Ap    (DrugBank: -)

4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症68
6パーキンソン病289
13多発性硬化症/視神経脊髄炎236
299嚢胞性線維症126

2. 筋萎縮性側索硬化症 [臨床試験数:508,薬物数:530(DrugBank:146),標的遺伝子数:170,標的パスウェイ数:221
Searched query = "Amyotrophic lateral sclerosis", "ALS"
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.
68 / 508 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
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size
PhaseCountries
1NCT03843710
(ClinicalTrials.gov)
April 30, 202114/2/201931P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis (REPAIR-ALS)A 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 Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Gold NanocrystalsClene NanomedicineUniversity of Texas Southwestern Medical CenterNot yet recruiting35 Years75 YearsAll24Phase 2United States
2EUCTR2019-001862-13-SE
(EUCTR)
14/10/202023/03/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
3NCT04579666
(ClinicalTrials.gov)
September 30, 202022/9/2020MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis;Motor Neuron DiseaseDrug: Pegcetacoplan (APL-2);Other: PlaceboApellis Pharmaceuticals, Inc.NULLRecruiting18 YearsN/AAll228Phase 2United States
4EUCTR2019-001862-13-ES
(EUCTR)
15/09/202012/06/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
5NCT04288856
(ClinicalTrials.gov)
April 28, 202026/2/2020Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults C9ORF72-Associated Amyotrophic Lateral Sclerosis (ALS)An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults With C9ORF72-Associated Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: BIIB078BiogenNULLEnrolling by invitation18 YearsN/AAll90Phase 1United States;Canada;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
6NCT04326283
(ClinicalTrials.gov)
April 2, 202024/3/2020Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)A Sequential Dose-Escalation, Randomized, Active-Controlled, Multi-Center, Phase 1/2a Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of SNR1611 in Patients With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Trametinib (0.5 mg);Drug: Trametinib (1 mg);Drug: Trametinib (2 mg);Drug: Riluzole (100 mg)Genuv Inc.NULLRecruiting19 Years75 YearsAll30Phase 1;Phase 2Korea, Republic of
7EUCTR2019-001862-13-SI
(EUCTR)
12/03/202019/02/2020Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
8NCT04220021
(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
9NCT03981536
(ClinicalTrials.gov)
October 10, 201930/5/2019A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS)A Multicenter, Open Label, Single-Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: AP-101AL-S PharmaNULLActive, not recruiting18 YearsN/AAll18Phase 1Canada
10ChiCTR1900024520
2019-07-222019-07-13Split-hand index calculated by F-wave test apply to the diagnosis of amyotrophic lateral sclerosisSplit-hand index calculated by F-wave test apply to the diagnosis of amyotrophic lateral sclerosis Amyotrophic lateral sclerosisGold Standard:Clinical outcome meet the Awaji-Shima Criteria 2008;Index test:Split-hand index calculated by F-wave test;Peking Union Medical College HospitaNULLRecruiting1880BothTarget condition:300;Difficult condition:50N/AChina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04176224
(ClinicalTrials.gov)
April 17, 201922/11/2019Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral SclerosisClinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)Japanese Patients With ALSDrug: MT-1186Mitsubishi Tanabe Pharma CorporationNULLCompleted20 Years75 YearsAll9Phase 1Japan
12NCT03693781
(ClinicalTrials.gov)
April 10, 201930/9/2018Colchicine for Amyotrophic Lateral SclerosisColchicine for Amyotrophic Lateral Sclerosis: a Phase II, Randomized, Double Blind, Placebo Controlled, Multicenter Clinical TrialAmyotrophic Lateral SclerosisDrug: Colchicine 1 MG Oral Tablet;Drug: Placebo Oral TabletAzienda Ospedaliero-Universitaria di ModenaUniversity of Modena and Reggio Emilia;University of Turin, Italy;Istituto Auxologico Italiano;IRCCS National Neurological Institute C. Mondino Foundation;University of Bari;IRCCS San Raffaele;University of Padova;University of Milan;Istituto Di Ricerche Farmacologiche Mario Negri;University of Campania Luigi Vanvitelli;Catholic University of the Sacred HeartRecruiting18 Years80 YearsAll54Phase 2Italy
13NCT02437110
(ClinicalTrials.gov)
April 1, 20195/5/2015HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Darunavir;Drug: Ritonavir;Drug: dolutegravir;Drug: Tenofovir alafenamide (TAF)National Institute of Neurological Disorders and Stroke (NINDS)NULLRecruiting18 YearsN/AAll200Phase 1United States
14JPRN-JMA-IIA00419
29/03/201929/03/2019Phase 1 dose-escalation study of bosutinib in patients with amyotrophic lateral sclerosis (ALS)Phase 1 dose-escalation study of bosutinib in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic Lateral SclerosisIntervention type:DRUG. Intervention1:Medicine, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:The study consists of a 12-week observation period, a 1-week (5- to 9-day) transitional period, a 12-week study treatment period, and a 4-week follow-up period. .Center for iPS Cell Research and Application (CiRA), Kyoto UniversityNULLRecruiting>=20 YEARS<80 YEARSBOTH24Phase 1Japan
15JPRN-UMIN000036295
2019/03/2926/03/2019Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS)Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) - Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral SclerosisThe study consists of a 12-week observation period, a 1-week (5- to 9-day) transitional period, a 12-week study treatment period, and a 4-week follow-up period.
3 to 6 ALS patients will be enrolled in each of the 4 bosutinib dose levels [100 mg/day (dose level 1), 200 mg/day (dose level 2), 300 mg/day (dose level 3), or 400mg/day (dose level 4)] to evaluate the safety and tolerability of the investigational drug (bosutinib) under a 3+3 dose escalation study design.
Center for iPS Cell Research and Application, Kyoto UniversityProvider of the investigational product: Pfizer Japan Inc.Recruiting20years-old80years-oldMale and Female24Phase 1Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03482050
(ClinicalTrials.gov)
April 12, 201814/3/2018A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS)A Phase I/IIa, Open Label, Dose-escalating Clinical Study to Evaluate the Safety, Tolerability and Theraputic Effects of Transplantation of Astrocytes Derived From Human Embryonic Stem Cells (hESC), in Patients With Amyotrophic Lateral Sclerosis (ALS)ALS (Amyotrophic Lateral Sclerosis)Biological: AstroRxKadimastemNULLRecruiting18 Years70 YearsAll21Phase 1;Phase 2Israel
17NCT03334786
(ClinicalTrials.gov)
April 5, 201826/10/2017Study to Evaluate Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Appendicular Muscle in Adult Subjects With ALSAn Open Label Study to Evaluate the Safety and Efficacy of FLX-787-ODT for Treatment of Fasciculations in the Tongue and One Appendicular Muscle in Adult Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis;FasciculationDrug: FLX-787-ODTFlex Pharma, Inc.NULLTerminated18 YearsN/AAll3Phase 1;Phase 2United States
18NCT03679975
(ClinicalTrials.gov)
April 4, 201819/9/2018Riluzole Oral Soluble Film (ROSF) Swallowing Safety in Amyotrophic Lateral Sclerosis (ALS)A Single Center Study to Evaluate the Effect of Riluzole Oral Soluble Film on Swallowing Safety in Individuals With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Riluzole Oral Soluble film (ROSF) 50 mgAquestive TherapeuticsinVentiv Health Clinical;CovanceTerminated18 Years80 YearsAll9Phase 2United States
19JPRN-UMIN000029308
2017/07/1830/09/2018Study on efficacy and safety as well as on the changes in blood purine compounds by the treatment of patients with amyotrophic lateral sclerosis with febuxostat and inosine in combination. Amyotrophic lateral sclerosisFebuxostat 20 mg, Inosine 500 mg, twice a day for 14 daysTeikyo UniversityNULLComplete: follow-up complete20years-old80years-oldMale and Female3Not applicableJapan
20JPRN-jRCTs031180173
07/07/201701/03/2019Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosisOpen-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis amyotrophic lateral sclerosis
amyotrophic lateral sclerosis;G122
gradual increase of lacosamide from 100mg to 400mg for 4 weeksKuwabara SatoshiNULLComplete>= 20age oldNot applicableBoth30Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21JPRN-UMIN000027476
2017/06/0101/06/2017Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosisOpen-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis - Open-label clinical trial of lacosamide in ALS amyotrophic lateral sclerosisgradual increase of lacosamide from 100mg to 400mg for 4 weeksDepartment of Neurology Chiba University HospitalNULLComplete: follow-up continuing20years-oldNot applicableMale and Female30Not selectedJapan
22NCT03019419
(ClinicalTrials.gov)
April 24, 201710/1/2017Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS)Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 TrialsALSDrug: Perampanel;Drug: placeboTokyo Medical UniversityNULLActive, not recruiting40 Years78 YearsAll60Phase 2Japan
23NCT03103815
(ClinicalTrials.gov)
April 24, 20171/4/2017Trial of Amivita in Amyotrophic Lateral SclerosisTrial of Amivita in Amyotrophic Lateral Sclerosis: a Single-center, Single-blind, Self-controlled Clinical TrialAmyotrophic Lateral SclerosisDrug: AmivitaWujin People's HospitalNanjing 1718 Biotech Co. LtdRecruiting18 Years70 YearsAll30N/AChina
24NCT03049046
(ClinicalTrials.gov)
April 7, 20173/2/2017CC100: Phase 1 Multiple-Dose Safety and Tolerability in Subjects With ALSProtocol CC100B. CC100: Phase 1 Multiple-Dose Safety and Tolerability in Subjects With ALSAmyotrophic Lateral SclerosisDrug: CC100;Drug: PlacebosChemigen, LLCNULLRecruiting18 Years64 YearsAll21Phase 1United States
25NCT02943850
(ClinicalTrials.gov)
April 1, 201720/10/2016CNS10-NPC-GDNF for the Treatment of ALSHuman Neural Progenitor Cells Secreting Glial Cell Line-Derived Neurotrophic Factor (CNS10-NPC-GDNF) for the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisBiological: Stem cell (HPC) implantation;Device: Stereotactic surgical deviceCedars-Sinai Medical CenterCalifornia Institute for Regenerative Medicine (CIRM)Completed18 YearsN/AAll18Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26JPRN-UMIN000026221
2017/03/0201/03/2017Safety of perampanel in patients with motor neuron disease amyotrophic lateral sclerosisOnce daily perampanel with dose escalation from 2mg to 8mg.Department of Neurology, Juntendo University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female15Phase 1Japan
27JPRN-UMIN000024854
2016/11/1616/11/2016Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosisClinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosis - Clinical study for the anti-oxidative stress by edaravone in ALS Amyotrophic Lateral Sclerosis (ALS)Edaravone treatment for ALS patientsOkayama universityNULLComplete: follow-up complete20years-old75years-oldMale and Female20Not applicableJapan
28NCT03241784
(ClinicalTrials.gov)
May 16, 201627/7/2017T-Regulatory Cells in Amyotrophic Lateral SclerosisExpansion and Infusion of T-Regulatory Cells in Amyotrophic Lateral SclerosisALS (Amyotrophic Lateral Sclerosis)Biological: Autologous T-regulatory lymphocytes;Biological: Interleukin-2Stanley H. Appel, MDNULLUnknown status18 YearsN/AAll4Phase 1United States
29NCT02710162
(ClinicalTrials.gov)
April 201629/2/2016Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)Determination of Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDevice: Micro Mouth Pressure Meter;Device: Iowa Oral Performance Instrument;Device: Electrical Impedance Myography;Drug: Capsaicin;Procedure: Videofluoroscopic Swallowing Study;Procedure: Pulmonary Function Testing;Other: Swallowing Related Quality of Life Questionnaire;Other: Functional Oral Intake Scale;Other: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised;Other: Eating Assessment Tool-10;Other: Communicative Effectiveness Survey;Other: The Center for Neurologic Studies Bulbar Function ScaleUniversity of FloridaNULLCompleted21 Years85 YearsAll21Early Phase 1United States
30NCT02709330
(ClinicalTrials.gov)
April 20165/3/2016ALS Reversals - Lunasin RegimenAn Open-label, Single-center, 12-month Trial of a Lunasin Regimen for Patients With Amyotrophic Lateral Sclerosis (ALS)ALS (Amyotrophic Lateral Sclerosis)Drug: Lunasin Regimen;Other: Historical controlRichard Bedlack, M.D., Ph.D.NULLCompleted18 YearsN/AAll60Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT02710110
(ClinicalTrials.gov)
April 201626/2/2016Respiratory Strength Training in Persons With Amyotrophic Lateral Sclerosis (ALS)The Impact of Respiratory Strength Training in Individuals With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDevice: PowerLung trainer;Device: Micro Mouth Pressure Meter;Procedure: Pulmonary Function Testing;Procedure: Videofluoroscopic swallowing study;Other: Swallowing Quality of Life Questionnaire;Device: Iowa Oral Pressure Instrument;Drug: CapsaicinUniversity of FloridaALS AssociationCompleted21 Years85 YearsAll50Early Phase 1United States
32NCT02881476
(ClinicalTrials.gov)
November 201522/4/2016Therapeutic Treatment of Amyotrophic Lateral SclerosisApplication of Wharton's Jelly-derived Mesenchymal Stem Cells in the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisOther: Biological: Cell-based therapyUniversity of Warmia and MazuryNULLEnrolling by invitation18 Years65 YearsBoth30Phase 1NULL
33JPRN-UMIN000019111
2015/10/0101/10/2015CaHMB L-arginine-glutamine blended drinks (Abound (TM)) for amyotrophic lateral sclerosis patients and sarcopenia improvement effect by drinking. Amyotrophic lateral sclerosisAbound(TM)
1,Take one pack twice a day in the moring and evening
2,Drinking was dissolved in water 240 ~ 300ml
3,Before meals, after meals does not matter
4,12 weeks
National Hospital Organization Takasaki General Medical CenterNULLRecruitingNot applicableNot applicableMale and Female20Not selectedJapan
34EUCTR2010-024423-24-NL
(EUCTR)
21/09/201509/09/2015Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 19.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLNot RecruitingFemale: yes
Male: yes
300Phase 2;Phase 3Portugal;United States;Serbia;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany
35NCT02987413
(ClinicalTrials.gov)
