufts Medical Center;Vanderbilt University Medical CenterRecruiting18 YearsN/AAll47Phase 2United States
33JPRN-JapicCTI-183929
17/7/201813/04/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AmyloidosisIntervention name : Cyclophosphamide, Bortezomib, dexamethasone plus Daratumumab
INN of the intervention : -
Dosage And administration of the intervention : Participants will receive dexamethasone (20mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing) followed by 1800 mg of daratumumab subcutaneously followed by cyclophosphamide (300 mg/m^2 orally or IV dose weekly) and bortezomib (1.3 mg/m^2 subcutaneous injection weekly) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 2 years.
Control intervention name : Cyclophosphamide, Bortezomib, dexamethasone
INN of the control intervention : -
Dosage And administration of the control intervention : Participants will receive dexamethasone (40milligrams [mg] orally or intravenous [IV]dose), followed by cyclophosphamide (300milligram per meter square [mg/m^2] orally or IV dose), then bortezomib (1.3 mg/m^2 subcutaneous injection) weekly on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles.
Janssen Pharmaceutical K.K.NULLcomplete20BOTH370Phase 3Japan, Asia except Japan, North America, Europe
34EUCTR2016-001737-27-SE
(EUCTR)
07/05/201820/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
35EUCTR2016-001737-27-DE
(EUCTR)
16/04/201816/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2016-001737-27-GR
(EUCTR)
16/04/201822/03/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
37EUCTR2016-001737-27-NL
(EUCTR)
15/03/201829/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Germany;Netherlands;Japan;China;Korea, Republic of;Sweden
38NCT03130348
(ClinicalTrials.gov)
March 15, 201821/4/2017Ibrutinib With or Without Bortezomib and Dexamethasone in Treating Patients With Relapsed or Refractory Immunoglobulin Light Chain AmyloidosisPhase II Study of Ibrutinib With or Without Bortezomib and Dexamethasone for the Treatment of Patients With Relapsed/Refractory Immunoglobulin Light Chain AmyloidosisAmyloidosis;Immunoglobulin Light Chain DepositionDrug: Bortezomib;Drug: Dexamethasone;Drug: Ibrutinib;Other: Laboratory Biomarker AnalysisMayo ClinicNational Cancer Institute (NCI)Withdrawn18 YearsN/AAll0Phase 2United States
39NCT03499808
(ClinicalTrials.gov)
March 8, 20189/4/2018S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary AmyloidosisA Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients With Previously Treated AL AmyloidosisAmorphous, Eosinophilic, and Acellular Deposit;Constipation;Diarrhea;Early Satiety;Gastrointestinal Hemorrhage;Hepatomegaly;Lymphadenopathy;Macroglossia;Nausea;Primary Systemic Amyloidosis;Purpura;Recurrent Primary Amyloidosis;Refractory Primary AmyloidosisBiological: Isatuximab;Other: Laboratory Biomarker AnalysisSouthwest Oncology GroupNational Cancer Institute (NCI)Active, not recruiting18 YearsN/AAll43Phase 2United States
40EUCTR2016-004664-18-DE
(EUCTR)
09/02/201824/05/2017A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT03283917
(ClinicalTrials.gov)
February 7, 201813/9/2017Daratumumab, Ixazomib, and Dexamethasone in AL AmyloidosisA Safety Study of Daratumumab, Ixazomib, and Dexamethasone in AL AmyloidosisNewly Diagnosed Primary Amyloidosis;Recurrent Primary Amyloidosis;Refractory Primary AmyloidosisBiological: Daratumumab;Drug: Dexamethasone;Drug: IxazomibM.D. Anderson Cancer CenterJanssen Pharmaceuticals;Takeda PharmaceuticalRecruiting18 YearsN/AAll20Phase 1United States
42EUCTR2016-001737-27-ES
(EUCTR)
06/02/201823/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
43EUCTR2016-001737-27-HU
(EUCTR)
25/01/201828/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
44EUCTR2016-001737-27-BE
(EUCTR)
16/01/201816/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
45NCT02994784
(ClinicalTrials.gov)
January 8, 201818/11/2016Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis PatientsA Phase II Single-Center, Open-Label, Safety and Efficacy Study of Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients Undergoing Autologous Stem Cell TransplantationAmyloidosis; SystemicDrug: Propylene Glycol-Free Melphalan HydrochlorideBoston Medical CenterSpectrum Pharmaceuticals, IncRecruiting18 YearsN/AAll43Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03315026
(ClinicalTrials.gov)
December 14, 201713/10/2017Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL AmyloidosisPhase II Study of Interleukin 6 Blockade With Siltuximab to Decrease Symptom Burden in Patients Age 60-75 Undergoing Autologous Stem Cell Transplantation for Multiple Myeloma and AL AmyloidosisMultiple Myeloma;AL AmyloidosisDrug: Siltuximab;Behavioral: The M.D. Anderson Symptom Inventory (MDASI)Memorial Sloan Kettering Cancer CenterJanssen Scientific Affairs, LLCActive, not recruiting60 Years75 YearsAll30Phase 2United States
47EUCTR2016-004664-18-AT
(EUCTR)
07/11/201720/09/2017A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;Australia;Austria;Israel;Germany;Italy;United Kingdom;United States;Greece;Spain
48NCT03201965
(ClinicalTrials.gov)
October 5, 201727/6/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL AmyloidosisAmyloidosisDrug: Cyclophosphamide;Drug: Bortezomib;Drug: Dexamethasone, 40 mg;Drug: DaratumumabJanssen Research & Development, LLCNULLActive, not recruiting18 YearsN/AAll416Phase 3United States;Australia;Belgium;Brazil;Canada;China;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Spain;Sweden;Turkey;United Kingdom;Romania
49ChiCTR-IPR-17012637
2017-10-012017-09-11Prospective Randomized controlled study of the combination regimen of bortezomib + thalidomide + dexamethasone (VTD) and bortezomib + cyclophosphamide + dexamethasone (VCD) for the initial treatment of type AL amyloidosisProspective Randomized controlled study of the combination regimen of bortezomib + thalidomide + dexamethasone (VTD) and bortezomib + cyclophosphamide + dexamethasone (VCD) for the initial treatment of type AL amyloidosis type AL amyloidosisGroup 1:the combination regimen of bortezomib +thalidomide + dexamethasone (VTD);Group 2:the combination regimen of bortezomib + cyclophosphamide + dexamethasone (VCD);Guangdong General HospitalNULLPending1875BothGroup 1:35;Group 2:35;China
50EUCTR2016-004664-18-GR
(EUCTR)
27/09/201702/06/2017A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT03252600
(ClinicalTrials.gov)
August 25, 201724/7/2017Lenalidomide, Dexamethasone, and Elotuzumab With or Without Cyclophosphamide in Treating Patients With Relapsed Primary AmyloidosisA Randomized Phase 2 Trial of Lenalidomide/ Dexamethasone/ Elotuzumab +/- Cyclophosphamide Followed by Lenalidomide/ Dexamethasone/Elotuzumab Maintenance as Second-Line Therapy for Patients With Relapsed AL AmyloidosisRecurrent Primary AmyloidosisDrug: Cyclophosphamide;Drug: Dexamethasone;Biological: Elotuzumab;Other: Laboratory Biomarker Analysis;Drug: Lenalidomide;Other: Pharmacological StudyBarbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI);Bristol-Myers Squibb;Multiple Myeloma Research ConsortiumRecruiting18 YearsN/AAll53Phase 2United States
52EUCTR2016-004664-18-GB
(EUCTR)
08/08/201709/05/2017A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
53EUCTR2016-004664-18-ES
(EUCTR)
31/07/201729/05/2017A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
54NCT03154047
(ClinicalTrials.gov)
June 14, 201728/4/2017Study in Subjects With Light Chain (AL) AmyloidosisA Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects With Light Chain (AL) Amyloidosis Who Were Previously Enrolled in Study NEOD001-201 (PRONTO)AL AmyloidosisDrug: NEOD001Prothena Therapeutics Ltd.NULLTerminated18 YearsN/AAll80Phase 2United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Spain;United Kingdom
55NCT03236792
(ClinicalTrials.gov)
June 12, 201720/7/2017Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL AmyloidosisPhase 1/2 Study Of Ixazomib In Combination With Cyclophosphamide And Dexamethasone In Patients With Newly Diagnosed Immunoglobulin Light Chain AL AmyloidosisAL AmyloidosisDrug: Ixazomib;Drug: Cyclophosphamide;Drug: DexamethasoneIcahn School of Medicine at Mount SinaiMillennium Pharmaceuticals, Inc.Recruiting18 YearsN/AAll30Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT02841033
(ClinicalTrials.gov)
March 20, 201714/6/2016Daratumumab for the Treatment of Patients With AL AmyloidosisA Phase I-II Trial of Daratumumab for the Treatment of Patients With AL AmyloidosisAL AmyloidosisDrug: daratumumabBoston Medical CenterJanssen PharmaceuticalsCompleted18 YearsN/AAll25Phase 1;Phase 2United States
57NCT03000660
(ClinicalTrials.gov)
January 201712/12/2016Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL AmyloidosisA Phase I Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL AmyloidosisAL AmyloidosisDrug: Venetoclax;Drug: DexamethasoneTufts Medical CenterNULLTerminated18 YearsN/AAll3Phase 1United States
58NCT02816476
(ClinicalTrials.gov)
September 201622/6/2016Daratumumab Therapy for Patients With Refractory or Relapsed AL AmyloidosisA Multicentre Open Label Phase II Study of Daratumumab in AL Amyloidosis Patients Not in VGPR or BetterAmyloidosisDrug: DaratumumabUniversity Hospital, LimogesNULLActive, not recruiting18 YearsN/AAll40Phase 2France;Italy
59EUCTR2015-004318-14-AT
(EUCTR)
07/07/201622/08/2016A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart.A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
129Phase 2France;United States;Greece;Spain;Australia;Austria;Israel;Germany;Italy;United Kingdom
60EUCTR2015-005333-49-GB
(EUCTR)
30/06/201604/04/2016A study to look at the long-term efficacy and safety of ALN-TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heartA Multicenter, Multinational, Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Revusiran in Patients with Transthyretin-mediated Familial Amyloidotic Cardiomyopathy Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
MedDRA version: 18.1;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Revusiran
Product Code: ALN-TTRSC
INN or Proposed INN: Revusiran
Other descriptive name: ALN-51547
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;France;Mexico;Canada;Spain;Brazil;Belgium;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2015-004318-14-DE
(EUCTR)
13/06/201626/11/2015A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart.A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
129Phase 2United States;France;Greece;Spain;Austria;Australia;Israel;Germany;United Kingdom;Italy
62EUCTR2016-000287-42-FR
(EUCTR)
18/05/201608/06/2016Amyloidosis Patients traitmentA Multicentre Open label Phase II study of Daratumumab in AL AmyloidosisPatients not in VGPR or Better - AMYDARA AL Amyloidosis
MedDRA version: 19.0;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]
Product Name: HuMax-CD38
INN or Proposed INN: DARATUMUMAB
CHU de LimogesNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France
63NCT02603172
(ClinicalTrials.gov)
May 12, 20169/11/2015A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic AmyloidosisA Three-part Open-label, Non-randomised, Dose-escalation Study to Investigate the Safety and Tolerability of GSK3039294 Administered as a Single Dose to Healthy Volunteers, and as Repeat Dose to Healthy Volunteers and Patients With Systemic AmyloidosisAmyloidosisDrug: GSK3039294GlaxoSmithKlineNULLTerminated18 Years70 YearsAll23Phase 1United Kingdom
64ChiCTR-IPR-16008422
2016-05-052016-05-08Randomized controlled study of the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD) and bortezomib +thalidomide + dexamethasone (BTD) for the initial treatment of primary systemic amyloidosis (AL)Randomized controlled study of the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD) and bortezomib +thalidomide + dexamethasone (BTD) for the initial treatment of primary systemic amyloidosis (AL) primary systemic amyloidosis (AL)the first group: the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD);the second group:the combination regimen of bortezomib +thalidomide + dexamethasone (BTD) ;People's Hospital, Beijing UniversityNULLRecruiting1875Boththe first group:60;the second group:60;China
65EUCTR2015-004318-14-GR
(EUCTR)
21/04/201611/02/2016A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart.A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia
MedDRA version: 18.1;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2015-004318-14-ES
(EUCTR)
10/03/201618/03/2016A study is to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart.A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction Light chain (AL) amyloidosis or primary systemic amyloidosis, involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains by plasma cells results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits of abnormal AL protein (amyloid), in the tissues and organs of individuals with AL amyloidosis.
MedDRA version: 18.1;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Germany;Italy;United Kingdom
67NCT02632786
(ClinicalTrials.gov)
March 20169/12/2015The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) AmyloidosisA Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis Who Have Persistent Cardiac DysfunctionAL AmyloidosisDrug: NEOD001;Drug: PlaceboProthena Therapeutics Ltd.NULLCompleted18 YearsN/AAll129Phase 2United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Spain;United Kingdom
68EUCTR2015-004318-14-GB
(EUCTR)
05/02/201627/11/2015A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart.A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
129Phase 2United States;France;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
69NCT02613182
(ClinicalTrials.gov)
February 201618/11/2015Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) AmyloidosisOpen-label Extension Study to Evaluate the Long-term Safety and Tolerability of NEOD001 in Subjects With Light Chain (AL) AmyloidosisAL AmyloidosisDrug: NEOD001Prothena Therapeutics Ltd.NULLTerminatedN/AN/AAll34Phase 2United States
70EUCTR2015-002231-18-GB
(EUCTR)
01/12/201523/09/2015A Phase I/IIa (early phase) Study of Targeted Radiotherapy alone for Stem Cell Transplant Conditioning in Systemic AL AmyloidosisA Phase I/IIa Study of Targeted Radiotherapy alone for Stem Cell Transplant Conditioning in Systemic AL Amyloidosis - Targeted Radiotherapy for AL-Amyloidosis –‘TRALA’ AL-Amyloidosis
MedDRA version: 18.0;Level: LLT;Classification code 10024460;Term: Light chain disease myeloma associated;System Organ Class: 100000004864;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: CHX-A-DTPA-Anti-CD66
INN or Proposed INN: CHX A-DTPA anti-CD66 antibody
Product Name: Indium­ 111 ­labelled Anti­-CD66
INN or Proposed INN: Indium 111-radiolabelled anti-CD66
Product Name: yttrium-90 radiolabelled anti-CD66 antibody
INN or Proposed INN: Yttrium­90 radiolabelled anti­CD66
University Southampton Hospital NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
18Phase 1;Phase 2aUnited Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT02545907
(ClinicalTrials.gov)
October 201527/8/2015A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL AmyloidosisA Single Arm Open Labeled Multicentre Phase 1b Dose Escalation Study of Carfilzomib Taken in Combination With Thalidomide and Dexamethasone in Relapsed AL AmyloidosisAmyloidosisDrug: Carfilzomib;Drug: Thalidomide;Drug: DexamethasoneUniversity College, LondonNULLNot yet recruiting18 YearsN/ABoth36Phase 1;Phase 2United Kingdom
72EUCTR2014-003835-20-DE
(EUCTR)
24/06/201502/12/2014A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heartA Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
MedDRA version: 19.0;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ALN-TTRSC
Product Code: ALN-TTRSC
INN or Proposed INN: Revusiran
Other descriptive name: ALN-51547
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Mexico;Canada;Brazil;Belgium;Spain;Germany;Italy;United Kingdom;Sweden
73NCT02489500
(ClinicalTrials.gov)
June 20159/3/2015Trial of High Dose Melphalan/Stem Cell Transplant With or Without BortezomibPhase III Trial of High-dose Melphalan and Stem Cell Transplantation Versus High-dose Melphalan and Bortezomib and Stem Cell Transplantation in Patients With AL AmyloidosisAL AmyloidosisDrug: Bortezomib;Drug: Melphalan;Drug: Neupogen;Procedure: Stem Cell Collection;Procedure: Stem cell infusionBoston Medical CenterNULLTerminated18 YearsN/AAll3Phase 3United States
74EUCTR2014-003835-20-SE
(EUCTR)
20/05/201527/11/2014A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heartA Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
MedDRA version: 19.0;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ALN-TTRSC
Product Code: ALN-TTRSC
INN or Proposed INN: Revusiran
Other descriptive name: ALN-51547
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Mexico;Canada;Brazil;Belgium;Spain;Germany;Italy;United Kingdom;Sweden
75EUCTR2014-003835-20-IT
(EUCTR)
05/05/201509/03/2016A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heartA phase 3 Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled Study to evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) - na Trasthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
MedDRA version: 20.0;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ALN-TTRSC
Product Code: ALN-TTRSC
ALNYLAM PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;France;Canada;Spain;Brazil;Belgium;Netherlands;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76JPRN-UMIN000019732
2015/03/3111/11/2015A randomised trial for the treatment of AL amyloidosis with the high dose Green Tea Extract. ligh chain amyloidosisstanderd therapy plus the high dose green tea therapy.
Drug: green tea extract powder
Pharmaceutical formulation: capsules
dose 2400 mg/d p.o. for 6 months every day
standerd therapy
Japanese Red Cross Medical Center, Division of HematologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female60Phase 2Japan
77EUCTR2014-003835-20-ES
(EUCTR)
30/03/201514/01/2015A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heartA Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
MedDRA version: 18.0;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ALN-TTRSC
Product Code: ALN-TTRSC
INN or Proposed INN: NA
Other descriptive name: ALN-51547
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Brazil;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom;Sweden
78EUCTR2014-003835-20-BE
(EUCTR)
25/03/201503/02/2015A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heartA Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
MedDRA version: 18.1;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ALN-TTRSC
Product Code: ALN-TTRSC
INN or Proposed INN: Revusiran
Other descriptive name: ALN-51547
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Mexico;Canada;Brazil;Spain;Belgium;Germany;Italy;United Kingdom;Sweden
79NCT02312206
(ClinicalTrials.gov)
February 20152/12/2014The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL AmyloidosisA Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects With Light Chain (AL) AmyloidosisPrimary Systemic (AL) AmyloidosisDrug: NEOD001;Other: PlaceboProthena Therapeutics Ltd.NULLTerminated18 YearsN/AAll260Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
80NCT01531751
(ClinicalTrials.gov)
February 201511/1/2012High Cut-off Hemodialysis in Patients With Advanced Cardiac AL Amyloidosis and End Stage Renal DiseaseAn Open Label Phase II Trial of Free Light Chain Removal by Extended High Cut-Off Hemodialysis in Patients With Advanced Cardiac AL Amyloidosis and End-Stage Renal Disease.Primary Amyloidosis of Light Chain TypeDevice: High Cut-off Hemodialysis;Drug: ChemotherapyIRCCS Policlinico S. MatteoNULLWithdrawn18 YearsN/AFemale0Phase 2Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT02245867
(ClinicalTrials.gov)
December 2, 201415/9/2014Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL AmyloidosisPhase Ia/Ib Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL AmyloidosisAmyloidosisDrug: Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4Andrew EisenbergerNULLCompleted21 YearsN/AAll31Phase 1United States
82EUCTR2014-003835-20-GB
(EUCTR)
26/11/201417/10/2014A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart.A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
MedDRA version: 18.1;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ALN-TTRSC
Product Code: ALN-TTRSC
INN or Proposed INN: Revusiran
Other descriptive name: ALN-51547
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3Brazil;Belgium;Spain;Germany;Italy;France;United States;Canada;United Kingdom;Sweden
83NCT02207556
(ClinicalTrials.gov)
October 1, 201423/7/2014Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis TrialDoxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis (DUAL) Trial: A Phase II Open Label Study of Oral Doxycycline Administered as an Adjunct to Plasma Cell Directed Therapy in Light Chain (AL) AmyloidosisPrimary Systemic AmyloidosisDrug: DoxycyclineMedical College of WisconsinNULLActive, not recruiting18 YearsN/AAll32Phase 2United States
84NCT02175004
(ClinicalTrials.gov)
June 201412/6/2014Open-Label Extension Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (FAP)FAP;Familial Amyloid Polyneuropathy;TTR;Transthyretin;AmyloidosisDrug: IONIS-TTR RxIonis Pharmaceuticals, Inc.NULLActive, not recruiting18 YearsN/AAll135Phase 3United States;Argentina;Brazil;France;Germany;Italy;Portugal;Spain;United Kingdom;New Zealand
85NCT01807286
(ClinicalTrials.gov)
January 20146/3/2013Pomalidomide With Melphalan and Dexamethasone for Untreated Systemic AL AmyloidosisA Phase I/II Clinical Trial of Pomalidomide With Melphalan and Dexamethasone in Patients With Newly Diagnosed Untreated Systemic AL Amyloidosis: Trial Stopped During Phase IMyelomaDrug: Pomalidomide;Drug: Melphalan;Drug: Dexamethasone;Behavioral: QuestionnairesM.D. Anderson Cancer CenterCelgeneTerminated18 YearsN/ABoth3Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2010-022395-31-CZ
(EUCTR)
01/10/201317/07/2013A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis.A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis. AL Amyloidosis
MedDRA version: 16.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: VELCADE
INN or Proposed INN: BORTEZOMIB
Trade Name: ALKERAN
Product Name: Melphalan
INN or Proposed INN: MELPHALAN
Trade Name: FORTECORTIN
Product Name: dexamethasone
Product Code: A01AC02
INN or Proposed INN: DEXAMETHASONE
E.M.N. - EUROPEAN MYELOMA NETWORKNULLNot RecruitingFemale: yes
Male: yes
110Phase 3United States;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
87NCT01777243
(ClinicalTrials.gov)
May 13, 201324/1/2013A Study to Evaluate the Safety of GSK2398852 When Co-administered With GSK2315698 in Patients With Systemic AmyloidosisA Single Dose First in Human Study of GSK2398852 Co-Administered With GSK2315698 in Patients With Systemic AmyloidosisAmyloidosisDrug: GSK2398852;Drug: GSK2315698GlaxoSmithKlineImperial College London;Heart Hospital;Royal Free Hospital NHS Foundation Trust;Quintiles, Inc.Completed18 Years70 YearsAll25Phase 1United Kingdom
88NCT01849783
(ClinicalTrials.gov)
April 4, 20136/5/2013Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple MyelomaSingle Autologous Transplant Followed by Consolidation and Maintenance for Participants = 65 Years of Age Diagnosed With Multiple Myeloma or a Related Plasma Cell MalignancyExtramedullary Plasmacytoma;Isolated Plasmacytoma of Bone;Light Chain Deposition Disease;Primary Systemic Amyloidosis;Stage I Multiple Myeloma;Stage II Multiple Myeloma;Stage III Multiple MyelomaDrug: dexamethasone;Drug: cisplatin;Drug: doxorubicin;Drug: cyclophosphamide;Drug: etoposide;Drug: bortezomib;Drug: thalidomide;Drug: melphalan;Procedure: autologous stem cell transplantYogesh JethavaNational Cancer Institute (NCI)Active, not recruiting65 Years85 YearsAll41Phase 2United States
89NCT02015312
(ClinicalTrials.gov)
April 201318/11/2013A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)A Randomised Trial for the Treatment of Cardiac AMyloid Light-chain Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)Light Chain (AL) Amyloidosis;Cardiac InvolvementDrug: Epigallocatechin-3-gallate (EGCG);Drug: PlaceboFlorian MichelGerman Federal Ministry of Education and ResearchCompleted18 YearsN/AAll38Phase 2Germany
90NCT01737398
(ClinicalTrials.gov)
March 15, 201327/11/2012Efficacy and Safety of Inotersen in Familial Amyloid PolyneuropathyA Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (NEURO-TTR Study)FAP;Familial Amyloid Polyneuropathy;TTR;Transthyretin;AmyloidosisDrug: Inotersen;Drug: PlaceboIonis Pharmaceuticals, Inc.NULLCompleted18 Years82 YearsAll173Phase 2;Phase 3United States;Argentina;Brazil;France;Germany;Italy;New Zealand;Portugal;Spain;United Kingdom;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT01728259
(ClinicalTrials.gov)
March 201313/11/2012First-line Pomalidomide, Bortezomib, and Dexamethasone For AL Amyloidosis or LCDDPhase I Study of Pomalidomide, Bortezomib, and Dexamethasone (PVD) as First-Line Treatment of AL Amyloidosis or Light Chain Deposition DiseaseLight Chain Deposition Disease;Primary Systemic AmyloidosisDrug: pomalidomide;Drug: bortezomib;Drug: dexamethasone;Other: Laboratory Biomarker AnalysisBarbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)Active, not recruiting18 YearsN/AAll36Phase 1United States;Canada;New Zealand
92NCT01222260
(ClinicalTrials.gov)
January 201314/10/2010Bendamustine and Dexamethasone in Patients With Relapsed AL AmyloidosisPhase II Study of the Combination of Bendamustine and Dexamethasone in Patients With Relapsed AL AmyloidosisAL AmyloidosisDrug: Bendamustine;Drug: DexamethasoneColumbia UniversityCephalonCompleted18 YearsN/AAll40Phase 2United States
93EUCTR2010-022395-31-DE
(EUCTR)
25/10/201218/10/2012Clinical trial of Melphalan and Dexamethasone versus Bortezomib, Melphalan and Dexamethasone for untreated patients with systemic light-chain (AL) amyloidosisA randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis - AC-004-EU AL amyloidosis
MedDRA version: 14.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
INN or Proposed INN: BORTEZOMIB
Trade Name: Fortecortin
Product Name: Dexamethason
INN or Proposed INN: Dexamethasone
Other descriptive name: DEXAMETHASONE
Trade Name: Alkeran
Product Name: Melphalan
INN or Proposed INN: MELPHALAN
European Myeloma NetworkNULLNot RecruitingFemale: yes
Male: yes
110Phase 3France;Czech Republic;Greece;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
94EUCTR2010-022395-31-ES
(EUCTR)
13/06/201221/05/2012A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosisA randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis AL Amyloidosis
MedDRA version: 14.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: VELCADE
INN or Proposed INN: BORTEZOMIB
Other descriptive name: VELCADE
Trade Name: Dexamethasone
Product Name: Dexamethasone
Product Code: Dexametasone
Other descriptive name: DEXAMETHASONE
Trade Name: melphalan
Product Name: Melphalan
Product Code: melphalan
INN or Proposed INN: MELPHALAN
Trade Name: betamethasone
Product Name: Dexamethasone
INN or Proposed INN: oral drops solution
Other descriptive name: DEXAMETHASONE
Trade Name: melphalan
Product Name: Melphalan
INN or Proposed INN: MELPHALAN
E.M.N. - EUROPEAN MYELOMA NETWORKNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3United Kingdom;Germany;Netherlands;Denmark;Norway;France;Spain;Italy;Greece;Sweden
95NCT01570387
(ClinicalTrials.gov)
June 201227/2/2012A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL AmyloidosisA Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL AmyloidosisAL AmyloidosisDrug: Pomalidomide;Drug: DexamethasoneBoston Medical CenterCelgene CorporationCompleted18 YearsN/AAll27Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2010-021445-42-BE
(EUCTR)
10/05/201210/10/2011A study in which is investigated if the medicine bortezomib is effective in patietns with AL amylodosis.A multicenter, randomized phase II study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis. - HOVON 104 AL amyloidosis AL Amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
INN or Proposed INN: BORTEZOMIB
HOVON FoundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2Belgium;Germany;Netherlands
97EUCTR2010-021445-42-DE
(EUCTR)
09/05/201223/01/2012A study to investigated whether bortezomib is effective in patients with AL amyloidosisA multicenter, prospective study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis. - HOVON 104 AL Amyloidosis AL Amyloidosis
MedDRA version: 17.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
INN or Proposed INN: BORTEZOMIB
Trade Name: Fortecortin
Product Name: Fortecortin
INN or Proposed INN: Dexamethasone
Trade Name: Fortecortin
Product Name: Fortecortin
INN or Proposed INN: Dexamethasone
HOVON FoundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Belgium;Netherlands;Germany
98EUCTR2011-001787-22-IT
(EUCTR)
02/05/201212/01/2012Treatment with pomalidomide and dexamethasone for previously treated patients with AL amyloidosis.An open-label, phase II study of Pomalidomide and Dexamethasone (PDex) for previously treated patients with AL amyloidosis - PDex Previously treated AL amyloidosis
MedDRA version: 14.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
INN or Proposed INN: DEXAMETHASONE SODIUM SULFATE
OSPEDALE POLICLINICO S. MATTEONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Italy
99EUCTR2010-022395-31-GR
(EUCTR)
02/05/201202/04/2012N/AN/A - BMDex vs MDex for AL amyloidosis Primary Systemic (AL) Amyloidosis
MedDRA version: 14.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: VELCADE
INN or Proposed INN: BORTEZOMIB
Trade Name: Dexaton
INN or Proposed INN: Dexamethasone
Other descriptive name: DEXAMETHASONE
Trade Name: Alkeran
INN or Proposed INN: MELPHALAN
Trade Name: Dexaton
INN or Proposed INN: Dexamethasone
Other descriptive name: DEXAMETHASONE
Trade Name: Alkeran
INN or Proposed INN: MELPHALAN
European Myeloma NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110United Kingdom;Denmark;Spain;Italy;Greece;Sweden;Australia
100NCT01510613
(ClinicalTrials.gov)
February 201211/1/2012Pomalidomide and Dexamethasone (PDex) in AL AmyloidosisAn Open-label, Phase II Study of Pomalidomide and Dexamethasone (PDex) for Previously Treated Patients With AL Amyloidosis.Primary Amyloidosis of Light Chain TypeDrug: Pomalidomide and DexamethasoneIRCCS Policlinico S. MatteoNULLCompleted18 YearsN/AAll28Phase 2Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT01511263
(ClinicalTrials.gov)
January 201210/1/2012Epigallocatechingallate (EGCG) in Cardiac AL AmyloidosisA Phase II Open-label Randomized Study of Dietary Supplement With Epigallocatechin Gallate (EGCG) to Improve Cardiac Dysfunction in Patients With AL Amyloidosis Who do Not Require Chemotherapy (EpiCardiAL)Primary Amyloidosis of Light Chain TypeDrug: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhithmias);Drug: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhythmias) plus EGCGIRCCS Policlinico S. MatteoNULLTerminated18 YearsN/AAll86Phase 2Italy
102EUCTR2010-022395-31-DK
(EUCTR)
14/11/201109/06/2011A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis AL Amyloidosis
MedDRA version: 14.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: VELCADE
Product Name: bortezomib
Product Name: Dexamethasone
Trade Name: Alkeran
Product Name: Melphalan
Product Name: Dexamethasone
Product Name: Melphalan
E.M.N. - EUROPEAN MYELOMA NETWORKNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Czech Republic;Greece;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden
103JPRN-UMIN000006604
2011/11/0124/10/2011Phase I/II study to evaluate the efficacy and safety of the combination treatment of melpharan, dexamethasone and bortezomib for relapsed or refractory systemic AL amyloidosis. To evaluate the efficacy and safety of the combination treatment melpharan, dexamethasone and bortezomib (BMD treatment) for relapsed or refractory systemic AL amyloidosis.Patients receive oral melphalan 8 mg/m2 on days 1-4, bortezomib SC (IV) on days 1, 4, 8 and 11, and dexamethasone orally on days 1-2, 4-5 8-9 11 and 12. Treatment repeats every 4 weeks (28 days) for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
*The preventive medication on last medication day after the 28th is recommended in principle from acyclovir 200 or 400 mg/the bortezomib medication opening day of a day.
Moreover, when the symptoms of herpes are shown, the acyclovir or the rose cyclo building of a therapeutic amount is promptly prescribed for the patient.
Japan Community Health care Organization Kyoto kuramaguchi Medical Center, Department of HematologyNULLComplete: follow-up complete20years-old65years-oldMale and Female21Phase 1;Phase 2Japan
104NCT01435655
(ClinicalTrials.gov)
November 201113/9/2011The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M TransthyretinThe Effect On Transthyretin Stabilization, Safety, Tolerablity, Efficacy And Pharmacokinetics Of Orally Administered Tafamidis In Transthyretin Amyloid Polyneuropathy Patients With V30m Or Non-v30m Transthyretin: A Phase Iii, Open-label StudyTransthyretin Familial Amyloid PolyneuropathyDrug: tafamidisPfizerNULLCompleted20 Years75 YearsAll10Phase 3Japan
105NCT01406314
(ClinicalTrials.gov)
October 13, 201126/7/2011SAP Depleter Dose Assessment Study in PatientsA Phase 1, Open Label, Dose Characteristic Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Intravenous and Subcutaneous Doses of GSK2315698A in Patients With Systemic AmyloidosisAmyloidosisDrug: GSK2315698GlaxoSmithKlineNULLCompleted18 Years80 YearsAll17Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2010-021445-42-NL
(EUCTR)
31/08/201127/01/2011A study in which is investigated if the medicine bortezomib is effective in patients with AL amyloidosisA multicenter, phase II study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis. - HOVON 104 AL amyloidosis AL Amyloidosis
MedDRA version: 16.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
INN or Proposed INN: BORTEZOMIB
HOVON FoundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2Belgium;Germany;Netherlands
107NCT01383759
(ClinicalTrials.gov)
June 24, 201127/6/2011Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL AmyloidosisPilot Study of Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL AmyloidosisLight Chain Deposition Disease (LCDD or MIDD);Light Chain and Heavy Chain Deposition Disease (LHCDD or MIDD);Monoclonal Immunoglobulin Deposition Disease (MIDD);AmyloidosisDrug: Bortezomib/Dexamethasone (BD), Followed By Autologous STC & Maintenance Bortezomib/DexamethasoneMemorial Sloan Kettering Cancer CenterMillennium Pharmaceuticals, Inc.Completed18 YearsN/AAll20N/AUnited States
108EUCTR2010-022395-31-SE
(EUCTR)
10/06/201112/04/2011A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis AL Amyloidosis
MedDRA version: 13.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders
Trade Name: VELCADE
Product Name: Dexamethasone
Product Name: Melphalan
Product Name: Dexamethasone
Product Name: Melphalan
E.M.N. - EUROPEAN MYELOMA NETWORKNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3United Kingdom;Denmark;Spain;Italy;Greece;Sweden
109NCT01273844
(ClinicalTrials.gov)
March 1, 20113/1/2011Study of Bortezomib +HSCT in Primary Systemic Amyloidosis (AL)Study of the Combination of Bortezomib and Dexamethasone Followed by HSCT in ALAmyloidosisDrug: BortezomibZhi-Hong Liu, M.D.Soochow University;Nanjing Medical UniversityCompleted18 Years65 YearsAll21N/AChina
110NCT01277016
(ClinicalTrials.gov)
January 201110/1/2011A Trial for Systemic Light-chain (AL) AmyloidosisA Randomized Open-label Multicenter Phase III Trial of Melphalan and Dexamethasone (MDex) Versus Bortezomib, Melphalan and Dexamethasone (BMDex) for Untreated Patients With Systemic Light-chain (AL) AmyloidosisAL AmyloidosisDrug: BMDexEuropean Myeloma NetworkNULLCompleted18 YearsN/AAll110Phase 3Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT01199562
(ClinicalTrials.gov)
December 20108/9/2010Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell TransplantModified Preemptive CMV Management Strategy After Allogeneic Hematopoietic Cell Transplantation and Laboratory Correlation With Innate Immune FunctionHematopoietic/Lymphoid Cancer;Accelerated Phase Chronic Myelogenous Leukemia;Acute Undifferentiated Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Atypical Chronic Myeloid Leukemia, BCR-ABL Negative;Blastic Phase Chronic Myelogenous Leukemia;Chronic Eosinophilic Leukemia;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Contiguous Stage II Adult Burkitt Lymphoma;Contiguous Stage II Adult Diffuse Large Cell Lymphoma;Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Contiguous Stage II Adult Lymphoblastic Lymphoma;Contiguous Stage II Grade 1 Follicular Lymphoma;Contiguous Stage II Grade 2 Follicular Lymphoma;Contiguous Stage II Grade 3 Follicular Lymphoma;Contiguous Stage II Mantle Cell Lymphoma;Contiguous Stage II Marginal Zone Lymphoma;Contiguous Stage II Small Lymphocytic Lymphoma;Cutaneous B-cell Non-Hodgkin Lymphoma;Cytomegalovirus Infection;de Novo Myelodysplastic Syndromes;Essential Thrombocythemia;Extramedullary Plasmacytoma;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Intraocular Lymphoma;Isolated Plasmacytoma of Bone;Mast Cell Leukemia;Meningeal Chronic Myelogenous Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Noncontiguous Stage II Adult Burkitt Lymphoma;Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Noncontiguous Stage II Adult Lymphoblastic Lymphoma;Noncontiguous Stage II Grade 1 Follicular Lymphoma;Noncontiguous Stage II Grade 2 Follicular Lymphoma;Noncontiguous Stage II Grade 3 Follicular Lymphoma;Noncontiguous Stage II Mantle Cell Lymphoma;Noncontiguous Stage II Marginal Zone Lymphoma;Noncontiguous Stage II Small Lymphocytic Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Primary Systemic Amyloidosis;Progressive Hairy Cell Leukemia, Initial Treatment;Prolymphocytic Leukemia;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Relapsing Chronic Myelogenous Leukemia;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Secondary Myelofibrosis;Splenic Marginal Zone Lymphoma;Stage 0 Chronic Lymphocytic Leukemia;Stage I Adult Burkitt Lymphoma;Stage I Adult Diffuse Large Cell Lymphoma;Stage I Adult Diffuse Mixed Cell Lymphoma;Stage I Adult Diffuse Small Cleaved Cell Lymphoma;Stage I Adult Hodgkin Lymphoma;Stage I Adult Immunoblastic Large Cell Lymphoma;Stage I Adult Lymphoblastic Lymphoma;Stage I Adult T-cell Leukemia/Lymphoma;Stage I Chronic Lymphocytic Leukemia;Stage I Cutaneous T-cell Non-Hodgkin Lymphoma;Stage I Grade 1 Follicular Lymphoma;Stage I Grade 2 Follicular Lymphoma;Stage I Grade 3 Follicular Lymphoma;Stage I Mantle Cell Lymphoma;Stage I Marginal Zone Lymphoma;Stage I Multiple Myeloma;Stage I Mycosis Fungoides/Sezary Syndrome;Stage I Small Lymphocytic Lymphoma;Stage II Adult Hodgkin Lymphoma;Stage II Adult T-cell Leukemia/Lymphoma;Stage II Chronic Lymphocytic Leukemia;Stage II Cutaneous T-cell Non-Hodgkin Lymphoma;Stage II Multiple Myeloma;Stage II Mycosis Fungoides/Sezary Syndrome;Stage III Adult Burkitt Lymphoma;Stage III Adult Diffuse Large Cell Lymphoma;Stage III Adult Diffuse Mixed Cell Lymphoma;Stage III Adult Diffuse Small Cleaved Cell Lymphoma;Stage III Adult Hodgkin Lymphoma;Stage III Adult Immunoblastic Large Cell Lymphoma;Stage III Adult Lymphoblastic Lymphoma;Stage III Adult T-cell Leukemia/Lymphoma;Stage III Chronic Lymphocytic Leukemia;Stage III Cutaneous T-cell Non-Hodgkin Lymphoma;Stage III Grade 1 Follicular Lymphoma;Stage III Grade 2 Follicular Lymphoma;Stage III Grade 3 Follicular Lymphoma;Stage III Mantle Cell Lymphoma;Stage III Marginal Zone Lymphoma;Stage III Multiple Myeloma;Stage III Mycosis Fungoides/Sezary Syndrome;Stage III Small Lymphocytic Lymphoma;Stage IV Adult Burkitt Lymphoma;Stage IV Adult Diffuse Large Cell Lymphoma;Stage IV Adult Diffuse Mixed Cell Lymphoma;Stage IV Adult Diffuse Small Cleaved Cell Lymphoma;Stage IV Adult Hodgkin Lymphoma;Stage IV Adult Immunoblastic Large Cell Lymphoma;Stage IV Adult Lymphoblastic Lymphoma;Stage IV Adult T-cell Leukemia/Lymphoma;Stage IV Chronic Lymphocytic Leukemia;Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma;Stage IV Grade 1 Follicular Lymphoma;Stage IV Grade 2 Follicular Lymphoma;Stage IV Grade 3 Follicular Lymphoma;Stage IV Mantle Cell Lymphoma;Stage IV Marginal Zone Lymphoma;Stage IV Mycosis Fungoides/Sezary Syndrome;Stage IV Small Lymphocytic Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenstrom MacroglobulinemiaProcedure: infection prophylaxis and management;Other: laboratory biomarker analysis;Other: flow cytometry;Genetic: DNA analysis;Genetic: RNA analysis;Procedure: management of therapy complications;Drug: ganciclovir;Drug: valganciclovir;Drug: foscarnet sodium;Procedure: antiviral therapy;Genetic: polymerase chain reaction;Genetic: protein expression analysisCity of Hope Medical CenterNational Cancer Institute (NCI)Completed18 YearsN/AAll153United States
112NCT01078454
(ClinicalTrials.gov)
November 201027/2/2010Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain AmyloidosisA Randomized Phase III Trial of Melphalan and Dexamethasone (MDex) Versus Bortezomib, Melphalan and Dexamethasone (BMDex) for Untreated Patients With Systemic Light-Chain (AL) Amyloidosis Ineligible for Autologous Stem-Cell TransplantationLight Chain Deposition Disease;Primary Systemic AmyloidosisDrug: melphalan;Drug: dexamethasone;Drug: bortezomibNational Cancer Institute (NCI)NULLCompleted18 YearsN/AAll11Phase 3United States
113EUCTR2010-022395-31-IT
(EUCTR)
07/10/201001/12/2010A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis - NDA randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis - ND AL amyloidosis
MedDRA version: 9.1;Level: HLGT;Classification code 10035227
Trade Name: VELCADE
INN or Proposed INN: Bortezomib
INN or Proposed INN: Melphalan
INN or Proposed INN: Dexamethasone
INN or Proposed INN: Melphalan
INN or Proposed INN: Dexamethasone
E.M.N. - EUROPEAN MYELOMA NETWORKNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
114NCT01194791
(ClinicalTrials.gov)
October 201026/7/2010Lendexal in Patients With Primary Systemic Amyloidosis (AL) Newly DiagnosedA Multicentric, Phase II Trial of Lenalidomide, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed, Not Candidates for Hematopoietic Stem Cell TransplantationPrimary Systemic AmyloidosisDrug: Lenalidomide;Drug: Cyclophosphamide;Drug: DexamethasonePETHEMA FoundationNULLCompleted18 YearsN/AAll30Phase 2Spain
115EUCTR2009-014906-33-GB
(EUCTR)
17/09/201018/06/2010A Pilot study of Response to Velcade combination chemotherapy in AL amyloidosis (REVEAL) - REVEALA Pilot study of Response to Velcade combination chemotherapy in AL amyloidosis (REVEAL) - REVEAL Systemic AL amyloidosis
MedDRA version: 14.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
Product Name: bortezomib
INN or Proposed INN: bortezomib
Trade Name: Velcade
Product Name: bortezomib
INN or Proposed INN: bortezomib
University College LondonNULLNot RecruitingFemale: yes
Male: yes
52United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT01072773
(ClinicalTrials.gov)
March 201017/2/2010Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain AmyloidosisPhase II Study of Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Light Chain AmyloidosisPrimary Systemic AmyloidosisDrug: bortezomib;Drug: cyclophosphamide;Drug: dexamethasoneMayo ClinicNULLCompleted18 YearsN/AAll2Phase 2United States
117NCT01083316
(ClinicalTrials.gov)
September 20092/11/2009Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) AmyloidosisPhase II Trial of Induction Therapy With Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation in Patients With AL AmyloidosisAmyloidosisDrug: Bortezomib;Drug: Dexamethasone;Drug: MelphalanBoston Medical CenterMillennium Pharmaceuticals, Inc.Completed18 YearsN/AAll35Phase 2United States
118NCT00890747
(ClinicalTrials.gov)
August 200929/4/2009Sunitinib Malate in Treating HIV-Positive Patients With Cancer Receiving Antiretroviral TherapyA Phase 1/Pharmacokinetic Study of Sunitinib in Patients With Cancer Who Also Have HIV and Are on HAART TherapyAccelerated Phase Chronic Myelogenous Leukemia;Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome;Acute Undifferentiated Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Langerhans Cell Histiocytosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Aggressive NK-cell Leukemia;AIDS-related Diffuse Large Cell Lymphoma;AIDS-related Diffuse Mixed Cell Lymphoma;AIDS-related Diffuse Small Cleaved Cell Lymphoma;AIDS-related Immunoblastic Large Cell Lymphoma;AIDS-related Lymphoblastic Lymphoma;AIDS-related Malignancies;AIDS-related Small Noncleaved Cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative;Chronic Eosinophilic Leukemia;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Clear Cell Renal Cell Carcinoma;Cutaneous B-cell Non-Hodgkin Lymphoma;de Novo Myelodysplastic Syndromes;Essential Thrombocythemia;Extramedullary Plasmacytoma;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;HIV Infection;HIV-associated Hodgkin Lymphoma;Intraocular Lymphoma;Isolated Plasmacytoma of Bone;Light Chain Deposition Disease;Mast Cell Leukemia;Myelodysplastic Syndrome With Isolated Del(5q);Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Myeloid/NK-cell Acute Leukemia;Nodal Marginal Zone B-cell Lymphoma;Noncutaneous Extranodal Lymphoma;Osteolytic Lesions of Multiple Myeloma;Peripheral T-cell Lymphoma;Plasma Cell Neoplasm;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Primary Systemic Amyloidosis;Progressive Hairy Cell Leukemia, Initial Treatment;Prolymphocytic Leukemia;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Renal Cell Cancer;Recurrent Small Lymphocytic Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Relapsing Chronic Myelogenous Leukemia;Stage IV Renal Cell Cancer;T-cell Large Granular Lymphocyte Leukemia;Testicular Lymphoma;Unspecified Adult Solid Tumor, Protocol Specific;Waldenström MacroglobulinemiaDrug: sunitinib malate;Other: pharmacological study;Other: laboratory biomarker analysisNational Cancer Institute (NCI)NULLCompleted18 YearsN/ABoth42Phase 1United States
119NCT00883623
(ClinicalTrials.gov)
April 200915/4/2009A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) AmyloidosisA Prospective Single Center Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With AL AmyloidosisPrimary AmyloidosisDrug: LenalidomideHeidelberg UniversityGesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbHCompleted18 Years74 YearsBoth50Phase 2Germany
120NCT00890552
(ClinicalTrials.gov)
April 200928/4/2009A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL AmyloidosisA Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL AmyloidosisLeukemia;AmyloidosisDrug: Lenalidomide;Drug: Melphalan;Drug: DexamethasoneStanford UniversityCelgene CorporationCompleted18 YearsN/AAll25N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT01815086
(ClinicalTrials.gov)
December 200813/3/2013Radioimmunoimaging of Light Chain (AL) AmyloidosisRadioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody (mAb) Murine (Mu) 11-F4AL AmyloidosisBiological: Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)University of TennesseeNULLCompleted21 Years90 YearsBoth30Phase 1United States
122NCT00807872
(ClinicalTrials.gov)
December 200811/12/2008Radioimmunoimaging of AL AmyloidosisRadioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4Primary AmyloidosisBiological: 124I-labeled monoclonal antibody Mu 11-1F4University of TennesseeFDA Office of Orphan Products DevelopmentCompleted21 Years90 YearsBoth40Phase 1United States
123NCT01409148
(ClinicalTrials.gov)
November 200828/7/2011Radioimmunoimaging of AL AmyloidosisRadioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4AL AmyloidosisBiological: 124I-labeled monoclonal antibody Mu 11-1F4University of TennesseeFood and Drug Administration (FDA)Completed21 Years90 YearsBoth38Phase 1United States
124EUCTR2008-001405-41-DE
(EUCTR)
24/10/200828/08/2008A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEXA prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX AL amyloidosisTrade Name: Revlimid
Other descriptive name: Lenalidomide
Trade Name: Alkeran
Product Code: L01AA03
Other descriptive name: melphalan
Trade Name: Fortecortin
Other descriptive name: dexamethasone
GMIHO mbHNULLNot RecruitingFemale: yes
Male: yes
Germany
125NCT00791492
(ClinicalTrials.gov)
July 200813/11/2008An Extension of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid PolyneuropathyAn Open-Label Extension Of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid PolyneuropathyFamilial Amyloid Polyneuropathy;ATTR-PNDrug: Fx-1006APfizerNULLCompleted18 Years75 YearsAll86Phase 2;Phase 3Argentina;Brazil;France;Germany;Portugal;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT00790647
(ClinicalTrials.gov)
June 200812/11/2008Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic AmyloidosisPhase II Trial of High-dose Melphalan and Bortezomib and Stem Cell Transplantation in Patients With AL AmyloidosisMultiple MyelomaBiological: filgrastim;Drug: bortezomib;Drug: melphalan;Procedure: Stem Cell InfusionBoston Medical CenterNULLCompleted18 Years65 YearsAll10Phase 2United States
127NCT00679367
(ClinicalTrials.gov)
May 200814/5/2008Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic AmyloidosisA Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL AmyloidosisMultiple MyelomaDrug: dexamethasone;Drug: lenalidomide;Drug: melphalanBoston Medical CenterNULLCompleted18 YearsN/AAll16Phase 2United States
128EUCTR2007-006037-13-IT
(EUCTR)
21/02/200810/12/2007An open-label, phase II study of cyclophosphamide, lenalidomide and dexamethasone (CLD) for previously treated patients with AL amyloidosis - NDAn open-label, phase II study of cyclophosphamide, lenalidomide and dexamethasone (CLD) for previously treated patients with AL amyloidosis - ND amyloidosis AL
MedDRA version: 6.1;Level: PT;Classification code 10002022
Trade Name: Revlimid
INN or Proposed INN: Cyclophosphamide
INN or Proposed INN: Dexamethasone
OSPEDALE POLICLINICO S. MATTEONULLNot RecruitingFemale: yes
Male: yes
Phase 2Italy
129NCT00607581
(ClinicalTrials.gov)
February 200822/1/2008Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL AmyloidosisAn Open-label, Phase II Study of Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL AmyloidosisAmyloidosisDrug: cyclophosphamide;Drug: lenalidomide;Drug: dexamethasoneIRCCS Policlinico S. MatteoCelgene CorporationCompleted18 YearsN/ABoth21Phase 2Italy
130NCT00981708
(ClinicalTrials.gov)
February 200819/9/2009Lenalidomide, Dexamethasone and Cyclophosphamide in Amyloidosis (AL)A Phase I/II Trial of Lenalidomide Combined With Cyclophosphamide and Intermediate Dose Dexamethasone in Patients With Primary (AL) Systemic AmyloidosisAmyloidosisDrug: Lenalidomide, Dexamethasone and CyclophosphamideUniversity of AthensHellenic Cooperative Oncology GroupActive, not recruiting18 YearsN/ABoth37Phase 1;Phase 2Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT01998503
(ClinicalTrials.gov)
December 200715/11/2013Bortezomib and Dexamethasone Followed by ASCT Compared With ASCT Alone in Treating Patients With AL AmyloidosisInduction Therapy With Bortezomib and Dexamethasone Followed by Autologous Stem Cell Transplantation Versus Autologous Stem Cell Transplantation Alone in the Treatment of AL AmyloidosisAmyloidosisDrug: Bortezomib;Drug: dexamethasone;Biological: filgrastim;Procedure: autologous hematopoietic stem cell transplantation (ASCT);Drug: MelphalanNanjing University School of MedicineNULLCompleted18 Years65 YearsBoth56Phase 3China
132NCT00564889
(ClinicalTrials.gov)
December 200728/11/2007Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic AmyloidosisA Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmDrug: cyclophosphamide;Drug: dexamethasone;Drug: lenalidomideMayo ClinicNational Cancer Institute (NCI)Completed18 YearsN/AAll35Phase 2United States
133EUCTR2006-007082-36-GR
(EUCTR)
16/10/200718/07/2007A Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosisA Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosis Primary (AL) amyloidosis in untreated patients or patientsw who have failed prior treatmentsTrade Name: REVLIMID
Trade Name: Endoxan
Trade Name: Dexamethasone
Trade Name: REVLIMID
INN or Proposed INN: Lenalidomide
INN or Proposed INN: Deaxamethasone
INN or Proposed INN: cyclophosphamide
Hellenic Oncology Cooperative GroupNULLNot RecruitingFemale: yes
Male: yes
55Phase 1;Phase 2Greece
134EUCTR2006-006395-37-GB
(EUCTR)
06/09/200731/07/2007A randomised, multi-centre feasibility trial in AL Amyloidosis, comparing CTD with SCT in patients with low risk of Treatment Related Mortality and CTD with Mel-Dex in patients in whom SCT would not be considered appropriate as first line therapy - UK Amyloidosis Treatment Trial (UKATT)A randomised, multi-centre feasibility trial in AL Amyloidosis, comparing CTD with SCT in patients with low risk of Treatment Related Mortality and CTD with Mel-Dex in patients in whom SCT would not be considered appropriate as first line therapy - UK Amyloidosis Treatment Trial (UKATT) The medical condition to be investigated is systemic AL Amyloidosis, a disorder of protein folding in which normally soluble proteins are deposited as abnormal, insoluble fibrils that progressively disrupt tissue structure and impair function.