April 28, 20151/7/2016Escalated Application of Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis PatientsSafety and Efficacy of Mesenchymal Stem Cells Escalated Application in Amyotrophic Lateral Sclerosis Patients: Study Design of a Phase I TrialMotor Neuron DiseaseBiological: Autologous Mesenchymal stem cells (MSCs)Hospital e Maternidade Dr. Christóvão da GamaIEP São Lucas - Instituto de Ensino e Pesquisa;Clinica Jordy Sinapse;TECHLIFE - Centro de Tecnologia CelularCompleted18 YearsN/AAll3Phase 1Brazil
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2010-024423-24-HU
(EUCTR)
21/04/201531/10/2014Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2;Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ireland;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Netherlands;Germany
37EUCTR2010-024423-24-PT
(EUCTR)
10/04/201503/11/2014Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
ABScienceNULLNot Recruiting Female: yes
Male: yes
381Phase 2;Phase 3Serbia;Portugal;United States;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany
38NCT02463825
(ClinicalTrials.gov)
April 201521/4/2015A Registry-Based Clinical Trial of Pimozide in Patients With Neuromuscular Junction Transmission Dysfunction Due to ALSA Registry-Based Randomized-Controlled, Double-Blinded Clinical Trial of Pimozide in Patients With Neuromuscular Junction Transmission Dysfunction Due to Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis (ALS)Drug: Pimozide 2 mg per day;Drug: Pimozide 4 mg per day;Drug: Placebo (Lactose tablet)University of CalgaryHotchkiss Brain Institute, University of CalgaryActive, not recruiting18 YearsN/ABoth25Phase 2Canada
39EUCTR2010-024423-24-GR
(EUCTR)
06/03/201521/11/2013Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable Patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
ABScienceNULLNot RecruitingFemale: yes
Male: yes
381Phase 2;Phase 3United States;Portugal;Slovakia;Greece;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Argentina;Netherlands;Germany
40JPRN-UMIN000016352
2015/02/0101/02/2015The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial amyotrophic lateral sclerosisedaravoneEhime University HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female10Phase 1;Phase 2Japan
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
41EUCTR2012-002099-15-SE
(EUCTR)
15/09/201401/08/2014Safety and Efficacy of Apovir for treatment of patients with ALS (Amyotrophic lateral sclerosis)A randomised, double blind, placebo controlled trial to evaluate the safety and efficacy of Apovir for treatment of patients with Amyotrophic lateral sclerosis Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 17.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pleconaril
Product Code: APO-P001
INN or Proposed INN: PLECONARIL
Trade Name: Copegus
Product Name: Ribavirin
Other descriptive name: RIBAVIRIN
Apodemus ABNULLNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
42EUCTR2010-024423-24-SK
(EUCTR)
07/04/201405/12/2013Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
ABScienceNULLNot Recruiting Female: yes
Male: yes
381Phase 2;Phase 3Portugal;Serbia;United States;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany
43NCT02166944
(ClinicalTrials.gov)
April 20149/6/2014Tamoxifen Treatment in Patients With Motor Neuron DiseaseThe Study of Tamoxifen Treatment in Patients With Motor Neuron DiseaseAmyotrophic Lateral Sclerosis;ALS Functional Ration Scale;TAR-DNA-binding Protein-43;Tamoxifen;mTORDrug: tamoxifen 40 mg daily for one yearTaipei Medical University Shuang Ho HospitalNULLCompleted20 Years80 YearsAll20Phase 1;Phase 2Taiwan
44JPRN-UMIN000011494
2013/09/0202/09/2013Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' drooling amyotrophic lateral sclerosisscopolamine patch 7days-washout 7days-placebo patch 7days
placebo patch 7days-washout 7days-scopolamine patch 7days
Mie University Graduate school of medicine,Department of neurologyMatsusaka Chuou HospitalNational Mie HospitalComplete: follow-up completeNot applicableNot applicableMale and Female10Not applicableJapan
45NCT02164253
(ClinicalTrials.gov)
September 201320/5/2014Focal Accumulation of Iron in Cerebral Regions in Early ALS (Amyotrophic Lateral Sclerosis) PatientsFeasibility and Safety Pilot Therapeutic Study of the Iron Chelator Deferiprone in Amyotrophic Lateral SclerosisALS (Amyotrophic Lateral Sclerosis);Iron OverloadDrug: DeferiproneUniversity Hospital, LilleApoPharmaCompleted18 Years85 YearsAll23Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT02588677
(ClinicalTrials.gov)
April 201320/10/2015Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of MasitinibAmyotrophic Lateral Sclerosis (ALS)Drug: Masitinib (4.5);Drug: Riluzole;Drug: Placebo;Drug: Masitinib (3.0)AB ScienceNULLCompleted18 YearsN/AAll394Phase 2;Phase 3Spain
47NCT01806857
(ClinicalTrials.gov)
April 20135/3/2013Clinical Trial Nuedexta in Subjects With ALSThe Experimental Treatment of Bulbar Dysfunction in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: Nuedexta;Drug: Matching PlaceboCenter for Neurologic Study, La Jolla, California,ALS Association;State University of New York - Upstate Medical UniversityCompleted18 YearsN/AAll90Phase 2United States
48EUCTR2010-024423-24-ES
(EUCTR)
29/01/201329/11/2012Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel group, phase 2 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable patients suffering from Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
Product Name: masitinib
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: MASITINIB
ABScienceNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Portugal;France;Hungary;Slovakia;Greece;Spain;Ireland;Netherlands;Italy
49JPRN-UMIN000006423
2011/10/0101/10/2011The clinical trial to assess efficacy of mexiletine for amyotrophic lateral sclerosis amyotrophic lateral sclerosisadministration of mexiletine and riluzole
administration of riluzole only
Department of Neurology, Graduate School of Medicine, Chiba University, Japan.NULLComplete: follow-up complete20years-oldNot applicableMale and Female60Not selectedJapan
50NCT00876772
(ClinicalTrials.gov)
March 20116/4/2009Olanzapine for the Treatment of Appetite Loss in Amyotrophic Lateral Sclerosis (ALS)Randomized, Placebo-controlled Parallel Group Study for the Evaluation of an Oral Dose of 10mg Olanzapine in Combination With Riluzole for the Treatment of Loss of Appetite in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: OlanzapineCharite University, Berlin, GermanyNULLRecruiting18 Years80 YearsBoth40Phase 2;Phase 3Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT02880033
(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
52EUCTR2008-003982-21-FR
(EUCTR)
10/06/201014/01/2010Etude des transporteurs de la dopamine et de la sérotonine en imagerie TEMP utilisant les radiopharmaceutiques 123I-FP-CIT (datscan) and 123 I-ADAM dans la sclérose latérale amyotrophique et dans une population contrôle. DOSERALS - DOSERALSEtude des transporteurs de la dopamine et de la sérotonine en imagerie TEMP utilisant les radiopharmaceutiques 123I-FP-CIT (datscan) and 123 I-ADAM dans la sclérose latérale amyotrophique et dans une population contrôle. DOSERALS - DOSERALS Patients présentant une SLA et volontaires sains
MedDRA version: 8.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: DaTSCAN
Product Name: Datscan
INN or Proposed INN: Ioflupane 123I
Product Name: [I-123] ADAM
INN or Proposed INN: [I-123] ADAM
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
France
53EUCTR2008-007320-25-ES
(EUCTR)
10/08/200916/07/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzoleEstudio fase II/III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, para valorar la seguridad y eficacia de TRO 19622 en pacientes con Esclerosis Lateral Amiotrófica (ELA) tratados con riluzol.Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzoleEstudio fase II/III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, para valorar la seguridad y eficacia de TRO 19622 en pacientes con Esclerosis Lateral Amiotrófica (ELA) tratados con riluzol. ESCLEROSIS LATERAL AMIOTRÓFICA.ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles due to destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: TRO19622
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
470Phase 2;Phase 3United Kingdom;Germany;Belgium;France;Spain
54JPRN-UMIN000002276
2009/08/0101/08/2009Developmental research of communication devices based on the brain machine interface using electroencephalograms amyotrophic lateral sclerosisLet the patients use the communication devices to select characters on a computer monitor as they intend by recording EEG.Osaka UniversityNULLComplete: follow-up complete20years-oldNot applicableMale and Female10Not applicableJapan
55EUCTR2008-007320-25-DE
(EUCTR)
24/06/200918/02/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzolePhase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
470Phase 2;Phase 3United Kingdom;Germany;Belgium;France;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2008-007320-25-BE
(EUCTR)
08/06/200928/04/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzolePhase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
470Phase 2;Phase 3France;Spain;Belgium;Germany;United Kingdom
57NCT00868166
(ClinicalTrials.gov)
April 30, 200923/3/2009Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALSPhase II/III, Multicenter, Randomized, Parallel Group, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With RiluzoleAmyotrophic Lateral SclerosisDrug: Olesoxime;Drug: Placebo Comparator;Drug: RiluzoleHoffmann-La RocheEuropean CommissionCompleted18 Years80 YearsAll512Phase 3Belgium;France;Germany;Spain;United Kingdom;Netherlands
58NCT00886977
(ClinicalTrials.gov)
April 200921/4/2009Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: YAM80Yoshino Neurology ClinicNULLActive, not recruiting25 Years65 YearsBoth25Phase 2Japan
59EUCTR2008-007320-25-FR
(EUCTR)
17/02/200916/03/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzolePhase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
470Phase 2;Phase 3United Kingdom;Germany;Belgium;France;Spain
60EUCTR2008-006891-31-GB
(EUCTR)
17/02/200928/07/2010A randomised placebo-controlled trial of Lithium carbonate in Amyotrophic Lateral Sclerosis (LiCALS) - LiCALSA randomised placebo-controlled trial of Lithium carbonate in Amyotrophic Lateral Sclerosis (LiCALS) - LiCALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: Lithium Apogepha
Product Name: Lithium Carbonate
Other descriptive name: LITHIUM CARBONATE
Trade Name: Lithium Carbonate
Product Name: Lithium Carbonate
Other descriptive name: LITHIUM CARBONATE
Trade Name: Lithium Citrate
Product Name: Lithium Citrate
Other descriptive name: LITHIUM CITRATE
King's College LondonNULLNot RecruitingFemale: yes
Male: yes
220Phase 4United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2007-003775-39-DE
(EUCTR)
29/10/200809/09/2008Randomised, placebo-controlled parallel-group trial to evaluate an oral dose of 10 mg Olanzapin combined with Riluzol for the treatment of appetite loss on patients with amyotrophic lateral sklerosis - Olanzapin in treatment of ALS-related appetite lossRandomised, placebo-controlled parallel-group trial to evaluate an oral dose of 10 mg Olanzapin combined with Riluzol for the treatment of appetite loss on patients with amyotrophic lateral sklerosis - Olanzapin in treatment of ALS-related appetite loss patients with amyotrophic lateral sclerosisTrade Name: Zyprexa
INN or Proposed INN: OLANZAPINE
Charité – Universitätsmedizin BerlinNULLNot RecruitingFemale: yes
Male: yes
Germany
62EUCTR2008-003707-32-FR
(EUCTR)
09/10/200822/08/2008Etude de l'effet du carbonate de lithium sur une population de patients atteints de SLA en ouvert en comparaison avec une population de référence. LISLA - LISLAEtude de l'effet du carbonate de lithium sur une population de patients atteints de SLA en ouvert en comparaison avec une population de référence. LISLA - LISLA Patient atteint de sclérose latérale amyotrophique.
MedDRA version: 8.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Trade Name: Téralithe LP
Product Name: Téralithe LP
INN or Proposed INN: Carbonate de lithium
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
63EUCTR2008-002110-22-NL
(EUCTR)
16/09/200805/08/2008A randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALSA randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALS Amyotrophic lateral sclerosis (ALS) is a disease characterised by progressive degeneration of motor neurons in brain and spinal cord leading to muscle weakness. ALS can occur at anytime in adulthood. Muscle weakness gradually progresses. Approximately 50% of patients die within 3 years after onset of symptoms, usually as the result of respiratory failure. To date, only one drug, i.e. riluzole, has proven to extend survival in patients with ALS, but only by approximately 3 to 6 months.
MedDRA version: 9.1;Level: LLT;Classification code 10052889;Term: ALS
Trade Name: Lithiumcarbonaat 400 PCH tabletten
Product Name: Lithiumcarbonaat
Other descriptive name: LITHIUM CARBONATE
Prof. dr L.H. van den Berg, UMC-UtrechtNULLNot RecruitingFemale: yes
Male: yes
Netherlands
64NCT00444613
(ClinicalTrials.gov)
April 20076/3/2007A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)A Phase II/III Study in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: E0302 (mecobalamin);Drug: PlaceboEisai Co., Ltd.NULLCompleted20 YearsN/ABoth373Phase 2;Phase 3Japan
65NCT00107770
(ClinicalTrials.gov)
April 20057/4/2005Safety Study of Oral Sodium Phenylbutyrate in Subjects With ALS (Amyotrophic Lateral Sclerosis)Safety and Dose Escalating Study of Oral Sodium Phenylbutyrate in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: sodium phenylbutyrateDepartment of Veterans AffairsMuscular Dystrophy AssociationCompleted18 YearsN/ABoth40Phase 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
66NCT00136110
(ClinicalTrials.gov)
April 200524/8/2005Trial of Sodium Valproate in Amyotrophic Lateral SclerosisA Randomized, Double-Blind, Placebo-Controlled Sequential Clinical Trial of Sodium Valproate in ALSAmyotrophic Lateral SclerosisDrug: Sodium ValproateUMC UtrechtPrincess Beatrix Fund, The NetherlandsCompleted18 Years85 YearsBoth165Phase 3Netherlands
67NCT00243932
(ClinicalTrials.gov)
April 200524/10/2005Clinical Trial of High Dose CoQ10 in ALSClinical Trial of High Dose CoQ10 in ALSAmyotrophic Lateral Sclerosis;Lou Gehrig's DiseaseDrug: coenzyme Q10;Drug: PlaceboColumbia UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed21 Years85 YearsAll185Phase 2United States
68NCT00812851
(ClinicalTrials.gov)
April 200521/11/2008Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)Cramps;Amyotrophic Lateral SclerosisDrug: DronabinolCantonal Hospital of St. GallenALS AssociationCompleted18 YearsN/ABoth24N/ASwitzerland