MedDRA version: 9.1;Level: LLT;Classification code 10002022;Term: Amyloidosis
Joint UCLH and UCL Biomedical Research UnitNULLNot Recruiting Female: yes
Male: yes
48Phase 2;Phase 3United Kingdom
135NCT00520767
(ClinicalTrials.gov)
September 200724/8/2007Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition DiseaseA Multicenter Phase II Trial of Bortezomib (Velcade), Melphalan, and Dexamethasone (V-MD) in Patients With Symptomatic AL-Amyloidosis or Light Chain Deposition DiseasePrimary Systemic Amyloidosis;Light Chain Deposition DiseaseDrug: bortezomib;Drug: dexamethasone;Drug: melphalan;Genetic: microarray analysis;Other: flow cytometry;Other: laboratory biomarker analysis;Procedure: quality-of-life assessmentBarbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)Active, not recruiting18 Years120 YearsAll35Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT00458822
(ClinicalTrials.gov)
February 20079/4/2007Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic AmyloidosisRisk-Adapted Intravenous Melphalan With Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients With Systemic Light-Chain (AL) AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmDrug: bortezomib;Drug: dexamethasoneMemorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)Completed18 Years70 YearsAll40Phase 2United States
137NCT00409175
(ClinicalTrials.gov)
January 20076/12/2006Safety and Efficacy Study of Fx-1006A in Patients With Familial AmyloidosisSafety and Efficacy of Orally Administered Fx-1006A in Patients With Familial Amyloid Polyneuropathy (FAP): A Randomized, Double-blind, Placebo-controlled StudyFamilial Amyloid PolyneuropathyDrug: Fx-1006A;Drug: PlaceboPfizerNULLCompleted18 Years75 YearsAll128Phase 2;Phase 3United States;Argentina;Brazil;France;Germany;Portugal;Spain;Sweden;United Kingdom
138NCT00536601
(ClinicalTrials.gov)
June 29, 200627/9/2007High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid TumorsAutologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid TumorsAdult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Burkitt Lymphoma;Childhood Diffuse Large Cell Lymphoma;Childhood Immunoblastic Large Cell Lymphoma;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET);Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Intraocular Lymphoma;Nodal Marginal Zone B-cell Lymphoma;Peripheral T-cell Lymphoma;Plasma Cell Neoplasm;Primary Systemic Amyloidosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Malignant Testicular Germ Cell Tumor;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Neuroblastoma;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Multiple Myeloma;Regional Neuroblastoma;Splenic Marginal Zone Lymphoma;Testicular Lymphoma;Unspecified Adult Solid Tumor, Protocol Specific;Unspecified Childhood Solid Tumor, Protocol Specific;Waldenström MacroglobulinemiaDrug: etoposide;Drug: cyclophosphamide;Drug: carmustine;Drug: melphalan;Drug: busulfan;Drug: carboplatin;Drug: thiotepa;Radiation: total-body irradiation;Procedure: autologous hematopoietic stem cell transplantation;Procedure: autologous-autologous tandem hematopoietic stem cell transplantationRoswell Park Cancer InstituteNational Cancer Institute (NCI)Completed4 YearsN/AAll174N/AUnited States
139NCT00294671
(ClinicalTrials.gov)
February 200621/2/2006The Effect of Diflunisal on Familial AmyloidosisThe Effect of Diflunisal on Familial AmyloidosisFamilial Amyloid Polyneuropathy;Familial AmyloidosisDrug: diflunisal;Other: placeboBoston UniversityFood and Drug Administration (FDA);National Institute of Neurological Disorders and Stroke (NINDS)Completed18 Years75 YearsAll130Phase 2;Phase 3United States;Italy;Japan;Sweden;United Kingdom;Portugal
140NCT00477971
(ClinicalTrials.gov)
October 200523/5/2007Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic AmyloidosisPhase III Trial of Stem Cell Transplantation Compared to Parenteral Melphalan and Oral Dexamethasone in the Treatment of Primary Systemic Amyloidosis (AL)Multiple Myeloma and Plasma Cell NeoplasmBiological: filgrastim;Drug: dexamethasone;Drug: melphalan;Procedure: autologous hematopoietic stem cell transplantationMayo ClinicNational Cancer Institute (NCI)Completed18 YearsN/AAll89Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
141EUCTR2004-004871-12-IT
(EUCTR)
02/05/200507/06/2005An Open-Label Phase 1/2 Study of VELCADE (bortezomib) for Injection in Subjects with Light-Chain (AL)-AmyloidosisAn Open-Label Phase 1/2 Study of VELCADE (bortezomib) for Injection in Subjects with Light-Chain (AL)-Amyloidosis Systemic AL-Amyloidosis
MedDRA version: 6.1;Level: PT;Classification code 10002022
Trade Name: VELCADE*1FL 3,5MG
Product Name: NA
Product Code: NA
INN or Proposed INN: Bortezomib
JANSSEN-CILAGNULLNot RecruitingFemale: yes
Male: yes
Phase 1;Phase 2Italy
142NCT00091260
(ClinicalTrials.gov)
January 20047/9/2004CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic AmyloidosisA Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL AmyloidosisMultiple MyelomaDrug: dexamethasone;Drug: lenalidomideVaishali SanchorawalaCelgene CorporationCompleted18 YearsN/AAll82Phase 2United States
143NCT00064337
(ClinicalTrials.gov)
January 20048/7/2003S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic AmyloidosisS0115, A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m) And Autologous Peripheral Blood Stem Cell Supported Transplant (SCT) For High Risk Patients With Multiple Myeloma And/Or Light Chain Amyloidosis (AL Amyloidosis) (A BMT Study)Multiple Myeloma;Plasma Cell MyelomaBiological: filgrastim;Drug: cyclophosphamide;Drug: dexamethasone;Drug: melphalan;Drug: thalidomide;Procedure: peripheral blood stem cell transplantationSouthwest Oncology GroupNational Cancer Institute (NCI)Completed18 Years120 YearsAll104Phase 2United States
144NCT01527032
(ClinicalTrials.gov)
September 200228/7/2011Risk-adapted Therapy for Primary Systemic (AL) AmyloidosisRisk-adapted Therapy for AL AmyloidosisAmyloidosisDrug: melphalan, thalidomide and dexamethasoneFDA Office of Orphan Products DevelopmentNULLCompletedPhase 2NULL
145NCT00030381
(ClinicalTrials.gov)
December 200114/2/2002Iododoxorubicin in Treating Patients With Primary Systemic AmyloidosisPhase I Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL)Primary Systemic AmyloidosisDrug: 4'-iodo-4'-deoxydoxorubicin;Other: pharmacological studyNational Cancer Institute (NCI)NULLTerminated18 YearsN/ABoth22Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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agemin
Inclusion_
agemax
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Target_
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PhaseCountries
146NCT00075608
(ClinicalTrials.gov)
August 20019/1/20042nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) AmyloidosisPhase II Trial of Second Autologous Transplantation in AL AmyloidosisMultiple Myeloma;Plasma Cell NeoplasmBiological: filgrastim;Drug: melphalan;Procedure: autologous stem cell transplantation;Procedure: stem cell infusionBoston Medical CenterNULLTerminated18 Years65 YearsAll12Phase 2United States
147NCT00014235
(ClinicalTrials.gov)
December 200010/4/2001Fludarabine Phosphate and Total-Body Radiation Followed by Donor Peripheral Blood Stem Cell Transplant and Immunosuppression in Treating Patients With Hematologic MalignanciesNonmyeloablative PBSC Allografting From HLA Matched Related Donors Using Fludarabine and/or Low Dose TBI With Disease-Risk Based ImmunosuppressionAcute Myeloid Leukemia/Transient Myeloproliferative Disorder;Acute Undifferentiated Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Blastic Plasmacytoid Dendritic Cell Neoplasm;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Burkitt Lymphoma;Childhood Diffuse Large Cell Lymphoma;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic Leukemia;Cutaneous B-cell Non-Hodgkin Lymphoma;de Novo Myelodysplastic Syndromes;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Intraocular Lymphoma;Juvenile Myelomonocytic Leukemia;Mast Cell Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Noncutaneous Extranodal Lymphoma;Peripheral T-cell Lymphoma;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Systemic Amyloidosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Small Intestine Lymphoma;Splenic Marginal Zone Lymphoma;Stage II Multiple Myeloma;Stage III Multiple Myeloma;T-cell Large Granular Lymphocyte Leukemia;Testicular Lymphoma;Untreated Adult Acute Lymphoblastic Leukemia;Untreated Adult Acute Myeloid Leukemia;Untreated Childhood Acute Lymphoblastic Leukemia;Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies;Waldenström MacroglobulinemiaDrug: fludarabine phosphate;Radiation: total-body irradiation;Procedure: peripheral blood stem cell transplantation;Procedure: allogeneic hematopoietic stem cell transplantation;Drug: cyclosporine;Drug: mycophenolate mofetil;Other: laboratory biomarker analysisFred Hutchinson Cancer Research CenterNational Heart, Lung, and Blood Institute (NHLBI);National Cancer Institute (NCI)CompletedN/A74 YearsAll160N/AUnited States;Germany;Italy
148NCT00075621
(ClinicalTrials.gov)
August 20009/1/2004Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) AmyloidosisA Phase II Trial of Tandem Transplantation in AL AmyloidosisMultiple MyelomaDrug: filgrastim;Drug: melphalan;Procedure: autologous peripheral blood stem cell transplantationBoston Medical CenterNULLCompleted18 Years65 YearsAll62Phase 2United States
149NCT00006251
(ClinicalTrials.gov)
May 200011/9/2000Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine, Mycophenolate Mofetil, Donor Lymphocyte Infusion in Treating Patients With Hematopoietic CancerInduction of Mixed Hematopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate MofetilAcute Undifferentiated Leukemia;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Childhood Burkitt Lymphoma;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic Leukemia;Cutaneous B-cell Non-Hodgkin Lymphoma;de Novo Myelodysplastic Syndromes;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Intraocular Lymphoma;Juvenile Myelomonocytic Leukemia;Mast Cell Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Myeloid/NK-cell Acute Leukemia;Nodal Marginal Zone B-cell Lymphoma;Noncutaneous Extranodal Lymphoma;Peripheral T-cell Lymphoma;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Systemic Amyloidosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Renal Cell Cancer;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Small Intestine Lymphoma;Splenic Marginal Zone Lymphoma;Stage II Multiple Myeloma;Stage III Multiple Myeloma;T-cell Large Granular Lymphocyte Leukemia;Testicular Lymphoma;Waldenström MacroglobulinemiaRadiation: total-body irradiation;Drug: fludarabine phosphate;Drug: cyclosporine;Drug: mycophenolate mofetil;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Biological: donor lymphocytes;Procedure: peripheral blood stem cell transplantation;Other: laboratory biomarker analysisFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)CompletedN/A74 YearsAll21Phase 1;Phase 2United States;Italy;Germany
150NCT00344526
(ClinicalTrials.gov)
January 200022/6/2006Intensive Versus Conventional Treatment in Patients With Primary AmyloidosisAutologous Stem Cell Transplantation (ASCT) Versus Oral Melphalan and High-Dose Dexamethasone in Patients With AL (Primary)Amyloidosis. A Prospective Randomized Trial .Primary Systemic Amyloidosis (AL)Drug: Melphalan;Drug: Dexamethasone;Procedure: Autologous stem cell transplantationUniversity Hospital, LimogesMinistry of Health, FranceCompleted18 Years70 YearsBoth100Phase 3France
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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151NCT00112593
(ClinicalTrials.gov)
November 19992/6/2005Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without CancerAllogeneic Hematopoietic Stem Cell Transplantation for Induction of Mixed Hematopoietic Chimerism in Patients Infected With Human Immunodeficiency Virus-1 Using a Non-Marrow Ablative Conditioning Regimen Containing Total Body Irradiation in Combination With Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate MofetilAccelerated Phase Chronic Myelogenous Leukemia;Acute Undifferentiated Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Aggressive NK-cell Leukemia;AIDS-related Diffuse Large Cell Lymphoma;AIDS-related Diffuse Mixed Cell Lymphoma;AIDS-related Diffuse Small Cleaved Cell Lymphoma;AIDS-related Immunoblastic Large Cell Lymphoma;AIDS-related Lymphoblastic Lymphoma;AIDS-related Peripheral/Systemic Lymphoma;AIDS-related Primary CNS Lymphoma;AIDS-related Small Noncleaved Cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Blastic Phase Chronic Myelogenous Leukemia;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Burkitt Lymphoma;Childhood Chronic Myelogenous Leukemia;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Eosinophilic Leukemia;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Contiguous Stage II Adult Burkitt Lymphoma;Contiguous Stage II Adult Diffuse Large Cell Lymphoma;Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Contiguous Stage II Adult Lymphoblastic Lymphoma;Contiguous Stage II Grade 1 Follicular Lymphoma;Contiguous Stage II Grade 2 Follicular Lymphoma;Contiguous Stage II Grade 3 Follicular Lymphoma;Contiguous Stage II Mantle Cell Lymphoma;Contiguous Stage II Marginal Zone Lymphoma;Contiguous Stage II Small Lymphocytic Lymphoma;Cutaneous B-cell Non-Hodgkin Lymphoma;Essential Thrombocythemia;Extramedullary Plasmacytoma;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;HIV Infection;HIV-associated Hodgkin Lymphoma;Intraocular Lymphoma;Isolated Plasmacytoma of Bone;Juvenile Myelomonocytic Leukemia;Mast Cell Leukemia;Meningeal Chronic Myelogenous Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Myeloid/NK-cell Acute Leukemia;Nodal Marginal Zone B-cell Lymphoma;Noncontiguous Stage II Adult Burkitt Lymphoma;Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Noncontiguous Stage II Adult Lymphoblastic Lymphoma;Noncontiguous Stage II Grade 1 Follicular Lymphoma;Noncontiguous Stage II Grade 2 Follicular Lymphoma;Noncontiguous Stage II Grade 3 Follicular Lymphoma;Noncontiguous Stage II Mantle Cell Lymphoma;Noncontiguous Stage II Marginal Zone Lymphoma;Noncontiguous Stage II Small Lymphocytic Lymphoma;Noncutaneous Extranodal Lymphoma;Peripheral T-cell Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Central Nervous System Lymphoma;Primary Myelofibrosis;Primary Systemic Amyloidosis;Progressive Hairy Cell Leukemia, Initial Treatment;Prolymphocytic Leukemia;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Small Intestine Lymphoma;Splenic Marginal Zone Lymphoma;Stage 0 Chronic Lymphocytic Leukemia;Stage I Adult Burkitt Lymphoma;Stage I Adult Diffuse Large Cell Lymphoma;Stage I Adult Diffuse Mixed Cell Lymphoma;Stage I Adult Diffuse Small Cleaved Cell Lymphoma;Stage I Adult Hodgkin Lymphoma;Stage I Adult Immunoblastic Large Cell Lymphoma;Stage I Adult Lymphoblastic Lymphoma;Stage I Adult T-cell Leukemia/Lymphoma;Stage I Childhood Anaplastic Large Cell Lymphoma;Stage I Childhood Hodgkin Lymphoma;Stage I Childhood Large Cell Lymphoma;Stage I Childhood Lymphoblastic Lymphoma;Stage I Childhood Small Noncleaved Cell Lymphoma;Stage I Chronic Lymphocytic Leukemia;Stage I Cutaneous T-cell Non-Hodgkin Lymphoma;Stage I Grade 1 Follicular Lymphoma;Stage I Grade 2 Follicular Lymphoma;Stage I Grade 3 Follicular Lymphoma;Stage I Mantle Cell Lymphoma;Stage I Marginal Zone Lymphoma;Stage I Multiple Myeloma;Stage I Small Lymphocytic Lymphoma;Stage IA Mycosis Fungoides/Sezary Syndrome;Stage IB Mycosis Fungoides/Sezary Syndrome;Stage II Adult Hodgkin Lymphoma;Stage II Adult T-cell Leukemia/Lymphoma;Stage II Childhood Anaplastic Large Cell Lymphoma;Stage II Childhood Hodgkin Lymphoma;Stage II Childhood Large Cell Lymphoma;Stage II Childhood Lymphoblastic Lymphoma;Stage II Childhood Small Noncleaved Cell Lymphoma;Stage II Chronic Lymphocytic Leukemia;Stage II Cutaneous T-cell Non-Hodgkin Lymphoma;Stage II Multiple Myeloma;Stage IIA Mycosis Fungoides/Sezary Syndrome;Stage IIB Mycosis Fungoides/Sezary Syndrome;Stage III Adult Burkitt Lymphoma;Stage III Adult Diffuse Large Cell Lymphoma;Stage III Adult Diffuse Mixed Cell Lymphoma;Stage III Adult Diffuse Small Cleaved Cell Lymphoma;Stage III Adult Hodgkin Lymphoma;Stage III Adult Immunoblastic Large Cell Lymphoma;Stage III Adult Lymphoblastic Lymphoma;Stage III Adult T-cell Leukemia/Lymphoma;Stage III Childhood Anaplastic Large Cell Lymphoma;Stage III Childhood Hodgkin Lymphoma;Stage III Childhood Large Cell Lymphoma;Stage III Childhood Lymphoblastic Lymphoma;Stage III Childhood Small Noncleaved Cell Lymphoma;Stage III Chronic Lymphocytic Leukemia;Stage III Cutaneous T-cell Non-Hodgkin Lymphoma;Stage III Grade 1 Follicular Lymphoma;Stage III Grade 2 Follicular Lymphoma;Stage III Grade 3 Follicular Lymphoma;Stage III Mantle Cell Lymphoma;Stage III Marginal Zone Lymphoma;Stage III Multiple Myeloma;Stage III Small Lymphocytic Lymphoma;Stage IIIA Mycosis Fungoides/Sezary Syndrome;Stage IIIB Mycosis Fungoides/Sezary Syndrome;Stage IV Adult Burkitt Lymphoma;Stage IV Adult Diffuse Large Cell Lymphoma;Stage IV Adult Diffuse Mixed Cell Lymphoma;Stage IV Adult Diffuse Small Cleaved Cell Lymphoma;Stage IV Adult Hodgkin Lymphoma;Stage IV Adult Immunoblastic Large Cell Lymphoma;Stage IV Adult Lymphoblastic Lymphoma;Stage IV Adult T-cell Leukemia/Lymphoma;Stage IV Childhood Anaplastic Large Cell Lymphoma;Stage IV Childhood Hodgkin Lymphoma;Stage IV Childhood Large Cell Lymphoma;Stage IV Childhood Lymphoblastic Lymphoma;Stage IV Childhood Small Noncleaved Cell Lymphoma;Stage IV Chronic Lymphocytic Leukemia;Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma;Stage IV Grade 1 Follicular Lymphoma;Stage IV Grade 2 Follicular Lymphoma;Stage IV Grade 3 Follicular Lymphoma;Stage IV Mantle Cell Lymphoma;Stage IV Marginal Zone Lymphoma;Stage IV Small Lymphocytic Lymphoma;Stage IVA Mycosis Fungoides/Sezary Syndrome;Stage IVB Mycosis Fungoides/Sezary Syndrome;T-cell Large Granular Lymphocyte Leukemia;Testicular Lymphoma;Unspecified Adult Solid Tumor, Protocol Specific;Unspecified Childhood Solid Tumor, Protocol Specific;Waldenström MacroglobulinemiaDrug: fludarabine phosphate;Radiation: total-body irradiation;Procedure: peripheral blood stem cell transplantation;Drug: cyclosporine;Drug: mycophenolate mofetil;Other: laboratory biomarker analysisFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)CompletedN/A75 YearsAll5N/AUnited States
152NCT00007995
(ClinicalTrials.gov)
July 19996/1/2001Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients Who Have Multiple Myeloma or Primary Systemic AmyloidosisPhase 2 Study Of High Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support In Patients With Multiple Myeloma And Primary Light Chain AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmBiological: filgrastim;Biological: recombinant interferon alfa;Biological: sargramostim;Drug: busulfan;Drug: cyclophosphamide;Drug: melphalan;Procedure: autologous bone marrow transplantation;Procedure: bone marrow ablation with stem cell support;Procedure: peripheral blood stem cell transplantationHerbert Irving Comprehensive Cancer CenterNational Cancer Institute (NCI)Completed18 YearsN/ABoth75Phase 2United States
153NCT00003853
(ClinicalTrials.gov)
April 19991/11/19994'-Iodo-4'-Deoxydoxorubicin in Treating Patients With Primary Systemic AmyloidosisPhase II Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL)Multiple Myeloma and Plasma Cell NeoplasmDrug: 4'-iodo-4'-deoxydoxorubicinNational Cancer Institute (NCI)NULLCompleted18 YearsN/ABoth45Phase 2United States;Italy
154NCT00002849
(ClinicalTrials.gov)
November 19961/11/1999S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic AmyloidosisPhase II Study of Dexamethasone/Alpha-Interferon in AL AmyloidosisMultiple MyelomaBiological: recombinant interferon alfa;Drug: dexamethasoneSouthwest Oncology GroupNational Cancer Institute (NCI);Cancer and Leukemia Group BCompleted18 YearsN/ABoth93Phase 2United States

51. 全身性強皮症 [臨床試験数:466,薬物数:536(DrugBank:142),標的遺伝子数:110,標的パスウェイ数:210
Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
190 / 466 trials found
No.TrialIDDate_
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1NCT04432545
(ClinicalTrials.gov)
September 1, 202210/6/2020Infusion of Allogeneic Mesenchymal Stem Cells in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary InvolvementInfusion of Allogeneic Stromal Mesenchymal Stem Cells From Wharton´s Jelly in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary Involvement to TreatmentSystemic Sclerosis Pulmonary;Pulmonary Hypertension;Pulmonary FibrosisBiological: Mesenchymal Stem Cells from Wharton ´s jellyintravenous infusion of Mesenchymal Stem Cells from Wharton ´s jellyUniversidad de la SabanaFundación Neumologica Colombiana;Stem Medicina Regenerativa;CryoHoldco LATAMAvailable18 Years65 YearsAllColombia
2NCT03800017
(ClinicalTrials.gov)
September 1, 202121/11/2018Skeletal Muscle Function in Interstitial Lung DiseaseInvestigating the Role of Skeletal Muscle Dysfunction on Dyspnea and Exercise Intolerance in Interstitial Lung DiseaseInterstitial Lung Disease;Idiopathic Pulmonary Fibrosis;Hypersensitivity Pneumonitis;Scleroderma;Nonspecific Interstitial PneumoniaBiological: HyperoxiaUniversity of British ColumbiaNULLNot yet recruiting40 Years80 YearsAll40N/ANULL
3NCT04647890
(ClinicalTrials.gov)
February 202116/11/2020Effects of FT011 in Systemic SclerosisA Phase II, Randomised, Double Blind, Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamic Effects, and Safety, of Oral FT011 in Participants With Diffuse Systemic SclerosisScleroderma, Systemic;Scleroderma, Diffuse;Sclerosis, SystemicDrug: FT011;Drug: PlaceboCerta TherapeuticsNULLNot yet recruiting18 Years75 YearsAll30Phase 2NULL
4NCT04515706
(ClinicalTrials.gov)
January 1, 202113/8/2020Iguratimod in Systemic SclerosisSafety, Tolerability, Efficacy of Iguratimod in Systemic SclerosisSystemic Sclerosis, DiffuseDrug: Iguratimod;Drug: PlaceboRenJi HospitalNULLNot yet recruiting19 Years74 YearsAll20N/ANULL
5NCT04627857
(ClinicalTrials.gov)
January 1, 20216/11/2020Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic SclerosisEffect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic SclerosisScleroderma SystemicDevice: Manual toothbrush;Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss);Device: Sonic toothbrush;Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)University Hospital, Strasbourg, FranceNULLNot yet recruiting18 YearsN/AAll100N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
6NCT04440592
(ClinicalTrials.gov)
December 31, 202017/6/2020Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic SclerosisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: MT-7117;Drug: PlaceboMitsubishi Tanabe Pharma Development America, Inc.NULLRecruiting18 Years75 YearsAll72Phase 2United States
7NCT04656704
(ClinicalTrials.gov)
December 1, 202030/11/2020Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin DiseaseInvestigating Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin DiseaseMicrostomia;Scleroderma;CREST Syndrome;Scleromyxedema;MorpheaDrug: hyaluronidase injected intradermallyBrigham and Women's HospitalNULLNot yet recruiting18 YearsN/AAll8Early Phase 1NULL
8NCT04303208
(ClinicalTrials.gov)
December 20203/3/2020Plasmacytoid Dendritic Cells and Toll Like Receptor 8 in Systemic SclerosisPlasmacytoid Dendritic Cells and Toll Like Receptor 8 in Systemic SclerosisSystemic SclerosisProcedure: 2 ml of whole blood sample will be collected on EDTA tubeAssiut UniversityNULLNot yet recruiting18 YearsN/AAll80N/ANULL
9NCT04478994
(ClinicalTrials.gov)
November 202016/7/2020A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics, and Explore Efficacy of TEPEZZA in Patients With Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisBiological: TEPEZZA;Other: PlaceboHorizon Therapeutics USA, Inc.NULLRecruiting18 Years80 YearsAll25Phase 1United States
10NCT04356287
(ClinicalTrials.gov)
October 202015/4/2020Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic SclerosisPhase I/II Randomized Controlled Trial of Umbilical Cord-derived mesenChymAl stRomal cElls in Systemic SclerosisSclerosis, Systemic;Mesenchymal Stem CellsBiological: UCMSC;Other: PlaceboMarie Hudson, MDAssistance Publique - Hôpitaux de Paris;University Paris 7 - Denis Diderot;Université de Montréal;Medical University of South Carolina;Centre hospitalier de l'Université de Montréal (CHUM);McGill University Health Centre/Research Institute of the McGill University Health CentreNot yet recruiting18 YearsN/AAll18Phase 1;Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04300426
(ClinicalTrials.gov)
September 24, 202025/2/2020Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue)Aiming to Reduce Disease-related Gastrointestinal Symptoms in Systemic Sclerosis by Repeat Intestinal Infusions of Anaerobic Cultivated Human Intestinal Microbiome (ACHIM); a Randomized, Double-blind Placebo-controlled 20 Week StudySystemic SclerosisDrug: ACHIM as solute (10^9 intestinal microbes/ml)Oslo University HospitalSouth-Eastern Norway Regional Health Authority;Haukeland University Hospital;St. Olavs Hospital;University Hospital of North NorwayRecruiting18 Years85 YearsAll70Phase 2Norway
12NCT04356755
(ClinicalTrials.gov)
September 22, 202011/3/2020Subcutaneous Injections of Autologous ASC to Heal Digital Ulcers in Patients With Scleroderma.Subcutaneous Injections of Autologous Cultured Adipose-derived Stroma/ Stem Cells to Heal Refractory Ischemic Digital Ulcers in Patients With SclerodermaSystemic SclerosisProcedure: Adipose tissue harvest;Drug: Autologous ASC;Drug: PlaceboUniversity Hospital, ToulouseNULLRecruiting18 YearsN/AAll32Phase 2France
13NCT04380831
(ClinicalTrials.gov)
September 22, 202030/4/2020TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic SclerosisPilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) and Cyclophosphamide Conditioning Regimen Prior to Autologous Hematopoietic Cell Transplantation in Patients With Severe Systemic SclerosisSystemic SclerodermaProcedure: Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Radiation: Intensity-Modulated Radiation Therapy;Procedure: Total-Body IrradiationCity of Hope Medical CenterNational Cancer Institute (NCI)Recruiting18 Years65 YearsAll15Early Phase 1United States
14NCT04166552
(ClinicalTrials.gov)
June 11, 20206/11/2019Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic SclerosisA Phase IIa, Double-Blind, Randomised, Intracohort Placebo-Controlled, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 in Patients With Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: Patients will be randomized to receive EHP-101 or PlaceboEmerald Health Pharmaceuticals Inc.Iqvia Pty LtdRecruiting18 Years70 YearsAll36Phase 2United States;Australia;New Zealand
15NCT04265144
(ClinicalTrials.gov)
June 8, 20205/2/2020Cohort of Patients With Systemic Sclerosis Within the Framework of the RESO Reference CentreCohort of Patients With Systemic Sclerosis and Associated Biological Collection Within the Framework of the RESO Reference Centre for Rare Systemic Autoimmune DiseasesScleroderma;Systemic SclerosisBiological: Blood samples;Other: Biopsy;Other: Bronchoalveolar samplesUniversity Hospital, BordeauxNULLRecruiting18 YearsN/AAll500N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT04244916
(ClinicalTrials.gov)
May 25, 20206/1/2020MPA AUC Monitoring in Patients Receiving MMF for Diffuse Cutaneous or Pulmonary Involvement in Systemic SclerosisProspective Study to Investigate the Relevance of Monitoring Area Under the Curve of Mycophenolic Acid in Patients Receiving Mycophenolate Mofetil to Treat a Diffuse Cutaneous or a Pulmonary Involvement of Systemic SclerosisSystemic SclerosisBiological: AUC of MPA measureAssistance Publique - Hôpitaux de ParisNULLRecruiting18 YearsN/AAll50France
17NCT04200755
(ClinicalTrials.gov)
May 19, 202010/12/2019Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized SclerodermaA Randomized, Placebo-controlled Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Dupilumab in Localized SclerodermaLocalized SclerodermaDrug: Dupilumab 300Mg Solution for Injection;Other: PlaceboUniversity of CologneNULLRecruiting18 YearsN/AAll45Phase 2Germany
18NCT04523506
(ClinicalTrials.gov)
May 8, 202019/7/2020The Effects of Botulinum Toxin on Oral Aperture in Patients With SclerodermaThe Effects of Botulinum Toxin on Oral Aperture in Patients With SclerodermaSclerodermaBiological: Botulinum toxin(Botox)University of Texas Southwestern Medical CenterNULLRecruiting18 Years65 YearsAll30Early Phase 1United States
19NCT04325217
(ClinicalTrials.gov)
April 15, 202026/3/2020Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in JapanPost-Marketing Surveillance (PMS) of Nintedanib (Ofev Capsule) in Systemic Scleroderma With Interstitial Lung Disease (SSc-ILD) in JapanLung Diseases, InterstitialDrug: NintedanibBoehringer IngelheimNULLRecruitingN/AN/AAll600Japan
20NCT03582800
(ClinicalTrials.gov)
January 6, 202013/6/2018Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot StudySubcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot StudySystemic Sclerosis;Dermatomyositis;iPPSD2Drug: STSUniversity Hospital, LimogesNULLRecruiting6 MonthsN/AAll40Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT04388176
(ClinicalTrials.gov)
January 3, 202011/5/2020Cold Challenge With C21 in RPA Phase 2, Single-center, Randomised, Double-blind, Placebo-controlled, Cross-over Cold Challenge Study Investigating the Effect of C21 on Cold-induced Vasoconstriction in Subjects With Raynaud's Phenomenon (RP) Secondary to Systemic Sclerosis (SSc)Raynaud Phenomenon;Systemic SclerosisDrug: C21;Drug: PlaceboVicore Pharma ABSGS Life Sciences, a division of SGS Belgium NVRecruiting19 Years75 YearsAll16Phase 2United Kingdom
22NCT04138485
(ClinicalTrials.gov)
December 20, 201914/10/2019Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults With Systemic SclerosisDiffuse Cutaneous Systemic SclerosisBiological: IgPro10;Biological: PlaceboCSL BehringNULLWithdrawn18 YearsN/AAll0Phase 2United States;Argentina;Australia;Belgium;Canada;France;Germany;Italy;Mexico;Poland;Spain;Switzerland;United Kingdom
23NCT03740724
(ClinicalTrials.gov)
December 18, 20196/11/2018A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)A Phase 1/2 Study of a Combination of FCX-013 (Genetically-Modified Autologous Human Dermal Fibroblasts) Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)Morphea;Scleroderma, Localized;SclerodermaGenetic: FCX-013;Drug: veledimexFibrocell Technologies, Inc.NULLRecruiting18 YearsN/AAll10Phase 1;Phase 2United States
24NCT04095351
(ClinicalTrials.gov)
December 9, 201913/9/2019Connective Tissue Diseases and Lung ManifestationsConnective Tissue Diseases and Lung Manifestations Prospective Trial With Focus on Systemic Sclerosis (Colipris)Connective Tissue Diseases;Interstitial Lung Disease;Systemic SclerosisDiagnostic Test: Pulmonary function test;Diagnostic Test: Imaging;Biological: Blood samplingMedical University InnsbruckBoehringer IngelheimRecruiting18 Years80 YearsAll120Austria
25NCT04040322
(ClinicalTrials.gov)
October 14, 201930/7/2019Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study)Raynaud's Phenomenon Secondary to Systemic SclerosisDrug: Placebo IV infusion;Drug: Iloprost Injection, for intravenous useEicos Sciences, Inc.NULLRecruiting18 YearsN/AAll180Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT04137224
(ClinicalTrials.gov)
September 19, 201921/10/2019Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) and IgPro10 (Intravenous Immunoglobulin, Privigen®) in Adults With Systemic Sclerosis (SSc)Diffuse Cutaneous Systemic SclerosisBiological: IgPro20;Biological: IgPro10CSL BehringNULLRecruiting18 YearsN/AAll26Phase 2Australia;France;Germany;Italy;Poland;United Kingdom
27NCT03844061
(ClinicalTrials.gov)