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.
289 / 2,123 trials found
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
1EUCTR2019-003315-60-NL
(EUCTR)
10/11/202008/10/2020A study investigating the effect and safety of a new potential drug for Parkinson's disease patients.A phase 1/2 study investigating the pharmacokinetics, safety and efficacy of a highly concentrated buccal formulation of apomorphine (APORON®) in subjects with Parkinson's Disease - Buccal apomorphine (APORON) administration 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]
Trade Name: Apo-go
Product Name: APO-go®
INN or Proposed INN: Apomorphine
Other descriptive name: APOMORPHINE HYDROCHLORIDE HEMIHYDRATE
Product Name: APORON
INN or Proposed INN: APORON
Other descriptive name: APOMORPHINE HYDROCHLORIDE HEMIHYDRATE
Criceto IKM B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 1;Phase 2Netherlands
2JPRN-jRCTs031200172
26/10/202026/10/2020Effects of Elobixibat administration in patients with Parkinson's syndrome complicated with chronic constipationMulticenter, Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study Investigating the Efficacy and Safety of Elobixibat in Patients with Parkinson's Disease Complicating Chronic Constipation. - CONST-PD Parkinson's disease, chronic constipation
Parkinson's syndrome,chronic constipation,Symptomatic constipation
Take 10mg of Elobixibat or placebo once a day before meal. After the 2-week screening period, the study drug will be started on the day of enrollment.Hatano TakuMochida Pharmaceutical Co., Ltd.;EA Pharma Co., Ltd.Recruiting>= 20age oldNot applicableBoth100N/AJapan
3ChiCTR2000037239
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
4ChiCTR2000036006
2020-10-012020-08-21The applications of multi- MRI in early diagnosis of Parkinson's Disease based on deep learningThe applications of multi- MRI in early diagnosis of Parkinson's Disease based on deep learning Parkinson's diseaseGold Standard:MDS clinical diagnostic criteria for Parkinson’s disease;Index test:multimodal MRI features in locus coeruleus and substantia nigra;Zhongshan Hospital, Fudan UniversityNULLPending1885BothTarget condition:400;Difficult condition:0China
5JPRN-UMIN000040889
2020/06/2424/06/2020Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's diseaseComparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease - Comparison of gastrointestinal function before and after LCIG therapy for Parkinson's disease Parkinson's diseaseLevodopa-carbidopa continuous infusion gel (LCIG) therapyFujita Health University School of MedicineDepartment of GastroenterologyNULLRecruiting20years-oldNot applicableMale and Female200Phase 4Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04459052
(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
7NCT04182399
(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
8NCT04167540
(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
9NCT02967250
(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
10ChiCTR1900027306
2019-11-152019-11-08Application of optical coherence tomography and detection of a-synuclein in tears in the diagnosis of Parkinson's diseaseMorphological changes of retina in patients with Parkinson's disease and the role of a-synuclein in retinal damage Parkinson's diseaseGold Standard:British brain bank Parkinson's disease diagnostic criteria;Index test:Application of optical coherence tomography to observe the retinal structure of the macular area, optic disc area and the expression level of a-synuclein in tears in the diagnosis of Parkinson's disease.;The First Affiliated Hospital of Chengdu Medical CollegeNULLRecruitingBothTarget condition:85;Difficult condition:85China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04148391
(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
12NCT04157933
(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
13JPRN-UMIN000036952
2019/06/0404/06/2019A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients.A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients. - A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients. Patients who are suspected Parkinson's disease or related disorders, including dementia with Lewy bodies, multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, frontotemporal lobe degeneration, vascular parkinsonism, drug-induced parkinsonism, normal pressure hydrocephalus, and others.18F-FDOPA, 11C-Raclopride PETNagoya City Rehabilitation AgencyNULLRecruiting20years-oldNot applicableMale and Female150Not applicableJapan
14JPRN-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
15NCT03693872
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03781167
(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
17NCT03899324
(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
18JPRN-JapicCTI-194763
22/4/201920/05/2019Safety and PK study of LY03003An open-label study in Japanese patients with Parkinson's disease to evaluate the safety, pharmacokinetics and preliminary efficacy of LY03003 following intramuscular injections and its comparative bioavailability to Rotigotine transdermal patch. Parkinson's DiseaseIntervention name : Rotigotine
INN of the intervention : Rotigotine
Dosage And administration of the intervention : LY03003 IM injections 14, 28 and 56 mg/week.
Control intervention name : Rotigotine
INN of the control intervention : Rotigotine
Dosage And administration of the control intervention : Rotigotine transdermal patch applications 4.5, 9 and 18 mg/day.
Shandong Luye Pharmaceutical Co., Ltd./CMIC Co., Ltd.NULLcomplete20BOTH32Phase 1Japan
19NCT04420910
(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
20NCT03661125
(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
21NCT03841604
(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
22NCT03775096
(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
23NCT03877510
(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
24NCT03858270
(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
25JPRN-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
26EUCTR2017-005170-19-FI
(EUCTR)
06/03/201907/12/2018A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension StudyA Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions Idiopathic Parkinson's Disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cerebral Dopamine Neurotrophic Factor
Product Code: CDNF
INN or Proposed INN: Not Applicable
Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor
Renishaw Neuro Solutions Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 1;Phase 2Finland;Sweden
27NCT03391882
(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
28NCT03822364
(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
29EUCTR2018-000346-19-FI
(EUCTR)
03/10/201809/07/2018An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease.A 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-2002. - Extension Study Idiopathic Parkinson's Disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cerebral Dopamine Neurotrophic Factor
Product Code: CDNF
INN or Proposed INN: Not Applicable
Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor
Herantis Pharma PlcNULLNot RecruitingFemale: yes
Male: yes
18Phase 1;Phase 2Finland;Sweden
30ChiCTR1800017084
2018-08-012018-07-11Investigation of new approaches and technologies in the management of Parkinson's diseaseThe efficacy of Butylphthalide on cognitive impairment of patients with idiopathic PD and DBS patients: A Randomized, double-blind, placebo-controlled, multicenter trial Parkinson's diseaseButylphthalide group:Butylphthalide, 2 capsules/time, 3 times/day, for 48 weeks;Control group:Placebo, 2 capsules/time, 3 times/day, for 48 weeks;Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyNULLRecruiting1880BothButylphthalide group:140;Control group:140;Phase 4China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31JPRN-UMIN000033285
2018/08/0105/07/2018The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trialThe preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial - The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease Parkinson's diseaseOral bisphosphonate agent group: taking orally Minodronic Acid Hydrate (50mg) 1 tablet per 4 weeks
Intravenous bisphosphonate agent group: injecting Zoledronic Acid (5mg) 1 ampule per 48 weeks
Department of Orthopaedic Surgery, Niigata University Medical and Dental HospitalDepartment of Neurology, Nishi-Niigata Chuo HospitalPending50years-oldNot applicableMale and Female100Not selectedJapan
32EUCTR2017-005170-19-SE
(EUCTR)
30/07/201810/04/2018A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension StudyA Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions Idiopathic Parkinson's Disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cerebral Dopamine Neurotrophic Factor
Product Code: CDNF
INN or Proposed INN: Not Applicable
Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor
Renishaw Neuro Solutions Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 1;Phase 2Finland;Sweden
33JPRN-UMIN000033409
2018/07/0217/07/2018Prevention of local skin reaction by heparinoid due to rotigotine transdermal patch: a pilot randomized clinical trial. Parkinson's diseasePretreatment by heparinoid
In the pretreatment group, heparinoid is applied daily to the sites (shoulder, upper arm, abdomen, thigh, buttocks on both sides) to be applied rotigotine transdermal patch from the beginning of 1 week before. The dose is one finger tip unit (about 0.5 g) for two palms. The period is 8 weeks.
Non-pretreatment by heparinoid.
The non-pretreatment group use rotigotine without using heparinoid. The period is 8 weeks.
Wakayama Medical UniversityNULLRecruiting20years-old85years-oldMale and Female20Phase 1Japan
34EUCTR2018-000346-19-SE
(EUCTR)
04/06/201809/04/2018An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease.A 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-2002. - Extension Study Idiopathic Parkinson's Disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cerebral Dopamine Neurotrophic Factor
Product Code: CDNF
INN or Proposed INN: Not Applicable
Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor
Herantis Pharma PlcNULLNot RecruitingFemale: yes
Male: yes
18Phase 1;Phase 2Finland;Sweden
35NCT03230526
(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
36NCT03374917
(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
37NCT03368170
(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
38EUCTR2016-003456-70-DE
(EUCTR)
04/04/201803/04/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Trade Name: APO-go
Product Name: s.c. apomorphine
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomor
Sunovion Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
106Phase 3France;Spain;Austria;Germany;United Kingdom;Italy
39NCT03827746
(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
40NCT04265027
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2016-000637-43-ES
(EUCTR)
06/02/201807/12/2017Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease.An 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). Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3France;United States;Canada;Spain;Austria;Germany;Italy;United Kingdom
42EUCTR2016-003456-70-ES
(EUCTR)
06/02/201807/12/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Trade Name: APO-go
Product Name: s.c. apomorphine
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
85Phase 3Spain;Austria;United Kingdom
43EUCTR2016-000637-43-AT
(EUCTR)
01/02/201815/12/2017Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease.An 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). Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;France;Canada;Spain;Austria;Germany;United Kingdom;Italy
44EUCTR2016-003456-70-AT
(EUCTR)
04/01/201816/11/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 21.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
106Phase 3France;Spain;Austria;Germany;Italy;United Kingdom
45JPRN-UMIN000030084
2017/12/0101/12/2017Practical evaluation of PET studies with [18F]-GE180, [18F]-FDOPA and [18F]-FLT for a future clinical trial of iPSC-based cell therapy in Parkinson's disease neuroinflammatory disorder, Parkinson's disease, Brain tumor[18F]GE180 is injected intravenously as 3-4 MBq/Kg. PET is dynamically scanned for 90 minutes.

Carbidopa 150mg is administrated orally 1hr before scan.[18F]FDOPA is injected intravenously as 3-4 MBq/Kg. Dynamic PET is scanned for 90 minutes.

[18F]FLT is injected intravenously as 3-4 MBq/Kg. Statical PET is scanned after 60 minutes
Kyoto UniversityNULLComplete: follow-up complete50years-oldNot applicableMale and Female12Phase 1;Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2015-004175-73-FI
(EUCTR)
27/09/201707/07/2016A clinical study to test the safety of CDNF by brain infusion in patients with Parkinson's disease.A Phase I-II, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intermittent Bilateral Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Administered via an Investigational Drug Delivery System to Patients with Idiopathic Parkinson’s Disease (PD) of Moderate Severity. Idiopathic Parkinson's Disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CDNF
INN or Proposed INN: Not Applicable
Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor
Herantis Pharma PlcNULLNot RecruitingFemale: yes
Male: yes
17Phase 1;Phase 2Finland
47NCT03272230
(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
48JPRN-jRCTs041180018
04/09/201720/12/2018Pupillary autonomic dysfunction and visual hallucination in Parkinson's diseaseAssociation between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease - Pupillary autonomic dysfunction and visual hallucination in Parkinson's disease Parkinson's disease and related diseasesTwo drops of 0.05% pilocarpine hydrochloride, which is a parasympathomimetic agent, on the right eye, 2 drops of 0.04% dipivefrin hydrochloride, which is a sympathomimetic agent, to the left eyekatsuno MasahisaNULLRecruiting>= 40age oldNot applicableBoth40Phase 2Japan
49NCT03292016
(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
50NCT03187301
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT03973502
(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
52NCT03111485
(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
53NCT03174938
(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
54NCT02702076
(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
55NCT03425877
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT03140956
(ClinicalTrials.gov)
April 19, 201712/4/2017Pharmacokinetic of Levodopa Study in Healthy MalesPharmacokinetics of Levodopa After Repeated Doses of Different Pellet Formulations; An Open, Randomized Study With Crossover Design in Healthy Male SubjectsParkinson DiseaseDrug: Levodopa, carbidopa, ODM-104Orion Corporation, Orion PharmaNULLCompleted18 Years65 YearsMale20Phase 1Finland
57NCT03115827
(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
58NCT03128450
(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
59EUCTR2016-004629-18-NL
(EUCTR)
13/04/201717/01/2017The influence of stress on Parkinson's tremorThe noradrenergic basis of Parkinson’s tremor: a systems-level fMRI approach - Noradrenergic basis of Parkinson tremor Tremor in Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Radboud University NijmegenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60Phase 3Netherlands
60NCT03011476
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT03051607
(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
62JPRN-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
63NCT02953665
(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
64EUCTR2016-003456-70-GB
(EUCTR)
22/03/201726/01/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-BlindedRater to evaluate APL-130277 compared to s.c. Apomorphine in LevodopaResponsive Subjects with Parkinson's Disease Complicated by MotorFluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 21.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Trade Name: APO-go
Product Name: s.c. apomorphine
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorp
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
106Phase 3France;Spain;Austria;Germany;Italy;United Kingdom
65JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2015-003513-24-SK
(EUCTR)
14/03/201704/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY 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 11 004
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
266Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
67JPRN-jRCTs071180014
08/03/201729/01/2019ODYSSEI StudyIntervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease - ODYSSEI Study Parkinson's disease
Parkinson's disease
Arm A: Treatment with Istradefylline combined with optimal medical therapy.
Treatment with Istradefylline will be started at a dose of 20 mg administered once daily at Week 0. 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.
From the following day of Week 4, Optimal medical therapy including Istradefylline will be applied to each patient.

Arm B: Optimal medical therapy without Istradefylline.
Treatment with increased dose of previously used antiparkinson drugs or addition of new antiparkinson drug other than Istradefylline will be started at Week 0.
After Week 4, Optimal medical therapy without Istradefylline will be applied to each patient.
Tsuboi YoshioKyowa Kirin Co., Ltd.Not Recruiting>= 30age old< 80age oldBoth280N/AN A;Japan
68NCT02864004
(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
69EUCTR2015-004344-19-DE
(EUCTR)
07/02/201727/09/2016An international trial of deferiprone in patients with Parkinson’s diseaseA Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 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]
ApoPharmaNULLNot Recruiting Female: yes
Male: yes
140Phase 2France;Canada;Germany;United Kingdom
70JPRN-UMIN000025645
2017/02/0117/01/2018Cross sectional analysis of Intestinal flora of Parkinson's disease: Parkinson's diseaseLevodopa/carbidopa intestinal gelJuntendo University School of MedicineNULLPendingNot applicableNot applicableMale and Female20Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71JPRN-UMIN000024859
2016/12/1416/11/2016The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide.The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. - The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. Parkinson's diseaseSwitching from Dopamine agonist to Zonisamide.

Intervention period of 12 weeks.
Medical Corporation Abe Neurology ClinicNULLComplete: follow-up continuing30years-oldNot applicableMale and Female50Not applicableJapan
72JPRN-UMIN000024536
2016/11/2825/10/2016Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease.Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease. - ODYSSEI Study(Onset of Dyskinesia and Safety/Efficacy of Istradefylline) Parkinson's diseaseTreatment with istradefylline combined with optimal medical therapy.