July 29, 201931/1/2019Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic SclerosisA Randomized, Double-Blind, Placebo-Controlled Study of Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic SclerosisSystemic SclerosisDrug: Belimumab;Drug: Rituximab;Other: Placebo Subcutaneous Injection;Other: Placebo Infusion;Drug: MMFHospital for Special Surgery, New YorkGlaxoSmithKlineRecruiting18 Years80 YearsAll30Phase 2United States
28NCT04045743
(ClinicalTrials.gov)
July 19, 201927/7/2019The Benefit of Bermekimab in Patients With Systemic SclerosisClinical Efficacy of Inhibition of Organ Dysfunction Through Bermekimab in Systemic Sclerosis: A Proof- Of-Concept Double-Blind Randomized Clinical Trial (the Light Trial)Scleroderma, SystemicDrug: MABp1 (Bermekimab) OR Placebo;Drug: MABp1 (Bermekimab)Hellenic Institute for the Study of SepsisNULLRecruiting18 YearsN/AAll20Phase 2Greece
29NCT03976648
(ClinicalTrials.gov)
July 18, 20194/6/2019A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic SclerosisA Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Orally Administered GLPG1690 in Subjects With Systemic SclerosisSclerosis, SystemicDrug: GLPG1690Galapagos NVNULLActive, not recruiting18 YearsN/AAll31Phase 2United States;Belgium;Italy;Spain;United Kingdom
30NCT03919799
(ClinicalTrials.gov)
July 9, 201921/11/2018KD025 in Subjects With Diffuse Cutaneous Systemic SclerosisA Phase 2, Randomized, Placebo-controlled, Double-blind, Open-label Extension Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil (KD025) in Subjects With Diffuse Cutaneous Systemic SclerosisSystem; Sclerosis;Diffuse Cutaneous Systemic SclerosisDrug: Belumosudil (KD025);Drug: PlaceboKadmon Corporation, LLCNULLRecruiting18 Years100 YearsAll60Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT04036227
(ClinicalTrials.gov)
July 3, 201923/7/2019Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248A Phase I, Placebo-controlled, Double-blind, First-in-human Study to Investigate Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GS-248 Solution in Healthy Subjects and Patients With Systemic Sclerosis (SSc)HealthyDrug: GS-248;Drug: PlaceboGesynta Pharma ABCTC Clinical Trial ConsultantsCompleted18 Years75 YearsAll72Phase 1Sweden
32NCT03957681
(ClinicalTrials.gov)
May 23, 201916/5/2019A Phase 3 Study of KHK4827 in Patients With Systemic SclerosisA Phase 3, Placebo-controlled, Double-blind Comparative Study of KHK4827 With an Open-label Extension Period in Subjects With Systemic Sclerosis Who Have Moderate to Severe Skin ThickeningModerate to Severe Systemic SclerosisDrug: KHK4827;Drug: PlaceboKyowa Kirin Co., Ltd.NULLActive, not recruiting18 Years70 YearsAll100Phase 3Japan
33NCT03198689
(ClinicalTrials.gov)
May 7, 201914/6/2017Brentuximab Vedotin in Early Diffuse Cutaneous Systemic SclerosisA Pilot Study of Adcetris Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma)Diffuse Cutaneous Systemic SclerosisDrug: Brentuximab VedotinLawson Health Research InstituteSeagen Inc.Recruiting18 YearsN/AAll10Phase 2Canada
34NCT03816345
(ClinicalTrials.gov)
April 4, 201924/1/2019Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant NeoplasmBiological: NivolumabNational Cancer Institute (NCI)NULLRecruiting18 YearsN/AAll264Phase 1United States
35NCT03867097
(ClinicalTrials.gov)
March 4, 20196/3/2019Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Pilot Study Evaluating Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic SclerosisRaynaud Phenomenon Secondary to Systemic SclerosisDrug: Placebo IV infusion;Drug: Iloprost Injection, for intravenous useEicos Sciences, Inc.NULLCompleted18 YearsN/AAll41Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT03798366
(ClinicalTrials.gov)
January 14, 20193/1/2019A Clinical Study to Test How Effective and Safe GLPG1690 is for Patients With Systemic SclerosisA Phase 2a Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered GLPG1690 for 24 Weeks in Subjects With Systemic SclerosisSclerodermaDrug: GLPG1690;Drug: PlaceboGalapagos NVNULLCompleted18 YearsN/AAll33Phase 2United States;Belgium;Germany;Italy;Spain;United Kingdom
37NCT03831438
(ClinicalTrials.gov)
January 1, 201931/1/2019Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic SclerosisA Phase 1 Open-Label Study to Determine the Safety and Tolerability of AVID200: A Transforming Growth Factor ß (TGFß) Inhibitor, in Patients With Diffuse Cutaneous Systemic SclerosisScleroderma, DiffuseDrug: AVID200Formation BiologicsNULLActive, not recruiting18 YearsN/AAll24Phase 1United States
38NCT03817424
(ClinicalTrials.gov)
December 13, 201822/1/2019A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisA Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisSystemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;DermatomyositisDrug: VIB7734;Drug: PlaceboViela BioNULLCompleted18 Years75 YearsAll31Phase 1United States;Poland;Spain
39EUCTR2018-001719-65-NL
(EUCTR)
10/12/201809/07/2018 CALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis CALC-SSc study CALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis CALC-SSc study - CALC-SSc study Systemic sclerosis (SSc) is a rare progressive autoimmune disease hallmarked by severe vasculopathy. Patients are prone to enhanced calcification of skin and the vasculature. Active calcifications may not only occur in the skin of patients with clinically overt calcinosis cutis, but also in SSc patients without. Since calcification is strongly associated with local inflammation, it may very well occur in internal organs and serve as an early proxy for long-term SSc-related complications.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]University Medial Center GroningenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120Phase 4Netherlands
40NCT03742466
(ClinicalTrials.gov)
November 10, 201810/11/2018Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma PatientsLocal Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients. A Single-blind Randomized Clinical TrialCarpal Tunnel Syndrome;Chronic Pain;SclerodermaDrug: Ozone;Drug: methylprednisolone acetateAssiut UniversityNULLCompleted20 Years60 YearsAll50N/AEgypt
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
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Inclusion_
gender
Target_
size
PhaseCountries
41NCT03211793
(ClinicalTrials.gov)
November 201827/4/2017Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic SclerosisMesenchymal Stromal Cells for Angiogenesis and Neovascularisation in Digital Ulcers of Systemic Sclerosis: the MANUS TrialSystemic Sclerosis;Digital UlcerDrug: Mesenchymal stromal cells;Other: PlaceboUMC UtrechtZonMw: The Netherlands Organisation for Health Research and DevelopmentUnknown status18 YearsN/AAll20Phase 1;Phase 2Netherlands
42NCT03717961
(ClinicalTrials.gov)
October 15, 201815/10/2018Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic SclerosisMulticenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Study to Assess Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic SclerosisRaynaud Phenomenon Secondary to Systemic SclerosisDrug: BOTOX® solution;Drug: Placebo groupAssistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/AAll91Phase 3France
43NCT03575156
(ClinicalTrials.gov)
September 20, 20187/6/2018Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic SclerosisMicroparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic SclerosisSystemic Lupus Erythematosus;Systemic SclerodermaBiological: blood sample;Biological: urine sampleUniversity Hospital, BordeauxNULLActive, not recruiting18 YearsN/AAll208N/AFrance
44NCT03678987
(ClinicalTrials.gov)
September 13, 201813/9/2018Mycophenolate Mofetil Pharmacokinetics in Systemic SclerosisMycophenolate Mofetil in Systemic Sclerosis: A Phase 1 Pharmacokinetic Study of Orally Ingested Mycophenolate Mofetil Tablets in Patients Suffering From Systemic SclerosisSystemic Sclerosis;Gastrointestinal ComplicationDiagnostic Test: P-MPA concentration;Drug: mycophenolic acidRegion SkaneNULLCompleted18 YearsN/AAll35Phase 1Sweden
45NCT03726398
(ClinicalTrials.gov)
September 1, 201821/10/2018CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PHCompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated Interstitial Lung DiseasE and Pulmonary Hypertension (PH): The CRuSADE PH StudyInterstitial Lung Disease;Scleroderma;Pulmonary HypertensionDrug: Opsumit 10 Mg TabletFranz Rischard, DONational Jewish Health;University of PittsburghRecruiting18 YearsN/AAll26Phase 2;Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03629002
(ClinicalTrials.gov)
September 20187/8/2018BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIABIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA IN THE CONTEXT OF THE DEVELOPMENT OF AN INNOVATIVE CELLULAR THERAPY FOR THE TREATMENT OF FUNCTIONAL HANDICAP OF THE HANDSystemic SclerodermaBiological: Study of the gene expression profileAssistance Publique Hopitaux De MarseilleNULLUnknown status18 YearsN/AAll30France
47NCT03558854
(ClinicalTrials.gov)
August 28, 20183/5/2018Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma PatientsEvaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic SclerosisSystemic SclerosisDrug: Acetylsalicylic acid;Drug: Placebo oral capsuleFederal University of São PauloNULLRecruiting18 Years65 YearsAll70Phase 4Brazil
48NCT03630211
(ClinicalTrials.gov)
July 31, 20187/8/2018Autologous Stem Cell Transplantation in Patients With Systemic SclerosisAutologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc)Systemic Sclerosis;Diffuse Sclerosis Systemic;Interstitial Lung Disease;Pulmonary HypertensionDrug: Cyclophosphamide;Drug: Mesna;Drug: Rituximab;Drug: Alemtuzumab;Drug: Thiotepa;Drug: GM-CSF;Drug: Intravenous immunoglobulin;Radiation: Total Body IrradiationPaul SzabolcsNULLRecruiting16 Years70 YearsAll8Phase 2United States
49NCT03856853
(ClinicalTrials.gov)
June 15, 201826/2/2019Efficacy and Safety of Pirfenidone in Patient With Systemic Sclerosis-associated Interstitial Lung DiseaseA Phase III, Randomized, Double-blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Pirfenidone in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild)Drug: Pirfenidone;Other: placeboBeijing Continent Pharmaceutical Co, Ltd.Shanghai Genomics, Inc.;GNI-EPS Pharmaceuticals, Inc. (GNI Group)Recruiting18 Years75 YearsAll144Phase 3China
50NCT03644225
(ClinicalTrials.gov)
June 11, 20184/5/2018Suction Based Characterization of Healthy and Diseased SkinMechanical Characterization of Healthy and Diseased Skin With Suction Based Assessment of Skin DeformabilitySystemic SclerosisDevice: Measurment with Aspirational Medical Device;Device: Measurment with Cutometer MPA 580Oliver DistlerSwiss Federal Institute of TechnologyCompleted18 YearsN/AAll67N/ASwitzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT03365869
(ClinicalTrials.gov)
June 1, 20184/12/2017A Pilot-Study of Sirolimus for the Treatment of Systemic SclerosisA Phase ? Pilot-Study With Sirolimus for the Treatment of Systemic SclerosisSystemic SclerosisDrug: SirolimusPeking University People's HospitalNULLNot yet recruiting18 Years80 YearsAll72Phase 2NULL
52NCT03593902
(ClinicalTrials.gov)
May 17, 201828/6/2018Cardiac Safe Transplants for Systemic SclerosisAutologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac DysfunctionSystemic Sclerosis;SclerodermaDrug: Rituximab;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem CellsNorthwestern UniversityNULLTerminated18 Years65 YearsAll9Phase 2;Phase 3United States
53NCT03508375
(ClinicalTrials.gov)
May 15, 201816/4/2018Evaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic SclerosisEvaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic SclerosisSystemic SclerodermaBiological: blood samplesAssistance Publique Hopitaux De MarseilleNULLRecruiting18 YearsN/AAll75N/AFrance
54NCT03607071
(ClinicalTrials.gov)
May 15, 201820/7/2018Outcome of Steroid Therapy for Myocardial Inflammation in SclerodermaOutcome of Myocardial Inflammation After Steroid Therapy in Thai Systemic Sclerosis Patients: an Open Label StudyMyocardial InflammationDrug: Prednisolone and taperKhon Kaen UniversityNULLCompleted18 YearsN/AAll20Phase 2Thailand
55NCT03430388
(ClinicalTrials.gov)
January 31, 201830/1/2018Yellow Fever Vaccine in Patients With Rheumatic DiseasesEvaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk AreaSystemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile DermatomyositisBiological: Yellow Fever vaccine (17D)University of Sao Paulo General HospitalNULLCompleted2 Years60 YearsAll600N/ABrazil
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT03708718
(ClinicalTrials.gov)
December 21, 20178/10/2018Prednisolone in Early Diffuse Systemic SclerosisA Phase II Randomised Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis (Initially Double-blind, Then Switched to Open-label Because of Covid-19)Systemic SclerosisDrug: Prednisolone 5 mg;Drug: Placebo oral capsule; From August 2020 'no additional treatment'Prof. Ariane herrickVersus ArthritisRecruiting18 YearsN/AAll72Phase 2United Kingdom
57NCT03398837
(ClinicalTrials.gov)
December 18, 20175/1/2018Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: Lenabasum 5 mg;Drug: Lenabasum 20 mg;Other: Placebo oral capsuleCorbus Pharmaceuticals Inc.NULLActive, not recruiting18 YearsN/AAll365Phase 3United States;Australia;Canada;Germany;Israel;Japan;Korea, Republic of;Netherlands;Poland;Spain;Switzerland;United Kingdom
58NCT04274257
(ClinicalTrials.gov)
December 4, 201713/2/2020A Study of the Efficacy and Safety of Rituximab in Participants With Systemic SclerosisDouble-Blind, Parallel-group Comparison, Investigators Initiated Phase II Clinical Trial of IDEC-C2B8 (Rituximab) in Patients With Systemic SclerosisScleroderma, Systemic;Skin Sclerosis;Lung Fibrosis;Autoimmune Diseases;Collagen DiseasesDrug: Double-Blind Placebo;Drug: Double-Blind RituximabTokyo UniversityJapan Agency for Medical Research and Development;Zenyaku Kogyo Co., Ltd.Completed20 Years80 YearsAll56Phase 2;Phase 3Japan
59NCT03221257
(ClinicalTrials.gov)
November 28, 201712/7/2017Scleroderma Lung Study III - Combining Pirfenidone With MycophenolateScleroderma Lung Study III (SLS III): Combining the Anti-fibrotic Effects of Pirfenidone (PFD) With Mycophenolate (MMF) for Treating Scleroderma-related Interstitial Lung DiseaseScleroderma, Systemic;Interstitial Lung DiseaseDrug: Pirfenidone (PFD);Drug: Placebo (Plac);Drug: Mycophenolate Mofetil (MMF)Michael RothUniversity of Michigan;Genentech, Inc.;University of California, Los AngelesActive, not recruiting18 YearsN/AAll150Phase 2United States
60NCT03313180
(ClinicalTrials.gov)
November 27, 201713/10/2017A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis.An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)Lung Diseases, InterstitialDrug: NintedanibBoehringer IngelheimNULLActive, not recruiting18 YearsN/AAll444Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;China;Czechia;Denmark;Finland;France;Germany;Greece;India;Israel;Italy;Japan;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland;Thailand;United Kingdom;Ireland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT04368403
(ClinicalTrials.gov)
October 6, 201713/4/2020A Study of KHK4827 in Patients With Systemic SclerosisA Phase 1, Open-label, Multiple-dose Study of KHK4827 in Subjects With Systemic SclerosisSystemic SclerosisDrug: KHK4827Kyowa Kirin Co., Ltd.NULLActive, not recruiting18 Years70 YearsAll8Phase 1Japan
62NCT03274076
(ClinicalTrials.gov)
September 25, 201728/8/2017Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Phase I/II Two Center Safety and Tolerability StudySystemic Sclerosis;SclerodermaDrug: Tofacitinib;Drug: Placebo Oral TabletUniversity of MichiganPfizerCompleted18 Years70 YearsAll15Phase 1;Phase 2United States
63NCT03222492
(ClinicalTrials.gov)
September 20, 201717/7/2017Brentuximab Vedotin for Systemic SclerosisEvaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis BRAVOS: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study (ITN075AI)Diffuse Cutaneous Systemic Sclerosis;Scleroderma;dcSScBiological: Brentuximab Vedotin;Biological: PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN);Seagen Inc.Recruiting18 Years70 YearsAll24Phase 1;Phase 2United States;Canada
64EUCTR2015-001617-27-BG
(EUCTR)
02/08/201717/05/2017A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
65NCT03120533
(ClinicalTrials.gov)
June 20, 201723/3/2017Treprostinil Iontophoresis in Systemic Sclerosis Digital UlcErations. A Proof of Concept StudyTherapeutic Iontophoresis of Treprostinil in Systemic Sclerosis Digital UlcErations. A Proof of Concept StudyScleroderma, SystemicDrug: Iontophoresis of treprostinil;Drug: Iontophoresis of placeboUniversity Hospital, GrenobleLinksium;University Grenoble AlpsCompleted18 YearsN/AAll18Phase 1;Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT03041025
(ClinicalTrials.gov)
June 5, 201731/1/2017Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic SclerosisA Multi-center, Randomized, Double-blind (Sponsor Open), Placebo-controlled, Repeat-dose, Proof of Mechanism Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Explore Efficacy of GSK2330811 in Participants With Diffuse Cutaneous Systemic SclerosisScleroderma, SystemicDrug: GSK2330811;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 YearsN/AAll35Phase 2United States;Canada;Netherlands;United Kingdom
67NCT03155464
(ClinicalTrials.gov)
June 1, 201724/4/2017Intraoperative ICG for Systemic SclerosisA Prospective Study of the Utility of Intraoperative, Quantitative Indocyanine Green Angiography in Microvascular Surgery for Systemic ScerlosisSystemic SclerosisProcedure: Order of two elements of surgical procedure;Drug: Indocyanine GreenDuke UniversityNULLWithdrawn18 YearsN/AAll0Phase 4NULL
68EUCTR2015-001617-27-SI
(EUCTR)
26/05/201715/05/2017A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
69NCT03068234
(ClinicalTrials.gov)
May 201716/2/2017Pirfenidone as Treatment of Skin Fibrosis in Systemic SclerosisA Randomized, Double-blinded, Placebo Controlled Study to Evaluate Clinical Efficacy and Safety of Pirfenidone for Skin Fibrosis in Systemic SclerosisSystemic SclerosisDrug: Pirfenidone;Drug: Placebo oral capsule;Drug: SteroidsRenJi HospitalNULLNot yet recruiting18 Years70 YearsAll72Phase 2;Phase 3China
70NCT03059979
(ClinicalTrials.gov)
January 201725/1/2017The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )Hit Hard and Early. The Effect of High Dose Methylprednisolone on Nailfold Capillary Changes and Biomarkers in Early SSc: a 12-week Randomised Explorative Double-blind Placebo-controlled Trial.Systemic Sclerosis;Raynaud PhenomenaDrug: Methylprednisolone;Other: sodium chlorideRadboud UniversityNULLRecruiting18 YearsN/AAll30Early Phase 1Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT02682511
(ClinicalTrials.gov)
January 20178/2/2016Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial HypertensionA Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (SSc-PAH)Scleroderma, Diffuse;Scleroderma, Systemic;Scleroderma, Limited;Sclerosis, Progressive Systemic;Skin Diseases;Connective Tissue Diseases;Pathologic Processes;Autoimmune DiseasesDrug: Oral Ifetroban;Drug: Oral PlaceboCumberland PharmaceuticalsNULLRecruiting18 Years80 YearsAll34Phase 2United States;India
72NCT03007004
(ClinicalTrials.gov)
December 12, 201628/12/2016Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic SclerosisTrial to Confirm the Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic SclerosisSystemic Sclerosis Patients With Digital UlcersDrug: Botulinum toxin type B (2500 units / vial);Drug: Physiological salineGunma UniversityNULLCompleted18 YearsN/AAll10Phase 2Japan
73NCT03053739
(ClinicalTrials.gov)
December 201629/12/2016To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisRandomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisAssociated Pulmonary Arterial HypertensionDrug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and PlaceboPostgraduate Institute of Medical Education and ResearchNULLRecruiting18 YearsN/AAll50Phase 4India
74NCT02981082
(ClinicalTrials.gov)
December 201630/11/2016Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial HypertensionA Double-blinded, Placebo-controlled Pilot Study of Dimethyl Fumarate (DMF) in Pulmonary Arterial Hypertension (PAH) Associated With Systemic Sclerosis (SSc-PAH): The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress.Systemic Sclerosis;Pulmonary; HypertensionDrug: Dimethyl Fumarate (DMF);Drug: Placebo Oral TabletRobert LafyatisBiogenTerminated18 Years80 YearsAll6Phase 1United States
75NCT02921971
(ClinicalTrials.gov)
November 23, 201630/9/2016Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic SclerosisEfficacy and Safety of SAR156597 in the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-blind, Placebo-controlled, 24-week, Proof of Concept StudySystemic SclerosisDrug: SAR156597 (ACT14604);Drug: PlaceboSanofiNULLCompleted18 YearsN/AAll97Phase 2United States;Argentina;Belgium;Estonia;France;Germany;Italy;Mexico;Poland;Romania;Russian Federation;Ukraine;United Kingdom;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT03388255
(ClinicalTrials.gov)
November 8, 201621/12/2017Efficacy and Safety of PLACENTEX ® i.m. in Patients With Scleroderma DiseasesA Phase IV, Single-arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of PLACENTEX ® Polydeoxyribonucleotide i.m. in Patients With Fibrotic and Atrophic Cutaneous Lesions in Scleroderma DiseasesScleroderma DiseaseDrug: PolydeoxyribonucleotidesMastelli S.r.lSintesi Research SrlActive, not recruiting18 YearsN/AAll25Phase 4Italy
77NCT02975960
(ClinicalTrials.gov)
October 25, 20169/11/2016ADMSCs for the Treatment of Systemic SclerosisAdipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic SclerosisSystemic SclerosisBiological: injection of autologous stromal vascular fractionThe Catholic University of KoreaSeoul St. Mary's HospitalCompleted18 YearsN/AAll7N/AKorea, Republic of
78NCT02663895
(ClinicalTrials.gov)
October 201619/1/2016Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic SclerosisA Pilot Study to Evaluate the Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic SclerosisSystemic Sclerosis;CalcinosisDrug: Oral treprostinilStanford UniversityUnited TherapeuticsCompleted18 YearsN/AAll12Phase 2United States
79NCT02896205
(ClinicalTrials.gov)
October 201627/8/2016Study to Compare the Efficacy of Mycophenolate Mofetil in Systemic Sclerosis Related Early Interstitial Lung DiseaseA Randomized Controlled Trial to Compare the Efficacy of Oral Mycophenolate Mofetil With Placebo in Patients With Systemic Sclerosis Related Early Interstitial Lung DiseaseSystemic Sclerosis;Scleroderma;Interstitial Lung DiseaseDrug: Mycophenolate mofetil;Drug: PlaceboPostgraduate Institute of Medical Education and ResearchNULLCompleted18 YearsN/AAll41Phase 3India
80NCT02798055
(ClinicalTrials.gov)
September 30, 20163/6/2016Bosentan Treatment of Digital Ulcers Related to Systemic SclerosisA National, Observational, Multi-center Registry to Examine the Characteristics of Patients With Systematic Sclerosis Digital Ulcers and Assess Bosentan Treatment.Systematic Sclerosis;Digital Ulcer;SclerodermaDrug: Bosentan groupElpen Pharmaceutical Co. Inc.NULLCompleted18 Years80 YearsAll148Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT02915835
(ClinicalTrials.gov)
September 201615/9/2016Riociguat in Scleroderma Associated Digital UlcersA Multi-center Randomized, Double Blind, Placebo-controlled, Pilot Study to Assess the Efficacy and Safety of Riociguat in Scleroderma - Associated Digital UlcersScleroderma;Digital UlcersDrug: Riociguat;Drug: PlaceboDinesh Khanna, MD, MSBayerCompleted18 YearsN/AAll17Phase 2United States
82EUCTR2015-002586-39-IT
(EUCTR)
27/07/201606/02/2018Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic SclerosisRandomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Terguride
Product Code: /
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
Product Code: /
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Trade Name: METOCLOPRAMIDE ACCORD - 10 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/PVDC/AL
Product Name: Metoclopramide
Product Code: /
INN or Proposed INN: METOCLOPRAMIDE
Other descriptive name: METOCLOPRAMIDE
MEDAC GMBHNULLNot RecruitingFemale: yes
Male: yes
148Phase 3Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;United Kingdom;Switzerland;Italy
83EUCTR2015-005023-11-PL
(EUCTR)
12/07/201620/06/2016Abituzumab in SSc-ILDA Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 20.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Abituzumab
INN or Proposed INN: abituzumab
Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
175Phase 2France;United States;Canada;Argentina;Spain;Poland;Singapore;Turkey;Australia;Israel;Italy;United Kingdom
84EUCTR2015-005023-11-GB
(EUCTR)
08/07/201625/05/2016Abituzumab in SSc-ILDA Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 20.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Abituzumab
INN or Proposed INN: abituzumab
Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
175Phase 2France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;Italy;United Kingdom
85EUCTR2015-005023-11-ES
(EUCTR)
04/07/201627/06/2016Abituzumab in SSc-ILDA Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 19.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Abituzumab
INN or Proposed INN: abituzumab
Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
175Phase 2France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2015-001617-27-NL
(EUCTR)
07/06/201606/04/2016A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs . Pulmonary fibrosis and pulmonary hypertension appear as the leading causes of mortality and patients with SSc have considerable morbidity from their disease due to skin fibrosis, Raynaud’s phenomenon and damage to the gastrointestinal tract, lungs, heart and kidneys.
MedDRA version: 18.1;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 18.1;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
Inventiva SASNULLNot RecruitingFemale: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Germany;Netherlands;United Kingdom;Italy;Switzerland
87NCT02801305
(ClinicalTrials.gov)
June 20169/6/2016Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital UlcersAssessing and Comparing the Effect of Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers.Digital Ulcer of SclerodermaDrug: Diltiazem Gel 2%;Drug: Nitroglycerin Ointment 2%;Drug: VaselineMohammad Ali NazariniaShiraz University of Medical SciencesCompleted20 Years70 YearsAll90Phase 2Iran, Islamic Republic of
88NCT02733978
(ClinicalTrials.gov)
June 201625/3/2016Ozone Therapy in the Treatment of Digital Ulcers in Patients With Systemic SclerosisNon-invasive Oxygen-Ozone Therapy in the Treatment of Digital Ulcers in Egyptian Patients With Systemic SclerosisUlcer;SclerodermaDevice: the ozone generator device (Human Pro medic, German)Assiut UniversityNULLCompletedN/AN/AAll50N/ANULL
89NCT02745145
(ClinicalTrials.gov)
May 31, 201615/4/2016Abituzumab in SSc-ILDA Phase II, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy and Safety of Abituzumab in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)Systemic Sclerosis-associated Interstitial Lung DiseaseDrug: Abituzumab 1500 mg;Drug: Abituzumab 500 mg;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyTerminated18 Years75 YearsAll24Phase 2United States;Argentina;Australia;Canada;Israel;Italy;Poland;Spain;United Kingdom;Germany;Turkey
90NCT02680717
(ClinicalTrials.gov)
March 20169/2/2016Comparative Effectiveness Trial in the Treatment of Pediatric Plaque MorpheaComparative Effectiveness Trial of Topical Calcipotriene, Clobetasol, and Tacrolimus in the Treatment of Pediatric Plaque MorpheaSclerodermaDrug: Clobetasol;Drug: Calcipotriene;Drug: TacrolimusMedical College of WisconsinMayo Clinic;Seattle Children's Hospital;University of TorontoWithdrawn2 Years18 YearsAll0Phase 1NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT02370693
(ClinicalTrials.gov)
March 201611/2/2015Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary FibrosisComparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis Grant Number: R34HL122558Interstitial Lung Disease;ILD;Systemic Sclerosis;SclerodermaDrug: Bortezomib;Drug: Placebo;Drug: Mycophenolate mofetilNorthwestern UniversityNational Heart, Lung, and Blood Institute (NHLBI)Recruiting18 YearsN/AAll30Phase 2United States
92NCT02426229
(ClinicalTrials.gov)
February 20164/3/2015Safety & Suitability of Dabigatran to Inhibit Thrombin in SclerodermaSafety & Suitability of Dabigatran to Inhibit Thrombin in SclerodermaScleroderma;Interstitial Lung DiseaseDrug: dabigatran etexilateMedical University of South CarolinaNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed18 Years70 YearsAll15Phase 1United States
93NCT02530996
(ClinicalTrials.gov)
January 1, 201629/7/2015Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and TreatmentSystemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and TreatmentRheumatologic DiseaseDrug: BH4;Other: Vasculopathy assessment;Drug: PlaceboVA Office of Research and DevelopmentNULLCompleted18 Years95 YearsAll32United States
94NCT03141125
(ClinicalTrials.gov)
January 201620/6/2016The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard TherapyThe Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy to Reduce Skin Fibrosis Based on Modified Rodnan Skin Score, Reduce Inflammation, Immunological Response and FibrosisSclerodermaOther: Physalis angulata ethanol extract;Other: PlaceboIndonesia UniversityNetherlands: Ministry of Health, Welfare and SportsCompleted18 Years60 YearsAll62N/AIndonesia
95NCT02453256
(ClinicalTrials.gov)
November 20, 201521/5/2015A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic SclerosisSystemic SclerosisDrug: Placebo;Drug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll212Phase 3United States;Argentina;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Italy;Japan;Lithuania;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Spain;Switzerland;United Kingdom;Brazil;Croatia;South Africa
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT02597933
(ClinicalTrials.gov)
November 12, 20158/10/2015A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung FibrosisA Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)Scleroderma, SystemicDrug: Nintedanib;Drug: PlaceboBoehringer IngelheimNULLCompleted18 YearsN/AAll580Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;China;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Japan;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland;Thailand;United Kingdom
97NCT03531216
(ClinicalTrials.gov)
November 2, 20159/5/2018Topical Rosemary Oil Application in Systemic SclerosisPsychophysiological Effect of Local Rosemary and Olive Oil Application Onto the Hands of Patients With Systemic Sclerosis - a Prospective Crossover, Open-label, Nonrandomized TrialSystemic SclerosisOther: Rosemary essential oil;Other: PlaceboARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity Hospital TuebingenCompleted18 YearsN/AAll12N/AGermany
98NCT02503644
(ClinicalTrials.gov)
October 29, 201530/6/2015Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Multicentre Proof-of-concept Trial of IVA337 in the Treatment of Diffuse Cutaneous Systemic SclerosisScleroderma, Diffuse;Diffuse Cutaneous Systemic SclerosisDrug: IVA337;Drug: PlaceboInventiva PharmaNULLCompleted18 Years75 YearsAll145Phase 2Bulgaria;France;Germany;Italy;Netherlands;Poland;Slovenia;Spain;Switzerland;United Kingdom
99EUCTR2015-001617-27-DE
(EUCTR)
23/10/201528/08/2015A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
100EUCTR2015-001617-27-IT
(EUCTR)
18/09/201517/06/2015A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs . Pulmonary fibrosis and pulmonary hypertension appear as the leading causes of mortality and patients with SSc have considerable morbidity from their disease due to skin fibrosis, Raynaud’s phenomenon and damage to the gastrointestinal tract, lungs, heart and kidneys.