Treatment with istradefylline will be started at a dose of 20 mg administered once daily at Week 0. 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.

From the following day of Week 4, Optimal medical therapy including istradefylline will be applied to each patient.
Optimal medical therapy without istradefylline.

Treatment with increased dose of previously used antiparkinson drugs or addition of new antiparkinson drug other than istradefylline will be started at Week 0.

After Week 4, Optimal medical therapy without istradefylline will be applied to each patient.
Fukuoka UniversityNULLComplete: follow-up complete30years-old80years-oldMale and Female280Not applicableJapan
73EUCTR2016-001690-33-FI
(EUCTR)
25/11/201623/11/2016Apomorfiini-infuusiohoito edenneen Parkinsonin taudin hoidossaApomorfiini-infuusiohoito edenneen Parkinsonin taudin hoidossa Edennyt parkinsonin tauti
MedDRA version: 19.0;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: Dacepton 5 mg/ml infuusioneste, liuos
Product Name: Dacepton 5 mg/ml
Eero PekkonenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Finland
74EUCTR2016-000102-11-NL
(EUCTR)
23/11/201608/11/2016Trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson’s disease patients with refractory visual hallucinations.Randomized, double-blind, placebo-controlled trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson’s disease patients with refractory visual hallucinations. - Apomorphine in PD patients with visual hallucinations: a RCT Parkinson's disease patients with refractory visual hallucinations
MedDRA version: 19.0;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: APO-go
Product Name: Apomorphine
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2;Phase 3Netherlands
75EUCTR2016-001762-29-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT02857244
(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
77EUCTR2016-002454-20-FR
(EUCTR)
17/10/201616/03/2017Apomorphine Pump in Early Stage of Parkinson’s DiseaseApomorphine Pump in Early Stage of Parkinson’s Disease - EARLY-PUMP Parkinson’s disease
MedDRA version: 19.1;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: APOKINON
Product Name: APOKINON
CHU de RennesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3France
78NCT02728843
(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
79EUCTR2016-002391-27-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
80NCT02935842
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT02940912
(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
82EUCTR2015-003513-24-DE
(EUCTR)
08/09/201615/04/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY 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 11 004
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Intec Pharma, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
266Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
83NCT02688465
(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
84NCT02615873
(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
85EUCTR2015-004344-19-FR
(EUCTR)
29/06/201620/04/2016An international trial of deferiprone in patients with parkinson’s diseaseA Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 Parkinson’s disease
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
ApoPharma Inc.NULLNot Recruiting Female: yes
Male: yes
140Phase 2United States;France;Canada;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
86EUCTR2015-003513-24-BG
(EUCTR)
27/06/201626/04/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY 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 11 004
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
266Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
87EUCTR2015-003513-24-IT
(EUCTR)
23/06/201605/11/2020OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY 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 11 004 - OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg
Product Code: [NA]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg
Product Code: [NA]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
INTEC PHARMA LTDNULLNot RecruitingFemale: yes
Male: yes
266Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;United Kingdom;Italy
88EUCTR2015-003512-20-PL
(EUCTR)
22/06/201601/04/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Intec Pharma, Ltd.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
89EUCTR2015-003512-20-IT
(EUCTR)
08/06/201605/11/2020Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill¿ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson¿s Disease Patients - Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852
MedDRA version: 20.0;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
Product Code: [na]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg
Product Code: [na]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg
Product Code: [na]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
INTEC PHARMA LTDNULLNot RecruitingFemale: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Russian Federation;Israel;Bulgaria;Germany;United Kingdom;Italy
90JPRN-UMIN000009062
2016/05/3009/10/2012An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease Parkinson's diseaseTake oral inosine 500-3000mg/day to achieve a serum UA level between 6.0-8.0 mg/dLDept. of Clinical pharmacology and NeurologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Phase 1Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2015-003513-24-HU
(EUCTR)
24/05/201602/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY 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 11 004
MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Intec Pharma, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
92EUCTR2015-003513-24-ES
(EUCTR)
18/05/201618/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY 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 11 004 Parkinson's Disease
MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
93EUCTR2015-003512-20-ES
(EUCTR)
18/05/201618/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson?s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill? Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson?s Disease Patients Parkinson's Disease
MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 10-100
Product Name: Immediate Release carbidopa/levodopa 10/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Intec Pharma, Ltd.NULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
94EUCTR2016-000636-18-GB
(EUCTR)
12/05/201604/03/2016 Phase 3, placebo controlled study to examine the efficacy, safety and tolerability of APL-130277 in patients with Parkinson's disease. A Phase 3, Randomized, 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). Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 19.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Sunuvion Pharmaceuticals IncNULLNot Recruiting Female: yes
Male: yes
126Phase 3United States;Canada;United Kingdom
95EUCTR2016-000637-43-GB
(EUCTR)
12/05/201604/03/2016Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease.An 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). Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Sunovion Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;France;Canada;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
96EUCTR2015-003512-20-HU
(EUCTR)
09/05/201602/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 10-100
Product Name: Immediate Release carbidopa/levodopa 10/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Intec Pharma, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
97JPRN-UMIN000022187
2016/05/0606/05/2016Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease Parkinson&#39;s diseasePD group, 200 mg caffeine administration, qd, 1 day
Control group, 200 mg caffeine administration, qd, 1 day
Department of Neurology, Juntendo UniversityNULLComplete: follow-up complete40years-old60years-oldMale and Female20Not applicableJapan
98NCT02762591
(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
99EUCTR2015-003513-24-GB
(EUCTR)
28/04/201604/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY 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 11 004
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
266Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
100EUCTR2015-003512-20-GB
(EUCTR)
28/04/201603/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;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
101EUCTR2015-003512-20-SK
(EUCTR)
22/04/201604/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
102NCT03034538
(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
103NCT02764125
(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
104NCT02775591
(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
105NCT02719496
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT03173781
(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
107NCT04470037
(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
108NCT02729714
(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
109EUCTR2015-004344-19-GB
(EUCTR)
31/03/201616/02/2016An international trial of deferiprone in patients with Parkinson’s diseaseA Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 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: Deferiprone 600 mg delayed release tablet
INN or Proposed INN: DEFERIPRONE
ApoPharmaNULLNot RecruitingFemale: yes
Male: yes
140Phase 2France;Canada;Germany;United Kingdom
110JPRN-jRCTs061180060
22/03/201618/03/2019Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's diseaseMulti-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease - Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease Parkinson's disease;D010300Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years or placebo (500mg/CP)Nagai MasahiroNULLRecruiting>= 20age oldNot applicableBoth100Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT02605434
(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
112JPRN-UMIN000020527
2016/02/0101/02/2016Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease Parkinson's diseaseInosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years
Lactose as a placebo for 2 years
Ehime University Graduate School of MedicineNULLRecruiting20years-oldNot applicableMale and Female100Phase 2Japan
113JPRN-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
114NCT02655315
(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
115NCT02549573
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116JPRN-UMIN000019654
2015/11/0606/11/2015The effect of rich-hydrogen water drinking to gut peptide Parkinson's disease, healthy controlhydrogen water
natural water
Nagoya graduate school of medicine universityNULLPending20years-old80years-oldMale and Female40Not applicableJapan
117JPRN-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
118JPRN-UMIN000019082
2015/10/1022/09/2015the effect of smell dysfunction using hydrogen gas for parkinson disease parkinson's diseasewe measured smell test and urine 8-OHdG before and after 3.5% hydrogen gas. After two month discontinuation of administration. we measured smell test and urine 8-OHdG before and after room air.
we measured smell test and urine 8-OHdG before and after room air. After two month discontinuation of administration. we measured smell test and urine 8-OHdG before and after 3.5% hydrogen gas.
Nagoya University Graduate School of MedicineNULLComplete: follow-up completeNot applicableNot applicableMale and Female20Not selectedJapan
119JPRN-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
120NCT02542696
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2014-000657-36-NL
(EUCTR)
22/06/201503/06/2015Trial to investigate the efficacy of treatments in apomorphine-induced skin reactionsOpen-label crossover trial to investigate the efficacy of treatments in apomorphine-induced skin reactions - Treatment of apomorphine-induced skin reactions: a pilot study Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]University Medical Center GroningenNULLNot Recruiting Female: yes
Male: yes
20Phase 2Netherlands
122NCT02469090
(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
123NCT02230930
(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
124NCT02439203
(ClinicalTrials.gov)
May 201530/4/2015Efficacy and Safety of JM-010 in PD With Levodopa-Induced DyskinesiaA Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study in Subjects With Parkinson's Disease With Moderate to Severe Levodopa-induced Dyskinesia, to Assess the Efficacy, Safety/Tolerability and Pharmacokinetics of JM-010Parkinson's Disease;Levodopa Induced Dyskinesia (LID)Drug: JM-010;Drug: PlaceboBukwang PharmaceuticalContera Pharma ApSCompleted18 YearsN/ABoth30Phase 2South Africa
125JPRN-UMIN000017036
2015/04/0303/04/2015Association of ghrelin and leptin in cardiovascular autonomic dysfunction in patients with primary dysautonomia. autonomic failure such as Parkinson's diseaseblood test of Leptin and Ghrelin
blood test of Leptin and Ghrelin
Nagoya University Graduate School of MedicineNULLComplete: follow-up complete40years-oldNot applicableMale and Female50Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126JPRN-UMIN000016591
2015/04/0120/02/2015Clinical trial of balance exercise "Assist" Stroke, Parkinson disease, Osteoarthrosisuse of balance exercise assist
ordinary balance exercise
Juntendo UniversityNULLComplete: follow-up complete20years-old75years-oldMale and Female40Not applicableJapan
127NCT02486432
(ClinicalTrials.gov)
April 201522/6/2015A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa)A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) Doses Administered Using a Divided Dose ApproachParkinson's DiseaseDrug: Levodopa/Carbidopa (Sinemet)NeuroDerm Ltd.Quotient ClinicalCompleted40 Years65 YearsBoth6Phase 1NULL
128NCT02424708
(ClinicalTrials.gov)
April 201515/4/2015Phase IIb Study of Intranasal Glutathione in Parkinson's DiseasePhase IIb Study of Intranasal Glutathione in Parkinson's DiseaseParkinson's DiseaseDrug: Reduced Glutathione 100mg;Drug: Reduced Glutathione 200mg;Drug: PlaceboBastyr UniversityMichael J. Fox Foundation for Parkinson's ResearchCompleted21 YearsN/ABoth45Phase 2United States
129NCT02359448
(ClinicalTrials.gov)
April 20154/2/2015Melatonin for Nocturia in Parkinson's DiseaseSingle-centre Open Label Exploratory Phase IIb Pilot Study of Exogenous Oral Melatonin for the Treatment of Nocturia in Adults With Parkinson's DiseaseParkinson's Disease;NocturiaDrug: MelatoninUniversity College, LondonNULLNot yet recruiting18 YearsN/ABoth20Phase 2United Kingdom
130NCT02390089
(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
131JPRN-UMIN000016664
2015/03/0101/03/2015Effect of nicotine patch in Cognitive function improvement in Parkinson's disease Parkinson's diseasenicotine patchDepartment of Clinical Pharmacology and Neurology Ehime University graduated School of MedicineNULLRecruitingNot applicableNot applicableMale and Female20Not selectedJapan
132NCT02696603
(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
133JPRN-UMIN000016485
2015/02/2509/02/2015Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome Healthy subjects, Parkinson's disease patients and Parkinson's syndrome patientsIntravenous injection of 18F-fluoro-dopa and 11C-raclopride
PET imaging
Institute of Biomedical Research and InnovationNULLComplete: follow-up complete35years-oldNot applicableMale and Female20Not selectedJapan
134NCT02339064
(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
135ChiCTR-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT02274324
(ClinicalTrials.gov)
October 201422/10/2014Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s DiseaseDietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson's DiseaseParkinson DiseaseDietary Supplement: different dietsSheba Medical CenterTel Aviv UniversityNot yet recruiting40 Years80 YearsBoth20N/ANULL
137JPRN-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
138NCT02228590
(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
139JPRN-UMIN000014709
2014/07/0101/08/2014Study on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2IStudy on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2I - DAT PET with [C-11]PE2I in PD and related disorders Patients of Parkinson's disease and related disordersThe dosage in the vein of [C-11]PE2I, [C-11]raclopride, and [F-18]FDG for PET/CT imaging.Tokyo Metropolitan Institute of GerontologyNULLComplete: follow-up complete18years-oldNot applicableMale and Female200Not selectedJapan
140EUCTR2013-000980-10-DK
(EUCTR)
06/06/201409/01/2014Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment
MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: Apomorphine hydrochloride
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Austria;Denmark;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT03314597
(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
142NCT02365012
(ClinicalTrials.gov)
April 201410/2/2015Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using MidodrineTreatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using MidodrineOrthostatic Intolerance;Parkinson's DiseaseDrug: MidodrinePhiladelphia Veterans Affairs Medical CenterNULLRecruiting22 Years89 YearsBoth50N/AUnited States
143NCT02741947
(ClinicalTrials.gov)
April 201431/3/2016Levodopa Benserazide Generic Formulation Versus the OriginatorClinical and Pharmacokinetics Study to Evaluate the Therapeutic Equivalence and Bioequivalence of Levodopa Benserazide Generic Formulation (Teva Italia) Versus the Originator (Madopar®)Parkinson DiseaseDrug: Levodopa Benserazide Madopar;Drug: Levodopa Benserazide Teva ItaliaIRCCS San RaffaeleAgenzia Italiana del FarmacoCompleted30 Years75 YearsBoth44Phase 4Italy
144NCT02111122
(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
145NCT02091739
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT01738178
(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
147EUCTR2013-000980-10-FR
(EUCTR)
03/03/201422/11/2013Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment
MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: Apomorphine hydrochloride
STADA Arzneimittel AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Netherlands;Germany
148NCT02006121
(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
149EUCTR2013-000980-10-ES
(EUCTR)
12/02/201412/11/2013Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson?s diseaseTOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson?s disease patients with motor complications not well controlled on medical treatment - TOLEDO Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment
MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: Apomorphine hydrochloride
STADA Arzneimittel AGNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Netherlands;Germany
150EUCTR2013-000980-10-NL
(EUCTR)
06/02/201427/01/2014Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment
MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: Apomorphine hydrochloride
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT02007785
(ClinicalTrials.gov)
February 201414/11/2013Study of the Effect of the Cognitive Orientation to Daily Occupational Performance (CO-OP) on Cognitive Impairment in Parkinson's DiseaseDetermining the Applicability of the Cognitive Orientation to Daily Occupational Performance (CO-OP) as a Meta-Cognitive Rehabilitation Strategy for Individuals With Parkinson's Disease-Related Cognitive ImpairmentParkinson's Disease;Cognitive ImpairmentBehavioral: CO-OP treatment protocolUniversity of ManitobaNULLCompleted40 YearsN/ABoth6N/ACanada
152EUCTR2012-002840-26-RO
(EUCTR)
12/11/201317/07/2014Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 Mood Parkinson's disease
MedDRA version: 17.0;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: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
153NCT01856738
(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
154EUCTR2013-000980-10-AT
(EUCTR)
18/10/201331/07/2013Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment
MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: Apomorphine hydrochloride
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Netherlands;Germany
155JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT01765257
(ClinicalTrials.gov)
June 20138/1/2013Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center StudyEvaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study.Drug-naïve Patients With Parkinson's Disease;ApathyDrug: AZILECT®;Drug: PlaceboUniversity Hospital, Clermont-FerrandH. Lundbeck A/S, TEVA;CHU Purpan (Toulouse);Hôpital Haut-Levêque (Pessac);Centre Hospitalier de la Côte Basque;Centre Hospitalier Universitaire de Poitiers (Poitiers);CHU de Rennes (Rennes);University Hospital, Lille;CHU Dupuytren (Limoges);University Hospital, Caen;Hôpital Caremeau (NIMES);Centre Hospitalier Pays D'Aix;Hôpital de la Timone (MARSEILLE);University Hospital, Rouen;Centre Hospitalier Universitaire, Amiens;Centre Hospitalier Universitaire de Saint Etienne;Fondation Rothschild ParisNot yet recruiting30 Years70 YearsBoth50Phase 4France
157JPRN-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
158JPRN-UMIN000010596
2013/05/0101/05/2013Randomized crossover trial comparing memantine or amantadine for Parkinson's disease with motor fluctuations in Juntendo Parkinson's diseaseMemantine preceding arm
Titrate the memantine, administered for 3 months. And tapering memantine and amantadine titrate the dose for 3 months.