MedDRA version: 18.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 18.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
Inventiva SASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;Switzerland;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2015-001617-27-GB
(EUCTR)
16/09/201517/07/2015A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337. Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis (DcSSc) - IVA337 SSc POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 19.1;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland;United Kingdom
102EUCTR2015-001617-27-ES
(EUCTR)
08/09/201510/07/2015A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337. Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis. - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 18.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 18.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
Inventiva SASNULLNot RecruitingFemale: yes
Male: yes
105Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland
103NCT02558543
(ClinicalTrials.gov)
September 201531/8/2015Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic SclerosisSubcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis : Controlled Clinical Trial With Efficacy AssessmentScleroderma, SystemicDrug: Stromal Vascular fraction;Drug: Ringer lactateAssistance Publique Hopitaux De MarseilleNULLTerminated18 YearsN/AAll40Phase 2France
104NCT04387825
(ClinicalTrials.gov)
August 13, 201510/5/2020Safety Of Fat Micrografts With Adipose-Derived Stromal Vascular Fraction In Hands Of Patients With Systemic SclerosisLipograft Safety Enriched With Vascular Stromal Fraction Derived From Adipose Tissue, to Treatment of Digital Joint Fibrosis and Refractory Ischemic Digital Ulcers Caused by Systemic SclerosisSystemic SclerosisDrug: ADSVF application in the right handInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranNational Council of Science and Technology, MexicoCompleted18 YearsN/AAll20Phase 2Mexico
105NCT02465437
(ClinicalTrials.gov)
August 20154/6/2015Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic SclerosisA Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: JBT-101;Drug: Placebo;Drug: Part B Open-Label ExtensionCorbus Pharmaceuticals Inc.NULLActive, not recruiting18 Years70 YearsAll42Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT02480335
(ClinicalTrials.gov)
June 26, 201515/6/2015The Clinical And Subclinical Effects on Arterial Stiffness of Bosentan in Patients With Systemic SclerosisThe Clinical Efficacy And Subclinical Effects on Arterial STIFFNESS of Bosentan Therapy Added to Usual Care in Patients With Systemic Sclerosis With Digital UlcersScleroderma, SystemicDrug: bosentanUniversity Medical Center GroningenActelionCompleted18 YearsN/AAll20Phase 4Netherlands
107NCT03692299
(ClinicalTrials.gov)
June 201520/12/2016Effectiveness of Saccharomyces Boulardii for Gastrointestinal Bacterial-overgrowth in Systemic SclerosisEfectividad de Saccharomyces Oulardii Para Reducir Los síntomas Gastrointestinales y Evitar el Sobrecrecimiento Bacteriano en Esclerosis sistémicaSystemic Sclerosis;Small Intestinal Bacterial OvergrowthDrug: Saccharomyces Boulardii Oral Tablet;Drug: MetronidazoleCoordinación de Investigación en Salud, MexicoNULLCompleted18 Years65 YearsAll39Phase 4Mexico
108NCT02349009
(ClinicalTrials.gov)
June 201518/1/2015Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety TrialA Randomized, Double-Blind, Placebo-Controlled Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety TrialSystemic SclerodermaDrug: C-82 Topical Gel, 1%;Drug: C-82 Topical Gel, PlaceboPrism Pharma Co., Ltd.NULLCompleted18 YearsN/AAll17Phase 1;Phase 2United States
109NCT02371005
(ClinicalTrials.gov)
June 201518/2/2015Oral Manifestations of Systemic SclerosisOral Manifestations of Systemic Sclerosis: Toward the Identification of New Prognostic MarkersScleroderma, SystemicRadiation: Cone Beam Computed Tomography (CBCT)University Hospital, Strasbourg, FranceNULLRecruiting18 YearsN/AAll90N/AFrance
110NCT02386436
(ClinicalTrials.gov)
April 21, 20156/3/2015A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of GSK2330811 in Healthy SubjectsA Phase I, Randomised, Double-blind (Sponsor Open), Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330811 in Healthy SubjectsScleroderma, SystemicDrug: GSK2330811;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 Years65 YearsAll41Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT02411643
(ClinicalTrials.gov)
March 20153/3/2015Molecular Effects of Topical Calcipotriene on MorpheaMolecular Effects of Topical Calcipotriene on MorpheaMorphea;Localized SclerodermaDrug: topical calcipotriene 0.005% ointmentNorthwestern UniversityNULLTerminated18 YearsN/AAll2N/AUnited States
112NCT02370784
(ClinicalTrials.gov)
February 201526/1/2015Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse SclerodermaThe Effect of Atorvastatin on Microvascular Endothelial Function and Raynaud in Early Diffuse Systemic SclerosisSclerodermaDrug: atorvastatin;Drug: PlaceboRobyn T. Domsic, MD, MPHNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed18 Years70 YearsAll24Phase 2United States
113NCT02283762
(ClinicalTrials.gov)
January 15, 20153/11/2014Efficacy and Safety of Riociguat in Patients With Systemic SclerosisA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)Scleroderma, SystemicDrug: Riociguat (Adempas, BAY63-2521);Drug: PlaceboBayerNULLCompleted18 YearsN/AAll121Phase 2United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Netherlands;New Zealand;Switzerland;Turkey;United Kingdom;Czech Republic;Spain
114NCT02642146
(ClinicalTrials.gov)
January 201524/12/2015Treatment of Digital Ulcers in Korean Patients With Systemic Sclerosis: a Prospective Cohort StudyRaynaud Disease;Systemic Sclerosis;Digital UlcerDrug: Calcium Channel Blockers;Drug: Phosphodiesterase Inhibitors;Drug: Endothelin receptor blocker;Drug: Prostanoids;Drug: Other vasodilatorSeoul National University HospitalNULLTerminated18 YearsN/AAll71Korea, Republic of
115NCT02165111
(ClinicalTrials.gov)
January 201511/6/2014Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's SyndromeA Randomized, Double-Blinded, Placebo-Controlled Clinical Trial Assessing the Therapeutic Efficacy of Botulinum Toxin In Treating Scleroderma-Associated Raynaud's SyndromeScleroderma;Raynaud's SyndromeDrug: Onabotulinumtoxin A;Drug: sterile saline solutionJohns Hopkins UniversityAllerganCompleted18 YearsN/AAll40Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT02363478
(ClinicalTrials.gov)
December 201429/1/2015Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)Systemic SclerosisDrug: buspironeLaikon General District Hospital, AthensNULLCompleted18 Years75 YearsAll22Early Phase 1Greece
117NCT01862926
(ClinicalTrials.gov)
November 201422/5/2013Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILDA Randomized, Double Blind Controlled Trial Comparing Rituximab Against Intravenous Cyclophosphamide in Connective Tissue Disease Associated Interstitial Lung DiseaseInterstitial Lung Disease;Scleroderma;Idiopathic Inflammatory Myositis;Mixed Connective Tissue DiseaseDrug: Rituximab;Drug: CyclophosphamideRoyal Brompton & Harefield NHS Foundation TrustImperial College London;University of East Anglia;University College London HospitalsActive, not recruiting18 Years80 YearsAll116Phase 2;Phase 3United Kingdom
118NCT02374320
(ClinicalTrials.gov)
November 201423/2/2015Exparel as a Nerve Block for Severe Hand PainChemical Sympathectomy Following Peripheral Nerve Block With Liposomal BupivacaineCREST Syndrome;Peripheral Vascular Disease;Raynaud Disease;Scleroderma, DiffuseDrug: liposomal bupivacaineJose Soberon, MDNULLTerminated18 YearsN/AAll14Phase 2;Phase 3United States
119NCT02228850
(ClinicalTrials.gov)
November 201420/8/2014Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic SclerosisA Phase 2a Double-Blind, Randomized, Placebo-Controlled Crossover Trial of the Acute Peripheral Vascular Effects, Safety and Tolerability of Alprostadil Topical Cream in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis (SSc, Scleroderma)Raynaud's Phenomenon Secondary to Systemic SclerosisDrug: Alprostadil;Other: PlaceboNexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)NULLCompleted18 Years79 YearsBoth35Phase 2United States
120NCT02047708
(ClinicalTrials.gov)
October 201422/1/2014Zibotentan Better Renal Scleroderma Outcome StudyA Phase II, Single Centre, Randomised, Placebo-controlled, 3-part Trial to Assess the Safety, Tolerability and Efficacy of Zibotentan in Patients With Renal Disease Secondary to SclerodermaScleroderma;Scleroderma Renal Crisis;Chronic Kidney DiseaseDrug: ZibotentanUniversity College, LondonMedical Research CouncilCompleted18 YearsN/AAll27Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT02161406
(ClinicalTrials.gov)
September 20143/6/2014A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic SclerosisA Phase 2 Study to Evaluate Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis- a Double-blind, Placebo-controlled, Randomized Controlled Trial.Diffuse Cutaneous Systemic SclerosisDrug: Abatacept;Drug: PlaceboDinesh Khanna, MD, MSBristol-Myers Squibb;National Institute of Allergy and Infectious Diseases (NIAID)Completed18 YearsN/AAll88Phase 2United States;Canada;United Kingdom
122NCT02290613
(ClinicalTrials.gov)
July 1, 201431/10/2014Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) A Randomized, Controlled, Double-blind, Parallel Group, Proof-of-concept Trial EDITASystemic Sclerosis;Pulmonary HypertensionDrug: Ambrisentan;Drug: PlaceboHeidelberg UniversityGlaxoSmithKlineCompleted18 YearsN/AAll38Phase 2Germany
123NCT02213705
(ClinicalTrials.gov)
May 6, 201417/7/2014Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem CellsTreatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem CellsSYSTEMIC SCLERODERMA;ALLOGENEIC MESENCHYMAL STEM CELLS;ADULTBiological: INJECTION OF ALLOGENEIC MESENCHYMAL STEM CELLSAssistance Publique - Hôpitaux de ParisNULLActive, not recruiting18 Years70 YearsAll20Phase 1;Phase 2France
124NCT01988506
(ClinicalTrials.gov)
January 6, 20147/11/2013Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory DiseasesInduction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic ApproachRheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic SclerosisDrug: Interleukin 2Assistance Publique - Hôpitaux de ParisIltoo PharmaActive, not recruiting18 YearsN/AAll81Phase 2France
125NCT01933334
(ClinicalTrials.gov)
October 201323/8/2013Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)The LOTUSS Trial: An Open-Label, Randomized, Phase 2 Study of the Safety and Tolerability of Pirfenidone When Administered to Patients With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)Systemic SclerosisDrug: PirfenidoneGenentech, Inc.NULLCompleted18 Years75 YearsAll63Phase 2United States;Canada;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT01878526
(ClinicalTrials.gov)
June 20137/6/2013Gastroesophageal Reflux Treatment in SclerodermaThe Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic SclerosisGastroesophageal Reflux Disease;Systemic Sclerosis;SclerodermaDrug: Alginic acid;Drug: placebo (for domperidone);Drug: Domperidone;Drug: placebo (of alginic acid)Khon Kaen UniversityNULLCompleted18 Years65 YearsAll80Phase 3Thailand
127NCT03561233
(ClinicalTrials.gov)
May 20137/6/2018Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic SclerosisPrevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic SclerosisSystemic Sclerosis;Gastroesophageal Reflux;Proton Pubm InhibitorDrug: Omeprazole 20mgKhon Kaen UniversityThai Rheumatism AssociationCompleted18 YearsN/AAll250Phase 1NULL
128NCT01804959
(ClinicalTrials.gov)
May 20133/3/2013Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal DiseaseA Proof-of-concept Double-blind Randomized Placebo-controlled Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal DiseaseSystemic SclerosisDietary Supplement: Vivomixx probioticsSingapore General HospitalNULLUnknown status18 YearsN/AAll40Phase 2Singapore
129NCT01748084
(ClinicalTrials.gov)
April 9, 201310/12/2012Rituximab in Systemic SclerosisEvaluation of Rituximab in Systemic Sclerosis Associated PolyarthritisSystemic SclerosisDrug: Rituximab;Drug: Placebo (NaCl)Assistance Publique - Hôpitaux de ParisNULLCompleted18 Years80 YearsAll22Phase 2;Phase 3France
130NCT01785056
(ClinicalTrials.gov)
April 201328/1/2013IVIG Treatment in Systemic SclerosisA Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of Intravenous Immunoglobulin Treatment in Patients With Systemic SclerosisSystemic Sclerosis;Diffuse SclerodermaBiological: PrivigenGeorgetown UniversityCSL BehringUnknown status18 YearsN/AAll14N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT01570764
(ClinicalTrials.gov)
January 14, 20132/4/2012Cyclophosphamide Systemic Sclerosis Associated Interstitial Lung DiseaseIntravenous Cyclophosphamide for the Treatment of Systemic Sclerosis Associated Interstitial Lung DiseaseSystemic Sclerosis;Scleroderma;Interstitial Lung Disease;Lung FibrosisDrug: Cyclophosphamide;Drug: PlaceboAssistance Publique - Hôpitaux de ParisHôpital Claude-HuriezCompleted18 YearsN/AAll40Phase 3France
132NCT01895244
(ClinicalTrials.gov)
September 20121/7/2013Autologous Stem Cell Transplantation for Progressive Systemic SclerosisHighdose Chemotherapy and Transplantation of 34+ Selected Stem Cell for Progressive Systemic Sclerosis - Modification According to ManifestationScleroderma;Cardiac Involvement;Autologous Stem Cell TransplantationDrug: Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cellsUniversity Hospital TuebingenNULLRecruiting18 Years65 YearsAll44Phase 2Germany
133NCT02169752
(ClinicalTrials.gov)
September 20126/5/2014Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionAmbrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionPre-Pulmonary Atrial HypertensionDrug: AmbrisentanNational Jewish HealthNULLTerminated18 Years80 YearsAll7N/AUnited States
134NCT01559129
(ClinicalTrials.gov)
August 9, 201219/3/2012Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness for Patients With Systemic Sclerosis With Interstitial Lung DiseaseA Phase 2, Proof-Of-Concept, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects With Systemic Sclerosis With Interstitial Lung DiseaseScleroderma, Systemic;Sclerosis, Systemic;Systemic Scleroderma;Systemic Sclerosis;Interstitial Lung DiseaseDrug: Pomalidomide (CC-4047);Drug: PlaceboCelgeneNULLTerminated18 Years80 YearsAll23Phase 2United States;Australia;France;Germany;Italy;Poland;Russian Federation;Spain;Switzerland;United Kingdom
135NCT01670565
(ClinicalTrials.gov)
August 201215/8/2012Belimumab for the Treatment of Diffuse Cutaneous Systemic SclerosisBelimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis: A Phase 2a, Single-centered, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Pilot Study.Systemic SclerosisDrug: BelimumabHospital for Special Surgery, New YorkHuman Genome Sciences Inc.Completed18 YearsN/AAll20Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2010-023047-15-PL
(EUCTR)
17/07/201214/05/2012A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 16.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Spain;Poland;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland
137EUCTR2010-023047-15-IT
(EUCTR)
20/03/201228/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects with Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease Diffuse cutaneous systemic sclerosis with interstitial lung disease
MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
Other descriptive name: Pomalidomide
CELGENE CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;Poland;Spain;Australia;Germany;United Kingdom;Italy
138EUCTR2010-023047-15-DE
(EUCTR)
15/03/201208/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2 Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 16.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Imnovid 1 mg hard capsules
INN or Proposed INN: Pomalidomide
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
139EUCTR2010-023047-15-GB
(EUCTR)
08/03/201215/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 17.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;Switzerland;United Kingdom
140EUCTR2010-023047-15-ES
(EUCTR)
02/03/201219/01/2012A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease diffuse cutaneous systemic sclerosis associated with interstitial lung disease
MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomida
Product Code: CC-4047
INN or Proposed INN: Pomalidomida
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Germany;Italy;United Kingdom;Switzerland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT01532869
(ClinicalTrials.gov)
March 201210/2/2012A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic SclerosisA Phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic SclerosisSclerosis, SystemicDrug: Placebo;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll87Phase 3United States;Canada;France;Germany;United Kingdom
142NCT02562079
(ClinicalTrials.gov)
March 201229/12/2014Vasculopathy, Inflammation and Systemic SclerosisVasculopathy, Inflammation and Systemic Sclerosis: The Role of Endothelial Cell Activation and OX40/OX40L in Modulation of T Lymphocyte ActivationSystemic SclerosisBiological: Blood samples;Biological: BiopsyUniversity Hospital, BordeauxSociété Française de RhumatologieCompleted18 Years75 YearsAll350N/AFrance
143NCT01474122
(ClinicalTrials.gov)
December 201131/10/2011Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis PatientsProspective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic SclerosisDigital UlcersDrug: Macitentan 3 mg;Drug: Macitentan 10 mg;Drug: PlaceboActelionNULLTerminated18 YearsN/AAll265Phase 3United States;Argentina;Belgium;China;Colombia;Germany;Greece;Ireland;Israel;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;South Africa;Spain;Turkey;Ukraine;United Kingdom
144NCT01538719
(ClinicalTrials.gov)
December 201121/2/2012IL1-TRAP, Rilonacept, in Systemic SclerosisRandomized, Double-Blind, Placebo-Controlled Trial if IL1-TRAP, Rilonacept, in Systemic Sclerosis -A Phase I/II Biomarker TrialScleroderma;Systemic Sclerosis;Diffuse Scleroderma;Diffuse Systemic SclerosisDrug: Rilonacept;Other: PlaceboBoston UniversityRegeneron PharmaceuticalsCompleted18 YearsN/AAll24Phase 1;Phase 2United States
145NCT01474109
(ClinicalTrials.gov)
December 201131/10/2011Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis PatientsProspective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic SclerosisSystemic Sclerosis;UlcersDrug: macitentan 3mg;Drug: macitentan 10mg;Drug: placeboActelionNULLCompleted18 YearsN/AAll289Phase 3United States;Australia;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Denmark;Finland;Germany;Hungary;India;Italy;Poland;Russian Federation;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT02240888
(ClinicalTrials.gov)
October 20114/9/2014Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody ResponseRA;SLE;Vasculitis;Scleroderma;Sjögrens;SyndromeBiological: 0,5 mg Prevenar i.m.;Biological: 0,5 mg seasonal influenza vaccine i.m.Region SkaneNULLCompleted18 YearsN/AAll300N/ASweden
147NCT01445821
(ClinicalTrials.gov)
September 15, 201129/9/2011Autologous Stem Cell Systemic Sclerosis Immune Suppression TrialRandomized Study of Different Non-myeloablative Conditioning Regimens With Hematopoietic Stem Cell Support in Patients With Scleroderma (Autologous Systemic Sclerosis Immune Suppression Trial - II ASSIST-IIb)Scleroderma, SystemicBiological: Peripheral Blood Stem Cells;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: Filgrastim;Drug: FludarabineNorthwestern UniversityNULLTerminated17 Years60 YearsAll44Phase 3United States
148NCT01413100
(ClinicalTrials.gov)
September 15, 20118/8/2011Scleroderma Treatment With Autologous Transplant (STAT) StudyA Phase II Multi-center Study of High-Dose Cyclophosphamide and Antithymocyte Globulin Followed by Autologous Hematopoietic Cell Transplantation With Post Transplant Maintenance for the Treatment of Systemic SclerosisSystemic SclerodermaBiological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Biological: Filgrastim;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Plerixafor;Other: Quality-of-Life Assessment;Other: Questionnaire AdministrationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)Active, not recruitingN/A70 YearsAll20Phase 2United States;Canada
149NCT01086540
(ClinicalTrials.gov)
June 24, 201111/3/2010Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)Systemic Sclerosis-Associated PAHBiological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophenNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.Completed18 Years75 YearsAll57Phase 2United States
150JPRN-UMIN000005550
2011/06/0123/05/2011Randomized, open-label, multicenter trial to assess humanized anti-IL-6 receptor antibody, tocilizumab, for the treatment of systemic sclerosis Systemic sclerosisAdministrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies
Continue existing conventional therapies
Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of MedicineRheumatology Keio University,Rheumatology Tokyo Women's Medical University,Dermatology Osaka UniversityComplete: follow-up complete20years-old65years-oldMale and Female24Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT01639573
(ClinicalTrials.gov)
April 201118/6/2012Campath-1h Phase I/II Pilot Trial as Immunoablative Therapy for Refractory Systemic SclerosisCampath-1h as Immunoablative Therapy for Children and Adolescents With Treatment Refractory Systemic SclerosisSclerodermaDrug: CampathChildren's Hospital Los AngelesNULLWithdrawn8 Years18 YearsAll0Phase 1;Phase 2United States
152EUCTR2010-024005-13-GB
(EUCTR)
11/03/201130/12/2010A study of ORM-12741 for the prevention of blood vessel spasm brought on by cold temperature.Efficacy of ORM-12741 for prevention of cold-induced vasospasm; a randomised, double-blind, placebo-controlled, single centre crossover study in patient with Raynaud's phenomenon secondary to systemic sclerosis - Reino Raynaud's phenomenon secondary to systemic sclerosis (Raynaud's syndrome)
MedDRA version: 14.0;Level: LLT;Classification code 10037914;Term: Raynaud's syndrome;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ORM-12741
Product Code: ORM-12741
Other descriptive name: alpha-2C AR antagonist
Product Name: ORM-12741
Product Code: ORM-12741
Other descriptive name: Alpha-2C AR antagonist
Orion Corporation Orion PharmaNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
153NCT01309997
(ClinicalTrials.gov)
March 20111/3/2011Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host DiseaseA Randomized Phase II Study of Imatinib and Rituximab for Cutaneous Sclerosis After Allogeneic Hematopoietic Cell TransplantationGraft Versus Host Disease;Systemic SclerodermaDrug: imatinib mesylate;Biological: rituximabLee, StephanieNational Cancer Institute (NCI)Completed2 YearsN/AAll72Phase 2United States
154NCT01166139
(ClinicalTrials.gov)
July 20101/7/2010Nilotinib in the Treatment of Systemic SclerosisPhase IIA Study of the Safety and Tolerability of the Use of Nilotinib in the Treatment of Systemic SclerosisSystemic SclerosisDrug: Nilotinib (Tasigna)Hospital for Special Surgery, New YorkRudolph Rupert Scleroderma Program;Novartis PharmaceuticalsCompleted18 YearsN/AAll10Phase 2United States
155NCT01093885
(ClinicalTrials.gov)
February 201024/3/2010Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic SclerosisAn Open Label Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Treatment of Diffuse Systemic SclerosisSystemic Sclerosis;SclerodermaDrug: AmbrisentanUniversity of PennsylvaniaGilead SciencesCompleted19 Years90 YearsAll15N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT01072669
(ClinicalTrials.gov)
February 201019/2/2010Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or FeetEvaluation of the Effect of Ambrisentan on Digital Microvascular Flow in Patients With Systemic Sclerosis Using Laser Doppler Perfusion ImagingIschemiaDrug: ambrisentanSoumya ChatterjeeGilead SciencesCompleted18 Years70 YearsAll20N/AUnited States
157NCT01047072
(ClinicalTrials.gov)
January 201011/1/2010Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic SclerosisPhase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic SclerosisSystemic SclerodermaDrug: fludarabine phosphate;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Biological: rituximab;Drug: cyclophosphamide;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantationFred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumNational Cancer Institute (NCI)Withdrawn18 Years65 YearsBoth0Phase 2United States
158NCT01042158
(ClinicalTrials.gov)
January 20104/1/2010A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisA Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisPulmonary Arterial Hypertension;Systemic Sclerosis;Scleroderma Spectrum of Diseases;Connective Tissue Disease;Pulmonary HypertensionDrug: tadalafil and ambrisentan upfront combination therapyJohns Hopkins UniversityNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);Eli Lilly and Company;United Therapeutics;The Cleveland Clinic;University of Texas;Stanford UniversityCompleted18 YearsN/AAll25Phase 4United States
159NCT00848107
(ClinicalTrials.gov)
September 200916/2/2009Open-Label Study of Oral Treprostinil in Digital UlcersDigital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: An Open-label Multicenter Extension StudySystemic SclerosisDrug: treprostinil diethanolamineUnited TherapeuticsNULLTerminated18 YearsN/AAll115Phase 2United States;Canada;United Kingdom
160NCT00883129
(ClinicalTrials.gov)
September 200916/4/2009Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II)Scleroderma;Interstitial Lung DiseaseDrug: Mycophenolate mofetil;Drug: Cyclophosphamide;Drug: PlaceboMichael RothNational Heart, Lung, and Blood Institute (NHLBI);Hoffmann-La RocheCompleted18 YearsN/AAll142Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT00962923
(ClinicalTrials.gov)
August 200919/8/2009Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)Systemic Sclerosis;Mesenchymal Stem CellsBiological: Allogeneic Mesenchymal Stem Cells (AlloMSC)The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolNULLRecruiting15 Years65 YearsBoth20Phase 1;Phase 2China
162NCT00775463
(ClinicalTrials.gov)
May 200917/10/2008Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil DiethanolamineDISTOL-1: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: A Randomized, Double-blind, Placebo-controlled, Multicenter StudySystemic Sclerosis;SclerodermaDrug: treprostinil diethanolamine;Drug: placeboUnited TherapeuticsNULLCompleted18 YearsN/AAll148Phase 2United States;Canada;United Kingdom
163NCT01051960
(ClinicalTrials.gov)
March 200919/1/2010Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With AmbrisentanExercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan: A Prospective Single Center, Open Label, Pilot StudySystemic Sclerosis;Shortness of Breath;Pulmonary HypertensionDrug: AmbrisentanUniversity of California, Los AngelesGilead SciencesCompleted18 Years80 YearsAll12Phase 4United States
164NCT00764309
(ClinicalTrials.gov)
January 20091/10/2008Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary FibrosisAn Open Label Study to Evaluate the Safety of Dasatinib in the Treatment of Scleroderma Pulmonary Interstitial FibrosisSclerodermaDrug: dasatinibBristol-Myers SquibbNULLCompleted18 YearsN/AAll47Phase 1;Phase 2United States
165NCT00769028
(ClinicalTrials.gov)
December 20087/10/2008AIMSPRO in Established Diffuse Cutaneous Systemic SclerosisA Double-Blind Placebo-Controlled Pilot Study of Safety and Tolerability of AIMSPRO in Established Diffuse Cutaneous Systemic SclerosisSystemic SclerosisDrug: Hyperimmune caprine serum;Drug: AlbuminDaval International LimitedNULLActive, not recruiting18 YearsN/ABoth20Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166NCT00442611
(ClinicalTrials.gov)
November 20081/3/2007A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)A Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Systemic SclerosisScleroderma, Diffuse;Scleroderma, SystemicDrug: Abatacept;Drug: PlaceboStanford UniversityBristol-Myers SquibbCompleted18 YearsN/AAll10Phase 1;Phase 2United States
167NCT00984932
(ClinicalTrials.gov)
September 200824/9/2009Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary HypertensionThe Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled TrialSystemic SclerosisDrug: RosuvastatinFaculty of Medicine, University of AlexandriaNULLCompletedN/AN/ABoth40Phase 3Egypt
168EUCTR2005-003775-21-GB
(EUCTR)
14/08/200810/11/2005Effects of atorvastatin on microcirculatory endothelial function in patients with systemic sclerosis - Atorvastatin in systemic sclerosisEffects of atorvastatin on microcirculatory endothelial function in patients with systemic sclerosis - Atorvastatin in systemic sclerosis Systemic sclerosis (also termed 'scleroderma')Salford Royal Hospitals NHS TrustUniversity of ManchesterNot Recruiting Female: yes
Male: yes
36Phase 4United Kingdom
169NCT00725361
(ClinicalTrials.gov)
June 200828/7/2008A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).A Pilot Study to Evaluate the Efficacy of Ambrisentan in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis.n Ulcer;Scleroderma, SystemicDrug: AmbrisentanStanford UniversityNULLCompleted18 YearsN/AAll20N/AUnited States
170NCT00613171
(ClinicalTrials.gov)
January 200825/1/2008Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Patients With Systemic SclerosisA Multi-centre, Open-label, Proof of Concept (PoC) Study to Evaluate the Efficacy and Tolerability of STI571 for the Treatment of Fibrosis in Patients With Systemic SclerosisSystemic Sclerosis, SclerodermaDrug: STI571Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll27Phase 2United States;Germany;Italy;Switzerland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2007-001508-19-IT
(EUCTR)
06/09/200729/07/2008TRATTAMENTO CON IMATINIB MESILATO DELLA GVH CRONICA SEVERA SCLERODERMA-LIKE REFRATTARIA ALLA TERAPIA IMMUNOSOPRESSIVA CONVENZIONALE - NDTRATTAMENTO CON IMATINIB MESILATO DELLA GVH CRONICA SEVERA SCLERODERMA-LIKE REFRATTARIA ALLA TERAPIA IMMUNOSOPRESSIVA CONVENZIONALE - ND GVH CRONICA ESTESA
MedDRA version: 9.1;Level: LLT;Classification code 10018651;Term: Graft versus host disease
Trade Name: GLIVEC
INN or Proposed INN: Imatinib
AZIENDA OSPEDALIERA S. CARLONULLNot RecruitingFemale: yes
Male: yes
Italy
172EUCTR2007-002015-38-ES
(EUCTR)
23/08/200702/07/2007ENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICAPHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSISENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICAPHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICASKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144
Product Code: P144
Other descriptive name: DIGNA P144 CREAM
ISDINNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2Hungary;Germany;United Kingdom;Spain;Italy
173NCT00684255
(ClinicalTrials.gov)
August 200722/5/2008Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)Reduced Intensity Conditioning And Allogeneic Stem Cell Transplantation in Patients With Medically Refractory Systemic Lupus Erythematosus and Medically Refractory Systemic Sclerosis (SSc)Systemic Lupus Erythematosus;Systemic SclerosisProcedure: Reduced Intensity Allogeneic Transplant;Drug: Fludarabine;Drug: Busulfan;Drug: CampathNew York Medical CollegeNULLTerminated7 Years50 YearsAll1Phase 1United States
174NCT00555581
(ClinicalTrials.gov)
August 20077/11/2007Imatinib Mesylate (Gleevec) in the Treatment of Systemic SclerosisPhase IIA Study of the Safety and Tolerability of the Use of Imatinib Mesylate (Gleevec) in the Treatment of Systemic SclerosisSystemic SclerosisDrug: Imatinib MesylateHospital for Special Surgery, New YorkNovartis PharmaceuticalsCompleted18 YearsN/AAll30Phase 2United States
175NCT00512902
(ClinicalTrials.gov)
August 20076/8/2007A Study Using The Experimental Drug Called Imatinib (Gleevec) in Subjects With Systemic SclerosisPilot Study to Examine The Use of Imatinib (Gleevec) For The Treatment of Active Alveolitis in Systemic SclerosisAlveolitis;Systemic SclerosisDrug: ImatinibUniversity of California, Los AngelesNovartis PharmaceuticalsCompleted18 YearsN/AAll20Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT00506831
(ClinicalTrials.gov)
July 200724/7/2007Imatinib in Systemic SclerosisA Pilot Study of Imatinib in the Treatment of Refractory Systemic SclerosisScleroderma, SystemicDrug: Imatinib mesylateStanford UniversityNULLCompleted18 Years80 YearsAll9Phase 1;Phase 2United States
177NCT00498615
(ClinicalTrials.gov)
April 20076/7/2007A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's PhenomenonEfficacy, Tolerability and Biology of a Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's PhenomenonRaynaud;SclerodermaDrug: FasudilJohns Hopkins UniversityNULLCompleted18 Years80 YearsAll17Phase 3United States
178NCT00622895
(ClinicalTrials.gov)
September 1, 200622/2/2008Allogeneic Hematopoietic Cell Transplantation for Severe Systemic SclerosisAllogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic SclerosisSystemic Scleroderma;Severe Systemic SclerosisDrug: fludarabine phosphate;Drug: Mycophenolic Acid;Drug: tacrolimus;Radiation: total-body irradiation;Procedure: bone marrow transplantation;Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation;Procedure: quality-of-life assessment;Other: laboratory biomarker analysis;Other: flow cytometry;Procedure: biopsyFred Hutchinson Cancer Research CenterNational Institute of Allergy and Infectious Diseases (NIAID)CompletedN/A70 YearsAll3Phase 1;Phase 2United States
179NCT00377455
(ClinicalTrials.gov)
September 200614/9/2006Placebo Controlled Trial of Bosentan in Scleroderma PatientsPlacebo Controlled Trial of Bosentan vs Placebo in NYHA Class I/II Scleroderma Patients With Exercise Induced Pulmonary HypertensionSystemic Scleroderma;Pulmonary HypertensionDrug: Bosentan;Drug: PlaceboGeorgetown UniversityActelionTerminated18 YearsN/AAll5Phase 2United States
180NCT00333437
(ClinicalTrials.gov)
May 20062/6/2006Pulmonary Involvement in Scleroderma: A Clinical Study of the Safety and Efficacy of Mycophenolate Mofetil in Scleroderma Patients With Lung InvolvementPulmonary Involvement in Scleroderma: Safety and Efficacy of Mycophenolate Mofetil in Scleroderma PatientsScleroderma, SystemicDrug: Mycophenolate mofetilUniversity of California, San FranciscoRoche Pharma AGCompleted21 Years70 YearsAll7N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT00278525
(ClinicalTrials.gov)
September 200515/1/2006Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic SclerodermaTrial of High Dose Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG) With Hematopoietic Stem Cell Support in Patients With Systemic Scleroderma: A Randomized TrialSYSTEMIC SCLERODERMADrug: standard of care;Procedure: stem cell transplantationNorthwestern UniversityNULLCompletedN/A60 YearsAll19Phase 2United States
182NCT00114530
(ClinicalTrials.gov)
June 200515/6/2005Scleroderma: Cyclophosphamide or Transplantation (SCOT)A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCSSc-01)Scleroderma, Systemic;Sclerosis;Autoimmune DiseaseBiological: mHSCT;Drug: cyclophosphamideNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 Years69 YearsAll75Phase 2;Phase 3United States;Canada
183NCT00860548
(ClinicalTrials.gov)
June 200511/3/2009SCOT Scleroderma Treatment Alternative Registry (STAR Registry)An Observational, Long-term Follow-up Study of Eligible Individuals Declining To Participate in the Scleroderma Cyclophosphamide or Transplantation (SCOT) Study (SCSSc-02)Scleroderma, Systemic;SclerosisDrug: currently available therapy in the communityNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 Years69 YearsAll19N/AUnited States
184NCT00282425
(ClinicalTrials.gov)
May 200524/1/2006Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic SclerosisNon-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic SclerosisSclerodermaBiological: Hematopoietic stem cell transplantationRichard Burt, MDNULLTerminated18 Years55 YearsBoth8Phase 1United States
185NCT00319696
(ClinicalTrials.gov)
July 8, 200427/4/2006Bosentan in Digital UlcersLong-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital UlcersDigital UlcersDrug: Bosentan 62.5 mg;Drug: Bosentan 125 mgActelionNULLCompleted18 YearsN/AAll116Phase 3United States;Austria;Canada;France;Germany;Italy;Switzerland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
186NCT00025818
(ClinicalTrials.gov)
May 200126/10/2001Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye SyndromeKeratoconjunctivitis Sicca;Sjogren's Syndrome;Lupus Erythematosus, Systemic;Arthritis, Rheumatoid;Scleroderma, SystemicDrug: Ophthalmic EmulsionAllerganNULLCompleted18 YearsN/ABoth290Phase 3United States
187NCT00501995
(ClinicalTrials.gov)
February 200113/7/2007High Dose Cyclophosphamide for Treatment of SclerodermaHigh Dose Cyclophosphamide for Treatment of Systemic Sclerosis (Scleroderma)SclerodermaDrug: IV CyclophosphamideJohns Hopkins UniversityNULLCompleted18 Years70 YearsAll6Phase 3United States
188NCT00005675
(ClinicalTrials.gov)
April 200026/5/2000Oral Type I Collagen for Relieving SclerodermaMulticenter Phase II Trial of Oral Type I Bovine Collagen in SclerodermaScleroderma;Connective Tissue DiseasesDrug: Oral bovine type I collagen;Drug: PlaceboNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Wayne State University;University of California, Los Angeles;UTHSC;MUSC;Beth Israel Medical Center;University of Alabama at Birmingham;Johns Hopkins University;Georgetown University;Baltimore VA Medical Center;Northwestern UniversityCompleted18 YearsN/ABoth168Phase 2United States
189NCT00004563
(ClinicalTrials.gov)
August 19999/2/2000Scleroderma Lung DiseaseCyclophosphamide Versus Placebo in Scleroderma Lung StudyLung Diseases;Pulmonary Fibrosis;Systemic Scleroderma;Scleroderma, SystemicDrug: Cyclophosphamide;Drug: PlaceboThe University of Texas Health Science Center, HoustonNational Heart, Lung, and Blood Institute (NHLBI)Completed18 YearsN/AAll158Phase 3NULL
190NCT00058578
(ClinicalTrials.gov)
June 19998/4/2003Stem Cell Transplant to Treat Patients With Systemic SclerosisAutologous T-Cell Depleted Peripheral Blood Stem Cell Transplantation for the Treatment of Selected Patients With Systemic SclerosisSystemic SclerosisDrug: Cyclophosphamide;Drug: Mesna;Drug: G-CSF;Procedure: Leukopheresis;Procedure: Total Body IrradiationBaylor College of MedicineThe Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of MedicineCompleted18 Years65 YearsAll24Phase 1United States

67. 多発性嚢胞腎 [臨床試験数:186,薬物数:196(DrugBank:47),標的遺伝子数:35,標的パスウェイ数:146
Searched query = "Polycystic kidney disease", "PKD", "PCKD", "Polycystic kidney", "ADPKD", "ARPKD"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
72 / 186 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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gender
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PhaseCountries
1NCT04064346
(ClinicalTrials.gov)
July 202119/8/2019Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney DiseaseA 52-Week, Phase 3, Double-blind, Placebo-controlled, Randomized Study of the Efficacy and Safety of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Polycystic Kidney Disease, AdultDrug: Lixivaptan;Drug: PlaceboPalladio BiosciencesNULLNot yet recruiting18 Years60 YearsAll1200Phase 3NULL
2NCT04578548
(ClinicalTrials.gov)
November 10, 20201/10/2020A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)An Exploratory, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Orally Administered GLPG2737 for 52 Weeks, in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: GLPG2737;Drug: PlaceboGalapagos NVNULLRecruiting18 Years50 YearsAll60Phase 2Belgium;Germany;Netherlands;Poland;Spain
3NCT04407481
(ClinicalTrials.gov)
November 1, 202019/5/2020PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD (PENGUIN)PENGUIN: PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKDPolycystic Kidney Disease, Adult;Polycystic Kidney, Autosomal DominantDrug: Aminohippurate Sodium Inj 20%;Drug: Iohexol Inj 300 milligrams per milliliter (MG/ML);Radiation: PET/CT ScanUniversity of Colorado Denver School of Medicine Barbara Davis CenterNULLRecruiting18 Years40 YearsAll20United States
4NCT04536688
(ClinicalTrials.gov)
October 202024/8/2020A Study of RGLS4326 in Patients With Autosomal Dominant Polycystic Kidney DiseaseA Phase 1b, Multicenter, Open-Label, Adaptive Design Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RGLS4326 Administered Via SC Injection to Patients With Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney Disease, Autosomal DominantDrug: RGLS4326Regulus Therapeutics Inc.NULLRecruiting18 Years70 YearsAll27Phase 1United States
5NCT04310319
(ClinicalTrials.gov)
September 7, 20203/3/2020Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and SaltWishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and SaltPolycystic Kidney, Autosomal Dominant;ADPKD;Autosomal Dominant Polycystic KidneyDietary Supplement: Sodiumchloride;Dietary Supplement: Protein;Dietary Supplement: Placebo comparator (salt);Dietary Supplement: Placebo comparator (protein)Esther MeijerNULLRecruiting18 YearsN/AAll12N/ANetherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04152837
(ClinicalTrials.gov)
September 2, 202031/10/2019Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney DiseaseAn Open-Label Study of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Previously Experienced Abnormal Liver Chemistry Test Results While Receiving Tolvaptan: The ALERT StudyPolycystic Kidney Disease, AdultDrug: LixivaptanPalladio BiosciencesNULLRecruiting18 Years65 YearsAll50Phase 3United States
7NCT03949894
(ClinicalTrials.gov)
July 1, 201916/4/2019Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney DiseaseEvaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: TolvaptanKorea Otsuka Pharmaceutical Co., Ltd.NULLActive, not recruiting19 Years50 YearsAll118Phase 4Korea, Republic of
8NCT03918447
(ClinicalTrials.gov)
May 29, 201912/4/2019A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCONA Phase 3 Trial of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney;ADPKDDrug: Bardoxolone methyl oral capsule;Drug: Placebo oral capsuleReata Pharmaceuticals, Inc.NULLRecruiting18 Years70 YearsAll300Phase 3United States;Australia;Belgium;Czechia;France;Germany;Italy;Japan;Spain;United Kingdom
9NCT03717181
(ClinicalTrials.gov)
May 22, 201922/10/2018Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney DiseaseExpanded Access Use of Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney DiseasePolycystic KidneyDrug: LixivaptanPalladio BiosciencesNULLActive, not recruiting15 Years60 YearsAll1Phase 2United States
10NCT03749447
(ClinicalTrials.gov)
March 8, 201919/11/2018An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney DiseaseChronic Kidney Diseases;Alport Syndrome;Autosomal Dominant Polycystic KidneyDrug: Bardoxolone methylReata Pharmaceuticals, Inc.NULLRecruiting12 YearsN/AAll480Phase 3United States;Australia;Japan;Puerto Rico
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03764605
(ClinicalTrials.gov)
January 30, 201929/11/2018Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney DiseaseMetformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease. A Phase 3a, Indipendent, Multicentre, Two Parallel Arms, Randomized Controlled TrialADPKDDrug: Metformin;Drug: TolvaptanAzienda Ospedaliero-Universitaria Consorziale Policlinico di BariNULLNot yet recruiting18 Years50 YearsAll150Phase 3Italy
12NCT04284657
(ClinicalTrials.gov)
January 30, 201911/4/2019Pravastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney DiseasePravastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Pravastatin;Drug: sodium citrateUniversity of Southern CaliforniaNULLRecruiting18 YearsN/AAll30Phase 2United States
13NCT03541447
(ClinicalTrials.gov)
December 12, 201817/5/2018Tolvaptan-Octreotide LAR Combination in ADPKDA Pilot, Phase II Study With a Prospective, Randomized, Cross-Over, Placebo-Controlled, Double-Blind Design to Assess the Short-Term Effects of Tolvaptan Plus Placebo vs Tolvaptan Plus Octreotide LAR Combination Therapy in ADPKD Patients With Normal Kidney Function or HyperfiltrationAutosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan;Drug: Octreotide LAR;Other: PlaceboMario Negri Institute for Pharmacological ResearchOtsuka Pharmaceutical Italy S.r.l.Recruiting18 YearsN/AAll20Phase 2Italy
14EUCTR2018-000477-77-IT
(EUCTR)
08/11/201804/11/2020Evaluation of Metformin and Tolvaptan in slowing disease progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD)Metformin versus Tolvaptan in adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD): a phase 3a, independent, multi-centre, 2 parallel arms randomized controlled trial - METROPOLIS Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: ZUGLIMET - 500 MG COMPRESSE RIVESTITE CON FILM 30 COMPRESSE IN BLISTER PVC/AL
Product Name: METFORMINA
Product Code: [METFORMINA]
INN or Proposed INN: METFORMINA
Other descriptive name: METFORMIN
Trade Name: JINARC - 15 MG - COMPRESSA - USO ORALE - BLISTER (ALU/PVC) - 28 COMPRESSE
Product Name: TOLVAPTAN 15
Product Code: [TOLVAPTAN 15]
INN or Proposed INN: TOLVAPTAN
Other descriptive name: TOLVAPTAN
Trade Name: JINARC - 30 MG - COMPRESSA - USO ORALE - BLISTER (ALU/PVC) - 28 COMPRESSE
Product Name: TOLVAPTAN 30
Product Code: [TOLVAPTAN 30]
INN or Proposed INN: TOLVAPTAN
Other descriptive name: TOLVAPTAN
Trade Name: JINARC - 15 MG +45 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28X15 MG + 28 X 45 MG)
Product Name: TOLVAPTAN 45/15
Product Code: [TOLVAPTAN 45/15]
INN or Proposed INN: TOLVAPTAN
Other descriptive name: TOLVAPTAN
Trade Name: JINARC - 30 MG + 60 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 60 MG)
Product Name: TOLVAPTAN 60/30
Product Code: [TOL
U.O. NEFROLOGIA, DIALISI E TRAPIANTO AZIENDA OSPEDALIERO UNIVERSITARIA POLICLINICO DI BARINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3Italy
15NCT03687554
(ClinicalTrials.gov)
October 5, 201826/9/2018Effect of Venglustat in Patients With Renal ImpairmentA Phase I, Single-Center, Open-label, Single Dose Pharmacokinetic and Tolerability Study of GZ402671 in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal FunctionHealthy Volunteers;Polycystic Kidney, Autosomal DominantDrug: Venglustat GZ/SAR402671Genzyme, a Sanofi CompanyNULLCompleted18 Years79 YearsAll24Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
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agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03523728
(ClinicalTrials.gov)
October 4, 20181/5/2018A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD PatientsMulticenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)Polycystic Kidney, Autosomal DominantDrug: Venglustat GZ402671;Drug: PlaceboGenzyme, a Sanofi CompanyNULLRecruiting18 Years55 YearsAll640Phase 2;Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;China;Czechia;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Romania;Spain;Taiwan;United Kingdom
17NCT03487913
(ClinicalTrials.gov)
September 14, 201816/3/2018The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney DiseaseA Phase 2, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: LixivaptanPalladio BiosciencesNULLCompleted18 Years65 YearsAll31Phase 2United States
18NCT03596957
(ClinicalTrials.gov)
September 12, 201814/2/2018Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney DiseaseSubacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic KidneyDrug: TolvaptanLisbet BrandiNULLUnknown status18 Years65 YearsAll90Phase 4Denmark
19NCT03423810
(ClinicalTrials.gov)
April 23, 201831/1/2018Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease PatientsAssessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease PatientsPolycystic Kidney DiseasesDrug: HydralazineUniversity of Kansas Medical CenterNULLCompleted18 Years65 YearsAll14Early Phase 1United States
20NCT03366337
(ClinicalTrials.gov)
December 26, 20174/12/2017A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIXA Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney DiseasesIgA Nephropathy;CKD Associated With Type 1 Diabetes;Focal Segmental Glomerulosclerosis;Autosomal Dominant Polycystic KidneyDrug: Bardoxolone methyl capsulesReata Pharmaceuticals, Inc.NULLCompleted18 Years65 YearsAll103Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03273413
(ClinicalTrials.gov)
August 31, 20171/9/2017Statin Therapy in Patients With Early Stage ADPKDStatin Therapy in Patients With Early Stage ADPKDADPKD;Autosomal Dominant Polycystic KidneyDrug: Pravastatin;Drug: PlaceboUniversity of Colorado, DenverNULLRecruiting25 Years60 YearsAll200Phase 4United States
22NCT03203642
(ClinicalTrials.gov)
August 9, 201726/6/2017Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKDA Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney;ADPKDDrug: Tesevatinib;Drug: PlaceboKadmon Corporation, LLCNULLActive, not recruiting18 Years60 YearsAll80Phase 2United States
23NCT03096080
(ClinicalTrials.gov)
June 14, 20176/3/2017A Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Polycystic Kidney Disease (ARPKD)A Phase 1, Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Polycystic Kidney Disease (ARPKD)Polycystic Kidney, Autosomal RecessiveDrug: TesevatinibKadmon Corporation, LLCNULLCompleted5 Years12 YearsAll10Phase 1United States
24NCT03102632
(ClinicalTrials.gov)
June 1, 201727/3/2017A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney DiseaseA Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic KidneyOther: High Water IntakeThe Rogosin InstituteWeill Medical College of Cornell UniversityRecruiting18 Years65 YearsAll32N/AUnited States
25NCT02903511
(ClinicalTrials.gov)
November 201613/9/2016Feasibility Study of Metformin Therapy in ADPKDFeasibility Study of Metformin Therapy in Autosomal Dominant Polycystic Kidney Disease.Polycystic Kidney, Autosomal DominantDrug: Metformin;Drug: PlaceboUniversity of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed30 Years60 YearsAll52Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
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gender
Target_
size
PhaseCountries
26NCT02729662
(ClinicalTrials.gov)
October 1, 201611/3/2016Efficacy of Tolvaptan on ADPKD PatientsLongitudinal Efficacy and Safety Study of Tolvaptan on Autosomal Dominant Polycystic Kidney Disease Patients (LET-PKD Study)Autosomal Dominant Polycystic Kidney DiseaseDrug: TolvaptanKyorin UniversityNULLActive, not recruiting18 YearsN/AAll118N/AJapan
27NCT02933268
(ClinicalTrials.gov)
September 26, 201618/9/2016High Water Intake in Polycystic Kidney DiseaseDetermining Feasibility of Randomisation to High vs ad Libitum Water Intake in Polycystic Kidney Disease: The DRINK Randomised Feasibility TrialAutosomal Dominant Polycystic Kidney DiseaseDietary Supplement: High water intake;Other: Ad libitum water intakeCambridge University Hospitals NHS Foundation TrustPKD Charity;Addenbrookes Charitable Trust;British Renal Society & British Kidney Patient AssociationCompleted16 YearsN/AAll42N/AUnited Kingdom
28NCT02964273
(ClinicalTrials.gov)
September 201615/9/2016Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan Followed by a Two Year Open-label Extension in Children and Adolescent Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Autosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: Tolvaptan;Drug: Matching PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.NULLActive, not recruiting4 Years17 YearsAll91Phase 3Belgium;Germany;Italy;United Kingdom
29NCT03406286
(ClinicalTrials.gov)
July 19, 201622/12/2017Samsca PMS in ADPKD PatientsPost-Marketing Surveillance(PMS) of Safety and Efficacy of Samsca® Tablets in Korean Patients With ADPKDSafetyDrug: TolvaptanKorea Otsuka Pharmaceutical Co., Ltd.NULLRecruiting18 YearsN/AAll600Korea, Republic of
30NCT02656017
(ClinicalTrials.gov)
June 27, 201623/12/2015Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney DiseaseMetformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney, Autosomal DominantDrug: Metformin;Other: PlaceboKyongtae Ty Bae, M.D., Ph.D.Tufts Medical Center;University of Maryland, Baltimore;University of Southern California;United States Department of DefenseActive, not recruiting18 Years60 YearsAll97Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT02697617
(ClinicalTrials.gov)
January 26, 201630/10/2015Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney DiseaseUse of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic KidneyPolycystic Kidney DiseaseDrug: Pioglitazone;Drug: PlaceboIndiana UniversityNULLActive, not recruiting18 Years55 YearsAll18Phase 2United States
32NCT03803124
(ClinicalTrials.gov)
December 20157/1/2019Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKDEffect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKDPolycystic Kidney, Autosomal DominantDrug: Tolvaptan;Drug: PlaceboRegional Hospital HolstebroNULLCompleted18 YearsN/AAll20Phase 3Denmark
33NCT02616055
(ClinicalTrials.gov)
December 201524/11/2015Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101 in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: tesevatinibKadmon Corporation, LLCNULLTerminated18 Years55 YearsAll15Phase 2United States
34NCT02494141
(ClinicalTrials.gov)
November 12, 201525/6/2015Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKDCurcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKDPolycystic Kidney, Autosomal DominantDrug: Curcumin;Other: PlaceboUniversity of Colorado, DenverNULLActive, not recruiting6 Years25 YearsAll68Phase 4United States
35NCT02558595
(ClinicalTrials.gov)
September 22, 201521/9/2015Pilot Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD2)Randomized, Controlled Pilot Study of Niacinamide in Polycystic Kidney DiseasePolycystic Kidney DiseaseDietary Supplement: Niacinamide;Other: PlaceboUniversity of Kansas Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 Years60 YearsAll36Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
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agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT02776241
(ClinicalTrials.gov)
September 20154/5/2016Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney DiseaseEffect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney: The HYDRA StudyADPKDOther: waterRigshospitalet, DenmarkAarhus University HospitalCompleted18 YearsN/AAll40N/ADenmark
37NCT02527863
(ClinicalTrials.gov)
February 201518/2/2015Effect of the Aquaretic Tolvaptan on Nitric Oxide SystemThe Effects of Tolvaptan on Renal Handling of Water and Sodium, Vasoactive Hormones and Central Hemodynamics During Baseline Conditions and After Inhibition of the Nitric Oxide System in Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan;Drug: PlaceboRegional Hospital HolstebroAarhus University HospitalCompleted18 Years65 YearsAll18Phase 2Denmark
38NCT02251275
(ClinicalTrials.gov)
October 17, 201425/9/2014Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney DiseaseA Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney, Autosomal DominantDrug: TolvaptanOtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 YearsN/AAll1803Phase 3United States;Argentina;Australia;Belgium;Canada;Czechia;Denmark;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Romania;Russian Federation;South Africa;Spain;Sweden;United Kingdom;Czech Republic
39NCT02134899
(ClinicalTrials.gov)
October 14, 201428/4/2014The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted RecipientsAn Open-labelled Multicenter Randomized Study on the Efficacy of Everolimus in Reducing Total Native Kidney Volume in Kidney Transplanted Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Everolimus;Drug: Calcineurin inhibitors maintenanceAssistance Publique - Hôpitaux de ParisNovartisCompleted18 Years75 YearsAll3Phase 3France
40NCT02127437
(ClinicalTrials.gov)
September 19, 20142/4/2014Lanreotide In Polycystic Kidney Disease StudyLanreotide In Polycystic Kidney Disease StudyAutosomal Dominant Polycystic Kidney Disease (ADPKDDrug: Lanreotide;Drug: salineAssistance Publique - Hôpitaux de ParisIPSEN pharmaceutical company, Boulogne-Billancourt, FranceCompleted18 YearsN/AAll159Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
41NCT02160145
(ClinicalTrials.gov)
May 20146/6/2014Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney DiseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney DiseaseChronic Kidney Disease;Autosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan (OPC-41061);Drug: PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years65 YearsAll1370Phase 3United States;Argentina;Australia;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Sweden;United Kingdom;Czech Republic
42NCT02140814
(ClinicalTrials.gov)
May 201414/5/2014Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney DiseaseUncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney DiseasePolycystic Kidney DiseaseDietary Supplement: NiacinamideAlan Yu, MB, BChirNULLCompleted18 Years50 YearsBoth10Phase 2United States
43NCT02225860
(ClinicalTrials.gov)
May 201420/8/2014Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney DiseaseLow Osmolar Diet and Adjusted Water Intake for Vasopressin Suppression in ADPKDAutosomal Dominant Polycystic Kidney Disease (ADPKD)Behavioral: Diet and water adjustmentTufts Medical CenterNULLCompleted18 Years60 YearsAll34Phase 2;Phase 3United States
44NCT02055079
(ClinicalTrials.gov)
April 201431/1/2014Pulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney DiseasePulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney Disease - The Vienna RAP StudyPolycystic Kidney, Type 1 Autosomal Dominant Disease;Polycystic Kidney, Type 2 Autosomal Dominant DiseaseDrug: Sirolimus;Drug: PlaceboMedical University of ViennaNULLUnknown status18 YearsN/AAll68Phase 3Austria
45NCT02847624
(ClinicalTrials.gov)
March 201425/7/2016Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKDPost-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD in JapanPolycystic Kidney, Autosomal DominantDrug: tolvaptanOtsuka Pharmaceutical Co., Ltd.NULLRecruitingN/AN/AAll1600Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT01853553
(ClinicalTrials.gov)
July 20138/5/2013Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease (ADPKD)Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic KidneyADPKDDrug: Spironolactone;Drug: Sugar pillUniversity of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed20 Years55 YearsAll61Phase 3United States
47NCT01559363
(ClinicalTrials.gov)
September 20129/3/2012A Safety, Pharmacokinetic and Dose-Escalation Study of KD019 (Tesevatinib) in Subjects With ADPKDA Phase 1b/2a, Safety, Pharmacokinetic and Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Polycystic Kidney, Autosomal DominantDrug: KD019 (tesevatinib)Kadmon Corporation, LLCNULLCompleted22 Years62 YearsAll74Phase 1;Phase 2United States
48NCT01670110
(ClinicalTrials.gov)
August 201217/8/2012Pasireotide LAR in Severe Polycystic Liver DiseaseA Randomized, Placebo Controlled Clinical Trial of SOM230 (Pasireotide LAR) In Severe Polycystic Liver DiseaseSomatostatin Analogs;Polycystic Liver Disease;Autosomal Dominant Polycystic Kidney Disease;Autosomal Dominant Polycystic Liver DiseaseDrug: Pasireotide LAR;Drug: PlaceboMayo ClinicNULLCompleted18 Years100 YearsAll48Phase 2United States
49NCT01616927
(ClinicalTrials.gov)
June 20126/6/2012Study of Lanreotide to Treat Polycystic Kidney DiseaseThe DIPAK 1 Study: A Randomised, Controlled Clinical Trial Assessing the Efficacy of Lanreotide to Halt Disease Progression in ADPKDAutosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: LanreotideUniversity Medical Center GroningenLeiden University Medical Center;Erasmus Medical Center;Radboud UniversityActive, not recruiting18 Years60 YearsAll300Phase 3Netherlands
50NCT01451827
(ClinicalTrials.gov)
October 201111/10/20118-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Placebo-masked, Parallel-group Pilot Trial to Compare the Efficacy, Tolerability, and Safety of Tolvaptan Modified-release and Immediate-release Formulations in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan MR;Drug: Tolvaptan IR;Drug: PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years50 YearsAll178Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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Target_
size
PhaseCountries
51NCT01377246
(ClinicalTrials.gov)
May 201120/6/2011Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal InsufficiencyA PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIAL TO ASSESS THE EFFECTS OF LONG-ACTING SOMATOSTATIN (OCTREOTIDE LAR) THERAPY ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE TO SEVERE RENAL INSUFFICIENCYAutosomal Dominant Polycystic Kidney DiseaseDrug: Octreotide-LAR;Other: Saline solution.Mario Negri Institute for Pharmacological ResearchNULLCompleted18 Years75 YearsAll100Phase 3Italy
52EUCTR2011-000138-12-IT
(EUCTR)
04/04/201128/12/2011A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2 Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
80Phase 3Italy
53EUCTR2010-023017-65-ES
(EUCTR)
18/03/201127/01/2011ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD, LA ACTIVIDAD CLÍNICA Y LA FARMACOCINÉTICA DE BOSUTINIB (PF-05208763) FRENTE A PLACEBO EN SUJETOS CON POLIQUISTOSIS RENAL AUTOSÓMICA DOMINANTE (PRAD). - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF-05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD).ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD, LA ACTIVIDAD CLÍNICA Y LA FARMACOCINÉTICA DE BOSUTINIB (PF-05208763) FRENTE A PLACEBO EN SUJETOS CON POLIQUISTOSIS RENAL AUTOSÓMICA DOMINANTE (PRAD). - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF-05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD). Poliquistosis renal autosómica dominante (PRAD).
MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Product Name: Bosutinib
Product Code: PF-05208763
INN or Proposed INN: Bosutinib (anhydrous)
Other descriptive name: SKI-606
PFIZER, S.L.U.NULLNot RecruitingFemale: yes
Male: yes
275Phase 2Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden
54NCT01233869
(ClinicalTrials.gov)
December 201028/10/2010Bosutinib For Autosomal Dominant Polycystic Kidney DiseaseA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety, Clinical Activity And Pharmacokinetics Of Bosutinib (PF-05208763) Versus Placebo In Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Polycystic Kidney, Autosomal DominantDrug: Bosutinib;Drug: PlaceboPfizerNULLCompleted18 Years50 YearsAll172Phase 2United States;Australia;Canada;Czech Republic;Hungary;Italy;Korea, Republic of;Lithuania;Moldova, Republic of;Poland;Romania;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom
55NCT01280721
(ClinicalTrials.gov)
November 20106/12/2010A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]A Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]Autosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: tolvaptanOtsuka Pharmaceutical Co., Ltd.NULLCompleted23 Years53 YearsAll135Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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agemax
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gender
Target_
size
PhaseCountries
56NCT01210560
(ClinicalTrials.gov)
October 201021/9/2010Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKDA Multi-center, Parallel-group, Randomized, Double-blind, Placebo-masked, Multiple Dose Trial of Modified-release (MR) and Immediate-release (IR) Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Autosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan MR;Drug: Tolvaptan IROtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years50 YearsAll25Phase 2United States
57NCT01336972
(ClinicalTrials.gov)
October 201015/4/2011Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 2a, Single-center Study Investigating the Short-term Renal Hemodynamic Effects, Safety and Pharmacokinetics/ Pharmacodynamics of Oral Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal FunctionAutosomal Dominant Polycystic Kidney DiseaseDrug: TolvaptanOtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years70 YearsAll29Phase 2Netherlands
58NCT01214421
(ClinicalTrials.gov)
May 201026/9/2010Open-Label Tolvaptan Study in Subjects With ADPKDMulti-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Autosomal Dominant Polycystic Kidney Disease (ADPKD)Drug: TolvaptanOtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 YearsN/AAll1083Phase 3United States;Argentina;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Romania;Russian Federation;United Kingdom
59EUCTR2009-012376-27-IT
(EUCTR)
16/11/200930/11/2009EFFECTS OF LONG-ACTING SOMATOSTATIN ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE/SEVERE RENAL INSUFFICIENCY(ALADIN II STUDY) - ALADIN IIEFFECTS OF LONG-ACTING SOMATOSTATIN ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE/SEVERE RENAL INSUFFICIENCY(ALADIN II STUDY) - ALADIN II Polycystic Kidney
MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Trade Name: SANDOSTATINA LAR
INN or Proposed INN: Octreotide
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot RecruitingFemale: yes
Male: yes
Italy
60NCT01022424
(ClinicalTrials.gov)
November 200927/11/2009A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]Autosomal Dominant Polycystic Kidney DiseaseDrug: OPC-41061Otsuka Pharmaceutical Co., Ltd.NULLCompletedN/AN/AAll13Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
61NCT00920309
(ClinicalTrials.gov)
June 200912/6/2009Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to TherapyRapamycin as Treatment for ADPKD: The Role of Biomarkers in Predicting a Response to TherapyAutosomal Dominant Polycystic Kidney DiseaseDrug: Rapamycin;Other: Standard of Care-PlaceboYale UniversityNULLTerminated18 Years70 YearsAll21Phase 2;Phase 3United States
62NCT00784030
(ClinicalTrials.gov)
November 200831/10/2008High Water Intake to Slow Progression of Polycystic Kidney DiseaseThe Effect of Water Loading on Urinary BiomarkersKidney, Polycystic, Autosomal DominantOther: WaterNew York University School of MedicineNULLCompleted18 Years65 YearsAll23N/AUnited States
63NCT00428948
(ClinicalTrials.gov)
January 200726/1/2007Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney Disease, Autosomal DominantDrug: Tolvaptan;Drug: PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.Otsuka Pharmaceutical Co., Ltd.Completed18 Years50 YearsAll1445Phase 3United States;Argentina;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Netherlands;Poland;Romania;Russian Federation;United Kingdom
64NCT00426153
(ClinicalTrials.gov)
January 200722/1/2007Octreotide in Severe Polycystic Liver DiseasePilot Study Of Long-Acting Octreotide (Octreotide LAR® Depot) In The Treatment Of Patients With Severe Polycystic Liver DiseasePolycystic Kidney, Autosomal Dominant;Polycystic Liver Disease;Hepatomegaly;Liver Diseases;Kidney, Polycystic;Abdominal PainDrug: Octreotide;Drug: PlaceboMayo ClinicNovartis;National Center for Research Resources (NCRR)Completed18 Years80 YearsAll42Phase 2;Phase 3United States
65NCT00414440
(ClinicalTrials.gov)
December 200620/12/2006Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney DiseaseA Multicenter, Randomized, Placebo-controlled, Double-blind Study on the Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease (ESRD) in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)Autosomal Dominant Polycystic Kidney DiseaseDrug: Placebo;Drug: EverolimusNovartis PharmaceuticalsNULLCompleted18 Years50 YearsAll431Phase 4Austria;France;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
66NCT00456365
(ClinicalTrials.gov)
November 200612/3/2007Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney, Autosomal DominantDrug: pravastatin;Drug: PlaceboUniversity of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed8 Years22 YearsAll110Phase 3United States
67NCT00286156
(ClinicalTrials.gov)
October 20061/2/2006Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney DiseasesDrug: RapamuneThe Cleveland ClinicWyeth is now a wholly owned subsidiary of PfizerCompleted18 Years75 YearsAll30Phase 1;Phase 2United States
68NCT00841568
(ClinicalTrials.gov)
April 20069/2/2009A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]Autosomal Dominant Polycystic Kidney DiseaseDrug: OPC-41061Otsuka Pharmaceutical Co., Ltd.NULLCompletedN/AN/AAll17Phase 2Japan
69EUCTR2005-005552-41-IT
(EUCTR)
20/02/200606/03/2007Effect of long-acting somatostatin on disease progression in nephropathy due to autosomal dominant polycystic disease a long-term three year follow-up study - ALADINEffect of long-acting somatostatin on disease progression in nephropathy due to autosomal dominant polycystic disease a long-term three year follow-up study - ALADIN Autosomal Dominant Polycystic Kidney Disease ADPKD
MedDRA version: 6.1;Level: SOC;Classification code 10038359
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
66Phase 3Italy
70NCT01885559
(ClinicalTrials.gov)
January 200617/6/2013HALT Progression of Polycystic Kidney Disease Study BHALT Progression of Polycystic Kidney Disease Study BKidney, PolycysticDrug: Lisinopril;Drug: Telmisartan;Drug: PlaceboNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Boehringer Ingelheim;Merck Sharp & Dohme Corp.;Polycystic Kidney Disease Foundation;University of Pittsburgh;Washington University School of MedicineCompleted15 Years64 YearsAll486Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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Target_
size
PhaseCountries
71NCT00283686
(ClinicalTrials.gov)
January 200626/1/2006HALT Progression of Polycystic Kidney Disease Study AHALT Progression of Polycystic Kidney Disease Study AKidney, PolycysticDrug: Lisinopril;Drug: Telmisartan;Drug: Placebo;Other: Standard Blood Pressure Control;Other: Low Blood Pressure ControlNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Boehringer Ingelheim;Merck Sharp & Dohme Corp.;Polycystic Kidney Disease Foundation;University of Pittsburgh;Washington University School of MedicineCompleted15 Years64 YearsAll558Phase 3United States
72NCT00413777
(ClinicalTrials.gov)
December 200518/12/2006Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 2, Multi-center, Open-label Study to Determine Long-term Safety, Tolerability and Efficacy of Split-dose Oral Regimens of Tolvaptan Tablets in a Range of 30 to 120 mg/d in Patients With Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney, Autosomal DominantDrug: TolvaptanOtsuka Pharmaceutical Development & Commercialization, Inc.Otsuka Pharmaceutical Co., Ltd.Completed18 YearsN/AAll46Phase 2United States

86. 肺動脈性肺高血圧症 [臨床試験数:1,083,薬物数:667(DrugBank:122),標的遺伝子数:98,標的パスウェイ数:185
Searched query = "Pulmonary arterial hypertension", "PAH", "IPAH", "HPAH", "Eisenmenger syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
317 / 1,083 trials found
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Status
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agemin
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gender
Target_
size
PhaseCountries
1NCT03833323
(ClinicalTrials.gov)
August 1, 20215/2/2019Implantable System for Remodulin Post-Approval StudyImplantable System for Remodulin Post-Approval StudyPulmonary Arterial HypertensionCombination Product: Implantable System for Remodulin (treprostinil)Medtronic Cardiac Rhythm and Heart FailureUnited TherapeuticsNot yet recruiting22 YearsN/AAll50NULL
2NCT04039464
(ClinicalTrials.gov)
April 1, 20211/7/2019Mono vs. Dual Therapy for Pediatric Pulmonary Arterial HypertensionKids MoD PAH Trial: Mono- vs. Duo-Therapy for Pediatric Pulmonary Arterial HypertensionPediatric Pulmonary HypertensionDrug: Mono-Therapy with Sildenafil;Drug: Duo-Therapy with Sildenafil + BosentanJohns Hopkins UniversityNULLNot yet recruiting4 Months18 YearsAll100Phase 3United States
3NCT04451850
(ClinicalTrials.gov)
January 1, 202125/6/2020HRV as a Marker of Treatment Response in PAH Arterial HypertensionHeart Rate Variability (HRV) as a Marker of Treatment Response in Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionOther: Noninvasive actigraphy monitorUniversity of CincinnatiNULLNot yet recruiting18 Years70 YearsAll35NULL
4NCT04435782
(ClinicalTrials.gov)
December 14, 202015/6/2020A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance ImagingA Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance ImagingPulmonary Arterial HypertensionDrug: JNJ-67896049ActelionNULLNot yet recruiting18 Years65 YearsAll80Phase 4United States;Argentina;Brazil;China;France;Germany;Hong Kong;Israel;Korea, Republic of;Malaysia;Netherlands;Russian Federation;Saudi Arabia;United Kingdom
5NCT04456998
(ClinicalTrials.gov)
December 202030/6/2020GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)Pulmonary Artery HypertensionDrug: GB002;Drug: Placebo;Device: Generic Dry Powder InhalerGB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.NULLRecruiting18 Years80 YearsAll80Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04576988
(ClinicalTrials.gov)
December 202028/9/2020A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (STELLAR)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAHPulmonary Arterial HypertensionDrug: Sotatercept;Drug: PlaceboAcceleron Pharma, Inc.NULLNot yet recruiting18 YearsN/AAll284Phase 3United States
7NCT04483115
(ClinicalTrials.gov)
November 16, 202015/7/2020Acute Haemodynamic Study of TPN171H in Patients With Pulmonary Arterial HypertensionMulti-center, Randomized,Placebo and Positive Controlled Clinical Study of TPN171H Tablets on Acute Haemodynamics in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: TPN171H;Drug: Placebo;Drug: TadalafilVigonvita Life SciencesShanghai Institute of Materia Medica, Chinese Academy of SciencesRecruiting18 Years75 YearsAll60Phase 2China
8NCT04280523
(ClinicalTrials.gov)
November 15, 202015/1/2020TranspulmonarY Estrogen Gradient and Estrogen Receptors (TYEGER) in PAHTranspulmonarY Estrogen Gradient and Estrogen Receptors (TYEGER) in PAHPulmonary Arterial HypertensionDrug: ESR-specific PET scanVanderbilt University Medical CenterNULLNot yet recruiting13 YearsN/AAll40Phase 2United States
9NCT04084678
(ClinicalTrials.gov)
October 29, 20206/9/2019A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PHA Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by CPET in Subjects With WHO Group 1 Pulmonary Hypertension Who Recently Initiated TherapyPAH;Pulmonary Hypertension;Hypertension;Connective Tissue Disease;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract Disease;Pulmonary Arterial HypertensionDrug: Ralinepag;Drug: PlaceboUnited TherapeuticsNULLRecruiting18 YearsN/AAll193Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Poland;Spain
10NCT04589390
(ClinicalTrials.gov)
October 15, 20208/10/2020Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial HypertensionSelexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial HypertensionPulmonary Hypertension;SchistosomiasisDrug: SelexipagUniversity of Sao Paulo General HospitalJanssen-Cilag Ltd.Recruiting18 YearsN/AAll20Phase 2Brazil
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04567602
(ClinicalTrials.gov)
October 6, 202023/9/2020A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or SelexipagNon-Interventional Study on Pulmonary Arterial Hypertension Patients Treated With Macitentan or Selexipag: Experience From an Italian Cohort (INSPECTIO)Pulmonary Arterial HypertensionDrug: PAH medicationJanssen-Cilag S.p.A.NULLRecruiting18 YearsN/AAll200Italy
12NCT04266197
(ClinicalTrials.gov)
September 25, 202022/1/2020Effects of RT234 on Exercise Parameters Accessed by CPET in Subjects With PAHA Phase 2, Open-label, Single Dose Study to Evaluated the Safety and Efficacy of RT234 on Exercise Parameters Assessed by Cardiopulmonary Exercise Testing (CPET) in Subjects With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionCombination Product: Drug: RT234 - vardenafil inhalation powder; Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI)Respira Therapeutics, Inc.Argint International;Precision For MedicineRecruiting18 Years80 YearsAll20Phase 2Serbia
13NCT04505137
(ClinicalTrials.gov)
September 2, 202031/7/2020A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy VolunteersA Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalation Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of A Single Intravenous Dose Of GMA301 Injection In Healthy VolunteersPulmonary Arterial HypertensionDrug: GMA301 Injection;Other: GMA301 Placebo InjectionGmax Biopharm Australia Pty Ltd.Metaclinical;Syneos HeathActive, not recruiting18 Years60 YearsAll16Phase 1Australia
14NCT04416750
(ClinicalTrials.gov)
September 1, 202028/5/2020Positioning Imatinib for Pulmonary Arterial HypertensionPositioning Imatinib for Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Imatinib MesylateImperial College LondonNational Institute for Health Research, United Kingdom;Medical Research Council;University of Cambridge;University of SheffieldNot yet recruiting18 Years75 YearsAll43Phase 2United Kingdom
15NCT04528056
(ClinicalTrials.gov)
August 1, 202014/8/2020Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial HypertensionPilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Sulfasalazine;Drug: Ambrisentan;Drug: Sulfasalazine's placebo;Drug: Ambrisentan's placeboRenJi HospitalNULLRecruiting18 Years75 YearsAll80Phase 1;Phase 2China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT04503733
(ClinicalTrials.gov)
July 1, 202024/7/2020A Study of GMA301 in Subjects With Pulmonary Arterial HypertensionA Randomized, Double-blind, Placebo-Controlled, Dose Escalation Study to Assess Safety, Efficacy and Pharmacokinetics of GMA301 in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Q4W GMA301 IV injections (300 mg);Drug: Q4W GMA301 IV injections (600 mg);Drug: Q4W GMA301 IV injections (1000 mg);Other: Q4W placebo IV injectionsGmax Biopharm LLC.NULLRecruiting18 Years75 YearsAll36Phase 1United States;China
17NCT04273945
(ClinicalTrials.gov)
June 30, 202031/1/2020Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial HypertensionA Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mgPulmonary Arterial HypertensionDrug: Macitentan 10 mg;Drug: Macitentan 37.5 mg;Drug: Macitentan 75 mg;Drug: PlaceboActelionNULLRecruiting18 YearsN/AAll900Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Brazil;Canada;China;Colombia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Vietnam;Romania
18NCT04278404
(ClinicalTrials.gov)
March 5, 202018/2/2020Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied DrugsCoronavirus Infection (COVID-19);Pulmonary Arterial Hypertension;Urinary Tract Infections in Children;Hypertension;Pain;Hyperphosphatemia;Primary Hyperaldosteronism;Edema;Hypokalemia;Heart Failure;Hemophilia;Menorrhagia;Insomnia;Pneumonia;Skin Infection;Arrythmia;Asthma in Children;Bronchopulmonary Dysplasia;Adrenal Insufficiency;Fibrinolysis; Hemorrhage;Attention Deficit Hyperactivity Disorder;Multisystem Inflammatory Syndrome in Children (MIS-C);Kawasaki Disease;Coagulation Disorder;Down SyndromeDrug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:Duke UniversityThe Emmes Company, LLC;Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)RecruitingN/A20 YearsAll5000United States;Canada
19NCT04309838
(ClinicalTrials.gov)
March 202020/2/2020Observation Study With Implantable Medication Pump for Intravenous Treprostinil Therapy in Patients With Pulmonary Arterial HypertensionLENUS Pro® Study (LPS-II) - Observation Study With Implantable Medication Pump for Intravenous REMODULIN® (Treprostinil) Therapy in Patients With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;PAHCombination Product: Treprostinil via implanted pumpUniversity Medicine GreifswaldOMT GmbH & Co. KGNot yet recruiting18 YearsN/AAll30Germany
20NCT03926793
(ClinicalTrials.gov)
February 4, 202022/4/2019Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial HypertensionA Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: GB002;Drug: Placebo;Device: Generic Dry Powder InhalerGB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.NULLRecruiting18 Years75 YearsAll16Phase 1United States;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT04175600
(ClinicalTrials.gov)
January 16, 20208/11/2019A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial HypertensionA Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study With Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged >=2 to <18 Years With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Selexipag;Drug: PlaceboActelionNULLRecruiting2 Years17 YearsAll237Phase 3United States;Australia;Belarus;Belgium;Brazil;Bulgaria;Canada;China;Colombia;Denmark;Finland;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;Poland;Portugal;Russian Federation;Serbia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;Vietnam;Argentina;Austria;Romania
22EUCTR2019-002414-40-GB
(EUCTR)
17/12/201924/10/2019An extension study, at multiple study sites, for patients with Pulmonary Arterial Hypertension who took part in study CXA-10-301, to look at the continuing safety of CXA-10 and how well it works long term: all patients will receive CXA-10 treatment.A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects with Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301. - Open label extension of CXA-10 in Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension (PAH).
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: CXA-10
Product Code: CXA-10
INN or Proposed INN: 10-nitro-9(E)-octadec-9-enoic acid
Complexa Inc.NULLNot RecruitingFemale: yes
Male: yes
115Phase 2United States;United Kingdom
23NCT03782818
(ClinicalTrials.gov)
November 20, 201917/12/2018Olaparib for PAH: a Multicenter Clinical TrialOlaparib for Pulmonary Arterial Hypertension: a Multicenter Clinical TrialPulmonary Arterial HypertensionDrug: OlaparibLaval UniversityCanadian Institutes of Health Research (CIHR);AstraZenecaRecruiting18 Years75 YearsAll20Phase 1;Phase 2Canada
24NCT03884465
(ClinicalTrials.gov)
November 11, 20194/3/2019Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of TreprostinilA Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) SubjectsPulmonary Arterial HypertensionDrug: Inhaled dry powder treprostinil (LIQ861)Liquidia Technologies, Inc.FGK Clinical Research GmbHRecruiting18 YearsN/AAll32Phase 2France;Germany
25NCT04125745
(ClinicalTrials.gov)
October 31, 201928/8/2018Oral CXA-10 in Pulmonary Arterial HypertensionPhase 2 Open-Label Study of Safety and Efficacy Trial of CXA-10 in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: CXA-10Gladwin, Mark, MDNational Heart, Lung, and Blood Institute (NHLBI);Complexa, Inc.Terminated18 Years80 YearsAll2Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03683186
(ClinicalTrials.gov)
September 23, 201919/9/2018A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label ExtensionA Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH)PAH;Pulmonary Hypertension;Pulmonary Arterial Hypertension;Hypertension;Connective Tissue Diseases;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract DiseaseDrug: RalinepagUnited TherapeuticsNULLEnrolling by invitation18 Years75 YearsAll1000Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Netherlands;Poland;Romania;Serbia;Singapore;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Sweden
27NCT03950739
(ClinicalTrials.gov)
September 17, 20199/5/2019Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using TyvasoAn Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects With Pulmonary Arterial Hypertension Currently Using TyvasoPulmonary Arterial HypertensionDrug: Treprostinil Inhalation PowderUnited TherapeuticsNULLRecruiting18 YearsN/AAll45Phase 1United States
28NCT03655704
(ClinicalTrials.gov)
August 22, 201928/8/2018Apabetalone for Pulmonary Arterial Hypertension: a Pilot StudyApabetalone for Pulmonary Arterial Hypertension: a Pilot StudyPulmonary Arterial HypertensionDrug: ApabetaloneSteeve ProvencherResverlogix CorpRecruiting18 Years75 YearsAll10Early Phase 1Canada
29NCT04053543
(ClinicalTrials.gov)
August 9, 201919/7/2019CXA-10 Study in Subjects With Pulmonary Arterial HypertensionA Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects With Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301PAHDrug: CXA-10Complexa, Inc.Medpace, Inc.;Innovative Analytics;Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Terminated18 YearsN/AAll33Phase 2United States;United Kingdom
30NCT04055415
(ClinicalTrials.gov)
August 1, 20198/8/2019Clinical Study of Adipose Derived Mesenchymal Stem Cells for Treatment of Pulmonary Arterial HypertensionSafety and Efficacy of Transplantation of Adipose Derived Mesenchymal Stem Cells to Treat Pulmonary Arterial HypertensionPulmonary HypertensionBiological: adipose derived mesenchymal stem cells;Drug: Conventional drug therapy(expectorant,bronchodilator)Liaocheng People's HospitalNULLRecruiting40 Years75 YearsAll60Phase 1;Phase 2China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT03924154
(ClinicalTrials.gov)
August 1, 20195/4/2019A Study of RVT-1201 in Patients With Pulmonary Arterial Hypertension (ELEVATE 1)A Phase 2a, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of RVT-1201 in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: RVT-1201;Drug: PlaceboAltavant Sciences GmbHAltavant Sciences, Inc.;PPDTerminated18 Years75 YearsAll3Phase 2United States;Canada
32NCT03904693
(ClinicalTrials.gov)
July 29, 20194/4/2019Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination TherapyPulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)Drug: FDC macitentan/tadalafil;Drug: Macitentan 10 mg;Drug: Tadalafil 40 mg;Drug: Placebo FDC;Drug: Placebo macitentan;Drug: Placebo tadalafilActelionNULLRecruiting18 YearsN/AAll170Phase 3United States;Australia;Brazil;Bulgaria;Canada;Czechia;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;South Africa;Spain;Taiwan;Turkey
33NCT03992755
(ClinicalTrials.gov)
July 18, 20195/6/2019Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of TreprostinilA Global, Open-Label Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) PatientsPrimary Pulmonary HypertensionDrug: LIQ861 Inhaled TreprostinilLiquidia Technologies, Inc.Nuventra, Inc.Active, not recruiting18 YearsN/AAll92Phase 3United States
34NCT03863990
(ClinicalTrials.gov)
July 15, 201919/2/2019Study Performed at Various Medical Centers to Learn More About Survival and Expected Course of Pulmonary Arterial Hypertension, a Type of High Blood Pressure in the Lungs Related to the Narrowing of the Small Blood Vessels in the LungsSurvival and Prognostic Factors in Pulmonary Arterial Hypertension. A Multicenter Observational Registry (START)Pulmonary Arterial HypertensionDrug: PAH medicationBayerNULLCompleted18 YearsN/AAll104Argentina
35NCT04316143
(ClinicalTrials.gov)
June 6, 201918/3/2020Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAHAn Open-label, Multicentre Study to Evaluate Pharmacokinetics, Safety and Efficacy of Zamicastat as Adjunctive Therapy in Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: ZamicastatBial - Portela C S.A.NULLRecruiting18 Years65 YearsAll32Phase 2Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT03738150
(ClinicalTrials.gov)
May 1, 20192/11/2018A Study of Sotatercept for the Treatment of Pulmonary Arterial HypertensionA Phase 2a Single-Arm, Open-Label, Multicenter Exploratory Study to Assess the Effects of Sotatercept (ACE-011) for the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionBiological: SotaterceptAcceleron Pharma, Inc.NULLRecruiting18 YearsN/AAll25Phase 2United States
37NCT03835676
(ClinicalTrials.gov)
May 1, 20196/2/2019Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial HypertensionEffects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: TreprostinilMagdi H. YacoubNULLRecruiting18 YearsN/AAll30Phase 4Egypt
38NCT03554291
(ClinicalTrials.gov)
May 1, 201931/5/2018Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary HypertensionRepurposing a Histamine Antagonist to Benefit Patients With Pulmonary HypertensionPulmonary Arterial Hypertension;Right Heart FailureDrug: Famotidine 20 MG;Other: PlaceboUniversity of WashingtonNational Heart, Lung, and Blood Institute (NHLBI)Recruiting18 Years80 YearsAll80Phase 2United States
39NCT03795428
(ClinicalTrials.gov)
April 10, 201918/12/2018Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) in PAH Subjects Following Completion of Study PB1046-PT-CL-0004A Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) Subcutaneous Injections in Pulmonary Arterial Hypertension Subjects Following Completion of Study PB1046-PT-CL-0004Pulmonary Arterial HypertensionDrug: Pemziviptadil (PB1046) InjectionPhaseBio Pharmaceuticals Inc.NULLRecruiting18 Years79 YearsAll63Phase 2United States
40NCT04207593
(ClinicalTrials.gov)
April 1, 201917/12/2019The Effect of Oxygen Therapy on 6MWD in PAH and CTEPH Patients With HypoxemiaProspective, Randomized, Controlled Trial of the Effect of Long-term Oxygen Therapy on 6-minute Walking Distance, Clinical Parameters and Hemodynamics in Patients With PAH and CTEPHOxygen Deficiency;Pulmonary Arterial Hypertension;CTEPHDrug: OxygenHeidelberg UniversityNULLRecruiting18 YearsN/AAll40Phase 2Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT04062565
(ClinicalTrials.gov)
March 25, 201929/3/2019Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAHA Prospective Trial to Evaluate Up-front Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Patients With Advanced Pulmonary Arterial Hypertension (IIR-3810)Pulmonary Arterial HypertensionDrug: Treprostinil Injectable Product;Drug: Riociguat PillUniversity of ArizonaNULLRecruiting18 YearsN/AAll20Phase 3United States
42NCT03522935
(ClinicalTrials.gov)
March 18, 20191/2/2018Subcutaneous Elafin in Healthy SubjectsSafety and Tolerability of Escalating Doses of Subcutaneous Elafin (Tiprelestat) Injection in Healthy Normal SubjectsPulmonary Arterial HypertensionDrug: Elafin;Drug: PlaceboRoham T. ZamanianDuke University;SRI InternationalActive, not recruiting18 Years55 YearsAll30Phase 1United States
43NCT03789643
(ClinicalTrials.gov)
March 201926/12/2018Study to Evaluate Efficacy and Safety of JTT-251 in Participants With Pulmonary Arterial HypertensionA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JTT-251 Administered for 24 Weeks to Participants With Pulmonary Arterial Hypertension (RELIEF-PAH)Pulmonary Arterial HypertensionDrug: JTT-251;Drug: PlaceboAkros Pharma Inc.NULLWithdrawn18 Years80 YearsAll0Phase 2NULL
44NCT03754660
(ClinicalTrials.gov)
January 21, 201923/11/2018This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH)A Non-randomized Two Part Multi-Center, Open-label, Single Dose Trial With an Escalation Part in Untreated Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients (Part A), Followed by a Parallel Group Part in Untreated and Pre-treated Patients With PAH and CTEPH (Part B) to Investigate the Safety, Tolerability and Pharmacodynamics of Inhaled BAY1237592Hypertension, PulmonaryDrug: BAY1237592;Drug: PH-monotherapy;Drug: PH-combination therapy;Procedure: NO gasBayerNULLRecruiting18 Years80 YearsAll60Phase 1Austria;Czechia;Germany;Poland
45NCT03744637
(ClinicalTrials.gov)
January 18, 201913/11/2018A Study of Single Doses of MK -5475 on Pulmonary Vascular Resistance (MK-5475-002)A Study to Assess the Effect of Single Doses of MK -5475 on Pulmonary Vascular Resistance in Patients With Moderate to Severe Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: MK-5475;Drug: PlaceboMerck Sharp & Dohme Corp.NULLActive, not recruiting18 Years70 YearsAll25Phase 1Moldova, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03648385
(ClinicalTrials.gov)
January 9, 201910/8/2018Effects of DHEA in Pulmonary HypertensionEffects of DHEA in Pulmonary HypertensionPulmonary Arterial HypertensionDrug: DHEA tablet;Other: PlaceboRhode Island HospitalNULLRecruiting18 YearsN/AAll24Phase 2United States
47NCT03657095
(ClinicalTrials.gov)
December 10, 201818/5/2018A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial HypertensionAn Open-label Extension of BPS-314d-MR-PAH-302 in Pulmonary Arterial Hypertension PatientsPulmonary Arterial HypertensionDrug: Esuberaprost;Drug: PlaceboLung Biotechnology PBCNULLTerminated18 Years85 YearsAll112Phase 3United States;Israel
48NCT04041648
(ClinicalTrials.gov)
November 9, 201823/7/2019Single Ascending Dose Study for Evaluation of Safety, Tolerability and Pharmacokinetics of L606A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dose of L606 for Inhalation in Healthy SubjectsPulmonary Arterial HypertensionDrug: L606 (Liposomal Treprostinil) Inhalation Solution 51ug;Device: L606 Inhalation System;Other: Placebo SolutionPharmosa Biopharm Inc.PPDRecruiting18 Years50 YearsAll64Phase 1United States
49NCT03251872
(ClinicalTrials.gov)
October 25, 201813/8/2017Olaparib for PAH: a Pilot StudyOlaparib for Pulmonary Arterial Hypertension: a Pilot Clinical StudyPulmonary Arterial HypertensionDrug: OlaparibLaval UniversityNULLTerminated18 Years75 YearsAll6Early Phase 1Canada
50NCT03528902
(ClinicalTrials.gov)
October 1, 201821/3/2018Tamoxifen Therapy to Treat Pulmonary Arterial HypertensionTamoxifen Therapy to Treat Pulmonary Arterial HypertensionHypertension;Pulmonary Arterial Hypertension;Familial Primary Pulmonary Hypertension;Primary Pulmonary Hypertension;Lung Diseases;Tamoxifen;Estrogen Receptor Antagonist;Hormone Antagonists;EstrogensDrug: Tamoxifen;Drug: Placebo Oral TabletVanderbilt University Medical CenterNULLRecruiting18 YearsN/AAll24Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT03497689
(ClinicalTrials.gov)
September 21, 201820/3/2018EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial HypertensionEXPEDITE: A 16-Week, Multicenter, Open-label Study of Remodulin Induction Followed by Orenitram Optimization in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Intravenous/Subcutaneous Treprostinil; Oral TreprostinilUnited TherapeuticsNULLRecruiting17 Years85 YearsAll30Phase 4United States
52NCT03626688
(ClinicalTrials.gov)
August 30, 201827/7/2018A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH PatientsA Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAHPAH;Pulmonary Hypertension;Pulmonary Arterial Hypertension;Hypertension;Connective Tissue Diseases;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract DiseaseDrug: Ralinepag;Drug: PlaceboUnited TherapeuticsNULLRecruiting18 Years75 YearsAll700Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Netherlands;Poland;Romania;Serbia;Singapore;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom
53NCT03617458
(ClinicalTrials.gov)
August 23, 20182/5/2018Interventions Against Insulin Resistance in Pulmonary Arterial HypertensionInterventions Against Insulin Resistance in Pulmonary Arterial HypertensionPulmonary Artery HypertensionDrug: Metformin;Drug: Placebo;Device: mHealth Intervention;Device: Usual CareVanderbilt University Medical CenterMayo Clinic;The Cleveland ClinicRecruiting18 YearsN/AAll130Phase 2United States
54EUCTR2015-005223-90-BE
(EUCTR)
16/08/201824/05/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
55NCT03449524
(ClinicalTrials.gov)
August 1, 201814/2/2018PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH)Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects With Pulmonary Arterial HypertensionPAHDrug: 75mg CXA-10;Drug: 150mg CXA-10;Other: PlaceboComplexa, Inc.Medpace, Inc.;Philips Healthcare;Cardiovascular Clinical Science Foundation;MicroConstants;Innovative Analytics;Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Terminated18 Years80 YearsAll69Phase 2United States;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT03602781
(ClinicalTrials.gov)
August 20186/7/2018Study of PAH Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled NitricPhase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Withdrawal Study of Pulmonary Arterial Hypertension(PAH) Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric Oxide (INO)Pulmonary Arterial HypertensionDrug: Placebo;Drug: iNOBellerophon Pulse TechnologiesWorldwide Clinical TrialsWithdrawn18 YearsN/AAll0Phase 3United States;Canada
57NCT03492177
(ClinicalTrials.gov)
July 23, 20183/4/2018A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial HypertensionA Prospective, Multicenter, Open Label, Single Arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: selexipag (Uptravi)ActelionNULLRecruiting2 Years18 YearsAll66Phase 2United States;Belarus;Canada;China;France;Germany;Hungary;Israel;Malaysia;Poland;Russian Federation;Serbia;Taiwan;Ukraine;United Kingdom;Romania
58NCT03556020
(ClinicalTrials.gov)
July 15, 20181/6/2018Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAHA Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous (SC) Injections of a Sustained-Release Vasoactive Intestinal Peptide (VIP) Analogue, Pemziviptadil (PB1046), in Adult Subjects With Symptomatic Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Pemziviptadil (PB1046)PhaseBio Pharmaceuticals Inc.NULLRecruiting18 Years79 YearsAll63Phase 2United States
59NCT03496207
(ClinicalTrials.gov)
June 27, 201829/3/2018A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Placebo;Drug: SotaterceptAcceleron Pharma, Inc.NULLActive, not recruiting18 YearsN/AAll100Phase 2United States;Australia;Brazil;France;Germany;Israel;Spain;United Kingdom
60NCT03683082
(ClinicalTrials.gov)
June 5, 201820/9/2018Oxygen Treatment and Pulmonary Arterial HypertensionAcute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension PatientsPulmonary Arterial HypertensionDrug: Oxygen supplementation;Drug: Sham O2 (medical air)George Papanicolaou HospitalNULLUnknown status18 Years80 YearsAll10N/AGreece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT03708146
(ClinicalTrials.gov)
May 28, 201812/10/2018Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 5-1058A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of BIA 5 1058 in Healthy VolunteersCardiovascular Disease+Pulmonary Disease;Pulmonary Arterial HypertensionDrug: BIA 5-1058;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years55 YearsAll157Phase 1United Kingdom
62NCT03166306
(ClinicalTrials.gov)
May 1, 20189/5/2017Angiogenic Imaging in Pulmonary Arterial HypertensionAngiogenic Imaging in Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Exercise Associated Pulmonary Arterial HypertensionDiagnostic Test: PET-CT Imaging with [89Zr]-bevacizumabBrigham and Women's HospitalNULLUnknown status18 YearsN/AAll30Phase 1;Phase 2United States
63NCT03489005
(ClinicalTrials.gov)
April 9, 201829/3/2018Effect of BIA 5 1058 on Cardiac RepolarizationA Randomized, Double-blind, Placebo-controlled and Open-label, Active Controlled, 4 Period Crossover Trial to Evaluate the Effect of BIA 5 1058 on Cardiac Repolarization in Healthy Adult Males and Females Under Fed ConditionsCardiovascular Disease;Pulmonary Arterial Hypertension;Heart FailureDrug: BIA 5-1058;Drug: Placebo Oral Tablet;Drug: Moxifloxacin 400 mgBial - Portela C S.A.CovanceCompleted18 Years55 YearsAll49Phase 1United Kingdom
64NCT03422328
(ClinicalTrials.gov)
April 4, 201830/1/2018A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Hypertension Who Were Previously Treated With Macitentan in Clinical Studies.mUlticenter, Single-arM, Open-laBel, Long-teRm Safety Study With macitEntan in Patients With puLmonary Hypertension previousLy Treated With mAcitentan in Clinical Studies (UMBRELLA)Pulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary HypertensionDrug: macitentanActelionNULLEnrolling by invitationN/AN/AAll94Phase 3Belarus;France;Ukraine;Poland
65NCT03344159
(ClinicalTrials.gov)
April 1, 201828/9/2017Spironolactone Therapy in Chronic Stable Right HF TrialSpironolactone Therapy in Chronic Stable Right HF TrialChronic Right-Sided Heart Failure;Pulmonary Arterial Hypertension;Pulmonary Hypertension, Primary, 2;Pulmonary Hypertension, Primary, 3;Pulmonary Hypertension, Primary, 4;Cardiomyopathy Right VentricularDrug: Spironolactone;Drug: Placebo;Radiation: PET/CT Scan: Two PET scans using 1. C-11 HED and 2. N-13 Ammonia or rubidium-82;Diagnostic Test: Cardiac MRI (Gadolinium enhanced)Ottawa Heart Institute Research CorporationNULLSuspended18 YearsN/AAll30Phase 4Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT03464864
(ClinicalTrials.gov)
March 9, 20181/3/2018Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal VolunteersA Phase 1, Single-center, Open-label, Dose-Rising Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder (TrIP) in Healthy Normal VolunteersPulmonary Arterial HypertensionDrug: Treprostinil Inhalation PowderMannkind CorporationNULLCompleted18 Years55 YearsAll36Phase 1United States
67NCT03362047
(ClinicalTrials.gov)
March 1, 201822/11/2017(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment)Untersuchung Des Einflusses PAH-spezifischer Medikation Auf Die rechtsventrikuläre Funktion Bei Patienten Mit Pulmonaler Arterieller Hypertonie (PAH) Unter Basalen BedingungenPulmonary Arterial Hypertension (PAH)Drug: Riciguat Group;Drug: Macitentan GroupUniversity of GiessenPhilipps University Marburg Medical CenterRecruiting18 Years85 YearsAll30Phase 2Germany
68NCT03177603
(ClinicalTrials.gov)
February 21, 201823/5/2017A Dose-escalation Study in Subjects With Pulmonary Arterial Hypertension (PAH)An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: GSK2586881GlaxoSmithKlineNULLCompleted18 Years75 YearsAll23Phase 2United States;Germany;Spain
69NCT03293407
(ClinicalTrials.gov)
February 1, 201820/9/2017Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial HypertensionVentavis® (Iloprost): Evaluation of Inhaled Iloprost Effects Using the Breelib™ Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Iloprost (Ventavis, BAYQ6256);Device: Breelib nebulizerBayerNULLCompleted18 YearsN/AAll31Germany
70NCT02939599
(ClinicalTrials.gov)
February 1, 201812/10/2016Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH PatientsLong-term, Open Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of QCC374 in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: QCC374Novartis PharmaceuticalsNULLTerminated18 YearsN/AAll5Phase 2United States;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT03399604
(ClinicalTrials.gov)
January 2, 20183/1/2018Investigation of the Safety and Pharmacology of Dry Powder Inhalation of TreprostinilA Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) PatientsPrimary Pulmonary HypertensionDrug: LIQ861 Inhaled TreprostinilLiquidia Technologies, Inc.Nuventra, Inc.Completed18 YearsN/AAll121Phase 3United States
72NCT03229499
(ClinicalTrials.gov)
December 7, 201718/7/2017Pulmonary Hypertension and Anastrozole TrialPulmonary Hypertension and Anastrozole Trial (PHANTOM)Pulmonary Arterial HypertensionDrug: Anastrozole;Drug: Placebo Oral TabletUniversity of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI);Johns Hopkins University;University of Colorado, Denver;Rhode Island Hospital;Stanford University;Vanderbilt University;Washington University School of MedicineRecruiting18 YearsN/AAll84Phase 2United States
73NCT03187678
(ClinicalTrials.gov)
December 4, 20179/6/2017Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial HypertensionA Multicenter, Open-label, Single-sequence Cross-over Study to Assess Safety, Tolerability, and Pharmacokinetics of Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension Switching From an Oral Stable Dose of SelexipagPulmonary Arterial HypertensionDrug: i.v. selexipag;Drug: oral selexipag (Uptravi)ActelionNULLCompleted18 Years75 YearsAll20Phase 3United States;Germany
74NCT03364244
(ClinicalTrials.gov)
November 30, 201730/11/2017Revavtio Special Investigation for Long-term Use in Pediatric PatientsREVATIO SPECIAL INVESTIGATION - INVESTIGATION FOR LONG-TERM USE OF REVATIO IN PEDIATRIC PATIENTS -Pulmonary Arterial HypertensionDrug: SildenafilPfizerNULLRecruitingN/A14 YearsAll190Japan
75NCT02932410
(ClinicalTrials.gov)
November 28, 201712/10/2016A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)A Multicenter, Open-label, Randomized, Event-driven Study to Assess Efficacy, Safety and Pharmacokinetics of Macitentan Versus Standard of Care in Children With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Macitentan;Other: Standard-of-careActelionNULLRecruiting2 YearsN/AAll300Phase 3United States;Australia;Austria;Canada;China;Colombia;Finland;France;Hungary;Israel;Korea, Republic of;Malaysia;Mexico;Philippines;Poland;Portugal;Russian Federation;South Africa;Spain;Thailand;Ukraine;Vietnam;Argentina;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT03078907
(ClinicalTrials.gov)
November 8, 20176/3/2017Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.A Multi-center, Double-blind, Placebo-controlled Phase 4 Study in Patients With Pulmonary Arterial Hypertension to Assess the Effect of Selexipag on Daily Life Physical Activity and Patient's Self-reported Symptoms and Their ImpactsPulmonary Arterial HypertensionDrug: Selexipag;Drug: PlaceboActelionNULLCompleted18 Years75 YearsAll108Phase 4United States;Austria;France;Germany;Ireland;Norway;Portugal;Sweden;Switzerland;United Kingdom
77NCT03315507
(ClinicalTrials.gov)
October 20, 20172/10/2017A Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046 in Subjects With PAHAn Open-Label, Dose Titration Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046, A Sustained-Release Analogue of Vasoactive Intestinal Peptide, In Adult Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: PB1046 Subcutaneous InjectionPhaseBio Pharmaceuticals Inc.NULLCompleted18 YearsN/AAll3Phase 1United States
78NCT03270332
(ClinicalTrials.gov)
October 12, 201730/8/2017Effect of Inhaled Albuterol in Pulmonary HypertensionEffect of Inhaled Albuterol on Pulmonary Hemodynamics in Patients With Group 1 Pulmonary Arterial Hypertension on Oral Pulmonary Vasodilator Therapy: A Proof of Concept StudyPulmonary HypertensionDrug: albuterol first then placebo;Drug: placebo first then albuterolUniversity of MiamiNULLRecruiting18 YearsN/AAll6Early Phase 1United States
79NCT03145298
(ClinicalTrials.gov)
October 1, 20172/5/2017ALlogeneic Cardiosphere-derived Stem Cells (CDCs) for Pulmonary Hypertension therApyA Phase I Study of the Safety and Feasibility of Central Intravenous Delivery of Allogeneic Human Cardiosphere-Derived Stem Cells in Patients With Pulmonary Arterial Hypertension ALPHA TrialPulmonary Arterial Hypertension (PAH)Biological: Allogeneic Human Cardiosphere-Derived Stem Cells;Biological: PlaceboCedars-Sinai Medical CenterCalifornia Institute for Regenerative Medicine (CIRM)Recruiting18 Years75 YearsAll26Phase 1United States
80NCT02999906
(ClinicalTrials.gov)
October 201719/12/2016Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial HypertensionA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Oral Treprostinil;Drug: PlaceboUnited TherapeuticsNULLWithdrawn18 Years79 YearsAll0Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT03001414
(ClinicalTrials.gov)
September 28, 201715/12/2016Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension: Intervention With Repeat Dosing of eNOS-enhanced EPCsA Multicentre, Phase 2 Clinical Trial to Establish the Efficacy and Safety of Repeat Dosing of Autologous Endothelial Progenitor Cells (EPCs) Transfected With Human Endothelial NO-synthase (eNOS) in Patients With Pulmonary Arterial Hypertension (PAH) on Top of Conventional TreatmentsHypertension,PulmonaryBiological: Placebo followed by Autologous EPCs transfected with human eNOS;Biological: Autologous EPCs transfected with human eNOS followed by Placebo;Biological: Autologous EPCs transfected with human eNOSNorthern TherapeuticsOttawa Hospital Research InstituteRecruiting18 Years80 YearsAll45Phase 2Canada
82NCT02927366
(ClinicalTrials.gov)
September 19, 20175/10/2016Safety, Pharmacokinetics and Efficacy Study of QCC374 in PAH PatientsA Randomized, Parallel-group, Placebo-controlled Subject and Investigator Blinded Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of QCC374 in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: QCC374;Drug: Placebo MatchingNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll8Phase 2United States;Germany;Korea, Republic of;United Kingdom;Taiwan
83NCT03273387
(ClinicalTrials.gov)
September 10, 20173/9/2017The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial HypertensionThe Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension Patients in National Cardiovascular Center Harapan Kita Hospital IndonesiaPrecapillary Pulmonary HypertensionDrug: Trimetazidine;Drug: Placebo oral capsuleIndonesia UniversityNULLCompleted18 Years65 YearsAll26Phase 2;Phase 3Indonesia
84EUCTR2015-005223-90-HR
(EUCTR)
23/08/201712/09/2017This is a multicenter, double-blind, randomized, placebo-controlled,parallel-group study to investigate the efficacy, tolerability and safety ofpulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longerfor 18 weeks in symptomatic subjects with pulmonary arterialhypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED,CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
85NCT03045029
(ClinicalTrials.gov)
July 18, 20172/2/2017ADAPT - A Patient Registry of the Real-world Use of Orenitram®ADAPT - A Patient Registry of the Real-world Use of Orenitram®Pulmonary Arterial HypertensionDrug: Oral treprostinilUnited TherapeuticsNULLRecruiting18 YearsN/AAll300United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT02800941
(ClinicalTrials.gov)
July 5, 201710/6/2016Bleeding Frequency Under Anticoagulant Treatment in Pulmonary HypertensionBleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension : HEMA-HTP Multicentric Study.Pulmonary Arterial HypertensionDrug: Oral anticoagulant treatmentCentre Hospitalier Universitaire de Saint EtienneNULLRecruiting18 YearsN/AAll203France
87NCT02882126
(ClinicalTrials.gov)
June 201724/8/2016An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial HypertensionAn Open-Label Extension Trial to Evaluate the Safety of Continued Therapy With Subcutaneous Remodulin® in Subjects With Pulmonary Arterial Hypertension Who Completed Study CVT-CV-003Pulmonary Arterial HypertensionDrug: Subcutaneous TreprostinilUnited TherapeuticsCVie Therapeutics Co. Ltd.Withdrawn18 YearsN/AAll0Phase 4China
88NCT03401476
(ClinicalTrials.gov)
May 8, 201730/4/2017Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial HypertensionEffect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Morphine SulfateJohn GrantonNULLUnknown status18 YearsN/AAll15Phase 2Canada
89NCT03365479
(ClinicalTrials.gov)
May 1, 201727/11/2017Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial HypertensionAcute Hemodynamic Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial HypertensionPulmonary Hypertension;Pulmonary Arterial HypertensionDrug: IloprostUniversity of GiessenNULLCompleted18 YearsN/AAll30N/AGermany
90NCT03016468
(ClinicalTrials.gov)
May 20176/1/2017Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAHA Multicenter, 16-Week, Open-label Study Evaluating the Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Parenteral Remodulin (treprostinil) injection;Drug: Oral TreprostinilUnited TherapeuticsNULLWithdrawn18 Years75 YearsAll0Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT02587325
(ClinicalTrials.gov)
April 1, 201723/10/2015ABI-009, an mTOR Inhibitor, for Patients With Severe Pulmonary Arterial HypertensionA Phase 1 Clinical Trial of ABI-009, an mTOR Inhibitor, for Patients With Severe Pulmonary Arterial Hypertension (PAH)Pulmonary HypertensionDrug: ABI-009, nab-rapamycin, albumin-bound rapamycinAadi, LLCNULLRecruiting18 YearsN/AAll25Phase 1United States
92NCT03431649
(ClinicalTrials.gov)
April 1, 201729/7/2017Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in ChildrenEfficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart DefectPediatric Pulmonary HypertensionDrug: Beraprost Sodium;Drug: Sildenafil CitrateDr. Soetomo General HospitalNULLCompleted1 Year17 YearsAll40Phase 4Indonesia
93EUCTR2015-005223-90-AT
(EUCTR)
28/02/201716/01/2017This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
94NCT02893995
(ClinicalTrials.gov)
February 201724/8/2016Safety, Tolerability, Pharmacokinetics and Efficacy of Two Different Rates of Subcutanous Remodulin® Dose Titration in Pulmonary Arterial HypertensionA 16-Week, Open-Label, Multi-Center, Parallel, Randomized Controlled Study to Compare the Safety, Tolerability, Pharmacokinetics and Efficacy of Slow and Rapid Dose Titration Regimens of Subcutaneous Remodulin Therapy in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Slow Dose Titration Group of Subcutaneous Treprostinil;Drug: Rapid Dose Titration Group of Subcutaneous TreprostinilUnited TherapeuticsCVie Therapeutics Co. Ltd.Withdrawn18 YearsN/AAll0Phase 4China
95EUCTR2015-005223-90-NL
(EUCTR)
17/01/201705/09/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Bellerophon Pulse Technologies LLCNULLNot Recruiting Female: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT02891850
(ClinicalTrials.gov)
January 11, 201726/8/2016Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapyA Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment GoalPulmonary Arterial HypertensionDrug: Adempas (Riociguat, BAY63-2521);Drug: Sildenafil;Drug: TadalafilBayerNULLCompleted18 Years75 YearsAll225Phase 4United States;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Spain;Taiwan;Turkey;United Kingdom;Australia;Switzerland
97JPRN-UMIN000025176
2017/01/0115/12/2016Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension. Pulmonary arterial hypertensionMedicine transition from beraprost to selexipag

In accordance with the Japanese package insert (http://www.info.pmda.go.jp/go/pack/2190037F1020_1_02/), selexipag is initiated at a dose of 0.2mg twice daily and is increased in twice-daily increments of 0.2mg until unmanageable adverse effects associated with prostacyclin use, such as headache or jaw pain, developed.