Amantadine preceding arm
Titrate the amantadine, administered for 3 months. And tapering amantadine and memantine titrate the dose for 3 months.
Department of Neurology, Juntendo University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale40Not selectedJapan
159EUCTR2012-002840-26-BG
(EUCTR)
26/04/201306/02/2013Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 Mood Parkinson's disease
MedDRA version: 16.0;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: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
160JPRN-UMIN000010778
2013/04/1022/05/2013Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1 - EDAP-2 Parkinson disease5mg donepezil hydroclorideNational Hospital of UtanoNULLComplete: follow-up complete20years-oldNot applicableMale and Female50Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161JPRN-UMIN000010371
2013/04/0801/04/2013Study of zonisamide ( TRERIEF&reg; tablet 25mg ) to tremor in patients with early Parkinson's disease. Parkinson's diseaseStart 25mg of Zonisamide and carry out observation 24weeks.
Evaluate start point, after 4weeks, after 8weeks, after 16weeks, and after 24weeks.
Department of Neurology, University of YamanashiNULLPendingNot applicableNot applicableMale and Female10Not selectedJapan
162NCT01777555
(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
163NCT02005029
(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
164NCT01829867
(ClinicalTrials.gov)
April 20139/4/2013A Study With an Increased Dose Step in Patients That Have Previously Received Placebo or sNN0031.A Phase I, Open-label Study in Patients With Parkinson's Disease to Further Assess Safety and Tolerability of sNN0031 Administered at the Total Dose of 95 µg by Intracerebroventricular InfusionParkinson's DiseaseDrug: sNN0031Newron Sweden ABNULLTerminated55 Years75 YearsBoth5Phase 1Sweden
165EUCTR2012-002840-26-SI
(EUCTR)
26/03/201318/03/2013Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 Mood Parkinson's disease
MedDRA version: 14.1;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: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4United States;Serbia;Slovenia;Slovakia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166JPRN-UMIN000009958
2013/03/0801/03/2013Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction Parkinson's diseaseDonepezil hydrochloride added to standard therapy
Placebo added to standard therapy
National Hospital Organization, Sendai-Nishitaga HospitalNULLComplete: follow-up complete55years-old75years-oldMale and Female200Not applicableJapan
167EUCTR2012-002840-26-AT
(EUCTR)
05/03/201306/11/2012Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 Mood Parkinson's disease
MedDRA version: 14.1;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: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4United States;Serbia;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria
168JPRN-UMIN000010014
2013/02/2813/02/2013Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease Parkinson's disesasehydrogen water made by "Suisosui5.0"
placebo-water (nitrogen filling water)
Juntendo University School of Medicine, NeurologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female200Not selectedJapan
169EUCTR2012-002840-26-IT
(EUCTR)
18/02/201311/01/2013Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 MOOD Parkinson's disease
MedDRA version: 14.1;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: Neupro
INN or Proposed INN: ROTIGOTINE
UCB BIOSCIENCES GMBHNULLNot RecruitingFemale: yes
Male: yes
600Phase 4United States;Hungary;Slovenia;Spain;Ukraine;Turkey;Austria;Bulgaria;Russian Federation;Italy
170EUCTR2012-002840-26-HU
(EUCTR)
11/02/201313/12/2012Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 Mood Parkinson's disease
MedDRA version: 16.0;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: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT01782222
(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
172EUCTR2012-002840-26-ES
(EUCTR)
23/01/201329/11/2012Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 Mood Parkinson's disease
MedDRA version: 14.1;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: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
173EUCTR2012-002840-26-SK
(EUCTR)
07/01/201309/03/2016Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 Mood Parkinson's disease
MedDRA version: 18.1;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: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria
174JPRN-UMIN000017695
2013/01/0127/05/2015Oxybuprocaine for apraxia of lid opening in Parkinson's disease apraxia of lid opening in Parkinson's diseaseArm 1 intervention consisted of 4%oxybuprocaine eye drop treatment, washout for 24 hours or more, and a saline eye drop treatment
Arm 2 intervention consisted of saline eye drop treatment, a washout period, and an oxybuprocaine treatment
Utano National Hospital, National Hospital OrganizationNULLComplete: follow-up completeNot applicableNot applicableMale and Female10Not selectedJapan
175NCT01770145
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT03652363
(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
177JPRN-UMIN000009099
2012/10/0112/10/2012The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia Parkinson's diseaselidocaine injection into the external oblique
normal saline injection into the external oblique
Parkinson's disease and Movement Disorder CenterNULLRecruiting20years-oldNot applicableMale and Female10Not applicableJapan
178NCT00947037
(ClinicalTrials.gov)
August 201224/7/2009Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension StudyAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease SubjectsParkinson's DiseaseDrug: AP-CD/LDIntec Pharma Ltd.NULLWithdrawn30 Years95 YearsBoth0Phase 2Israel
179NCT02419313
(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
180JPRN-UMIN000008477
2012/07/1919/07/2012Clinical study of selegiline hydrochloride ( FP OD tablet 2.5) to flexion of spine in Parkinson's disease. Parkinson diseaseSelegiline hydrochloride 5mg 8weeks, 7.5mg 8weeks and stop it, followed after 8weeks, and evaluate each points.Department of Neurology, Juntendo Koshigaya HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181JPRN-UMIN000008138
2012/07/0101/07/2012Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease Parkinson's diseaseSilodosin 8mg BIDJuntendo University School of MedicineNULLComplete: follow-up completeNot applicableNot applicableMale100Not selectedJapan
182JPRN-UMIN000008057
2012/06/0106/06/2012Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease Parkinson's DiseaseDaily oral administration of enteral nutrition formula (Racol NF) 400ml for 12 weeks consecutively.St. Mariannna University School of MedicineNULLComplete: follow-up complete35years-old80years-oldMale and Female25Not applicableJapan
183NCT02786667
(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
184JPRN-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
185NCT01494532
(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
186NCT01486628
(ClinicalTrials.gov)
April 20124/12/2011Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy VolunteersA Phase I, Single Dose, Single-centre, Randomized, Double-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in Healthy VolunteersParkinson's DiseaseDrug: ND0612;Drug: PlaceboNeuroDerm Ltd.NULLCompleted18 Years40 YearsMale36Phase 1Israel
187NCT01491529
(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
188NCT01523301
(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
189NCT01331122
(ClinicalTrials.gov)
April 201213/10/2010Study to Assess Droxidopa in the Treatment of Freezing Of Gait Symptoms in Patients With Parkinson's DiseaseA Phase II, Double-Blind, Placebo-Controlled Randomized Crossover Study to Assess the Clinical Benefit and Safety of Droxidopa in the Treatment of Freezing of Gait Symptoms in Patients With Parkinson's DiseaseGait Disorders, NeurologicDrug: droxidopaChelsea TherapeuticsNULLWithdrawn30 YearsN/ABoth0Phase 1;Phase 2United States;Canada
190NCT01527695
(ClinicalTrials.gov)
April 201222/12/2011PET Study in Parkinson's Disease PatientsA Phase IIA, Multi Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment With Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: ER tablet 25 mg AZD3241;Drug: ER tablet 100 mg AZD3241;Drug: Placebo for AZD3241 25 mg;Drug: Placebo for AZD3241 100 mgAstraZenecaNULLCompleted45 Years75 YearsBoth24Phase 2Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191NCT01550484
(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
192NCT01556165
(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
193EUCTR2011-002901-31-DE
(EUCTR)
08/03/201206/10/2011not applicableA multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg
Product Code: OXN 5 mg/2.5 mg PR
INN or Proposed INN: Oxycodone hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg
Product Code: OXN 10 mg / 5 mg PR
INN or Proposed INN: Oxycodone Hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 20 mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg
Product Code: OXN 20 mg / 10 mg PR
INN or Proposed INN: OXYCODONE HYDROCHLORIDE
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: NAL
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Hungary;Czech Republic;Spain;Germany;United Kingdom
194EUCTR2011-002901-31-HU
(EUCTR)
21/12/201113/10/2011not applicableA multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg
Product Code: OXN 5 mg/2.5 mg PR
INN or Proposed INN: Oxycodone hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg
Product Code: OXN 10 mg / 5 mg PR
INN or Proposed INN: Oxycodone Hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 20 mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg
Product Code: OXN 20 mg / 10 mg PR
INN or Proposed INN: OXYCODONE HYDROCHLORIDE
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: NAL
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Czech Republic;Hungary;Spain;Germany;United Kingdom
195EUCTR2011-002901-31-CZ
(EUCTR)
12/12/201110/10/2011not applicableA multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg
Product Code: OXN 5 mg/2.5 mg PR
INN or Proposed INN: Oxycodone hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg
Product Code: OXN 10 mg / 5 mg PR
INN or Proposed INN: Oxycodone Hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 20 mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg
Product Code: OXN 20 mg / 10 mg PR
INN or Proposed INN: OXYCODONE HYDROCHLORIDE
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: NAL
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Hungary;Czech Republic;Spain;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
196EUCTR2011-002901-31-ES
(EUCTR)
30/11/201105/10/2011not applicableA multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson?s disease associated pain Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
MedDRA version: 14.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg
Product Code: OXN 5 mg/2.5 mg PR
INN or Proposed INN: Oxycodone hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg
Product Code: OXN 10 mg / 5 mg PR
INN or Proposed INN: Oxycodone Hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 20 mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg
Product Code: OXN 20 mg / 10 mg PR
INN or Proposed INN: OXYCODONE HYDROCHLORIDE
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: NAL
Mundipharma Research GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Hungary;Czech Republic;Germany;United Kingdom;Spain
197JPRN-UMIN000006521
2011/10/0111/10/2011Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's diseaseSwitch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease - Switch trial from IR to ER of Pramipexole Parkinson's diseaseRapid switch of Pramipexole ER (once in a day) which is same dose as IR. The period of administration is 8 weeks.Department of Neurology, Juntendo UniversityNULLRecruiting20years-oldNot applicableMale and Female30Not selectedJapan
198EUCTR2010-020299-42-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
199NCT01504178
(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
200NCT01338896
(ClinicalTrials.gov)
April 201118/4/2011Study to Compare Adhesiveness of Two Different Rotigotine Patch FormulationsA Multicenter, Randomized, Double-blind, Two-way Cross-over Study to Compare the Adhesiveness of Two Different Rotigotine Patch Formulations in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: Rotigotine transdermal patchUCB PharmaNULLCompleted18 YearsN/ABoth56Phase 1Austria;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
201NCT01336088
(ClinicalTrials.gov)
April 20114/4/2011ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's DiseasePhase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ADX48621 in the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: ADX48621;Drug: PlaceboAddex Pharma S.A.NULLCompleted30 Years75 YearsBoth83Phase 2United States;Austria;France;Germany
202NCT01313819
(ClinicalTrials.gov)
April 201110/3/2011The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic TherapyA Double Blind, Placebo-controlled Study for the Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic TherapyParkinson`s Disease;Freezing of GaitDrug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml injSeoul National University HospitalNULLRecruiting30 Years80 YearsBoth20Phase 4Korea, Republic of
203NCT01662414
(ClinicalTrials.gov)
April 20117/8/2012Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's DiseaseEffect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease: Changes in Biomarkers of Oxidative Stress, Profiles of Plasma Amino Acids and Their Derivatives and Brain FunctionParkinson Disease;Parkinsonian Disorders;Basal Ganglia Diseases;Brain Diseases;Central Nervous System Diseases;Nervous System Diseases;Movement Disorders;Neurodegenerative DiseasesDietary Supplement: Whey protein;Dietary Supplement: Soy proteinChulalongkorn UniversityNULLCompleted30 Years80 YearsBoth38Phase 4Thailand
204NCT01937078
(ClinicalTrials.gov)
April 201126/7/2012Famotidine for Levodopa-induced Dyskinesia in PDAn 'N-of-1' Study of the Histamine H@ Antagonist, Famotidine in Levodopa-induced Dyskinesia in Parkinson's DiseaseDyskinesiaDrug: FamotidineUniversity Health Network, TorontoNULLCompleted18 Years80 YearsBoth7Phase 2Canada
205NCT02880033
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206EUCTR2010-018650-12-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
207NCT01113320
(ClinicalTrials.gov)
April 20108/4/2010Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease SubjectsA Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose Escalation Trial to Explore the Potential Antidyskinetic Properties of Safinamide in Patients With Parkinson's Disease Suffering From Levodopa Induced DyskinesiasParkinson's DiseaseDrug: Placebo;Drug: SafinamideNewronNULLCompleted30 YearsN/ABoth26Phase 2Austria;Canada;France;Germany;South Africa
208NCT01484990
(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
209NCT01103011
(ClinicalTrials.gov)
April 201012/4/2010Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611A Phase I, Single Center, Blinded, Controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Repeated Administration of Oral Levodopa/Carbidopa and Continuously Delivered ND0611Parkinson's DiseaseDrug: ND0611NeuroDerm Ltd.NULLCompleted18 Years50 YearsMale8Phase 1Israel
210NCT00988117
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2009-017416-33-DE
(EUCTR)
18/01/201021/12/2009Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol.Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. Male and female patients with Parkinson´s disease meeting UKPDS criteria
MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: Tasmar
Product Name: Tolcapon
Product Code: TO
INN or Proposed INN: TOLCAPONE
Trade Name: Comtess
Product Name: Entacapon
Product Code: EN
INN or Proposed INN: ENTACAPONE
Trade Name: Isicom
Product Name: Levodopa/Carbidopa
Product Code: LD/CD
INN or Proposed INN: LEVODOPA
Other descriptive name: CARBIDOPA MONOHYDRATE
Trade Name: Tasmar
Product Name: Tolcapon
Product Code: TO
INN or Proposed INN: TOLCAPONE
Trade Name: Comtess
Product Name: Entacapon
Product Code: EN
INN or Proposed INN: ENTACAPONE
Trade Name: Isicom
Product Name: Levodopa/Carbidopa
Product Code: LD/CD
INN or Proposed INN: LEVODOPA
Other descriptive name: CARBIDOPA MONOHYDRATE
Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-UniversityNULLNot RecruitingFemale: yes
Male: yes
Germany
212EUCTR2009-012643-42-NL
(EUCTR)
06/01/201030/11/2009Freezing of gait in Parkinson's disease: in search of the underlying mechanism and the application of a new treatment option - Freezing of gait in Parkinson's diseaseFreezing of gait in Parkinson's disease: in search of the underlying mechanism and the application of a new treatment option - Freezing of gait in Parkinson's disease Parkinson's disease, in particular the symptom Freezing of GaitTrade Name: Ritalin
Product Name: Not applicable
Product Code: Not applicable
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
Other descriptive name: Ritalin
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
213JPRN-UMIN000007497
2010/01/0114/03/2012Trial of molecular hydrogen water in Parkinson disease Parkinson diseaseThe subjects should make 1000 ml of molecular hydrogen water which contains 1.6 ppm dissolved hydrogen by Aquerable, and consume for 48 weeks.
Placebo water which is not contained molecular hydrogen water made from pseudo-machine. The subjects consume for48 weeks.
Department of Neurology, Juntendo University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female18Not applicableJapan
214JPRN-UMIN000003080
2010/01/0130/01/2010Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease Parkinson's diseaseDonepezil hydrochloride (3mg for 2 weeks, 5mg for 2 weeks)
Placebo
Clinical Research Center, Utano National Hospital, National Hospital OrganizationNULLComplete: follow-up complete40years-old75years-oldMale and Female30Not applicableJapan
215NCT00918177
(ClinicalTrials.gov)
July 20091/6/2009An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's DiseaseDual Release Gastric Retentive AP09004, Vs. Active Control; a Pharmacokinetic/Pharmacodynamic, Comparative, Safety Evaluation in Parkinson's PatientsParkinson's DiseaseDrug: AP09004;Drug: Carbidopa/Levodopa, immediate releaseIntec Pharma Ltd.NULLCompleted18 YearsN/ABoth72Phase 2Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216NCT00845000
(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
217JPRN-JapicCTI-090888
01/4/2009A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopaA Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopa Parkinson's Disease Treated Concomitantly with L-dopaIntervention name : SPM 962
Dosage And administration of the intervention : SPM 962: transdermal application, 1 time per day. Initial dose:4.5mg/day, weekly increment of 4.5mg/day, maximal maintenance dose : 36.0mg/day. Placebo of ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day
Control intervention name : Ropinirole
Dosage And administration of the control intervention : placebo SPM 962: transdermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Ropinirole: oral application 3 times per day. Initial dose:0.75mg/day, weekly increment of 0.75mg/day (up to 3.0mg/day), then 1.5mg/day (up to 15.0mg/day), maximal maintenance dose 15.0 mg/day.
Control intervention name : Placebo
Dosage And administration of the control intervention : placebo SPM 962: transermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Placebo ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day.
Otsuka Pharmaceutical Co., Ltd.NULL3079BOTH400Phase 3NULL
218NCT00880620
(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
219NCT00875316
(ClinicalTrials.gov)
April 20092/4/2009Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease PatientsA Randomised, Double-blind, Multiple Dose-ascending, Placebo-controlled Study in Healthy Volunteers and Parkinson's Disease Patients to Assess the Safety, Tolerability and PK of Daily Oral Administration of Cogane™ Over One MonthParkinson's DiseaseDrug: Cogane™ (PYM50028)PhytopharmNULLCompleted40 Years80 YearsBoth36Phase 1United Kingdom
220NCT01568034
(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
221NCT00914134
(ClinicalTrials.gov)
April 20091/6/2009Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's DiseaseEffect of Duodenal Levodopa Infusion on Quality of Life and Autonomic Dysfunction in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: Levodopa infusionHelsinki UniversitySolvay PharmaceuticalsCompleted40 Years80 YearsBoth12Phase 4Finland
222NCT00865579
(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
223EUCTR2008-004447-11-GB
(EUCTR)
27/03/200907/01/2009A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s DiseaseA Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease
MedDRA version: 11;Level: LLT;Classification code 10067209;Term:
Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Vectura LimitedNULLNot RecruitingFemale: yes
Male: yes
66Phase 2bGermany;United Kingdom;Italy
224NCT00758368
(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
225NCT00767091
(ClinicalTrials.gov)
March 20091/9/2008Study of Rivastigmine to Treat Parkinsonian Apathy Without DementiaA Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicentric TrialParkinson's Disease;Apathy;no DementiaDrug: rivastigmine;Drug: placeboUniversity Hospital, LilleNULLCompleted15 Years80 YearsBoth40Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226NCT01039090
(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
227NCT00809302
(ClinicalTrials.gov)
December 200815/12/2008Efficacy and Safety Study of Aplindore in Patients With Early Parkinson DiseaseA Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Doses of Aplindore MR (1, 3, and 6 mg Twice Daily) in Patients With Early Parkinson Disease (APLIED)Early Parkinson DiseaseDrug: aplindore MR tablets or PlaceboNeurogen CorporationNULLTerminated30 YearsN/ABoth9Phase 2United States
228NCT00755027
(ClinicalTrials.gov)
September 200817/9/2008Rasagiline and Apathy in Parkinson's DiseaseA Randomised Placebo-controlled Trial of Rasagiline in Parkinson Disease Patients With Symptoms of ApathyParkinson's DiseaseDrug: RasagilineFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauNULLCompleted18 Years80 YearsBoth40Phase 4Spain
229EUCTR2008-001336-13-FR
(EUCTR)
16/07/200809/06/2008Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients. - NICOPARK2Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients. - NICOPARK2 Maladie Parkinson
MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Nicorette 5 mg/ 16 h
Product Name: Nicorette 5 mg/ 16 h
INN or Proposed INN: Nicotine
Product Name: Nicorette 10mg/ 16 h
INN or Proposed INN: Nicotine
Product Name: Nicorette 15 mg/ 16 h
INN or Proposed INN: Nicotine
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
230NCT02071810
(ClinicalTrials.gov)
April 200819/1/2012Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Four Multiple Rising Dose Regimens of BIA 9-1067 in Healthy Male VolunteersParkinson's Disease (PD)Drug: BIA 9-1067;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years45 YearsMale34Phase 1France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231NCT00651183
(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
232NCT00753636
(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
233NCT00605553
(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
234NCT00623324
(ClinicalTrials.gov)
January 200814/2/2008The Effects of Aplindore on the Treatment of Signs and Symptoms of Parkinson's DiseaseA Phase II, Dose Ranging, Randomized, Double Blind, Placebo-controlled, Multi-center, Pilot Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of Aplindore in Patients With Early Stage Parkinson's DiseaseEarly Stage Parkinson's DiseaseDrug: Aplindore;Drug: PlaceboLigand PharmaceuticalsNULLCompleted30 YearsN/ABoth40Phase 2United States
235EUCTR2007-004400-12-ES
(EUCTR)
27/12/200703/01/2008ENSAYO RANDOMIZADO A DOBLE CIEGO Y CONTROLADO CON PLACEBO DE RASAGILINA EN PACIENTES CON ENFERMEDAD DE PARKINSON Y SINTOMAS DE APATIA - Rasagiline and ApathyENSAYO RANDOMIZADO A DOBLE CIEGO Y CONTROLADO CON PLACEBO DE RASAGILINA EN PACIENTES CON ENFERMEDAD DE PARKINSON Y SINTOMAS DE APATIA - Rasagiline and Apathy Apatía en la Enfermedad de Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Azilect
INN or Proposed INN: RASAGILINE
Institut de Recerca de l'Hospital de la santa Creu i Sant PauNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236NCT00610103
(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
237EUCTR2005-005791-32-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
238NCT00524914
(ClinicalTrials.gov)
September 20074/9/2007Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging StudyApomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study.Parkinson's DiseaseDrug: apomorphine;Drug: placeboUniversity Hospital, ToulouseNULLCompleted30 Years70 YearsBoth16N/AFrance
239EUCTR2006-005318-11-FR
(EUCTR)
06/07/200710/05/2007Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons.Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons. maladie de Parkinson
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: APOKINONCHU ToulouseNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
240JPRN-UMIN000000780
2007/06/0101/08/2007A randomized, double-blind, placebo-controlled, cross-over, multi-center study concerning the efficacy and safety of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease Parkinson's diseaseAn observation period (2 to 3 weeks)