The maximum dose allowed is 1.6mg twice daily.
Hamamatsu University School of MedicineNULLOpen public recruiting16years-oldNot applicableMale and Female33Not selectedJapan
98NCT02682511
(ClinicalTrials.gov)
January 20178/2/2016Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial HypertensionA Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (SSc-PAH)Scleroderma, Diffuse;Scleroderma, Systemic;Scleroderma, Limited;Sclerosis, Progressive Systemic;Skin Diseases;Connective Tissue Diseases;Pathologic Processes;Autoimmune DiseasesDrug: Oral Ifetroban;Drug: Oral PlaceboCumberland PharmaceuticalsNULLRecruiting18 Years80 YearsAll34Phase 2United States;India
99EUCTR2015-005223-90-DE
(EUCTR)
16/12/201609/05/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part2) which provides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Bellerophon Pulse Technologies LLCNULLNot Recruiting Female: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
100EUCTR2016-001067-36-IT
(EUCTR)
12/12/201605/11/2020A study to find out whether some PAH patients may benefit by replacing their current hosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
Product Name: Adempas¿ 1.0
INN or Proposed INN: Riociguat
Other descriptive name: Riociguat
Trade Name: ADEMPAS - 1,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
Product Name: Adempas¿ 1.5 mg
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: ADEMPAS - 0,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
Product Name: Adempas¿ 0.5 mg compressa rivestita con film
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: ADEMPAS - 2 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
Product Name: Adempas¿ 2.0 mg
INN or Proposed INN: Riociguat
Other descriptive name: Riociguat
Trade Name: ADEMPAS - 2,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
Product Name: Adempas¿ 2.5 mg
INN or Proposed INN: Riociguat
BAYER AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Germany;Japan;New Zealand;Portugal;United States;Taiwan;Greece;Spain;Italy;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT02981082
(ClinicalTrials.gov)
December 201630/11/2016Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial HypertensionA Double-blinded, Placebo-controlled Pilot Study of Dimethyl Fumarate (DMF) in Pulmonary Arterial Hypertension (PAH) Associated With Systemic Sclerosis (SSc-PAH): The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress.Systemic Sclerosis;Pulmonary; HypertensionDrug: Dimethyl Fumarate (DMF);Drug: Placebo Oral TabletRobert LafyatisBiogenTerminated18 Years80 YearsAll6Phase 1United States
102NCT03053739
(ClinicalTrials.gov)
December 201629/12/2016To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisRandomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisAssociated Pulmonary Arterial HypertensionDrug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and PlaceboPostgraduate Institute of Medical Education and ResearchNULLRecruiting18 YearsN/AAll50Phase 4India
103NCT02736149
(ClinicalTrials.gov)
December 20164/4/2016Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)A Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety and Efficacy of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)Pulmonary Arterial HypertensionDrug: ubenimexEiger BioPharmaceuticalsNULLTerminated18 Years75 YearsAll51Phase 2United States;Canada
104NCT03049995
(ClinicalTrials.gov)
November 20162/2/2017Stress Echo 2020 - The International Stress Echo StudyThe International Stress Echo Study in Ischemic and Non-ischemic Heart DiseaseCoronary Artery Disease;Heart Failure;Hypertrophic Cardiomyopathy;Aortic Valve Disease;Athletes Heart;Tetralogy of Fallot;Pulmonary Arterial HypertensionProcedure: Left ventricular contractile reserve SE;Procedure: B-lines SE;Procedure: Left ventricular outflow tract gradient SE;Procedure: Diastolic function SE;Procedure: Mitral regurgitation SE;Procedure: Pulmonary hemodynamics SE;Procedure: Coronary flow reserve SEFatebenefratelli HospitalInstitute of Clinical Physiology, CNR, Pisa,Italy;Salerno Hospital, Italy;Monaldi Hospital, Napoli, Italy;University of Pisa, Italy;San Luca Hospital, Lucca, Italy;Careggi University Hospital, Florence, Italy;Federico II University, Napoli, Italy;San Carlo Public Hospital, Potenza, Italy;Royal Brompton & Harefield NHS Foundation Trust;Ospedale dell'Angelo, Venezia-Mestre, Italy;University of Parma;Hospital Clinics, Trieste, Italy;Hospital de Clinicas de Porto Alegre - Universidade Federal do Rio Grande do Sul, Porto Alegre, Brasil;Hospital San José, Criciuma, Brasil;Hospital San Vicente de Paulo, Passo Fundo, Brasil;University of Belgrade,Serbia;University of Szeged, Hungary;Elisabeth Hospital, Hodmezovasarhely, Hungary;Sandro Pertini Hospital, Rome, Italy;Hospital Clinics, Bari, Italy;Ospedale Nottola, Siena, Italy;University of Catania, Italy;Medika Cardiocenter, Saint Petersburg, Russian Federation;Acibadem City Clinic, University Hospital,Sofia,Bulgaria;Investigaciones Medicas, Buenos Aires, Argentina;Tomsk National Research Scientific Centre of Russian Academy of Sciences, Tomsk, Russian FederationRecruiting18 Years85 YearsAll300N/AItaly
105NCT02657356
(ClinicalTrials.gov)
October 4, 201613/1/2016Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYSTA Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial HypertensionConnective Tissue Disease-Associated Pulmonary Arterial HypertensionDrug: Placebo capsules;Drug: Bardoxolone methyl capsulesReata Pharmaceuticals, Inc.NULLTerminated18 Years75 YearsAll202Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Germany;Israel;Japan;Mexico;Netherlands;Philippines;Spain;United Kingdom;Chile;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2015-005223-90-CZ
(EUCTR)
27/09/201622/06/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
107NCT02826252
(ClinicalTrials.gov)
September 15, 20165/7/2016Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 µg/mL (V10) to 20 µg/mL (V20)VENTASWITCH, Examination of Ventavis® (Iloprost) Inhalation Behavior Using the I-Neb® AAD® System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 µg/mL (V10) to 20 µg/mL (V20)Hypertension, PulmonaryDrug: Iloprost,(Ventavis, BAYQ6256);Device: I-Neb AAD systemBayerNULLCompleted18 YearsN/AAll64N/AGermany
108NCT02825160
(ClinicalTrials.gov)
August 1, 201615/6/2016Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: Ventavis (Iloprost, BAYQ6256)BayerNULLRecruitingN/AN/AAll270Japan
109EUCTR2015-005223-90-GB
(EUCTR)
12/07/201611/04/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3United States;Serbia;Portugal;Spain;Ukraine;Austria;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
110NCT02782052
(ClinicalTrials.gov)
July 201617/5/2016Bronchodilator's Effects on Exertional Dyspnoea in Pulmonary Arterial HypertensionBronchodilator's Effects on Exertional Dyspnoea in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Nebulized ipratropium bromide;Drug: Nebulized combination ipratropium bromide with salbutamol;Drug: Nebulized PlaceboAssistance Publique - Hôpitaux de ParisNULLWithdrawn18 YearsN/AAll0Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT02759419
(ClinicalTrials.gov)
June 16, 201629/4/2016A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension.An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial.Hypertension, PulmonaryDrug: Adempas (Riociguat, BAY63-2521)BayerNULLRecruiting18 YearsN/AAll25Phase 4France;Italy;Korea, Republic of;Poland;Thailand
112NCT02885012
(ClinicalTrials.gov)
June 20163/5/2016Crossover Study From Macitentan or Bosentan Over to AmbrisentanA Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: AmbrisentanMedical University of South CarolinaOchsner Health SystemTerminated18 Years80 YearsAll3Phase 4United States
113NCT02558231
(ClinicalTrials.gov)
May 1, 201622/9/2015The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial HypertensionThe Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b StudyPulmonary Arterial HypertensionDrug: Macitentan;Drug: Tadalafil;Drug: SelexipagActelionNULLCompleted18 Years75 YearsAll247Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom;Norway
114NCT02705807
(ClinicalTrials.gov)
May 201625/2/2016Evaluation of a New Thermostable Formulation of FLOLAN in Japanese SubjectsAn Open Label, Single-arm Study Evaluating a New Thermostable Formulation of FLOLAN™ in Japanese Subjects With Pulmonary Arterial Hypertension (PAH)Cardiovascular DiseaseDrug: FLOLAN injection with currently marketed diluent;Drug: FLOLAN injection with reformulated diluentGlaxoSmithKlineNULLCompleted18 Years75 YearsAll10Phase 4Japan
115NCT03809156
(ClinicalTrials.gov)
April 26, 20169/1/2019Upfront Combination Pulmonary Arterial Hypertension TherapyUpfront Riociguat and Ambrisentan Combination Therapy for Pulmonary Arterial Hypertension: A Safety and Efficacy Pilot StudyPulmonary HypertensionDrug: Riociguat Oral ProductUniversity of CalgaryBayerRecruiting18 YearsN/AAll20Phase 4Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT03057028
(ClinicalTrials.gov)
April 20164/5/2016Pilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial HypertensionPilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: AnakinraVirginia Commonwealth UniversityNULLCompleted18 YearsN/AAll7Phase 1United States
117NCT02664558
(ClinicalTrials.gov)
April 201621/1/2016A Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)A Phase 2, Randomized, Double-BLInd, Placebo- Controlled Study of UBEnimex in Patients With Pulmonary ARTerial HYpertension (WHO Group 1) (LIBERTY)Pulmonary Arterial HypertensionDrug: ubenimex;Other: placeboEiger BioPharmaceuticalsNULLCompleted18 Years75 YearsAll61Phase 2United States;Canada
118NCT02725372
(ClinicalTrials.gov)
April 201619/1/2016Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAHA Phase 3, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Efficacy, Safety, and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Symptomatic Subjects With PAH (Part 1 and Part 2)Pulmonary Arterial HypertensionDrug: Inhaled Nitric Oxide 75 mcg/kg IBW/hr;Drug: PlaceboBellerophon Pulse TechnologiesWorldwide Clinical TrialsTerminated18 Years85 YearsAll162Phase 3United States;Australia;Austria;Belgium;Canada;Colombia;Croatia;Czechia;France;Germany;Israel;Italy;Netherlands;Portugal;Serbia;Spain;Ukraine;United Kingdom
119NCT02734953
(ClinicalTrials.gov)
April 201626/3/2016Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAHEffects of iNO on Invasively Derived Pulmonary Vascular Parameters in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Nitric OxideAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)NULLCompleted18 Years80 YearsAll10Phase 2United States
120NCT02652429
(ClinicalTrials.gov)
March 201617/12/2015Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAHAn Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for PAH for Subjects in the PULSE-PAH-006 and PULSE-PAH-004 Studies Who Continue to Need iNO TherapyPulmonary Arterial HypertensionDrug: Inhaled Nitric OxideBellerophon Pulse TechnologiesNULLActive, not recruitingN/AN/AAll22Phase 3United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT02507011
(ClinicalTrials.gov)
January 31, 201622/7/2015Beta-blockers in Pulmonary Arterial HypertensionBeta-blockers in Pulmonary Arterial Hypertension - A Phase 2 Double-Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy, and Safety of Carvedilol for Right Ventricular Dysfunction in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Carvedilol;Drug: PlaceboUniversity of MinnesotaNULLTerminated18 YearsN/AAll2Phase 2United States
122NCT02676947
(ClinicalTrials.gov)
January 201621/12/2015A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial HypertensionA Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: TocilizumabPapworth Hospital NHS Foundation TrustRoche Pharma AG;National Institute for Health Research, United KingdomCompleted18 Years70 YearsAll29Phase 2United Kingdom
123NCT02551653
(ClinicalTrials.gov)
November 17, 201514/9/2015Positron Emission Tomography (PET) Study to Evaluate Biodistribution of [11C]-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) PatientsA Microdose Study to Evaluate the Biodistribution of [11C]-GSK2256098 in the Lungs and Heart of Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients Using Positron Emission Tomography (PET)Hypertension, PulmonaryDrug: [11C]-GSK2256098 500 MBqGlaxoSmithKlineNULLCompleted40 Years70 YearsAll10Phase 1United Kingdom
124NCT02471183
(ClinicalTrials.gov)
November 4, 201511/6/2015Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial HypertensionMulticenter, Open-label, Single-group Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Adult Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: SelexipagActelionNULLCompleted18 Years75 YearsAll30Phase 3United States
125NCT02562235
(ClinicalTrials.gov)
October 29, 201528/9/2015Riociguat in Children With Pulmonary Arterial Hypertension (PAH)Open-label, Individual Dose Titration Study to Evaluate Safety, Tolerability and Pharmacokinetics of Riociguat in Children From 6 to Less Than 18 Years of Age With Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: Riociguat (Adempas, BAY63-2521)BayerMerck Sharp & Dohme Corp.Active, not recruiting6 Years17 YearsAll24Phase 3Colombia;Germany;Hungary;Italy;Japan;Mexico;Poland;Taiwan;Turkey;Belgium;Brazil;France;Netherlands;Romania;Spain;United Kingdom;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2015-000709-38-AT
(EUCTR)
20/10/201528/07/2015Effects of the drug Benzbromaron on the pulmonary vesselsAcute Effects of Benzbromaron on the pulmonary circulation Pulmonary arterial hypertension
MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Benzbromaron AL
Product Name: Benzbromaron
INN or Proposed INN: BENZBROMARONE
Medical University of GrazNULLNot RecruitingFemale: yes
Male: yes
Phase 2Austria
127NCT02545465
(ClinicalTrials.gov)
September 15, 20158/9/2015A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical PracticeRetrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to AdempasHypertension, PulmonaryDrug: Riociguat (Adempas, BAY63-2521)BayerNULLCompletedN/AN/AAll125N/ABelgium;Canada;Colombia;Germany;Japan;Sweden;Turkey;Denmark;United Kingdom
128NCT02968901
(ClinicalTrials.gov)
September 1, 201514/11/2016Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA)Prospective, Multicenter, Open-label Study Evaluating the Effects of First-line Oral Combination Therapy of Macitentan and Tadalafil in Patients With Newly Diagnosed Pulmonary Arterial Hypertension (OPTIMA).Pulmonary Arterial HypertensionDrug: macitentan;Drug: tadalafilActelionNULLTerminated18 Years75 YearsAll46Phase 4France
129NCT02253394
(ClinicalTrials.gov)
September 201517/9/2014The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension StudyThe Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (The CAPS-PAH Study)Pulmonary Arterial HypertensionDrug: Ambrisentan plus Spironolactone;Drug: Ambrisentan plus PlaceboBrigham and Women's HospitalGilead SciencesTerminated18 YearsN/AAll2Phase 4United States
130NCT02279745
(ClinicalTrials.gov)
July 201525/10/2014Long Term Safety and Efficacy of Ralinepag in Pulmonary Arterial HypertensionAn Open-Label Extension Study of Ralinepag in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: RalinepagUnited TherapeuticsNULLActive, not recruiting18 Years75 YearsAll60Phase 2United States;Australia;Bulgaria;Czechia;Hungary;Poland;Romania;Serbia;Slovakia;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT02428985
(ClinicalTrials.gov)
June 29, 201521/4/2015Prospective, Non-interventional, Multi-center, Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension (PAH)Drug Use Investigation of Riociguat for Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: Riociguat (ADEMPAS, BAY63-2521)BayerNULLRecruitingN/AN/AAll600Japan
132NCT02310672
(ClinicalTrials.gov)
June 1, 20154/12/2014REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtensionA Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance ImagingPulmonary Arterial HypertensionDrug: MacitentanActelionNULLCompleted18 Years64 YearsAll89Phase 4United States;Australia;France;Germany;Hong Kong;Israel;Italy;Malaysia;Netherlands;Russian Federation;Singapore;United Kingdom
133NCT03195543
(ClinicalTrials.gov)
March 12, 20158/6/2017Assessment of Blood Coagulation Disorders in Patients With Pulmonary HypertensionAssessment of Blood Coagulation Disorders in Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension.Pulmonary Artery Hypertension;Chronic Thromboembolic Pulmonary HypertensionDiagnostic Test: Platelet function analyzer-100;Diagnostic Test: Light transmission aggregometry;Diagnostic Test: Rotational thromboelastometry;Diagnostic Test: Endogenous thrombin potentialNational and Kapodistrian University of AthensNULLRecruiting18 YearsN/AAll60Greece
134NCT02276872
(ClinicalTrials.gov)
December 18, 201421/10/2014Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 YearsA Multicenter, Open-Label, 24-Week, Uncontrolled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil Extended Release Tablets Following Transition From Remodulin or Inhaled Prostacyclin Therapy or as Add-on to Current PAH Therapy in De Novo Prostacyclin Pediatric Subjects Aged 7 to 17 Years With Pulmonary Arterial HypertensionPAHDrug: oral treprostinilUnited TherapeuticsNULLCompleted7 Years17 YearsAll32Phase 2United States
135NCT02279160
(ClinicalTrials.gov)
December 201425/10/2014Safety and Efficacy of APD811 in Pulmonary Arterial HypertensionA Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of Ralinepag, an Oral IP Receptor Agonist, in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: APD811;Drug: PlaceboUnited TherapeuticsNULLCompleted18 Years75 YearsAll61Phase 2United States;Australia;Bulgaria;Czechia;Hungary;Poland;Romania;Serbia;Spain;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT02284737
(ClinicalTrials.gov)
November 28, 201428/10/2014A Study to Investigate the Efficacy of PADN to Improved Functional Capacity and Hemodynamics in Patients With PAHA Prospective, Multi-center, Randomized Control Trial to Investigate the Efficacy of Pulmonary Artery Denervation to Improved Functional Capacity and Hemodynamics in Patients With Pulmonary Artery HypertensionPulmonary Arterial HypertensionProcedure: PADN;Procedure: sham PADN;Drug: SildenafilNanjing First Hospital, Nanjing Medical UniversityNULLRecruiting18 YearsN/AAll270Phase 4China
137NCT02234141
(ClinicalTrials.gov)
November 20142/9/2014Selonsertib in Adults With Pulmonary Arterial HypertensionA Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Placebo;Drug: SelonsertibGilead SciencesNULLCompleted18 Years75 YearsAll151Phase 2United States;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
138NCT02191137
(ClinicalTrials.gov)
September 23, 201427/6/2014Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active TreatmentHypertension, PulmonaryDrug: Riociguat (Adempas, BAY63-2521)BayerNULLCompleted18 Years80 YearsAll75Phase 4United States;Puerto Rico
139NCT02060487
(ClinicalTrials.gov)
September 22, 201429/1/2014Effects of Oral Sildenafil on Mortality in Adults With PAHA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)Pulmonary Arterial HypertensionDrug: sildenafil citratePfizerNULLActive, not recruiting18 Years74 YearsAll385Phase 4United States;Australia;Belgium;Bosnia and Herzegovina;Croatia;Czechia;Germany;Greece;Hong Kong;Israel;Latvia;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;Singapore;South Africa;Spain;Thailand;Turkey;Ukraine;Austria;Czech Republic;Netherlands;Portugal
140NCT02290613
(ClinicalTrials.gov)
July 1, 201431/10/2014Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) A Randomized, Controlled, Double-blind, Parallel Group, Proof-of-concept Trial EDITASystemic Sclerosis;Pulmonary HypertensionDrug: Ambrisentan;Drug: PlaceboHeidelberg UniversityGlaxoSmithKlineCompleted18 YearsN/AAll38Phase 2Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT02112487
(ClinicalTrials.gov)
June 23, 20148/4/2014Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAHAn Extension of AC-055-310, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™Pulmonary Arterial HypertensionDrug: MacitentanActelionNULLCompleted18 Years80 YearsAll88Phase 3France;Italy;Spain
142NCT02108743
(ClinicalTrials.gov)
June 20147/4/2014Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial HypertensionAlbuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial HypertensionIdiopathic Pulmonary Arterial Hypertension.Drug: Albuterol.;Drug: Normal saline placeboAmerican Medical Association FoundationNULLWithdrawn18 Years75 YearsBoth0Phase 2United States
143NCT02036970
(ClinicalTrials.gov)
May 201413/1/2014Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIATA Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary HypertensionPulmonary Arterial Hypertension;Pulmonary Hypertension;Interstitial Lung Disease;Idiopathic Interstitial Pneumonia;Idiopathic Pulmonary Fibrosis;Sarcoidosis;Respiratory Bronchiolitis Associated Interstitial Lung Disease;Desquamative Interstitial Pneumonia;Cryptogenic Organizing Pneumonia;Acute Interstitial Pneumonitis;Idiopathic Lymphoid Interstitial Pneumonia;Idiopathic Pleuroparenchymal FibroelastosisDrug: Bardoxolone methyl;Drug: PlaceboReata Pharmaceuticals, Inc.NULLCompleted18 Years75 YearsAll166Phase 2United States;Germany;Spain;United Kingdom
144NCT02120339
(ClinicalTrials.gov)
May 201417/4/2014Carvedilol PAH A Pilot Study of Efficacy and SafetyBeta Blockers in Pulmonary Arterial Hypertension (PAH) A Pilot Study of Efficacy and SafetyPulmonary Hypertension;Cardiac MRI <40Drug: CarvedilolUniversity of MinnesotaNULLTerminated18 Years99 YearsAll5Phase 1United States
145NCT02126943
(ClinicalTrials.gov)
April 30, 201429/4/2014OPsumit USers RegistryUS-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical PracticePulmonary Arterial HypertensionDrug: Opsumit (macitentan)ActelionNULLCompletedN/AN/AAll2686United States;Puerto Rico
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT02032836
(ClinicalTrials.gov)
March 10, 20149/1/2014Comparative PK PD Study in PAH Patients (Fox vs. I-Neb)A Multi-center, Open-label, Randomized Cross-over Study to Compare the Acute Tolerability and Pharmacokinetics of BAYQ6256 (Iloprost; Ventavis) Inhalation Using the I-Neb Nebulizer and the FOX Nebulizer in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: lloprost(Ventavis,BAYQ6252, 20 µg/mL);Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL)BayerNULLCompleted18 YearsN/AAll27Phase 1;Phase 2Austria;Germany
147NCT02081690
(ClinicalTrials.gov)
March 1, 20145/3/2014A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and SpainA Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™Pulmonary Arterial HypertensionDrug: MacitentanActelionNULLTerminated18 Years80 YearsAll160Phase 3France;Italy;Spain
148NCT02007629
(ClinicalTrials.gov)
February 18, 20146/12/2013Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 InhibitorAn Open-label, International, Multicenter, Single-arm, Uncontrolled, Phase IIIb Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Demonstrate an Insufficient Response to Treatment With Phosphodiesterase-5 Inhibitors (PDE-5i)Hypertension, PulmonaryDrug: Riociguat (Adempas, BAY63-2521)BayerNULLCompleted18 Years75 YearsAll61Phase 3United States;Belgium;Canada;Czechia;France;Germany;Italy;Switzerland;United Kingdom;Czech Republic
149NCT01824290
(ClinicalTrials.gov)
February 5, 20141/4/2013A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Tadalafil;Drug: Placebo;Drug: ERA as specific PAH treatmentEli Lilly and CompanyNULLActive, not recruiting6 Months17 YearsAll35Phase 3United States;Austria;Belgium;Brazil;France;Germany;Israel;Italy;Japan;Mexico;Netherlands;Poland;Spain;Turkey;Canada;Romania;Switzerland
150NCT02042014
(ClinicalTrials.gov)
January 22, 201417/1/2014Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in JapanAn Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan and Are Judged by the Investigator to Benefit From Continued QTI571 TreatmentSevere Pulmonary Arterial HypertensionDrug: QTI571Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll8Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT01712620
(ClinicalTrials.gov)
January 10, 201420/10/2012Spironolactone for Pulmonary Arterial HypertensionA Pilot Study of the Effect of Spironolactone Therapy on Exercise Capacity and Endothelial Dysfunction in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Spironolactone;Drug: PlaceboNational Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI);National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);University of Pennsylvania;University of Maryland, College Park;Medstar Health Research Institute;New England Medical Center, Tufts University School of MedicineRecruiting18 YearsN/AAll70Phase 2United States
152NCT01934647
(ClinicalTrials.gov)
November 22, 201330/8/2013Acute Dosing of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-003)A Non-randomized, Single-Panel, Open-Label Trial to Study the Safety, Tolerability and Pharmacodynamics of MK-8892 Acute Dosing in Subjects With Moderate to Severe Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: MK-8892Merck Sharp & Dohme Corp.NULLTerminated18 Years70 YearsAll7Phase 1Germany
153NCT01926509
(ClinicalTrials.gov)
November 14, 201319/8/2013Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-005)A 28-Day Multiple-Dose Titration Study to Assess the Effects of MK-8892 on Safety, Tolerability and Pharmacokinetics in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: MK-8892;Drug: Placebo for MK-8892Merck Sharp & Dohme Corp.NULLCompleted18 Years70 YearsAll23Phase 1Bulgaria;Germany;Moldova, Republic of
154EUCTR2013-001100-10-ES
(EUCTR)
12/11/201312/11/2013This study is to allow continued access to QTI571 for patients whoreceived QTI571 for pulmonary arterial hypertension in one of thelong-term extension studies (A2301E1, A2102E1 and E2203) andhave been judged by the investigator to benefit from continuedQTI571 treatment.An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in one of the extension studies and are judged by the investigator to benefit from continued QTI571 treatment Pulmonary Arterial Hypertension
MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: GLIVEC 100 mg comprimidos recubiertos con película
Product Name: Imatinib mesilate
Product Code: QTI571
INN or Proposed INN: IMATINIB MESILATE
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
81United States;Spain;Australia;Switzerland
155NCT02000856
(ClinicalTrials.gov)
November 201319/11/2013BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial HypertensionBEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDietary Supplement: Beetroot juiceUppsala UniversityKarolinska InstitutetCompleted18 YearsN/AAll15N/ASweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT01966302
(ClinicalTrials.gov)
November 201315/10/2013Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH)Compassionate Use of Beraprost Sodium 314d Modified Release (BPS-314d-MR) for Three Patients With Pulmonary Arterial Hypertension (PAH).Pulmonary Arterial HypertensionDrug: BPS-314d-MRLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLung Biotechnology PBCCompleted18 Years75 YearsAll1Phase 2United States
157NCT03638908
(ClinicalTrials.gov)
November 201312/7/2018Fluoxetine in Pulmonary Arterial Hypertension (PAH) TrialA Phase 2, Open-label, Clinical Trial of Fluoxetine, a Selective Serotonin Reuptake Inhibitor, in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: FluoxetineUniversity of Texas Southwestern Medical CenterNULLCompleted16 Years80 YearsAll8Phase 2United States
158NCT01827059
(ClinicalTrials.gov)
October 20135/4/2013Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasEA Randomized Placebo Controlled Trial to Analyze Changes in Pulmonary Arterial Pressures at Peak Exercise in Congenital Heart Disease Patients With Exercise-induced Pulmonary Arterial Hypertension Before and After Treatment With Bosentan, Compared to PlaceboPulmonary Arterial Hypertension;Congenital Heart DiseaseDrug: Bosentan;Drug: PlaceboAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)NULLActive, not recruiting18 YearsN/AAll12Phase 2Netherlands
159NCT01894035
(ClinicalTrials.gov)
September 23, 20133/7/2013Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for InhalationStudy to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost.Pulmonary HypertensionDrug: Iloprost (Ventavis, BAYQ 6256)BayerNULLCompleted18 YearsN/AAll13Portugal
160NCT01781052
(ClinicalTrials.gov)
September 11, 201322/1/2013Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension PatientsDAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension PatientsPulmonary Arterial HypertensionDrug: Ventavis (Iloprost, BAYQ6256)BayerNULLCompleted18 YearsN/AAll17N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT01739400
(ClinicalTrials.gov)
September 10, 201329/11/2012Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger SyndromeLong Term, Single-arm, Open-label Extension Study of Protocol AC-055-305 to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Eisenmenger SyndromePulmonary Arterial HypertensionDrug: Macitentan 10 mg tablet, once daily.ActelionNULLTerminated12 YearsN/AAll217Phase 3United States;Austria;Bulgaria;Chile;China;France;Germany;Greece;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;United Kingdom;Vietnam;Belgium;Canada;Czech Republic;Hungary;India;Israel;Italy;Netherlands;South Africa;Taiwan;Turkey
162NCT01950585
(ClinicalTrials.gov)
September 6, 201321/9/2013Hydroxyurea in Pulmonary Arterial HypertensionHydroxyurea in Pulmonary Arterial HypertensionPulmonary HypertensionDrug: HydroxyureaNational Heart, Lung, and Blood Institute (NHLBI)The Cleveland ClinicWithdrawn18 Years110 YearsAll0Early Phase 1United States
163NCT01847014
(ClinicalTrials.gov)
September 1, 20132/5/2013Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT InstrumentAC-055-402: An Extension of AC-055-401, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT InstrumentPulmonary Arterial HypertensionDrug: MacitentanActelionNULLTerminated18 Years80 YearsAll4Phase 3United States
164NCT01934582
(ClinicalTrials.gov)
August 201329/8/2013A Pharmacokinetic Substudy of the TDE-PH-304 ProtocolA Pharmacokinetic Substudy of Subjects Transitioning From Twice Daily to Three Times Daily Dosing of UT-15C SR (Treprostinil Diethanolamine) in the TDE-PH-304 ProtocolPulmonary Arterial HypertensionDrug: UT-15C SR;Drug: treprostinil diethanolamineUnited TherapeuticsNULLCompleted12 Years75 YearsAll13Phase 3United States
165NCT01897740
(ClinicalTrials.gov)
July 20138/7/2013Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With SildenafilA LOCAL, SINGLE-CENTRE, EXTENSION, OPEN LABEL ACCESS STUDY, TO PROVIDE SILDENAFIL THERAPY FOR SUBJECTS WHO COMPLETED A1481156 STUDY AND ARE JUDGED BY THE INVESTIGATOR TO DERIVE CLINICAL BENEFIT FROM CONTINUED TREATMENT WITH SILDENAFIL, PRIOR TO REIMBURSEMENT AND AVAILABILITY FOR SUBJECTS IN RUSSIAN FEDERATIONPulmonary Arterial HypertensionDrug: sildenafilPfizerNULLNo longer available10 Years30 YearsAllRussian Federation
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166NCT01908699
(ClinicalTrials.gov)
May 31, 201316/7/2013Beraprost-314d Added-on to Tyvaso® (BEAT)A Multicenter, Double-blind, Randomized, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-MR added-on to Treprostinil, Inhaled (Tyvaso®) in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Beraprost Sodium 314d Modified Release Tablets;Drug: PlaceboLung Biotechnology PBCNULLCompleted18 Years80 YearsAll273Phase 3United States;Israel
167NCT01743001
(ClinicalTrials.gov)
May 21, 201329/11/2012Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger SyndromeA Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger SyndromePulmonary Arterial HypertensionDrug: Macitentan 10 mg;Drug: PlaceboActelionNULLCompleted12 YearsN/AAll226Phase 3United States;Austria;Bulgaria;Chile;China;France;Germany;Greece;Israel;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Turkey;United Kingdom;Vietnam;Belgium;Canada;Czech Republic;Hungary;India;Italy;Netherlands;South Africa;Taiwan
168NCT03236818
(ClinicalTrials.gov)
May 201318/3/2013Goal Oriented Strategy to Preserve Ejection Fraction TrialRaising the Bars in the Treatment of Pulmonary Arterial Hypertension: Goal Oriented Strategy to Preserve Ejection Fraction TrialPulmonary Arterial HypertensionDrug: ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan)VU University Medical CenterNULLActive, not recruiting18 Years80 YearsAll30Phase 4Netherlands
169NCT01841762
(ClinicalTrials.gov)
April 1, 201327/3/2013Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT InstrumentA Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT InstrumentPulmonary Arterial HypertensionDrug: MacitentanActelionNULLCompleted18 YearsN/AAll284Phase 3United States
170NCT01808313
(ClinicalTrials.gov)
December 1, 201228/2/2013Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH)An Open Label Phase IIIb Study to Evaluate Efficacy and Safety of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH)Vascular DiseaseDrug: ambrisentanGlaxoSmithKlineNULLCompleted18 Years75 YearsAll134Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT01586156
(ClinicalTrials.gov)
December 201223/4/2012PAHTCH Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure (Carvedilol)Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart FailurePulmonary HypertensionDrug: Carvedilol;Drug: placeboThe Cleveland ClinicNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI)Completed18 Years65 YearsAll30N/AUnited States
172NCT01517854
(ClinicalTrials.gov)
November 14, 201214/12/2011Revatio Portal-Pulmonary Arterial Hypertension TrialRevatio Portal-Pulmonary Arterial Hypertension Trial (RePo1 Trial): A Randomized, Double-blinded, Placebo-controlled, Multi-center Study to Evaluate the Effects of Sildenafil Citrate (Revatio) 20 mg TID on Patients With Portal Pulmonary Arterial Hypertension (PPAH)Portopulmonary HypertensionDrug: Sildenafil;Drug: PlaceboUniversity Health Network, TorontoNULLTerminated18 Years75 YearsAll12Phase 2Canada
173NCT01582438
(ClinicalTrials.gov)
November 201219/4/2012An Open Label Access Study For Subjects Who Completed A1481156A Local, Multicentre, Open Label Access Study, To Provide Sildenafil Therapy For Subjects Who Completed A1481156 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil For Subjects In IndiaPulmonary Arterial HypertensionDrug: Access program - sildenafil citrate, Viagra, RevatioPfizerNULLNo longer available12 Years30 YearsAllN/AIndia
174NCT01545336
(ClinicalTrials.gov)
October 201229/2/2012Anastrozole in Patients With Pulmonary Arterial HypertensionA Double-blind, Placebo-controlled Phase II Study of Anastrozole in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Anastrozole;Drug: PlaceboUniversity of PennsylvaniaNULLCompleted18 YearsN/AAll18Phase 2United States
175NCT02169752
(ClinicalTrials.gov)
September 20126/5/2014Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionAmbrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionPre-Pulmonary Atrial HypertensionDrug: AmbrisentanNational Jewish HealthNULLTerminated18 Years80 YearsAll7N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT01642407
(ClinicalTrials.gov)
August 24, 201215/6/2012Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial HypertensionA Phase 3, Multi-center, Open-label Study To Investigate Safety, Efficacy, And Tolerability Of Sildenafil Citrate In Pediatric Patients With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Hypertension, PulmonaryDrug: SildenafilPfizerNULLCompleted1 Year17 YearsAll6Phase 4Japan
177NCT01484431
(ClinicalTrials.gov)
July 17, 201230/11/2011A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial HypertensionA Multiple Ascending Dose Study of Tadalafil to Assess the Pharmacokinetics and Safety in a Pediatric Population With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Tadalafil- Tablet or Oral suspensionEli Lilly and CompanyNULLCompleted6 Months17 YearsAll20Phase 1;Phase 2United States;Canada;France;Poland;Spain;United Kingdom
178NCT01615627
(ClinicalTrials.gov)
July 1, 20126/6/2012Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site PainHypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site PainPulmonary Arterial HypertensionDrug: HypotonicTreprostinil Solution;Drug: Eutonic Treprostinil SolutionJewish General HospitalNULLWithdrawn18 YearsN/AAll0Phase 4Canada
179NCT01523548
(ClinicalTrials.gov)
July 201227/1/2012Carbon Monoxide Therapy for Severe Pulmonary Arterial HypertensionCarbon Monoxide Therapy for Severe Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Carbon MonoxideUniversity of Illinois at ChicagoNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI)Withdrawn18 YearsN/AAll0Phase 1;Phase 2United States
180NCT01647945
(ClinicalTrials.gov)
July 201218/7/2012FK506 (Tacrolimus) in Pulmonary Arterial HypertensionSingle-Center Randomized Controlled Phase II Study of Safety and Efficacy of FK-506 (Tacrolimus) in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Placebo;Drug: FK506 level < 2 ng/ml;Drug: FK506 level 2-3 ng/ml;Drug: FK506 level 3-5 ng/mlEdda SpiekerkoetterStanford UniversityCompleted18 Years70 YearsAll23Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT01645826
(ClinicalTrials.gov)
July 201218/10/2011Efficacy Study of Cardizem in Pulmonary Arterial HypertensionCalcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension.Idiopathic Pulmonary Arterial Hypertension;Primary Pulmonary Hypertension;Pulmonary Arterial Hypertension;Familial Primary Pulmonary HypertensionDrug: Diltiazem Hydrochloride;Drug: Sugar PillUniversity of South FloridaNULLWithdrawn18 YearsN/AAll0N/AUnited States
182NCT01560624
(ClinicalTrials.gov)
June 26, 20129/3/2012Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral MonotherapyA Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects With Pulmonary Arterial Hypertension Receiving Background Oral MonotherapyPulmonary Arterial HypertensionDrug: Treprostinil Diolamine;Drug: PlaceboUnited TherapeuticsNULLCompleted18 Years75 YearsAll690Phase 3United States;Argentina;Australia;Austria;Brazil;Canada;Chile;China;Denmark;France;Germany;Greece;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Singapore;Sweden;Taiwan;United Kingdom
183NCT01469169
(ClinicalTrials.gov)
June 19, 20128/11/2011Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation StudyA Multi-center, Non-randomized, Open Label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of BAY q 6256 (Iloprost) Inhalation in Patients With Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: Iloprost (Ventavis inhaled, BAYQ6256)BayerNULLCompleted18 Years75 YearsAll27Phase 3Japan
184NCT01560637
(ClinicalTrials.gov)
May 20129/3/2012An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial HypertensionOpen-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310Pulmonary Arterial HypertensionDrug: UT-15C (treprostinil diethanolamine)United TherapeuticsNULLActive, not recruiting18 Years75 YearsAll471Phase 3United States;Argentina;Australia;Austria;Brazil;Canada;Chile;China;Denmark;France;Germany;Greece;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Singapore;Sweden;Taiwan;United Kingdom
185NCT01457781
(ClinicalTrials.gov)
April 201212/10/2011Inhaled Nitric Oxide/INOpulse DS for Pulmonary Arterial Hypertension (PAH)A Phase 2, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Safety, Tolerability and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo as Add-On Therapy in Symptomatic Subjects With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Nitric Oxide;Other: PlaceboBellerophon Pulse TechnologiesNULLCompleted16 Years80 YearsAll80Phase 2United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT01588405
(ClinicalTrials.gov)
April 20126/1/2012Remodulin® to Oral Treprostinil TransitionA Multicenter, Open-Label Study of the Safety and Tolerability of Transitioning From Remodulin® to Oral Treprostinil in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: UT-15C SRUnited TherapeuticsNULLCompleted15 Years80 YearsAll33Phase 2United States
187NCT02847260
(ClinicalTrials.gov)
April 201225/7/2016Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID)A 16 Week, Open Label, Multi-centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: RemodulinUnited TherapeuticsNULLCompleted18 YearsN/AAll39Phase 4NULL
188NCT01433328
(ClinicalTrials.gov)
January 20129/9/2011Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site PainLidocaine Subcutaneous Infusion for Control of Treprostinil Related Site PainPulmonary Arterial HypertensionDrug: Lidocaine;Drug: PlaceboJewish General HospitalNULLTerminated18 Years85 YearsAll4Phase 4Canada
189NCT01462565
(ClinicalTrials.gov)
November 1, 201113/10/2011Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN® in Subjects With Pulmonary Arterial Hypertension (PAH). (FLOLAN® is a Registered Trademark of the GlaxoSmithKline Group of Companies.)Hypertension, PulmonaryDrug: current marketed FLOLAN (epoprostenol sodium);Drug: new thermo stable formulation of epoprostenol sodiumGlaxoSmithKlineNULLCompleted18 Years75 YearsAll16Phase 4United States;Canada;Netherlands
190NCT01431326
(ClinicalTrials.gov)
November 201117/8/2011Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of CarePharmacokinetics of Understudied Drugs Administered to Children Per Standard of CareAdenovirus;Anesthesia;Anxiety;Anxiolysis;Autism;Autistic Disorder;Bacterial Meningitis;Bacterial Septicemia;Benzodiazepine;Bipolar Disorder;Bone and Joint Infections;Central Nervous System Infections;Convulsions;Cytomegalovirus Retinitis;Early-onset Schizophrenia Spectrum Disorders;Epilepsy;General Anesthesia;Gynecologic Infections;Herpes Simplex Virus;Infantile Hemangioma;Infection;Inflammation;Inflammatory Conditions;Intra-abdominal Infections;Lower Respiratory Tract Infections;Migraines;Pain;Pneumonia;Schizophrenia;Sedation;Seizures;Skeletal Muscle Spasms;Skin and Skin-structure Infections;Treatment-resistant Schizophrenia;Urinary Tract Infections;Withdrawal;Sepsis;Gram-negative Infection;Bradycardia;Cardiac Arrest;Cardiac Arrhythmia;Staphylococcal Infections;Nosocomial Pneumonia;Neuromuscular Blockade;Methicillin Resistant Staphylococcus Aureus;Endocarditis;Neutropenia;Headache;Fibrinolytic Bleeding;Pulmonary Arterial Hypertension;CMV Retinitis;Hypertension;Chronic Kidney Diseases;Hyperaldosteronism;Hypokalemia;Heart Failure;Hemophilia;Heavy Menstrual Bleeding;InsomniaDrug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:Daniel BenjaminEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);The Emmes Company, LLCCompletedN/A21 YearsAll3520United States;Canada;Israel;Singapore;United Kingdom;Australia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191NCT01477333
(ClinicalTrials.gov)
October 201114/11/2011Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®An Evaluation of the Safety and Efficacy of the Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®Pulmonary Arterial HypertensionDrug: UT-15C SR;Drug: Tyvaso Inhalation SolutionUnited TherapeuticsNULLCompleted18 Years75 YearsAll18Phase 2United States
192NCT01447628
(ClinicalTrials.gov)
October 20114/10/2011IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) PatientsWhat is the Effect of Intravenous Iron Supplementation on Cardiopulmonary Haemodynamics, Exercise Capacity and Quality of Life in Patients With IPAH and Iron Deficiency?Pulmonary Arterial Hypertension;Iron DeficiencyDrug: Saline;Drug: Ferinject or CosmoFerImperial College LondonFu Wai Hospital, Beijing, ChinaCompleted16 Years75 YearsAll40Phase 2China;Germany;United Kingdom
193NCT01548950
(ClinicalTrials.gov)
September 20115/3/2012Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary HypertensionCombined Clinical and Surgical Approaches to Congenital Heart Disease Associated With Pulmonary Arterial Hypertension (PAH-CHD)Congenital Heart Disease;Pulmonary Arterial HypertensionDrug: Sildenafil singly or in association with BosentanUniversity of Sao Paulo General HospitalInstituto do Coracao;Fundação de Amparo à Pesquisa do Estado de São PauloCompleted2 MonthsN/AAll50N/ABrazil
194NCT01757808
(ClinicalTrials.gov)
August 201126/4/2012A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial HypertensionA Phase I Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Ranolazine;Drug: PlaceboUniversity of ChicagoNULLCompleted18 Years72 YearsAll12Phase 1United States
195NCT01365585
(ClinicalTrials.gov)
July 20111/6/2011Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial HypertensionEvaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: sildenafil citratePfizerNULLCompleted18 YearsN/AAll227N/AGermany;Ireland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196NCT01086540
(ClinicalTrials.gov)
June 24, 201111/3/2010Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)Systemic Sclerosis-Associated PAHBiological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophenNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.Completed18 Years75 YearsAll57Phase 2United States
197NCT01342952
(ClinicalTrials.gov)
June 21, 201126/4/2011Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529An Open-label, Long Term Extension Study for Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years Who Have Participated in AMB112529 and in Whom Continued Treatment With Ambrisentan is DesiredHypertension, PulmonaryDrug: AmbrisentanGlaxoSmithKlineNULLActive, not recruiting8 Years18 YearsAll66Phase 2United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Mexico;Netherlands
198NCT01470144
(ClinicalTrials.gov)
June 1, 201128/10/2011Epoprostenol for Injection in Patients With Pulmonary Arterial HypertensionAn Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: EpoprostenolActelionChiltern International Ltd.;Effi-statCompletedN/AN/AAll41Phase 3Belgium;Canada;France;Italy;Netherlands;Spain
199NCT01389206
(ClinicalTrials.gov)
June 1, 20116/7/2011Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension ProgramPulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension ProgramPulmonary Arterial HypertensionDrug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or UptraviActelionCanadian Heart Research CentreCompleted18 YearsN/AAll797United States;Puerto Rico
200NCT01319045
(ClinicalTrials.gov)
June 201118/3/2011Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart DiseasePulmonary Arterial Hypertension;Congenital Heart Disease;Eisenmenger's SyndromeDrug: IloprostUniversity of California, Los AngelesActelionTerminated18 YearsN/AAll5N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201NCT01392495
(ClinicalTrials.gov)
June 201111/7/2011Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)An Open-label Extension Study to CQTI571A2102 to Evaluate the Long-term Safety, Tolerability and Efficacy of QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: ImatinibNovartis PharmaceuticalsNULLTerminatedN/AN/AAll17Phase 3United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Turkey
202NCT01330108
(ClinicalTrials.gov)
May 20114/4/2011Safely Change From Bosentan to Ambrisentan in Pulmonary HypertensionSafely Change From Bosentan to Ambrisentan in Pulmonary HypertensionPulmonary Arterial HypertensionDrug: ambrisentanUniversity of Alabama at BirminghamNULLCompleted19 YearsN/AAll32Phase 4United States
203EUCTR2010-021793-12-ES
(EUCTR)
28/04/201103/03/2011Estudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonarEstudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar Hipertensión arterial pulmonar (PAH) en niños.
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película
INN or Proposed INN: BOSENTAN MONOHIDRATO
Other descriptive name: BOSENTAN MONOHIDRATO
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Czech Republic;Hungary;Spain;Netherlands;Germany;Italy
204NCT01392469
(ClinicalTrials.gov)
April 20, 201110/5/2011Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension PatientsA Non-randomized, Multiple Dose, Three Treatment Period, Open-label, Single Sequence, Single Group Study to Evaluate the Pharmacokinetic Effect of Two Doses of QTI571 (Imatinib) on the Co-administered Drugs Sildenafil and Bosentan in Pulmonary Arterial Hypertension (PAH) PatientsPulmonary Arterial HypertensionDrug: ImatinibNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll21Phase 3United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Romania;Turkey
205NCT01223352
(ClinicalTrials.gov)
March 8, 201112/10/2010Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial HypertensionAn Open-label, Prospective Multicenter Study to Assess the Pharmacokinetics, Tolerability, Safety and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: bosentanActelionNULLCompleted3 Months12 YearsAll64Phase 3United States;Australia;Belarus;China;Czechia;France;Germany;Hungary;India;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206NCT01338415
(ClinicalTrials.gov)
March 8, 201115/4/2011FUTURE 3 Study ExtensionA Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: BosentanActelionNULLCompleted3 Months12 YearsAll58Phase 3United States;Australia;Belarus;China;Czechia;France;Germany;Hungary;India;Israel;Italy;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;Czech Republic;Netherlands
207NCT01302444
(ClinicalTrials.gov)
March 201116/2/2011Treprostinil Combined With Tadalafil for Pulmonary HypertensionRandomized Placebo Controlled Trial of Treprostinil Infusion Combined With Oral Tadalafil or Placebo in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Tadalafil;Drug: PlaceboRhode Island HospitalUnited TherapeuticsTerminated18 Years80 YearsAll1Phase 4United States
208NCT01431716
(ClinicalTrials.gov)
March 20117/9/2011Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial HypertensionA Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to EFI/ACT-385781A in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: EFI/ACT-385781AActelionNULLCompleted18 YearsN/AAll42Phase 3Belgium;Canada;France;Italy;Netherlands;Spain
209ChiCTR-ONC-11001799
2011-02-172011-12-15A single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart diseaseA single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease pediatric patients with severe pulmonary arterial hypertension due to congenital heart diseaseAll groups:Bosentan therapy ;Beijing Anzhen HospitalNULLCompleted018BothAll groups:50;China
210NCT01332331
(ClinicalTrials.gov)
January 4, 201124/3/2011Efficacy and Safety of Ambrisentan in Children 8-18yrsA Randomized, Open Label Study Comparing Safety and Efficacy Parameters for a High and a Low Dose of Ambrisentan (Adjusted for Body Weight) for the Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 YearsHypertension, PulmonaryDrug: Ambrisentan - low dose;Drug: Ambrisentan - high doseGlaxoSmithKlineNULLTerminated8 Years18 YearsAll41Phase 2United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Greece;Mexico;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211NCT01028651
(ClinicalTrials.gov)
January 20118/12/2009A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary HypertensionAn Open-Label Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary HypertensionPortopulmonary Hypertension;Pulmonary Arterial Hypertension;Pulmonary HypertensionDrug: TreprostinilUnited TherapeuticsUniversity of California, Los Angeles;Brigham and Women's Hospital;University of Texas;Emory UniversityCompletedN/AN/AAll13N/AUnited States
212EUCTR2010-021825-11-ES
(EUCTR)
22/12/201012/11/2010Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3 Hpertensión arterial pulmonar (PAH) en niños
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película
INN or Proposed INN: BOSENTAN MONOHIDRATO
Other descriptive name: BOSENTAN MONOHIDRATO
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Phase 3Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
213NCT01406327
(ClinicalTrials.gov)
December 14, 201028/7/2011Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)Hypertension, PulmonaryDrug: AmbrisentanGlaxoSmithKlineNULLCompletedN/AN/AAll900NULL
214NCT01266265
(ClinicalTrials.gov)
December 201022/12/2010Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH TherapiesA Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation SolutionPulmonary Arterial HypertensionDrug: inhaled prostacyclin;Drug: prostacyclin;Drug: subcutaneous and intravenous prostacyclin;Drug: oral ERA;Drug: oral PDE5 inhibitorsUnited TherapeuticsNULLCompletedN/AN/AAll1333N/AUnited States
215NCT01251835
(ClinicalTrials.gov)
December 20101/12/2010Effect Of Rifampin On Pharmacokinetics Of SitaxsentanA Phase 1, Open Label, Fixed Sequence Design, Multiple Dose Study To Assess The Effect Of Rifampin On The Pharmacokinetics Of Sitaxsentan In Healthy SubjectsPulmonary Arterial HypertensionDrug: Sitaxsentan alone;Drug: Sitaxsentan;Drug: RifampinPfizerNULLWithdrawn21 Years55 YearsBoth0Phase 1NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216NCT01210443
(ClinicalTrials.gov)
November 201011/8/2010Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension PatientsA Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: SitaxentanPfizerNULLTerminated16 Years80 YearsAll2Phase 3Japan
217NCT01244620
(ClinicalTrials.gov)
November 201015/11/2010A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple DosesA Phase 1, Open Label, Randomized, Four Period, Crossover, Multiple Dose Study To Assess The Pharmacokinetic Interaction Between Sitaxsentan and Tadalafil and The Effect Of Sildenafil On Sitaxsentan PK In Healthy SubjectsPulmonary Arterial HypertensionDrug: sitaxentan;Drug: tadalafil;Drug: sitaxsentan;Drug: sildenafilPfizerNULLTerminated21 Years55 YearsAll16Phase 1Singapore
218NCT01260454
(ClinicalTrials.gov)
November 20109/12/2010The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site PainThe Qutenza® Patch for Disabling Treprostinil Infusion Site PainPulmonary Hypertension;Pulmonary Arterial HypertensionDrug: Qutenza (8% capsaicin)University of RochesterUnited TherapeuticsCompleted15 Years80 YearsAll6Phase 2United States
219EUCTR2010-019547-19-ES
(EUCTR)
06/10/201015/07/2010 Estudio abierto, aleatorizado, para comparar parámetros de seguridad y eficacia para una dosis alta y una baja de ambrisentan (ajustadas al peso corporal), como tratamiento para la hipertensión arterial pulmonar en pacientes pediátricos entre 8 y 18 años. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Estudio abierto, aleatorizado, para comparar parámetros de seguridad y eficacia para una dosis alta y una baja de ambrisentan (ajustadas al peso corporal), como tratamiento para la hipertensión arterial pulmonar en pacientes pediátricos entre 8 y 18 años. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Hipertensión arterial pulmonar
MedDRA version: 13;Level: LLT;Classification code 10064911;Term: Hipertensión arterial pulmonar
MedDRA version: 13;Level: PT;Classification code 10065150;Term: Hipertensión pulmonar arterial primaria asociada
MedDRA version: 13;Classification code 10065151;Term: Hipertensión pulmonar arterial primaria idiopática
MedDRA version: 13;Classification code 10065152;Term: Hipertensión pulmonar arterial primaria familiar
GlaxoSmithKline, S.A.NULLNot Recruiting Female: yes
Male: yes
66Phase 2France;Hungary;Greece;Spain;Germany;Netherlands;Italy
220NCT01178073
(ClinicalTrials.gov)
October 1, 201015/7/2010A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: ambrisentan;Drug: tadalafilGlaxoSmithKlineGilead SciencesCompleted18 Years75 YearsAll610Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Greece;Italy;Japan;Netherlands;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221NCT01092559
(ClinicalTrials.gov)
October 201016/2/2010Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric OxideAn Open Label Pilot Study Evaluating Preliminary Safety and Performance of the GeNO Nitrosyl Delivery SystemPulmonary Arterial HypertensionDrug: Nitric Oxide generated by the GeNO nitrosyl delivery systemGeno LLCNULLCompleted18 YearsN/AAll10Phase 2United States
222NCT01054105
(ClinicalTrials.gov)
October 201021/1/2010Effect of BMPR-2 Gene Mutations on Hemodynamic Response by Iloprost Inhalation in Pulmonary Arterial HypertensionThe Prevalence of BMPR-2 Gene Mutations in Korean Patients With Pulmonary Arterial Hypertension (PAH) and the Effects of Gene Mutations on Hemodynamic Response by Drug TherapyPulmonary Arterial HypertensionDrug: IloprostGachon University Gil Medical CenterSeoul National University Hospital;Seoul National University Bundang Hospital;The Catholic University of Korea;BayerCompleted20 Years80 YearsAll73Korea, Republic of
223NCT01094067
(ClinicalTrials.gov)
September 1, 201025/3/2010Tezosentan in Patients With Pulmonary Arterial HypertensionMulti-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Demonstrate That a Single Infusion of Tezosentan Has Minimal Effect on Blood Pressure in Patients With Pulmonary Arterial Hypertension, Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or a Combination of Both.Pulmonary Arterial HypertensionDrug: ACT-050089;Other: PlaceboIdorsia Pharmaceuticals Ltd.NULLTerminated18 YearsN/AAll2Phase 2United States;France;Japan
224NCT01165047
(ClinicalTrials.gov)
September 201016/7/2010Nitric Oxide, GeNO Nitrosyl Delivery SystemAn Open Label, Non-Randomized Pilot Study to Evaluate the Safety and Performance of the GeNO Nitrosyl Delivery System in Subjects Being Evaluated for Orthotopic Heart Transplantation (OHT), or Left Ventricular Assist Device (LVAD) ImplantationPulmonary Arterial HypertensionDrug: Nitric OxideAurora Health CareNULLCompleted18 YearsN/AAll10Phase 2United States
225NCT01355380
(ClinicalTrials.gov)
August 5, 201017/5/2011Efficacy of Ventavis Used in Real-life Setting.The Efficacy of Inhaled Iloprost in Patients Treated Within the Pulmonary Arterial Hypertension Therapeutic Programme.Pulmonary Arterial HypertensionDrug: Inhaled iloprost (Ventavis, BAYQ6256)BayerNULLCompleted18 YearsN/AAll55N/APoland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
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size
PhaseCountries
226NCT01204853
(ClinicalTrials.gov)
August 20106/8/2010A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension PatientsA Phase 3, Multi-Center, Open Label Study To Evaluate The Safety And Efficacy Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: SitaxentanPfizerNULLTerminated16 Years80 YearsAll2Phase 3Japan
227NCT01077297
(ClinicalTrials.gov)
August 201025/2/2010Tezosentan in Pulmonary Arterial HypertensionMulticenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or ProstacyclinesPulmonary Arterial HypertensionDrug: TezosentanIdorsia Pharmaceuticals Ltd.NULLTerminated18 YearsN/AAll3Phase 2United States;France;Switzerland
228NCT01179334
(ClinicalTrials.gov)
August 201010/8/2010Evaluation of the Pharmacodynamic Effect of the Combination of Sildenafil and Riociguat on Blood Pressure and Other Safety Parameters.An Interaction Study to Evaluate Changes in Blood Pressure Following 1, 1.5, 2, and 2.5 mg Riociguat Tid (Dose Titration) Compared to Placebo Treatment on the Background of Stable Sildenafil Pretreatment in Subjects With Symptomatic Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Riociguat (Adempas, BAY63-2521);Drug: Placebo;Drug: SildenafilBayerNULLCompleted18 Years75 YearsAll18Phase 2United States;Austria;Czech Republic;Germany;Italy;New Zealand;Poland;Spain;United Kingdom
229NCT01268553
(ClinicalTrials.gov)
August 201029/12/2010Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin MedicationTransition From Parenteral Prostanoids to Inhaled TreprostinilPulmonary Arterial HypertensionDrug: TreprostinilLos Angeles Biomedical Research InstituteUnited TherapeuticsCompleted18 Years80 YearsAll6Phase 4United States
230EUCTR2009-011150-17-ES
(EUCTR)
13/07/201002/06/2010AMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONAMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Hipertensión arterial pulmonar
MedDRA version: 11;Level: PT;Classification code 10064911;Term: Hipertensión arterial pulmonar
MedDRA version: 11;Level: LLT;Term: Hipertensión arterial pulmonar
Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
Trade Name: CIALIS 20 mg comprimidos recubiertos con película
INN or Proposed INN: TADALAFILO
Other descriptive name: TADALAFIL
GlaxoSmithKline,S.A.NULLNot RecruitingFemale: yes
Male: yes
352France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231NCT01112306
(ClinicalTrials.gov)
July 7, 20108/4/2010ACT-293987 in Pulmonary Arterial HypertensionLong-term Single-arm Open-label Study, to Assess the Safety and Tolerability of ACT-293987 in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: ACT-293987ActelionNULLActive, not recruiting18 YearsN/AAll1187Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Colombia;Czechia;Denmark;France;Germany;Greece;Hungary;India;Ireland;Israel;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Czech Republic;Italy
232NCT00796510
(ClinicalTrials.gov)
July 201020/11/2008Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term SafetyA Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Sitaxsentan;Drug: Sitaxsentan and SildenafilPfizerNULLTerminated16 Years80 YearsAll3Phase 3United States;Romania;Ukraine;Argentina;Bulgaria;Chile;China;Colombia;Costa Rica;Czech Republic;Dominican Republic;India;Mexico;Peru;Philippines;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Thailand
233NCT01179737
(ClinicalTrials.gov)
July 20103/8/2010Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)A 24 Week, Randomized, Double Blind, Multicenter, Placebocontrolled Efficacy, Safety, Tolerability and PK Trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Nilotinib;Drug: Placebo to nilotinibNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll23Phase 2United States;Canada;Germany;Korea, Republic of;Singapore;Switzerland;Hungary;Italy
234NCT01305252
(ClinicalTrials.gov)
July 20102/11/2010A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).CombinatiON Up-FRON t Therapy for PAH - A Phase 4, Randomized, Multicenter Study of Inhaled Treprostinil in Treatment naïve Pulmonary Arterial Hypertension Patients Starting on TadalafilHypertension, PulmonaryDrug: treprostinil inhalations;Drug: tadalafilStanford UniversityNorthwestern UniversityCompleted18 Years69 YearsAll21Phase 4United States
235NCT01174173
(ClinicalTrials.gov)
June 201023/7/2010Ranolazine and Pulmonary HypertensionEffects of Ranolazine in Patients With Angina Due to Right Ventricular Ischemia in Pulmonary Arterial HypertensionAngina;Pulmonary Arterial HypertensionDrug: RanolazineNorthwestern UniversityGilead SciencesCompleted18 Years80 YearsAll11Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236NCT00964678
(ClinicalTrials.gov)
June 201024/8/2009Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial HypertensionPilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: CarvedilolVirginia Commonwealth UniversityGlaxoSmithKlineCompleted18 YearsN/AAll10Phase 1;Phase 2United States
237NCT01105117
(ClinicalTrials.gov)
May 201015/4/2010Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401An Open-label Extension of Study AC-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan®ActelionNULLCompleted18 Years65 YearsAll2Phase 4United States
238NCT01117987
(ClinicalTrials.gov)
April 20103/5/2010Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES ExtensionPulmonary Arterial HypertensionDrug: Imatinib;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll144Phase 3United States;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Switzerland;United Kingdom;Sweden
239NCT00995566
(ClinicalTrials.gov)
April 201017/9/2009A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed ThelinThelin (Sitaxentan Sodium) Patient Safety Registry A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed ThelinPulmonary Arterial HypertensionDrug: Sitaxentan sodiumPfizerNULLTerminated18 YearsN/AAll54N/ABelgium;France;Germany;Sweden
240NCT01083524
(ClinicalTrials.gov)
March 20108/3/2010Dichloroacetate (DCA) for the Treatment of Pulmonary Arterial HypertensionA Phase I, Open-Label, Two Centre Study to Evaluate Dichloroacetate(DCA) in Advanced Pulmonary Arterial Hypertension.Pulmonary Hypertension (Idiopathic, Familial or Anorexigen-associated)Drug: Dichloroacetate SodiumUniversity of AlbertaImperial College LondonCompleted18 YearsN/ABoth30Phase 1Canada;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241NCT01105091
(ClinicalTrials.gov)
March 201015/4/2010Epoprostenol for Injection in Pulmonary Arterial HypertensionA Phase IV, Open-label, Randomized, Multicenter Study of the Safety, Tolerability,and Pharmacokinetics of ACT- 385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan®ActelionNULLCompleted18 Years65 YearsAll30Phase 4United States
242NCT00989963
(ClinicalTrials.gov)
February 1, 20105/10/2009Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH)A 12-week, Double-blind, International, Multicenter, Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Beraprost Sodium Modified ReleaseLung Biotechnology PBCNULLCompleted18 Years75 YearsAll36Phase 2United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic
243NCT01042158
(ClinicalTrials.gov)
January 20104/1/2010A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisA Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisPulmonary Arterial Hypertension;Systemic Sclerosis;Scleroderma Spectrum of Diseases;Connective Tissue Disease;Pulmonary HypertensionDrug: tadalafil and ambrisentan upfront combination therapyJohns Hopkins UniversityNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);Eli Lilly and Company;United Therapeutics;The Cleveland Clinic;University of Texas;Stanford UniversityCompleted18 YearsN/AAll25Phase 4United States
244NCT01148836
(ClinicalTrials.gov)
January 201019/3/2010Coenzyme Q-10 and Pulmonary Arterial HypertensionCoenzyme Q-10 in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDietary Supplement: Coenzyme Q-10 in Pulmonary Hypertension subjects;Dietary Supplement: Coenzyme Q-10 in Normal Control subjectsThe Cleveland ClinicNULLCompleted18 Years55 YearsAll18N/AUnited States
245NCT01445873
(ClinicalTrials.gov)
December 1, 200930/9/2011Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)NON-INTERVENTIONAL (NI) DRUG STUDY PROTOCOL: THREE-COUNTRY PILOT STUDY FOR RETROSPECTIVE CHART REVIEW OF EFFECTIVENESS OF THELIN® (SITAXSENTAN) IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)Pulmonary Arterial HypertensionDrug: Sitaxentan sodiumPfizerNULLCompleted18 YearsN/AAll36NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246NCT01106014
(ClinicalTrials.gov)
December 20092/4/2010Selexipag (ACT-293987) in Pulmonary Arterial HypertensionA Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Selexipag;Drug: PlaceboActelionNULLCompleted18 Years75 YearsAll1156Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Colombia;Czech Republic;Denmark;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom
247NCT00990314
(ClinicalTrials.gov)
November 30, 20095/10/2009Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) PatientsAn Open-label Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) PatientsPulmonary Arterial HypertensionDrug: Beraprost Sodium Modified ReleaseLung Biotechnology PBCNULLCompleted18 Years75 YearsAll31Phase 2United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic
248EUCTR2009-009366-13-ES
(EUCTR)
18/11/200924/09/2009Estudio internacional, multicéntrico, aleatorizado, doble ciego y controlado con placebo de 16 semanas de duración sobre la eficacia y la seguridad de UT-15C por vía oral en comprimidos de liberación lenta en pacientes con hipertensión arterial pulmonarA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2Estudio internacional, multicéntrico, aleatorizado, doble ciego y controlado con placebo de 16 semanas de duración sobre la eficacia y la seguridad de UT-15C por vía oral en comprimidos de liberación lenta en pacientes con hipertensión arterial pulmonarA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Hipertensión Arterial PulmonarPulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: treprostinil dietanolamina
Product Code: UT-15C SR
INN or Proposed INN: treprostinil dietanolamina
Product Name: treprostinil dietanolamina
Product Code: UT-15C
INN or Proposed INN: treprostinil dietanolamina
Product Name: treprostinil dietanolamina
Product Code: UT-15C
INN or Proposed INN: treprostinil dietanolamina
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
249EUCTR2009-012057-38-ES
(EUCTR)
02/10/200902/07/2009Ensayo clínico multicéntrico, aleatorizado controlado con placebo, doble ciego y de 24 semanas de duración, para evaluar la eficacia y seguridad de QTI571 oral como terapia adicional en el tratamiento de la hipertensión arterial pulmonar severa: Imatinib en hipertensión arterial pulmonar, un estudio aleatorizado de eficacia (IMPRES) - IMPRESEnsayo clínico multicéntrico, aleatorizado controlado con placebo, doble ciego y de 24 semanas de duración, para evaluar la eficacia y seguridad de QTI571 oral como terapia adicional en el tratamiento de la hipertensión arterial pulmonar severa: Imatinib en hipertensión arterial pulmonar, un estudio aleatorizado de eficacia (IMPRES) - IMPRES Pacientes con Hipertensión Arterial Pulmonar (HAP) que tienen una RVP>1000 dynes.sec.cm-5 a pesar de estar en tratamiento con dos o mas terapias específicas para la HAP.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: GLIVEC 100 mg comprimidos recubiertos con película
INN or Proposed INN: IMATINIB
Other descriptive name: IMATINIB
Novartis Farmacéutica SANULLNot RecruitingFemale: yes
Male: yes
200France;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
250EUCTR2008-007455-26-ES
(EUCTR)
28/09/200923/04/2009A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial HypertensionEstudio en fase II , de asignación aleatoria, doblemente ciego, controlado con placebo y multicéntrico. Estudio de búsqueda de dosis con cicletanina en sujetos con hipertensión arterial pulmonarA Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial HypertensionEstudio en fase II , de asignación aleatoria, doblemente ciego, controlado con placebo y multicéntrico. Estudio de búsqueda de dosis con cicletanina en sujetos con hipertensión arterial pulmonar Pulmonary hypertension (PH) is a serious and life-threatening disease of the pulmonary vasculature, characterized by profound vasoconstriction and an abnormal proliferation of smooth muscle cells in the walls of the pulmonary arteries.La hipertensión pulmonar (PH) es una enfermedad grave y potencialmente mortal de la vasculatura pulmonar, caracterizada por una vasoconstricción profunda y una proliferación anómala de células musculares lisas en las paredes de las arterías pulmonares
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: Cicletanine hydrochloride
Product Name: Cicletanine hydrochloride
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
160Phase 2United Kingdom;Germany;Belgium;Spain;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251JPRN-JapicCTI-121998
01/9/200926/10/2012Bosentan PAH (WHO-FC II)Open label multicenter study to assess the efficacy, safety, and tolerability of bosentan in Japanese patients with pulmonary arterial hypertension (PAH) in WHO functional class II. Pulmonary arterial hypertension (PAH)Intervention name : Ro47-0203
INN of the intervention : Bosentan
Dosage And administration of the intervention : Oral administration, Initial dose: 62.5 mg b.i.d. for 4 weeks for all patients, Target dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)
Actelion Pharmaceuticals Japan Ltd.NULL1874BOTH16Phase 3NULL
252NCT00902174
(ClinicalTrials.gov)
September 200913/5/2009Imatinib (QTI571) in Pulmonary Arterial HypertensionA 24-week Randomized Placebo-controlled, Double-blind Multi-center Clinical Trial Evaluating the Efficacy and Safety of Oral QTI571 as an add-on Therapy in the Treatment of Severe Pulmonary Arterial Hypertension: Imatinib in Pulmonary Arterial Hypertension, a Randomized, Efficacy Study (IMPRES)Pulmonary Arterial HypertensionDrug: imatinib mesylate;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll202Phase 3United States;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Switzerland;United Kingdom
253NCT00942708
(ClinicalTrials.gov)
September 200919/7/2009Safety and Efficacy of Fluoxetine in Pulmonary Arterial HypertensionSafety and Efficacy of Fluoxetine in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: FluoxetineUniversity of Texas Southwestern Medical CenterNational Center for Research Resources (NCRR)Completed16 Years75 YearsAll6Phase 2United States
254EUCTR2008-003482-68-ES
(EUCTR)
08/06/200924/10/2008 Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg ,tid )administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática-Estudio PATENT -1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg ,tid )administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática-Estudio PATENT -1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Hipertensión Arterial Pulmonar (HAP) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
462Phase 3Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
255NCT00887978
(ClinicalTrials.gov)
June 200923/4/2009Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial HypertensionA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: UT-15C SR;Drug: PlaceboUnited TherapeuticsNULLCompleted18 Years75 YearsAll310Phase 3United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Portugal;Spain;Sweden;United Kingdom;Ireland;Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256NCT00796666
(ClinicalTrials.gov)
May 200920/11/2008Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding SildenafilA Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 (NCT00795639)Pulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Sitaxsentan;Drug: Sitaxsentan and SildenafilPfizerNULLTerminated16 Years80 YearsAll131Phase 3United States;Argentina;Bulgaria;Chile;China;Colombia;Czech Republic;India;Malaysia;Mexico;Peru;Romania;Russian Federation;Serbia;South Africa;Thailand;Turkey;Ukraine;Costa Rica;Dominican Republic;Philippines;Saudi Arabia;Slovakia
257NCT00853112
(ClinicalTrials.gov)
April 200927/2/2009A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial HypertensionA Phase 2a, Randomized, Double Blind, Placebo-controlled, Parallel Group Study Investigating The Dose-response Of Pf-00489791 On Acute Hemodynamics In Subjects With Idiopathic And Familial Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: PF-00489791;Drug: placebo;Drug: sildenafilPfizerNULLTerminated18 YearsN/AAll48Phase 2United States;Canada;Germany;India;Russian Federation;Spain;Sweden;Switzerland;Belgium
258NCT00878943
(ClinicalTrials.gov)
March 31, 20098/4/2009Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 StudyA Local, Multi-centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study In India Or Ongoing In A1481269 Study Who Continue To Receive Benefit From Sildenafil Therapy.Pulmonary Arterial HypertensionDrug: Sildenafil citratePfizerNULLNo longer available18 YearsN/AAllN/AIndia
259NCT00863681
(ClinicalTrials.gov)
March 12, 200913/3/2009BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial HypertensionLong-term Extension, Multicentre, Multi-national Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg,1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: Riociguat (BAY63-2521)BayerNULLCompleted18 Years80 YearsAll396Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Russian Federation;Singapore;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom;Czech Republic;Ireland;Israel;Netherlands;New Zealand;Slovakia;Spain
260NCT00792571
(ClinicalTrials.gov)
February 28, 200914/11/2008An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) PatientsAn Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients.Pulmonary Arterial HypertensionDrug: Beraprost Sodium Modified ReleaseLung Biotechnology PBCNULLCompleted18 Years75 YearsAll18Phase 2United States;Belgium;Ireland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261NCT00781885
(ClinicalTrials.gov)
January 31, 200927/10/2008A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH PatientsA Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH PatientsPulmonary Arterial HypertensionDrug: Beraprost sodium modified releaseLung Biotechnology PBCNULLCompleted18 Years75 YearsAll19Phase 2United States;Belgium;Ireland
262EUCTR2008-003572-21-ES
(EUCTR)
15/01/200915/10/2008Estudio en fase 2a, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para investigar la respuesta a la dosis de PF-00489791 sobre la hemodinamia a corto plazo en sujetos con hipertensión arterial pulmonar idiopática y familiarA PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSIONEstudio en fase 2a, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para investigar la respuesta a la dosis de PF-00489791 sobre la hemodinamia a corto plazo en sujetos con hipertensión arterial pulmonar idiopática y familiarA PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSION Hipertensión arterial pulmonarPulmonary arterial hypertension.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: PF-00489791
Product Name: PF-00489791
Product Name: PF-00489791
Trade Name: REVATIO 20 mg, comprimidos recubiertos con película
INN or Proposed INN: SILDENAFILO
Other descriptive name: SILDENAFIL
Pfizer, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
79Phase 2AGermany;Belgium;Spain;Sweden
263NCT00810693
(ClinicalTrials.gov)
December 200817/12/2008A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)Pulmonary HypertensionDrug: Riociguat (Adempas, BAY63-2521);Drug: PlaceboBayerNULLCompleted18 Years80 YearsAll445Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czech Republic;Denmark;France;Germany;Greece;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Singapore;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom;Slovakia
264NCT00795639
(ClinicalTrials.gov)
December 200820/11/2008Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Sitaxsentan;Drug: PlaceboPfizerNULLTerminated16 Years80 YearsAll183Phase 3United States;Argentina;Bulgaria;Chile;China;Colombia;Costa Rica;Czech Republic;Dominican Republic;Guatemala;India;Malaysia;Mexico;Peru;Philippines;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Thailand;Turkey;Ukraine;Egypt;Jordan;Lebanon;United Arab Emirates
265NCT00667823
(ClinicalTrials.gov)
October 17, 200824/4/2008Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial HypertensionLong-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: MacitentanActelionNULLActive, not recruiting12 YearsN/AAll550Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;Croatia;Finland;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Sweden;Taiwan;Thailand;Ukraine;United Kingdom;Brazil;Czech Republic;Denmark;Japan;Korea, Republic of;Norway;Portugal;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266NCT00800592
(ClinicalTrials.gov)
October 200819/11/2008Sildenafil IV Bolus StudyAn Open Single Dose Study To Assess The Safety, Tolerability And Pharmacokinetics Of An Intravenous Bolus Dose (10 Mg) Of Sildenafil In Patients With Pulmonary Arterial Hypertension (PAH).Hypertension, PulmonaryDrug: sildenafilPfizerNULLCompleted18 YearsN/AAll12Phase 1Belgium
267NCT00741819
(ClinicalTrials.gov)
September 200823/8/2008Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) SubjectsAn Open Label, Multi-center Study Evaluating the Safety of Long-term Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis® (Iloprost) in Subjects With Pulmonary Arterial Hypertension.Pulmonary Arterial HypertensionDrug: Inhaled treprostinilUnited TherapeuticsNULLCompleted18 Years75 YearsAll73Phase 4United States
268NCT00709098
(ClinicalTrials.gov)
September 20081/7/2008Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial HypertensionA Multicenter, Double-blind, Randomized Study Comparing the Safety and Tolerability of Iloprost Inhalation Solution Delivered by I-neb Utilizing Power Disc-15 and Power Disc-6 in Patients With Symptomatic Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: iloprostActelionNULLCompleted18 YearsN/AAll49Phase 3United States;Austria;Germany
269NCT01338636
(ClinicalTrials.gov)
September 200818/4/2011An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Participants With Exercise-Induced Pulmonary Arterial Hypertension (PAH)An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Patients With Exercise Induced Pulmonary Arterial HypertensionExercise-induced Pulmonary Arterial HypertensionDrug: AmbrisentanBrigham and Women's HospitalGilead SciencesCompleted18 YearsN/AAll30Phase 4United States
270NCT00825266
(ClinicalTrials.gov)
September 200816/1/2009Insulin Resistance in Pulmonary Arterial HypertensionThe Effect of Bosentan and Pioglitazone on Insulin Resistance in Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: bosentan;Drug: PioglitazoneStanford UniversityNULLTerminated18 Years75 YearsAll2Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271EUCTR2007-003621-24-ES
(EUCTR)
07/07/200812/05/2008Estudio doble ciego, aleatorizado, controlado por placebo, de determinación de dosis, de grupos paralelos, para valorar los efectos hemodinámicos, la eficacia clínica, la tolerabilidad y la seguridad de Aviptadil (Péptido intestinal Vasoactivo) tras una inhalación, e inhalaciones repetidas, en pacientes con hipertensión arterial pulmonar.Estudio doble ciego, aleatorizado, controlado por placebo, de determinación de dosis, de grupos paralelos, para valorar los efectos hemodinámicos, la eficacia clínica, la tolerabilidad y la seguridad de Aviptadil (Péptido intestinal Vasoactivo) tras una inhalación, e inhalaciones repetidas, en pacientes con hipertensión arterial pulmonar. Hipertensión arterial pulmonar (HAP) debida a hipertensión arterial pulmonar idiopática (HAPI), HAP familiar o HAP asociada con enfermedades del tejido conjuntivo (ETC) (p. ej. esclerosis sistémica, lupus eritematoso sistémico) o con defectos cardiacos congénitos reparados(DCCR).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot RecruitingFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
272NCT00705133
(ClinicalTrials.gov)
July 200823/6/2008Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial HypertensionUsing Either Intravenous (IV) or Subcutaneous (SQ) Treprostinil to Treat Pulmonary Hypertension Related to Underlying Interstitial Lung DiseasePulmonary Arterial Hypertension;Interstitial Lung Disease;Idiopathic Pulmonary FibrosisDrug: TreprostinilRajan SaggarUnited TherapeuticsCompletedN/AN/AAll15Phase 2United States
273NCT00723554
(ClinicalTrials.gov)
July 200824/7/2008Iloprost Power Disc-15 in Pulmonary Arterial HypertensionA Phase IIIb, Multicenter, Open-label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 (PD-6) to Power Disc-15 (PD-15) With the I-neb® AAD®Pulmonary Arterial HypertensionDrug: Iloprost PD-6;Drug: Iloprost PD-15ActelionNULLTerminated18 Years85 YearsAll63Phase 3United States
274NCT00709956
(ClinicalTrials.gov)
July 20081/7/2008Iloprost Power 15 in Pulmonary Arterial HypertensionA Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients With Symptomatic Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: iloprost (5 µg);Drug: placeboActelionNULLCompleted18 YearsN/AAll64Phase 3United States;Austria;Germany
275EUCTR2005-005068-97-ES
(EUCTR)
11/05/200803/03/2008Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2 Hipertensión Arterial PulmonarPatients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
MedDRA version: 9.1;Classification code 10064909;Term:
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 4Portugal;Czech Republic;United Kingdom;Germany;Denmark;Spain;Greece;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276NCT00660179
(ClinicalTrials.gov)
May 200814/4/2008Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial HypertensionA Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: macitentan (ACT-064992);Drug: placeboActelionNULLCompleted12 YearsN/AAll742Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;Croatia;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Malaysia;Mexico;Netherlands;Norway;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Brazil;Czech Republic;Denmark;Finland;Former Serbia and Montenegro;Portugal
277NCT00430716
(ClinicalTrials.gov)
April 8, 200831/1/2007To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH)Pulmonary Arterial HypertensionDrug: Sildenafil citratePfizerNULLTerminated18 YearsN/AAll130Phase 4United States;Belgium;Brazil;Bulgaria;China;Greece;India;Italy;Latvia;Malaysia;Netherlands;Philippines;Poland;Romania;Russian Federation;Thailand;United Kingdom;Denmark;Panama
278NCT00617305
(ClinicalTrials.gov)
April 20086/2/2008Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)An Open-label, Multicenter Study of Ambrisentan and a Phosphodiesterase Type-5 Inhibitor Combination Therapy in Subjects With Pulmonary Arterial Hypertension Who Have Demonstrated a Sub-Optimal Response to a Phosphodiesterase Type-5 InhibitorPulmonary Arterial HypertensionDrug: Ambrisentan;Drug: Placebo;Drug: Sildenafil;Drug: TadalafilGilead SciencesNULLCompleted16 Years75 YearsAll38Phase 4United States
279NCT00643604
(ClinicalTrials.gov)
March 200820/3/2008Rapid Switch From Flolan to Remodulin in the Outpatient ClinicRapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension in the Outpatient Clinic: Safety, Efficacy and Treatment SatisfactionHypertension, PulmonaryDrug: treprostinil sodiumUnited TherapeuticsNULLTerminated18 Years70 YearsAll7Phase 4United States
280NCT00554619
(ClinicalTrials.gov)
February 20085/11/2007A Study to Evaluate GSK1325760A - a Long-Term Extension StudyStudy AMB107818, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open Label Study of GSK1325760A to Evaluate the Safety and Efficacy of GSK1325760A - a Long-term Extension Study -Pulmonary Arterial Hypertension;Hypertension, PulmonaryDrug: GSK1325760AGlaxoSmithKlineNULLCompletedN/AN/AAll21Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281NCT00625469
(ClinicalTrials.gov)
October 200719/2/2008Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With BosentanTreatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot StudyPulmonary Arterial Hypertension;Idiopathic Pulmonary FibrosisDrug: bosentanRajan SaggarActelionWithdrawnN/AN/AAll0Phase 4United States
282NCT00540436
(ClinicalTrials.gov)
August 20075/10/2007Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial HypertensionStudy AMB107816, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open-Label Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A -Hypertension, PulmonaryDrug: GSK1325760AGlaxoSmithKlineNULLCompleted18 YearsN/AAll25Phase 2Japan
283EUCTR2006-000800-17-ES
(EUCTR)
29/05/200702/03/2010Estudio internacional, multicéntrico, doble ciego, aleatorizado, controlado con placebo y de 16 semanas de duración para comparar la eficacia y la seguridad de UT-15C en comprimidos orales de liberación prolongada en combinación con un antagonista del receptor de la endotelina y/o con un inhibidor de la fosfodiesterasa-5 en sujetos con hipertensión arterial pulmonarA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-CEstudio internacional, multicéntrico, doble ciego, aleatorizado, controlado con placebo y de 16 semanas de duración para comparar la eficacia y la seguridad de UT-15C en comprimidos orales de liberación prolongada en combinación con un antagonista del receptor de la endotelina y/o con un inhibidor de la fosfodiesterasa-5 en sujetos con hipertensión arterial pulmonarA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C HAP idiopática o familiar incluyendo HAP asociada a:1) Uso de un inhibidor del apetito2) Corticircuito sistémico-pulmonar congénito corregido (corrección = 5 años)3) HAP asociada a enfermedad del tejido conjuntivo vascular4) HIV
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Dietanolamina de treprostinilo
Product Code: UT-15C LP
INN or Proposed INN: Dietanolamina de treprostinilo
Product Name: Dietanolamina de treprostinilo
Product Code: UT-15C LP
INN or Proposed INN: Treprostinil diethanolamine
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Germany;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria
284NCT00454207
(ClinicalTrials.gov)
April 200728/3/2007Open Label Study of Sildenafil in Patients With Pulmonary Arterial HypertensionA Phase 3, Multi-Center, Open-Label Study to Assess Safety and Efficacy of Sildenafil Citrate 20 mg TID in Subjects With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: sildenafil citrate (UK-92,480)PfizerNULLCompleted16 YearsN/AAll44Phase 3Japan
285NCT00433329
(ClinicalTrials.gov)
March 20077/2/2007Combination Therapy in Pulmonary Arterial HypertensionCOMPASS 3: An Open-label, Multi-Center Study Employing a Targeted 6-Minute Walk Test (6-MWT) Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of Magnetic Resonance Imaging (MRI) on Cardiac RemodelingPulmonary Arterial HypertensionDrug: Bosentan;Drug: SildenafilActelionNULLCompleted12 YearsN/AAll100Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286NCT00439946
(ClinicalTrials.gov)
February 200722/2/2007Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAHRapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) Using the Crono Five Ambulatory Infusion Pump in Patients With Stable Pulmonary Arterial Hypertension (PAH): Safety, Efficacy and Treatment SatisfactionPulmonary Arterial HypertensionDrug: treprostinil;Device: Crono Five ambulatory pumpUnited TherapeuticsNULLTerminated18 Years65 YearsAll8Phase 4United States
287NCT00625079
(ClinicalTrials.gov)
February 200719/2/2008Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With SildenafilRandomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot StudyPulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis;Interstitial Lung Disease;Pulmonary HypertensionDrug: sildenafilUniversity of California, Los AngelesPfizerWithdrawnN/AN/AAll0Phase 4United States
288NCT00325403
(ClinicalTrials.gov)
October 200611/5/2006FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Oral treprostinil (UT-15C) Sustained Release Tablets;Other: PlaceboUnited TherapeuticsNULLCompleted12 Years75 YearsAll349Phase 3United States;Austria;Belgium;Canada;China;France;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico
289NCT00325442
(ClinicalTrials.gov)
October 200611/5/2006FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Oral treprostinil (UT-15C) sustained release tablets;Drug: PlaceboUnited TherapeuticsNULLCompleted12 Years70 YearsAll354Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
290NCT00373360
(ClinicalTrials.gov)
September 20067/9/2006Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to RemodulinRapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment SatisfactionPulmonary HypertensionDrug: treprostinil sodiumUnited TherapeuticsNULLCompleted18 Years70 YearsAll10Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291NCT00323297
(ClinicalTrials.gov)
September 20065/5/2006Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial HypertensionA Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah)Pulmonary Arterial HypertensionDrug: Bosentan;Other: Placebo;Drug: Sildenafil CitratePfizerNULLCompleted18 YearsN/AAll105Phase 4United States;Australia;Czech Republic;France;Germany;Greece;Israel;Italy;Taiwan;United Kingdom;Belgium
292NCT00384865
(ClinicalTrials.gov)
September 200630/9/2006A Study of Aspirin and Simvastatin in Pulmonary Arterial HypertensionA Clinical Trial of Aspirin and Simvastatin in Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Simvastatin;Drug: Aspirin;Drug: PlaceboUniversity of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI)Terminated18 YearsN/AAll64Phase 2United States
293EUCTR2005-006192-13-ES
(EUCTR)
09/06/200612/05/2006Estudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISIONEstudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISION Spanish: hipertensión arterial pulmonar English: Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death.