An administration of amantadine hydrochloride (27 days)

A wash out period (15 days)

An administration of placebo (27 days)
An observation period (2 to 3 weeks)

An administration of placebo (27 days)

A wash out period (15 days)

An administration of amantadine hydrochloride (27 days)
Comprehensive clinical study group concerning diagnosis, treatment, and prevention of the neurological disordersMusashi Hospital, National Center of Neurology and Psychiatry, JapanEhime University HospitalComplete: follow-up complete20years-old75years-oldMale and Female60Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241NCT00489255
(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
242NCT00434304
(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
243NCT00623363
(ClinicalTrials.gov)
April 20072/1/2008Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's DiseaseParkinson's DiseaseDrug: piclozotan;Drug: 0.9% sodium chloride (normal saline)Asubio Pharmaceuticals, Inc.NULLCompleted40 Years85 YearsBoth27Phase 2United States;Guatemala;Romania
244NCT00459420
(ClinicalTrials.gov)
April 200711/4/2007Caffeine for Excessive Daytime Somnolence in Parkinson's DiseaseCaffeine for Excessive Daytime Somnolence in Parkinson's DiseaseParkinson's Disease;Excessive Daytime SomnolenceDrug: Caffeine 100-200 mg BID;Drug: placeboRon PostumaCanadian Institutes of Health Research (CIHR);University of TorontoCompleted18 YearsN/ABoth58Phase 2;Phase 3Canada
245NCT00466167
(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
246NCT00460148
(ClinicalTrials.gov)
April 200711/4/2007Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of RopiniroleAn Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets.Parkinson DiseaseDrug: RopiniroleGlaxoSmithKlineNULLCompleted30 Years85 YearsBoth28Phase 2Germany;South Africa
247NCT00438607
(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
248EUCTR2006-005509-79-GB
(EUCTR)
21/12/200607/12/2006A Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s DiseaseA Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s Disease Idiopathic Parkinson's Disease patients who have motor fluctuations with recognisable motor off” periodsProduct Name: apomorphine hydrochloride
Product Code: VR040
INN or Proposed INN: apomorphine hydrochloride
Vectura Group plcNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United Kingdom
249EUCTR2006-002339-26-IT
(EUCTR)
16/12/200605/06/2007Studio di Estensione Multi-centrico, in Aperto per Valutare Sicurezza, Tollerabilita' ed Efficacia a Lungo Termine di E2007 come Terapia Aggiuntiva in Pazienti affetti da Morbo di Parkinson con Fluttuazioni Motorie Trattati con Levodopa. - E2007-G000-303Studio di Estensione Multi-centrico, in Aperto per Valutare Sicurezza, Tollerabilita' ed Efficacia a Lungo Termine di E2007 come Terapia Aggiuntiva in Pazienti affetti da Morbo di Parkinson con Fluttuazioni Motorie Trattati con Levodopa. - E2007-G000-303 Levodopa treated Parkinson's Disease Patients with Motor Fluctuations
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: E2007EISAI LTD UKNULLNot RecruitingFemale: yes
Male: yes
1400Phase 3Portugal;Hungary;Czech Republic;Estonia;Spain;Belgium;Lithuania;Austria;Germany;United Kingdom;Italy;Sweden
250EUCTR2006-004582-33-GB
(EUCTR)
03/11/200623/01/2012A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s DiseaseA Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s Disease Hypomobility (off or freezing) episodes associated with advanced Parkinson's diseaseProduct Name: Apomorphine hydrochloride
Product Code: VR040
Vectura Group plcNULLNot RecruitingFemale: yes
Male: yes
48Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251EUCTR2005-001006-12-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
252EUCTR2006-000391-32-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
253EUCTR2006-000391-32-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
254NCT00408915
(ClinicalTrials.gov)
July 20065/12/2006Continuous Application of Lisuride in Parkinson's Disease by Subcutaneous InfusionDouble-blind, Placebo-controlled, Randomized, Multicentre Phase II/III Study to Evaluate the Efficacy and Safety of Lisuride, Applied Subcutaneously by Means of a Minipump in Patients With Advanced Parkinson's Disease Refractory to Conventional Oral TherapyParkinson's DiseaseDrug: Continuous Subcutaneous Lisuride InfusionAxxonis Pharma AGNULLCompleted18 Years75 YearsBoth60Phase 3Germany
255NCT00346827
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256EUCTR2006-000391-32-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
257NCT03094156
(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
258EUCTR2005-005791-32-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
259EUCTR2005-001006-12-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
260NCT00349310
(ClinicalTrials.gov)
April 20065/7/2006Profile of Depressive Symptoms in Parkinsons DiseaseProfile of Depressive Symptoms in Parkinson's Disease (PRODEST-PD)Parkinson Disease;DepressionDrug: PramipexoleBoehringer IngelheimNULLCompleted18 YearsN/ABoth1018Austria;France;Germany;Italy;Netherlands;Spain;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
261NCT00461942
(ClinicalTrials.gov)
April 200617/4/2007Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease PatientsA Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Neuroprotection Effect of Green Tea Polyphenol in De Novo Parkinson's Disease PatientsParkinson's DiseaseDrug: Green Tea Polyphenols (EGCG/ECG)Xuanwu Hospital, BeijingMinistry of Health, China;Michael J. Fox Foundation for Parkinson's ResearchCompleted30 YearsN/ABoth480Phase 2China
262NCT00646204
(ClinicalTrials.gov)
April 200628/12/2007Namenda (Memantine) for Non-Motor Symptoms in Parkinson's DiseaseA 16 WEEK, INVESTIGATOR-INITIATED, SINGLE-CENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF NAMENDA® (MEMANTINE HCL) FOR NON-MOTOR SYMPTOMS IN PARKINSON'S DISEASEParkinson's DiseaseDrug: Memantine;Drug: placeboBaylor College of MedicineForest LaboratoriesCompleted18 Years80 YearsBoth40Phase 4United States
263NCT00467597
(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
264NCT00294554
(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
265EUCTR2005-001006-12-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266NCT01683292
(ClinicalTrials.gov)
January 20067/9/2012Single-Centre Study of VR040(Inhaled Apomorphine) in Idiopathic Parkinson's DiseaseAn Ascending-Dose, Single-Centre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040(Inhaled Apomorphine)in Parkinson's DiseaseParkinson's DiseaseDrug: Inhaled VR040;Drug: Placebo for VR040South Glasgow University Hospitals NHS TrustVectura LimitedCompleted30 YearsN/ABoth29Phase 2United Kingdom
267EUCTR2005-005120-13-GB
(EUCTR)
21/12/200502/11/2005A clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s DiseaseA clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s Disease Hypomobility (off” or freezing”) episodes associated with advanced Parkinson’s diseaseProduct Name: Apomorphine hydrochloride
Product Code: VR040
INN or Proposed INN: apomorphine hydrochloride
Vectura Group plcNULLNot RecruitingFemale: yes
Male: yes
24Phase 2United Kingdom
268NCT00472355
(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
269EUCTR2004-001485-41-GB
(EUCTR)
26/07/200521/06/2005A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/AA single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria).Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: carbidopa/levodopa
Trade Name: Cabaser
Product Name: Cabaseril
INN or Proposed INN: Cabergoline
Trade Name: DaTSCAN
Product Name: DatSCAN
INN or Proposed INN: Ioflupane [123 I]
Institute for Neurodegenerative DisordersNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom;Spain
270EUCTR2004-001485-41-ES
(EUCTR)
28/04/200530/01/2006A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s DiseaseA single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria).Trade Name: SINEMET
Product Name: carbodopa/levadopa
INN or Proposed INN: CARBODOPA LEVADOPA
Trade Name: SOLIGEN
Product Name: Cabergoline
INN or Proposed INN: CABERGOLINA
Trade Name: DaTSCAN
INN or Proposed INN: Ioflupane [123I]
Institute for Neurodegenerative DisordersNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120United Kingdom;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271EUCTR2004-001485-41-AT
(EUCTR)
20/04/200516/03/2005A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/AA single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria).Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: carbidopa/levodopa
Trade Name: Cabaseril
Product Name: Cabaseril
INN or Proposed INN: Cabergoline
Trade Name: DaTSCAN
Product Name: DatSCAN
INN or Proposed INN: Ioflupane [123 I]
Institute for Neurodegenerative DisordersNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Spain;Austria;United Kingdom
272NCT00199355
(ClinicalTrials.gov)
April 200512/9/2005A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking LevodopaPlacebo-Controlled , Double-Blind , Exploratory Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Adjunctive Therapy to Levodopa]Parkinson's DiseaseDrug: Istradefylline (KW-6002)Kyowa Hakko Kirin Company, LimitedNULLCompleted30 YearsN/ABoth75Phase 2Japan
273NCT00375778
(ClinicalTrials.gov)
April 200512/9/2006Parkinson's Disease Evaluated by PET and the Effect of MemantineParkinson's Disease Evaluated by Positron Emission Tomography and the Effect of the NMDA Receptor Antagonist MemantineParkinson's DiseaseDrug: memantine (drug)University of AarhusLundbeck FoundationCompleted50 Years70 YearsBoth12N/ADenmark
274NCT00108667
(ClinicalTrials.gov)
April 200515/4/2005Talampanel to Treat Parkinson's DiseaseAMPA Receptor Antagonist Treatment of Parkinson's DiseaseParkinson DiseaseDrug: IV Levodopa;Drug: TalampanelNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth40Phase 2United States
275NCT00058838
(ClinicalTrials.gov)
April 200314/4/2003Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's DiseaseA Phase III, Double-Blind, Placebo-Controlled, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease.Parkinson DiseaseDrug: sumanirolePfizerNULLCompleted30 YearsN/ABoth854Phase 3United States;Argentina;Australia;Austria;Belgium;Colombia;France;Germany;Greece;Italy;Mexico;Peru;Puerto Rico;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276NCT00058721
(ClinicalTrials.gov)
April 200311/4/2003Single Photon Emission Computed Tomography to Study Receptors in Parkinson's DiseaseSPECT Evaluation of Nicotinic Cholinergic Receptors in Parkinson's DiseaseParkinson DiseaseDrug: I-123-5-IA85380National Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth60N/AUnited States
277NCT00040209
(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
278NCT00456586
(ClinicalTrials.gov)
April 20023/4/200712-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/CarbidopaA 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of 40 mg/Day KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa TherapyParkinson's DiseaseDrug: KW-6002 (istradefylline)Kyowa Kirin Pharmaceutical Development, Inc.NULLCompleted30 YearsN/ABoth180Phase 2United States
279NCT00200525
(ClinicalTrials.gov)
July 200113/9/2005Continued Efficacy and Safety of Apomorphine in Patients With Late-Stage Parkinsons DiseaseA Randomized, Placebo-Controlled Study of the Continued Efficacy and Safety of SC Apomorphine in the Treatment of Off Episodes in Patients With On/Off or Wearing-Off Effects Associated With Late-Stage PD After Apomorphine UseParkinson DiseaseDrug: apomorphine HCl injectionMylan Bertek PharmaceuticalsNULLCompleted18 YearsN/ABoth60Phase 3NULL
280NCT02763839
(ClinicalTrials.gov)
April 20014/5/2016Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Carbidopa (100/25 mg)Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Carbidopa (100/25 mg): a Double-blind, Randomised, Crossover, Placebo Controlled Study in Healthy VolunteersParkinson's DiseaseDrug: BIA 3-202;Drug: Placebo;Drug: Sinemet 25/100Bial - Portela C S.A.NULLCompleted18 Years45 YearsBoth19Phase 1Portugal
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281NCT02763852
(ClinicalTrials.gov)
April 20014/5/2016Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg)Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg): a Double-blind, Randomised, Crossover, Placebo Controlled Study in Healthy VolunteersParkinson's DiseaseDrug: BIA 3-202;Drug: Placebo;Drug: Madopar® 125Bial - Portela C S.A.NULLCompleted18 Years45 YearsBoth18Phase 1Portugal
282NCT00145171
(ClinicalTrials.gov)
February 20012/9/2005A Sub-Study With Patients in APO401 to Evaluate Adverse Events During Dose Introduction in Apomorphine-naïve Patients.Study of Orthostatic Changes Upon Apomorphine Dose Initiation in Late Stage Parkinson’s Disease Patients. A Dose Escalation Study With a Double-Blind Placebo-Controlled Efficacy Determination at 4 Mg.Parkinson DiseaseDrug: apomorphine HCl injectionMylan Bertek PharmaceuticalsNULLCompleted18 YearsN/ABoth56Phase 3NULL
283NCT02763787
(ClinicalTrials.gov)
April 20004/5/2016Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of BIA 3-202A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Single Doses of BIA 3-202 in Healthy Volunteers.Parkinson's DiseaseDrug: BIA 3-202;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years35 YearsMale71Phase 1United Kingdom
284NCT00134784
(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
285NCT00200512
(ClinicalTrials.gov)
September 199913/9/2005Continued Efficacy of Apomorphine After Previous Exposure of at Least Three MonthsA Prospective, Randomized, Placebo-Controlled, Crossover Study of the Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of Off Episodes in Patients With On/Off or Wearing Off Effects Associated With Late Stage Parkinson's DiseaseParkinson DiseaseDrug: apomorphine HCl injectionMylan Bertek PharmaceuticalsNULLCompleted18 YearsN/ABoth16Phase 2;Phase 3United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286NCT00142545
(ClinicalTrials.gov)
July 199931/8/2005Long Term Safety and Efficacy of SC Apomorphine in Treatment of Off Episodes in Late-Stage Parkinson's DiseaseLong-Term Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of Off” Episodes in Patients With On-Off” or Wearing-Off” Effects Associated With Late-Stage Parkinson’s DiseaseParkinson DiseaseDrug: apomorphine HCl injectionMylan Bertek PharmaceuticalsNULLCompleted18 YearsN/ABoth800Phase 3United States
287NCT00001931
(ClinicalTrials.gov)
May 199931/7/2007Treatment of Parkinson's Disease With a Transdermal Skin PatchTransdermal Application of Dopamine Agonist N-0923 in Parkinson's DiseaseParkinson DiseaseDrug: N-0923National Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth20Phase 2United States
288NCT02172573
(ClinicalTrials.gov)
April 199920/6/2014Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's DiseaseA Double-blind, Placebo-controlled, Randomised, Multicenter Trial to Compare the Safety and Efficacy of Oral Administration of Pramipexole up to 4.5mg and Bromocriptine up to 22.5mg Combined With L-dopa in Advanced Parkinson's DiseaseParkinson DiseaseDrug: Pramipexole;Drug: Bromocriptine;Drug: Placebo pramipexole;Drug: Placebo bromocriptineBoehringer IngelheimNULLCompleted20 YearsN/ABoth315Phase 3NULL
289EUCTR2008-004447-11-DE
(EUCTR)
17/10/2008A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s DiseaseA Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease
MedDRA version: 11;Level: LLT;Classification code 10067209;Term:
Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Vectura LimitedNULLNot RecruitingFemale: yes
Male: yes
66Phase 2bGermany;Italy;United Kingdom