MedDRA version: 8.1;Classification code 10037400
Trade Name: **Comment**- IMP inhalation solution identical to ventavis inhalation solution, but IMP is in a different volume presentation. Please see covering letter.
Product Name: Iloprost (Ventavis®)
INN or Proposed INN: Iloprost
CoTherix, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Portugal;Germany;United Kingdom;Spain;Italy;Austria
294EUCTR2005-005066-37-DE
(EUCTR)
09/06/200606/11/2006COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks.Product Name: sildenafil
Product Code: N/A
INN or Proposed INN: Sildenafil citrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
44Phase 2United Kingdom;Germany;Italy
295NCT00946114
(ClinicalTrials.gov)
June 200622/7/2009To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 WeeksA Local, Multi-Centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For One Hundred Twelve Weeks / Prior To Reimbursement And Availability For Patients In Poland.Pulmonary HypertensionDrug: sildenafilPfizerNULLCompleted18 YearsN/AAll32N/APoland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296NCT00303459
(ClinicalTrials.gov)
May 200616/3/2006Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH)Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV StudyPulmonary Arterial HypertensionDrug: bosentan;Drug: placeboActelionNULLCompleted12 YearsN/AAll334Phase 4United States;Brazil;Czech Republic;Denmark;Germany;Greece;Portugal;Saudi Arabia;Slovakia;Spain;Sweden;United Kingdom
297NCT01027949
(ClinicalTrials.gov)
May 20064/12/2009An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial HypertensionAn Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Treprostinil diethanolamineUnited TherapeuticsNULLActive, not recruiting12 YearsN/AAll900Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;India;Ireland;Israel;Italy;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Spain;Sweden;United Kingdom;Czech Republic
298EUCTR2005-005066-37-BE
(EUCTR)
21/04/200615/02/2006COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks.Trade Name: viagra
Product Name: sildenafil
Product Code: N/A
INN or Proposed INN: Sildenafil citrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
44Phase 2Belgium;Germany;Italy;United Kingdom
299NCT00477269
(ClinicalTrials.gov)
April 200622/5/2007Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial HypertensionA Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of the Six Months Treatment With the Tyrosine Kinase Inhibitor STI571 for the Treatment of Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Imatinib mesylate;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll59Phase 2;Phase 3United States;Austria;Germany;United Kingdom
300NCT01721564
(ClinicalTrials.gov)
April 20061/11/2012Bosentan and Pulmonary Endothelial FunctionPulmonary Artery Remodelling With BosentanPulmonary Arterial HypertensionDrug: BosentanProf David S CelermajerNULLCompleted18 Years80 YearsAll8N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301EUCTR2005-005066-37-GB
(EUCTR)
15/03/200613/02/2006COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxins Patients are already on prescribed bosentan therapy for at least 12 weeks.Actelion Pharmaceuticals Ltd.NULLNot Recruiting Female: yes
Male: yes
44Phase 2Belgium;Germany;Italy;United Kingdom
302EUCTR2005-002692-33-ES
(EUCTR)
02/02/200612/12/2005Estudio aleatorizado, doble ciego, comparativo con placebo y Fase III del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGYEstudio aleatorizado, doble ciego, comparativo con placebo y Fase III del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY La hipertensión arterial pulmonar (HAP) es una enfermedad crónica y progresiva caracterizada por el aumento de la presión arterial pulmonar y de la resistencia vascular pulmonar, conduciendo a insuficiencia cardíaca derecha y muerteTrade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Germany;United Kingdom;Ireland;Spain;Italy
303NCT00302211
(ClinicalTrials.gov)
February 1, 200610/3/2006The VISION Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial HypertensionA Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients With Pulmonary Arterial Hypertension Receiving Oral SildenafilPulmonary HypertensionDrug: Inhaled Iloprost (5 µg);Drug: Inhaled Placebo;Drug: Sildenafil;Drug: BosentanActelionNULLTerminated12 Years85 YearsAll67Phase 3United States
304NCT00549302
(ClinicalTrials.gov)
December 200523/10/2007Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the LungsAn Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: tadalafilEli Lilly and CompanyICOS CorporationCompleted12 YearsN/AAll357Phase 3United States;Belgium;Canada;France;Germany;Ireland;Italy;Japan;Spain;United Kingdom
305NCT00319020
(ClinicalTrials.gov)
August 23, 200526/4/2006Bosentan in Children With Pulmonary Arterial Hypertension Extension StudyAn Open Label, Long-term, Safety, and Tolerability Extension Study Using the Pediatric Formulation of Bosentan in the Treatment of Children With Idiopathic or Familial Pulmonary Arterial Hypertension Who Completed FUTURE 1Pulmonary Arterial HypertensionDrug: BosentanActelionNULLCompleted2 Years11 YearsAll33Phase 3United States;France;Germany;Italy;Netherlands;Switzerland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306NCT00593905
(ClinicalTrials.gov)
July 20053/1/2008Pharmacogenomics in Pulmonary Arterial HypertensionPharmacogenomics in Pulmonary Arterial Hypertension: A Multi-Center International Study to Determine Whether in PAH Patients Clinical Associations Exist Between the Efficacy and Toxicity of Endothelin Receptor Antagonists and Several Gene Polymorphisms in Several Key Disease-Specific and Therapy Specific GenesPulmonary Arterial Hypertension;Pulmonary Hypertension;PAH WHO Group IDrug: Sitaxsentan;Drug: Bosentan, AmbrisentanWest Penn Allegheny Health SystemNational Institutes of Health (NIH);Baylor College of Medicine;Emory University;University of Chicago;Johns Hopkins University;Tufts Medical Center;Sir Mortimer B. Davis - Jewish General Hospital;London Health Sciences Centre;University of Maryland;University of California, San Francisco;University of Calgary;Chest Medical Associates;Columbia University;Lung Diagnostics, Ltd.;Duke University;University of California, Los Angeles;Latter Day Saints Hospital;Louisiana State University Health Sciences Center in New Orleans;Massachusetts General Hospital;Mayo Clinic;Medical College of Wisconsin;Southeastern Lung Care;Suncoast Lung Center;Children's Hospital Colorado;University Hospital Case Medical Center;University of Colorado, Denver;University of Michigan;University of Pittsburgh;University of Southern California;The University of Texas, Galveston;Vanderbilt University;Wayne State University;Ohio State University;University of Alabama at Birmingham;Washington University School of Medicine;Sentara Norfolk General Hospital;University of Texas Southwestern Medical Center;Bay Area Chest PhysiciansRecruitingN/AN/ABoth1300N/AUnited States
307NCT03055221
(ClinicalTrials.gov)
June 10, 20059/2/2017TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Intravenous TreprostinilUnited TherapeuticsNULLCompleted16 Years75 YearsAll20Phase 4NULL
308NCT00147199
(ClinicalTrials.gov)
June 20052/9/2005Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Inhaled treprostinil;Drug: Placebo inhalation solutionUnited TherapeuticsNULLCompleted18 Years75 YearsAll235Phase 3United States;Austria;Belgium;France;Germany;Ireland;Israel;Italy;Spain;United Kingdom
309NCT00423592
(ClinicalTrials.gov)
May 200517/1/2007Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial HypertensionA Phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects With Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase AbnormalitiesPulmonary HypertensionDrug: ambrisentanGilead SciencesNULLCompleted12 Years75 YearsAll36Phase 2NULL
310NCT00626028
(ClinicalTrials.gov)
September 200420/2/2008Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator TestingComparison of Supplemental Oxygen and Nitric Oxide for Inhalation Plus Oxygen in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator TestingIdiopathic Pulmonary Arterial Hypertension;CardiomyopathyDrug: Nitric Oxide for inhalation;Drug: Oxygen;Drug: Nitric Oxide plus OxygenMallinckrodtNULLCompletedN/A18 YearsAll136Phase 3United States;France;Netherlands;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311NCT00578786
(ClinicalTrials.gov)
February 200419/12/2007A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)Pulmonary Arterial HypertensionDrug: ambrisentanGilead SciencesNULLCompleted18 YearsN/AAll383Phase 3Argentina;Brazil;Chile;Mexico
312NCT00159874
(ClinicalTrials.gov)
January 20048/9/2005A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In ChildrenA Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131Pulmonary Arterial HypertensionDrug: Sildenafil citratePfizerNULLCompleted1 Year17 YearsAll234Phase 3United States;Brazil;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;Sweden;Taiwan;Canada;Costa Rica;Panama;Singapore
313NCT00367770
(ClinicalTrials.gov)
January 200421/8/2006BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger PhysiologyA Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger PhysiologyPulmonary Arterial HypertensionDrug: Tracleer®ActelionNULLCompleted12 YearsN/AAll37Phase 4United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
314NCT00159913
(ClinicalTrials.gov)
August 20038/9/2005A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension.Pulmonary Arterial Hypertension, ChildrenDrug: Sildenafil citrate;Drug: PlaceboPfizerNULLCompleted1 Year17 YearsAll235Phase 3United States;Brazil;Canada;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Peru;Poland;Russian Federation;Sweden;Taiwan;Australia;Costa Rica;Panama;Singapore
315NCT00159861
(ClinicalTrials.gov)
July 20038/9/2005The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAHA Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension.Pulmonary HypertensionDrug: Sildenafil citratePfizerNULLCompleted16 YearsN/AAll267Phase 3United States;Belgium;Canada;Czech Republic;Denmark;France;Israel;Italy;Netherlands;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316NCT00424021
(ClinicalTrials.gov)
April 200317/1/2007Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial HypertensionAn Open-Label, Long-Term Study of Ambrisentan in Pulmonary Hypertension Subjects Having Completed Myogen Study AMB-220Pulmonary HypertensionDrug: ambrisentanGilead SciencesNULLCompleted18 YearsN/AAll54Phase 2NULL
317NCT00811018
(ClinicalTrials.gov)
March 20039/12/2008A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial HypertensionA Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: SitaxsentanPfizerNULLTerminated12 Years75 YearsAll1192Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Spain;United Kingdom

114. 非ジストロフィー性ミオトニー症候群 [臨床試験数:10,薬物数:14(DrugBank:5),標的遺伝子数:18,標的パスウェイ数:10
Searched query = "Non-dystrophic myotonia syndrome", "Non-dystrophic Myotonia", "Myotonia congenita", "Thomsen disease", "Becker disease", "Paramyotonia congenita", "Sodium channel myotonia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
3 / 10 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-002627-10-IT
(EUCTR)
03/11/201505/11/2020Pivotal study to evaluate the efficacy and safety of riluzole versus mexiletine in patients with non dystrophic myotonia mutated in SCN4A orCLCN1 genes.A randomized, double-blind, controlled, monocenter, pivotal phase IIb study to evaluate the efficacy and safety of riluzole versus mexiletine in patients with non dystrophic myotonia mutated in SCN4A or CLCN1 genes. - RILUMEX NDM patients with mutations in SCN4A or CLCN1 gene
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: RILUZOLO TEVA - 50 MG COMPRESSE RIVESTITE CON FILM 90 COMPRESSE IN BLISTER AL/PVC
Product Name: RILUZOLO
INN or Proposed INN: RILUZOLO
INN or Proposed INN: MEXILETINA CLORIDRATO
FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
58Phase 2Italy
2NCT02251457
(ClinicalTrials.gov)
August 201425/9/2014Study of Ranolazine in Myotonia Congenita, Paramyotonia Congenita and Myotonic Dystrophy Type 1Open Label Trial of Ranolazine in Myotonia Congenita, Paramyotonia Congenita, & Myotonic Dystrophy Type 1Myotonia Congenita;Paramyotonia Congenita;Myotonic Dystrophy 1Drug: RanolazineOhio State UniversityGilead SciencesCompleted18 Years100 YearsAll35Phase 1United States
3NCT00832000
(ClinicalTrials.gov)
December 200827/1/2009Effectiveness of Mexiletine for Treating People With Non-Dystrophic MyotoniaPhase II Therapeutic Trial of Mexiletine in Non-Dystrophic MyotoniaMyotonia;Non-Dystrophic MyotoniaDrug: Mexiletine;Drug: PlaceboRichard Barohn, MDNULLCompleted16 YearsN/AAll59Phase 2United States;Canada;Italy;United Kingdom

127. 前頭側頭葉変性症 [臨床試験数:74,薬物数:83(DrugBank:28),標的遺伝子数:29,標的パスウェイ数:99
Searched query = "Frontotemporal lobar degeneration", "Frontotemporal dementia", "Semantic dementia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
52 / 74 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-004066-18-GB
(EUCTR)
03/12/202025/09/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Portugal;United States;Spain;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
2EUCTR2019-004066-18-SE
(EUCTR)
06/10/202010/06/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Portugal;United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
3EUCTR2019-004066-18-NL
(EUCTR)
02/09/202003/03/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;France;Canada;Spain;Belgium;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden
4EUCTR2019-004066-18-BE
(EUCTR)
31/07/202026/05/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;France;Canada;Spain;Belgium;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
5NCT04408625
(ClinicalTrials.gov)
July 30, 202021/5/2020Phase 1/2 Clinical Trial of PR006 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN)A Phase 1/2 Ascending Dose Study to Evaluate the Safety and Effects on Progranulin Levels of PR006A in Patients With Fronto-Temporal Dementia With Progranulin Mutations (FTD-GRN)Frontotemporal DementiaBiological: PR006;Drug: Methylprednisolone;Drug: Sirolimus;Drug: PrednisonePrevail TherapeuticsNULLRecruiting30 Years80 YearsAll15Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04374136
(ClinicalTrials.gov)
July 23, 202023/4/2020A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin GeneFrontotemporal DementiaDrug: AL001;Drug: PlaceboAlector Inc.NULLRecruiting18 Years85 YearsAll180Phase 3United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Portugal;Spain;Sweden;Switzerland;United Kingdom
7EUCTR2019-004066-18-DE
(EUCTR)
06/07/202020/02/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Portugal;United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
8EUCTR2019-004066-18-PT
(EUCTR)
29/05/202021/02/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Portugal;United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
9EUCTR2019-004066-18-ES
(EUCTR)
22/04/202006/03/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;France;Canada;Belgium;Spain;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
10NCT04220021
(ClinicalTrials.gov)
January 10, 20203/1/2020Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTDA Single-Center, Open Label Study to Assess the Safety and Tolerability of Metformin in Subjects With C9orf72 Amyotrophic Lateral Sclerosis Over 24 Weeks of TreatmentC9orf72 Amyotrophic Lateral Sclerosis (ALS);Frontotemporal DementiaDrug: MetforminUniversity of FloridaNULLRecruiting18 Years80 YearsAll18Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-000138-20-GB
(EUCTR)
18/11/201921/05/2019An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTDA Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9ORF72 Mutations Causative of Frontotemporal Dementia Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2United States;Canada;Netherlands;Germany;Italy;United Kingdom
12EUCTR2019-000138-20-DE
(EUCTR)
08/10/201927/05/2019An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTDA Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9ORF72 Mutations Causative of Frontotemporal Dementia Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Netherlands;Germany;United Kingdom;Italy
13NCT03987295
(ClinicalTrials.gov)
September 27, 201914/5/2019A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal DementiaFrontotemporal DementiaDrug: AL001Alector Inc.NULLRecruiting18 Years85 YearsAll40Phase 2United States;Canada;Germany;Italy;Netherlands;United Kingdom
14EUCTR2019-000138-20-NL
(EUCTR)
20/09/201906/06/2019An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTDA Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9ORF72 Mutations Causative of Frontotemporal Dementia Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Germany;Netherlands;United Kingdom;Italy
15NCT04115384
(ClinicalTrials.gov)
September 9, 20192/10/2019Intranasal Insulin in Frontotemporal Dementia (FTD)A Single Center Feasibility Study of Intranasal Insulin in Frontotemporal Dementia NIFT-DFrontotemporal Dementia, Behavioral VariantDrug: Novolin-R insulinHealthPartners InstituteNULLRecruiting41 Years89 YearsAll12Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT04489017
(ClinicalTrials.gov)
June 1, 201913/4/2020Palmitoylethanolamide Combined With Luteoline in Frontotemporal Dementia Patients. A Randomized Controlled TrialPalmitoylethanolamide Combined With Luteoline in Frontotemporal Dementia Patients. A Randomized Controlled TrialFrontotemporal DementiaDietary Supplement: PEA-LUT;Dietary Supplement: PLACEBOI.R.C.C.S. Fondazione Santa LuciaNULLRecruiting40 Years80 YearsAll50N/AItaly
17NCT03636204
(ClinicalTrials.gov)
September 14, 201812/7/2018A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) MutationA First in Human Phase 1 Study in Healthy Volunteers and in Participants With Frontotemporal Dementia (FTD) With Granulin MutationHealthy;Frontotemporal DementiaBiological: AL001;Other: PlaceboAlector Inc.NULLCompleted18 Years80 YearsAll64Phase 1United States;Canada;United Kingdom;Netherlands
18NCT03658135
(ClinicalTrials.gov)
September 12, 201813/8/2018BIIB092 in Primary Tauopathies: CBS, nfvPPA, sMAPT, and TESA Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel Cohort Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Intravenously Infused BIIB092 in Patients With Four Different Primary Tauopathy SyndromesPrimary Tauopathies;Corticobasal Degeneration Syndrome;Frontotemporal Lobar Degeneration With Tau Inclusions;MAPT Mutation Carriers, Symptomatic;Traumatic Encephalopathy Syndrome;Nonfluent Aphasia, ProgressiveDrug: BIIB092;Other: PlaceboUniversity of California, San FranciscoNULLTerminated35 Years80 YearsAll22Phase 1United States
19NCT03510572
(ClinicalTrials.gov)
June 4, 201817/4/2018Evaluation of [18F]PI-2620 as a Potential Positron Emission Computed Tomography Radioligand for Imaging Tau Protein in the BrainClinical Evaluation of [18F]PI-2620 Positron Emission Computed Tomography for Imaging Tau Protein in Patients With Tauopathies and Healthy Volunteers: Phase 0 StudyHealthy Volunteer;Alzheimer Disease;Frontotemporal Dementia;Parkinson DiseaseDrug: [18F]PI-2620Asan Medical CenterKorea Health Industry Development InstituteCompleted40 Years80 YearsAll20Early Phase 1Korea, Republic of
20NCT03260920
(ClinicalTrials.gov)
January 31, 201819/7/2017Intranasal Oxytocin for Frontotemporal DementiaA Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal DementiaFrontotemporal DementiaDrug: SyntocinonLawson Health Research InstituteWeston Brain Institute;Canadian Institutes of Health Research (CIHR);Berry ConsultantsRecruiting30 Years80 YearsAll112Phase 2United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03625128
(ClinicalTrials.gov)
January 2, 201812/7/201818F-PM-PBB3 PET Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal ControlsPhase 0 Evaluation of Clinical and Neuroimage (18F-PM-PBB3 PET) Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal ControlsAlzheimer's Disease;Cortical Basal Syndrome;Frontotemporal Dementia;Progressive Supranuclear Palsy;Vascular Cognitive ImpairmentDrug: F-18Chang Gung Memorial HospitalNULLCompleted20 Years90 YearsAll36Early Phase 1Taiwan
22NCT02707978
(ClinicalTrials.gov)
September 30, 20177/4/2015F 18 T807 Tau PET Imaging of Frontotemporal Dementia (FTD)F 18 T807 Tau PET Imaging of Frontotemporal DementiaAlzheimer DiseaseDrug: F 18 T807Tammie L. S. Benzinger, MD, PhDNULLWithdrawn18 YearsN/AAll0Phase 2United States
23NCT03272230
(ClinicalTrials.gov)
September 6, 20173/8/2017Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based SystemAssessment of Apathy in a Real-life Situation, With a Video and Sensors-based System in Healthy Subject and Patient With Cerebral DiseaseApathy;Frontotemporal Dementia;Parkinson Disease;Depressive SymptomsBehavioral: ECOCAPTURE;Behavioral: Cognitive and Behavioral experimental tasks;Diagnostic Test: Neuropsychological assessment;Behavioral: ICM_APATHY_TASKS;Other: MRI;Biological: Neurohormonal mechanisms;Diagnostic Test: Supplementary Neuropsychological Assessment - Parkinson's DiseaseInstitut National de la Santé Et de la Recherche Médicale, FranceNULLRecruiting40 Years85 YearsAll135N/AFrance
24NCT03545126
(ClinicalTrials.gov)
August 21, 201712/3/2018Human CNS Tau Kinetics in TauopathiesHuman CNS Tau Kinetics in TauopathiesProgressive Supranuclear Palsy (PSP);Corticobasal Degeneration (CBD);Frontotemporal Dementia (FTD MAPT Mutation)Other: 13C6 LeucineWashington University School of MedicineAssociation of Frontotemporal Degeneration;Tau ConsortiumRecruiting18 YearsN/AAll32United States
25NCT03174938
(ClinicalTrials.gov)
May 15, 201728/5/2017The Swedish BioFINDER 2 StudyThe Swedish BioFINDER 2 StudyDementia;Alzheimer Disease;Parkinson Disease;Lewy Body Disease;Parkinson-Dementia Syndrome;Frontotemporal Degeneration;Semantic Dementia;Progressive Nonfluent Aphasia;Progressive Supranuclear Palsy;Corticobasal Degeneration;Multiple System Atrophy;Mild Cognitive ImpairmentDiagnostic Test: Flutemetamol F18 Injection;Diagnostic Test: [18F]-RO6958948;Diagnostic Test: Elecsys (Roche) Abeta42, Ttau and Ptau;Diagnostic Test: Lumipulse (Fujirebio) Abeta42, Ttau and PtauSkane University HospitalLund UniversityRecruiting20 Years100 YearsAll1505N/ASweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03040713
(ClinicalTrials.gov)
April 11, 201731/1/2017Flortaucipir PET Imaging in Subjects With FTD18F-AV-1451 PET Imaging in Subjects With Frontotemporal DementiaFrontotemporal DementiaDrug: Flortaucipir F18;Procedure: Brain PET scanAvid RadiopharmaceuticalsNULLCompleted18 YearsN/AAll16Phase 1United States
27EUCTR2017-000094-36-SE
(EUCTR)
31/03/201730/01/2017The BioFINDER 2 study - improved diagnostics and increased understanding of the underlying mechanisms of cognitive disordersThe BioFINDER 2 study - improved diagnostics and increased understanding of the pathophysiology of cognitive disorders Neurodegenerative disorders with Tau-pathology; including, but not limited to, Alzheimers disease, progressive supranuclear palsy,frontotemporal dementia, corticobasal degeneration and mild cognitive impairment.
MedDRA version: 19.1;Level: PT;Classification code 10053643;Term: Neurodegenerative disorder;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.1;Classification code 10012267;Term: Dementia;Classification code 10067889;Term: Dementia with Lewy bodies;Level: HLGT;Classification code 10028037;Term: Movement disorders (incl parkinsonism);Classification code 10012271;Term: Dementia Alzheimer's type;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes);Level: LLT;Classification code 10009846;Term: Cognitive impairment;Classification code 10048598;Term: Cognitive disorders;Classification code 10001896;Term: Alzheimer's disease;Classification code 10012285;Term: Dementia due to Pick's disease;Classification code 10036813;Term: Progressive supranuclear palsy;Classification code 10074616;Term: Prodromal Alzheimer's;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Product Name: 18F-RO6958948
Trade Name: Vizamyl (flutemetamol(F-18))
Product Name: Vizamyl
Skåne University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Sweden
28NCT02862210
(ClinicalTrials.gov)
January 27, 20177/8/2016Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal DementiaLow-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal DementiaFrontotemporal Dementia (FTD)Drug: Lithium Carbonate;Drug: PlaceboColumbia UniversityAlzheimer's Drug Discovery FoundationRecruiting40 Years85 YearsAll60Phase 2United States
29EUCTR2015-005604-29-NL
(EUCTR)
16/11/201620/01/2016Imaging of tau in patients with dementiaTau-imaging in tauopathies; Alzheimer’s disease and non-AD dementias - TITAN Dementia inducing Alzheimer's disease, Frontotemporal dementia (FTD) and Lewy Body Dementia (DLB)
MedDRA version: 20.0;Level: PT;Classification code 10012271;Term: Dementia Alzheimer's type;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10057095;Term: Diffuse Lewy body disease;System Organ Class: 100000072901
MedDRA version: 20.0;Classification code 10068968;Term: Frontotemporal dementia;Classification code 10012283;Term: Dementia due to other general medical conditions;System Organ Class: 100000014717;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 18F-AV-1451
INN or Proposed INN: not applicable
Other descriptive name: T807
VU University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Netherlands
30NCT02676843
(ClinicalTrials.gov)
April 201615/1/2016Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT MutationsTau PET Imaging With 18F-AV-1451 in Subjects With MAPT MutationsFrontotemporal Lobar Degeneration (FTLD);Frontotemporal Dementia (FTD);TauopathiesDrug: 18F-AV-1451Columbia UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed18 YearsN/AAll7Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2014-002013-37-NL
(EUCTR)
24/03/201613/07/2015An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trialAn Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer’s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
966Phase 3United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
32EUCTR2014-002013-37-BE
(EUCTR)
03/06/201531/03/2015An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trialAn Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer’s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
1400Phase 3United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
33EUCTR2014-002013-37-FI
(EUCTR)
11/05/201525/03/2015An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trialAn Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer’s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
966Phase 3United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Belgium;Malaysia;Singapore;Romania;Croatia;Australia;Netherlands;Germany;Korea, Republic of
34EUCTR2014-002013-37-HR
(EUCTR)
04/03/201531/03/2015An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trialAn Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer’s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
966Phase 3United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Argentina;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
35EUCTR2014-002013-37-ES
(EUCTR)
13/02/201516/12/2014An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trialAn Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer?s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer?s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 17.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.1;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Leuco-methylthioninium bis(hydromethanesulfonate)
Product Code: LMTM/TRx0237
INN or Proposed INN: N/A
Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate)
TauRx Therapeutics LtdNULLNot RecruitingFemale: yes
Male: yes
1400Phase 3United States;Taiwan;Finland;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Argentina;Poland;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2014-001315-40-IT
(EUCTR)
03/12/201410/10/2014Florbetapir-PET scan in subjects with a known mutation for autosomal dominant Alzheimer's Disease taking part in the ItalianDIAfN studyAmyloid Imaging in the Italian Network for autosomal dominant Alzheimer’s disease and frontotemporal lobar degeneration (ItalianDIAfN)” - Amyloid-PET in ItalianDIAfN Autosomal Dominant Alzheimer's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Amyvid
Product Name: Florbetapir (18F)
Product Code: Florbetapir (18F)
INN or Proposed INN: florbetapir (18F)
Other descriptive name: N/A
IRCCS Istituto Centro San Giovanni di Dio FatebenefratelliNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
37EUCTR2014-002013-37-GB
(EUCTR)
06/10/201420/08/2014An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trial An Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia Alzheimer’s Disease and behavioral variant Frontotemporal Dementia
MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
TauRx Therapeutics LtdNULLNot Recruiting Female: yes
Male: yes
966Phase 3United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
38EUCTR2014-000422-38-SE
(EUCTR)
19/09/201405/08/2014A study evaluating the diagnostic accuracy of [18F]-AV-1451 PET to detect and distinguish neurodegenerative disorders characterized by cerebral accumulation of the protein tauAn open-label study evaluating the diagnostic accuracy of [18F]-AV-1451 PET to detect and distinguish neurodegenerative disorders characterized by cerebral accumulation of tau Neurodegenerative disorders with Tau-pathology; including Alzheimer's disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration and important differential diagnostic conditions.
MedDRA version: 17.0;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes);System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0;Level: PT;Classification code 10053643;Term: Neurodegenerative disorder;Level: LLT;Classification code 10009846;Term: Cognitive impairment;Classification code 10001896;Term: Alzheimer's disease;Classification code 10012285;Term: Dementia due to Pick's disease;Classification code 10012267;Term: Dementia;Classification code 10067889;Term: Dementia with Lewy bodies;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Product Name: 18F-AV-1451Skåne University Hospital, Region SkåneNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Sweden
39NCT02245568
(ClinicalTrials.gov)
August 201427/8/2014Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)An Open-Label, Extension Study of the Effects of LMTM in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)Alzheimer's Disease;Behavioral Variant Frontotemporal DementiaDrug: LMTMTauRx Therapeutics LtdNULLTerminatedN/AN/AAll913Phase 3United States;Australia;Belgium;Canada;Croatia;Finland;France;Germany;Korea, Republic of;Malaysia;Netherlands;Romania;Russian Federation;Singapore;Spain;Taiwan;United Kingdom;Argentina;Bulgaria;Italy;Poland
40NCT01937013
(ClinicalTrials.gov)
September 12, 20133/9/2013Impact of Emotional Mimicry and Oxytocin on Frontotemporal DementiaImpact of Emotional Mimicry and Oxytocin on Frontotemporal DementiaFrontotemporal DementiaDrug: Intranasal oxytocin;Drug: Saline Nasal MistLawson Health Research InstituteCanadian Institutes of Health Research (CIHR)Completed30 Years85 YearsAll52Phase 2Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT01626378
(ClinicalTrials.gov)
May 201320/6/2012Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)Behavioral Variant Frontotemporal Dementia (bvFTD)Drug: TRx0237;Drug: PlaceboTauRx Therapeutics LtdNULLCompletedN/A79 YearsAll220Phase 3United States;Australia;Canada;Croatia;Germany;Italy;Netherlands;Poland;Romania;Singapore;Spain;United Kingdom;Argentina;Bulgaria;Finland
42EUCTR2012-004328-40-IT
(EUCTR)
01/03/201323/11/2012study of neuroinflammation in pathologies like Alzheimer, mild cognitive impairment, dementia and SLAIMAGING OF NEUROINFLAMMATION IN NEURODEGENERATIVE DISEASES mild cognitive impairment, Alzheimer disease,frontotemporal dementia, SLA
MedDRA version: 14.1;Level: LLT;Classification code 10050727;Term: RI scan;System Organ Class: 100000004848;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NA
Product Code: (R)-[N-metil-11C1-PK11195(PK)
OSPEDALE S. RAFFAELE DI MILANONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
43NCT00604591
(ClinicalTrials.gov)
July 201119/1/2008Effects of Tolcapone on Frontotemporal DementiaInvestigation of the Dopamine System in Frontotemporal DementiaFrontotemporal Lobar DegenerationDrug: Tolcapone;Drug: PlaceboColumbia UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed40 Years85 YearsAll28Phase 2United States
44JPRN-UMIN000003683
2010/06/0131/05/2010The efficacy of ferulic acid in the treatment of dementia Alzheimer's Disease, Dementia of Lewy Body,Vascular Dementia, Frontotemporal DementiaTaking of Ferulic Acid for 6 months followed by Not taking of Ferulic Acid for 6 months.

Not taking of Ferulic Acid for 6 months followed by taking of Ferulic Acid for 6 months.
Shimane University HospitalNULLComplete: follow-up complete20years-old90years-oldMale and Female50Not selectedJapan
45NCT01056965
(ClinicalTrials.gov)
January 201021/1/2010Davunetide (AL-108) in Predicted Tauopathies - Pilot StudyA 12 Week Randomized, Double Blind, Placebo-Controlled Pilot Study of Davunetide (NAP, AL-108) in Predicted TauopathiesPredicted Tauopathies, Including;Progressive Supranuclear Palsy;Frontotemporal Dementia With Parkinsonism Linked to Chromosome 17;Corticobasal Degeneration Syndrome;Progressive Nonfluent AphasiaDrug: davunetide (AL-108, NAP);Drug: Placebo nasal sprayUniversity of California, San FranciscoNULLCompleted40 Years85 YearsAll12Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT01890343
(ClinicalTrials.gov)
September 200927/6/2013Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.A Study Evaluating the Imaging Characteristics of Florbetapir 18F (18F-AV-45) in Patients With Frontotemporal Dementia Compared to Patients With Alzheimer's Disease and Normal Controls.Alzheimer's Disease;Frontotemporal DementiaDrug: florbetapir 18F;Drug: 18F-FDGAvid RadiopharmaceuticalsNULLCompleted45 YearsN/AAll34Phase 2United Kingdom
47NCT01002300
(ClinicalTrials.gov)
September 200923/10/2009Oxytocin and Social Cognition in Frontotemporal DementiaInvestigation of the Effects of Intranasal Oxytocin on Cognition and Emotion Processing in Frontotemporal DementiaFrontotemporal Dementia;Pick's DiseaseDrug: intranasal oxytocinLawson Health Research InstituteThe Alzheimer Society London and MiddlesexCompleted30 Years80 YearsBoth24N/ACanada
48EUCTR2008-003597-18-GB
(EUCTR)
28/05/200914/04/2009Amyloid imaging in Alzheimer’s disease, frontotemporal dementia and healthy volunteersA study evaluating the imaging characteristics of 18F-AV-45 in patients with frontotemporal dementia compared to patients with Alzheimer's disease and normal controls Use of 18F-AV-45 positron emission tomography as early diagnostic technique in frontal lobe dementia and Alzheimer's disease.
MedDRA version: 14.0;Level: PT;Classification code 10061816;Term: Diagnostic procedure;System Organ Class: 10022891 - Investigations
Avid Radiopharmaceuticals, IncNULLNot Recruiting Female: yes
Male: yes
40Phase 2United Kingdom
49NCT00950430
(ClinicalTrials.gov)
April 200829/7/2009Imaging of Brain Amyloid Plaques in the Aging PopulationBrain Amyloid Imaging With Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and DementiaAlzheimer's Disease;Dementia With Lewy Bodies;Frontotemporal Dementia;Vascular DementiaDrug: Pittsburgh Compound B (C-11 PiB);Drug: F-18 FDG;Drug: Tau (18-F-AV-1451)Mayo ClinicNational Institute on Aging (NIA)Enrolling by invitation30 Years100 YearsAll2500Phase 4United States
50NCT00545974
(ClinicalTrials.gov)
October 200716/10/2007Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal DementiaA Prospective, Randomized, Multi-Center, Double-Blind, 26 Week, Placebo-Controlled Trial of Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal DementiaFrontal Lobe Dementia;Frontotemporal Lobe Dementia;Semantic DementiaDrug: memantine;Drug: Placebo pillUniversity of California, San FranciscoForest LaboratoriesCompleted40 Years80 YearsAll81Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT00376051
(ClinicalTrials.gov)
September 200613/9/2006Serotonergic Function and Behavioural and Psychological Symptoms of Frontotemporal DementiaSerotonergic Function and Behavioural and Psychological Symptoms of Frontotemporal DementiaFrontotemporal DementiaDrug: CitalopramSunnybrook Health Sciences CentreAlzheimer Society of CanadaCompleted18 YearsN/AAll22Phase 4Canada
52NCT00127114
(ClinicalTrials.gov)
September 20053/8/2005Amantadine for the Treatment of Behavioral Disturbance in Frontotemporal Dementia (FTD)Amantadine for the Treatment of Behavioral Disturbance in Frontotemporal Dementia (FTD)DementiaDrug: Amantadine;Drug: PlaceboJohns Hopkins UniversityNULLWithdrawn40 Years90 YearsAll0Phase 4United States