13. 多発性硬化症/視神経脊髄炎 [臨床試験数:3,050,薬物数:2,147(DrugBank:348),標的遺伝子数:244,標的パスウェイ数:228
Searched query = "Multiple sclerosis/Neuromyelitis optica", "Multiple sclerosis", "Neuromyelitis optica", "MS", "NMOSD", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
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.
236 / 3,050 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-003995-42-DE
(EUCTR)
18/12/202029/10/2020Extension to the MAGNIFY MS trial on Mavenclad®A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension Highly-active relapsing multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: CLADRIBINE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
256Phase 4Canada;Finland;Australia;Israel;Germany
2EUCTR2017-003008-30-GB
(EUCTR)
01/07/202017/05/2018Simvastatin in Secondary Progressive Multiple SclerosisA double-blind, randomised, placebo-controlled single-site study of high dose simvastatin treatment for secondary progressive multiple sclerosis: impact on vascular perfusion and oxidative damage - MS-OPT Version 1.3 dated 23/05/18 Multiple Sclerosis (Secondary Progressive)
MedDRA version: 20.0;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Simvastatin 40 mg film-coated tablets
Product Name: Simvastatin 40 mg film-coated tablets
Product Code: Not applicable
INN or Proposed INN: Simvastatin
University College LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United Kingdom
3NCT03404388
(ClinicalTrials.gov)
April 1, 202011/1/2018Brain and Behavioral Influences on Motor Skill Learning in Multiple SclerosisBrain and Behavioral Influences on Motor Skill Learning in Multiple SclerosisMultiple SclerosisBehavioral: Balance TrainingWayne State UniversityNULLEnrolling by invitation18 Years65 YearsAll150N/AUnited States
4NCT04267185
(ClinicalTrials.gov)
February 4, 202016/1/2020A Dyadic Approach for Promoting Physical Activity Among People With MS and Their Support PartnersPhysical Activity Together for MS (PAT-MS): Pilot Study of a Dyadic Rehabilitation Intervention for People With Moderate-to-Severe Multiple Sclerosis Disability and Their Family CaregiversMultiple SclerosisBehavioral: Physical Activity Together for PwMS and their CGs (PAT-MS)University of OttawaThe Ottawa Hospital;Consortium of Multiple Sclerosis CentersActive, not recruiting18 YearsN/AAll40N/ACanada
5EUCTR2019-000069-19-AT
(EUCTR)
20/11/201906/06/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck, S.L.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4United States;Portugal;Serbia;Estonia;Morocco;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-000069-19-PT
(EUCTR)
14/10/201913/05/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4Romania;Serbia;United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
7EUCTR2019-000069-19-PL
(EUCTR)
08/09/201927/06/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4Lithuania;United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
8EUCTR2019-000069-19-BG
(EUCTR)
05/09/201904/06/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4Serbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
9EUCTR2019-000069-19-LT
(EUCTR)
27/08/201910/06/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4Serbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
10EUCTR2019-000069-19-SE
(EUCTR)
14/08/201910/05/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4Serbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-000069-19-CZ
(EUCTR)
12/07/201907/05/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4United States;Portugal;Serbia;Estonia;Morocco;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
12NCT03824938
(ClinicalTrials.gov)
April 30, 20199/1/2019Aspirin for Exercise in Multiple Sclerosis (ASPIRE)Aspirin for Exercise in Multiple Sclerosis (ASPIRE): A Double-Blind RCT of Aspirin or Acetaminophen Pretreatment to Improve Exercise Performance in Multiple Sclerosis (MS)Multiple SclerosisDrug: Aspirin 650mg Oral Capsule;Drug: Acetaminophen Tab 650mg;Other: PlaceboColumbia UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Recruiting18 Years65 YearsAll60Phase 1;Phase 2United States
13NCT04408742
(ClinicalTrials.gov)
April 15, 201926/5/2020Relationship Between Pain, Anxiety and Fatigue and Knee Position Sense, Balance and Dual Task Performance During Menstrual Cycle in Females With Multiple SclerosisThe Relationship Between Pain, Anxiety and Fatigue and Knee Position Sense, Balance and Dual Task Performance During Menstrual Cycle in Females With Multiple SclerosisMultiple Sclerosis;Menstrual Pain;Anxiety;Fatigue;Neurologic SymptomsOther: pain;Other: fatigue;Other: anxiety;Other: position sense;Other: balance;Other: dual task performanceAnkara Yildirim Beyazit UniversityNULLCompleted26 Years49 YearsFemale14Turkey
14NCT03816345
(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
15NCT03025269
(ClinicalTrials.gov)
April 2, 201916/1/2017Ocrelizumab Effects on Physiological and Cognitive Changes in Multiple SclerosisEffect of Ocrelizumab on Gray Matter Pathology, Leptomeningeal Inflammation and Cognitive Dysfunction in Multiple SclerosisMultiple SclerosisDrug: OcrelizumabUniversity at BuffaloNULLEnrolling by invitation18 Years60 YearsAll30United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03853746
(ClinicalTrials.gov)
April 1, 201922/2/2019Short-term B-cell Depletion in Relapsing Multiple SclerosisEvaluating the Effects of Short-term B-cell Depletion on Long-term Disease Activity and Immune Tolerance in Relapsing Multiple SclerosisMultiple SclerosisDrug: OcrelizumabJohns Hopkins UniversityNational Multiple Sclerosis SocietyActive, not recruiting18 Years99 YearsAll10Phase 4United States
17NCT03888924
(ClinicalTrials.gov)
April 1, 20194/9/2018Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS)Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS)Multiple SclerosisDrug: Bacille Calmette-Guerin vaccine;Drug: PlaceboS. Andrea HospitalNULLNot yet recruiting18 YearsN/AAll100Phase 2Italy
18NCT03710655
(ClinicalTrials.gov)
April 20196/10/2018Evaluate Safety and Efficacy of Apitox Add-on Therapy for Improving Disability and Quality of Life in MS PatientsMulti-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Apitox Add-on Therapy for Improving Disability and QOL in MS PatientsMultiple SclerosisDrug: Apitox - pure honeybee toxin;Drug: PlaceboApimeds, Inc.NULLUnknown status18 Years65 YearsAll468Phase 3NULL
19NCT03889639
(ClinicalTrials.gov)
March 29, 20191/3/2019Dose-finding Study for SAR442168 in Relapsing Multiple SclerosisA Phase 2b Dose-finding Study for SAR442168, a Bruton's Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: SAR442168;Drug: Placebo;Drug: Locally approved intravenous contrast medium for contrast enhanced MRISanofiNULLCompleted18 Years55 YearsAll128Phase 2United States;Canada;Czechia;Estonia;France;Netherlands;Russian Federation;Slovakia;Spain;Ukraine;Sweden
20NCT03535298
(ClinicalTrials.gov)
January 3, 201914/5/2018Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMSDetermining the Effectiveness of earLy Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Early Highly Effective Therapies Group;Drug: Escalation Therapies GroupThe Cleveland ClinicUniversity of NottinghamRecruiting18 Years60 YearsAll800Phase 4United 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
21EUCTR2017-004158-40-FR
(EUCTR)
11/09/201804/07/2018NAA Prospective study evaluating the effect of ocrelizumab on brain innate immune Microglial cells Activation in Multiple Sclerosis using PET-MRI with 18F-DPA714 - INN-MS Patients with Relapsing MS or primary progressive MS
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
71Phase 3France
22NCT03464448
(ClinicalTrials.gov)
April 17, 20187/3/2018Mechanistic Studies of Teriflunomide in RRMSMechanistic Studies of Teriflunomide in Relapsing Remitting Multiple Sclerosis: Regulatory B Lymphocytes as Central Mediators of the Therapeutic Effects of Teriflunomide in MSRelapsing Remitting Multiple SclerosisDrug: TeriflunomideUniversity of MichiganNULLActive, not recruiting18 Years65 YearsAll30United States
23NCT03501342
(ClinicalTrials.gov)
April 9, 201810/4/2018Effects of Immersive Virtual Reality on Balance, Mobility, and Fatigue in Patients With Multiple SclerosisEffects of Immersive Virtual Reality on Balance, Mobility, and Fatigue in Patients With Multiple SclerosisMultiple SclerosisOther: Virtual reality group;Other: Dynamic Balance TrainingGazi UniversityNULLCompleted18 Years65 YearsAll39N/ATurkey
24NCT04550650
(ClinicalTrials.gov)
April 6, 201810/9/2020Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS PatientsFollow-up Study of the Effectiveness of Virtual Reality Therapy in MS PatientsMultiple Sclerosis, Chronic Progressive;Multiple Sclerosis, Primary ProgressiveOther: Training groupe;Other: PNF;Other: Spinning grp;Other: BalanceSomogy Megyei Kaposi Mór Teaching HospitalNULLCompleted35 Years60 YearsAll4N/AHungary
25NCT03319732
(ClinicalTrials.gov)
April 3, 201813/10/2017A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MSAn Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients With Spasticity (Study OS440-3005)Multiple Sclerosis;Spasticity, MuscleDrug: ArbaclofenOsmotica Pharmaceutical US LLCNULLActive, not recruiting18 Years65 YearsAll323Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03850301
(ClinicalTrials.gov)
April 1, 201812/2/2019Validation of the 18 kiloDalton Translocator Protein (TSPO) as a Novel Neuroimmunodulatory TargetAn Experimental Medicine Study to Validate the 18 kiloDalton Translocator Protein (TSPO) as a Novel Neuroimmunodulatory Target in Multiple SclerosisMultiple SclerosisDrug: XBD173;Drug: EtifoxineImperial College LondonNULLRecruiting35 Years65 YearsAll44N/AUnited Kingdom
27NCT03266965
(ClinicalTrials.gov)
March 23, 20184/7/2017Histaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel ApproachHistaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel ApproachMultiple SclerosisDrug: Carbidopa;Dietary Supplement: L-HistidineUniversity of MiamiUnited States Department of DefenseCompleted18 Years60 YearsAll18Phase 1United States
28ChiCTR-DND-17013749
2017-12-012017-12-07Application of 3.0 T MRI 3D sequences of CUBE-T2 FLAIR?DIR for brain lesions of childhood-onset multiple sclerosisApplication of 3.0 T MRI 3D sequences of CUBE-T2 FLAIR?DIR for brain lesions of childhood-onset multiple sclerosis childhood-onset multiple sclerosisGold Standard:CUBE-T2 FLAIR scanning;Index test:DIR scanning;Children's Hospital of Chongqing Medical UniversityNULLRecruitingBothTarget condition:80;Difficult condition:0China
29EUCTR2017-002634-24-SE
(EUCTR)
29/09/201706/07/2017MultipleMS – a study with the aim to accelerate personalised medicine in multiple sclerosis.MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients. - MultipleMS Newly diagnosed patients with Clinically Isolated Syndrome (CIS) and multiple sclerosis (MS) -both relapsing remitting and primary progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Tecfidera
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Gilenya
INN or Proposed INN: FINGOLIMOD
Other descriptive name: FINGOLIMOD
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Betaferon
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Extavia
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name:
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Sweden
30NCT03345940
(ClinicalTrials.gov)
April 30, 201716/5/2017Fingolimod Versus Dimethyl-fumarate in Multiple SclerosisA Multicentric Randomized PRAGmatic Trial to Compare the Effectiveness of Fingolimod Versus Dimethyl-Fumarate on Patient Overall Disease Experience in Relapsing Remitting Multiple Sclerosis: Novel Data to Inform Decision-makersRelapsing Remitting Multiple SclerosisDrug: Fingolimod;Drug: Dimethyl FumarateFondazione I.R.C.C.S. Istituto Neurologico Carlo BestaPatient-Centered Outcomes Research Institute;Universita degli Studi di GenovaTerminated18 YearsN/AAll55Phase 4Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT03073603
(ClinicalTrials.gov)
April 20, 201718/1/2017Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)Multiple SclerosisDrug: Discontinuation of disease modifying therapy;Drug: Standard of CareUniversity of Colorado, DenverPatient-Centered Outcomes Research Institute;National Multiple Sclerosis Society;University of Alabama at BirminghamActive, not recruiting55 YearsN/AAll260Phase 4United States
32NCT02881567
(ClinicalTrials.gov)
April 18, 201724/8/2016Efficacy and Safety of Daclizumab in Participants With RRMS Switching From NatalizumabA Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN)Relapsing-Remitting Multiple Sclerosis (RRMS)Drug: DaclizumabBiogenAbbVieTerminated18 Years55 YearsAll41Phase 3United States;Canada;Germany;Italy;Puerto Rico;France;United Kingdom
33NCT03085810
(ClinicalTrials.gov)
April 4, 201716/3/2017Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: OcrelizumabHoffmann-La RocheNULLActive, not recruiting18 Years55 YearsAll1225Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Denmark;France;Germany;Hungary;Italy;Kuwait;Lebanon;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Slovakia;Slovenia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Finland
34NCT02688985
(ClinicalTrials.gov)
April 29, 201618/2/2016Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)An Open-Label, Multicenter, Biomarker Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Patients With Relapsing Multiple Sclerosis or Primary Progressive Multiple SclerosisRelapsing Multiple Sclerorsis;Multiple Sclerosis, Primary ProgressiveDrug: Ocrelizumab;Procedure: Lumbar Puncture;Drug: Methyloprednisolone;Drug: AntihistamineGenentech, Inc.NULLActive, not recruiting18 Years55 YearsAll127Phase 3United States;Canada;Germany;Sweden
35NCT02769689
(ClinicalTrials.gov)
April 201617/3/2016Methylprednisolone During the Switch Between Natalizumab and FingolimodOnce a Month High-dose Methylprednisolone During Wash-out Period Between Natalizumab and Fingolimod Treatments in Patients With Multiple Sclerosis: a Randomised, Controlled, Double-blind Trial (NTZ2FTY)Multiple SclerosisDrug: Methylprednisolone;Drug: Placebo;Drug: natalizumab (NTZ);Drug: fingolimob (FTY)University Hospital, Clermont-FerrandNULLRecruiting18 Years65 YearsBoth56Phase 4France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT02782858
(ClinicalTrials.gov)
April 201623/5/2016Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MSAn International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: GNbAC1;Drug: PlaceboGeNeuro SALes Laboratoires Servier (LLS);Institut de Recherches Internationales Servier;Worldwide Clinical TrialsCompleted18 Years55 YearsAll270Phase 2Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine
37NCT02675413
(ClinicalTrials.gov)
April 201611/1/2016Mechanisms of Action of Dimethyl Fumarate (Tecfidera) in Relapsing MSMechanisms of Action of Dimethyl Fumarate in Relapsing MSMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: Dimethyl FumarateWashington University School of MedicineBiogenWithdrawn18 YearsN/ABoth0Phase 4United States
38EUCTR2015-000922-12-DE
(EUCTR)
12/02/201602/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
39EUCTR2015-000922-12-PL
(EUCTR)
05/01/201603/12/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
40EUCTR2015-000922-12-BE
(EUCTR)
04/01/201601/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2015-004116-38-SE
(EUCTR)
18/12/201520/10/2015A clincial study comparing the effectiveness of two drugs, named Rituximab and Dimethyl Fumarate (Tecfidera®), for the neurological disease Multiple Sclerosis.RItuximab versus FUmarate in Newly Diagnosed Multiple Sclerosis – RIFUND-MSA randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple SclerosisObjective: To compare the efficacy of rituximab on the ability to prevent relapses in early RRMS and CIS compared with dimethyl fumarate (DMF), which is an approved first-line medication for RRMS today, using a phase 3 design.Population: Patients with newly diagnosed RRMS or CIS with no more than 10 years disease duration (since diagnosis), 18 – 50 years of age and previously not treated with immunomodulating drugs OR treated with first-line injectables. Patients should display protocol-defined clinical or radiological disease activity during the preceding year before screening for inclusion.Intervention: Treatment with rituximab (Mabthera®) with an initial dose of 1000 mg intravenously (iv) followed by 500 mg iv every six months.Control: Treatment with DMF (Tecfidera®) 240 mg twice daily. The two treatments are randomised in a 1:1 proportion.Outcome: Primary outcome is the relative risk of experiencing a relapse during the two–year period for either compound. As secondary endpoints worsening on neurological disability, magnetic-resonance imaging-defined disease activity and effect on cerebrospinal fluid biomarkers will be analysed. In addition, health-economic evaluations of using rituximab as first-line treatment for RRMS will be performed. Patients with multiple sclerosis (MS) or patients presenting with symptoms highly suspicious of MS while not completely fulfilling diagnostic criteria, 18 - 50 years of age and no more than 10 years of disease duration (from diagnosis). Patients treated with immunomodulatory drugs or treated with first-line injectable therapies (eg interferons or glatiramer acetate) may be included.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Tecfidera
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Department of Clinical Sciences, Danderyd HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Sweden
42EUCTR2015-000922-12-FI
(EUCTR)
15/12/201507/12/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
43EUCTR2015-000922-12-HR
(EUCTR)
11/12/201504/02/2016A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
44EUCTR2015-000922-12-AT
(EUCTR)
19/11/201501/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
45EUCTR2014-004483-38-DE
(EUCTR)
16/07/201528/04/2015TMP001 in relapsing-remitting multiple sclerosis: a multicentre open, baseline-controlled phase IIa clinical trialTMP001 in relapsing-remitting multiple sclerosis: a multicentre open, baseline-controlled phase IIa clinical trial Patients with defined diagnosis of relapsing-remitting multiple sclerosis and at least 1 documented relapse during the previous year OR at least 2 documented relapses during the previous 2 years.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tarenflurbil
Product Code: TMP001
INN or Proposed INN: Tarenflurbil
Other descriptive name: FLURBIPROFEN
Fraunhofer Gesellschaft for its Institute Fraunhofer Institute for Molecular Biology and Applied Ecology (IME)NULLNot RecruitingFemale: yes
Male: yes
55Phase 2Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46JPRN-UMIN000018154
2015/07/0101/07/201511C-acetate PET for Multiple sclerosis11C-acetate PET for Multiple sclerosis - 11C-acetate PET for Multiple sclerosis Multiple Sclerosis, NMOWithdraw blood before and after the injection of 11C-acetatedepartment of neurology, Osaka university school of medicineNULLRecruiting20years-old75years-oldMale and Female30Not applicableJapan
47NCT02665221
(ClinicalTrials.gov)
July 201522/1/2016Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDYSingle Center, Randomized, Open Label Study in Relapsing MS Patients on PLEGRIDY to Assess Topical Application of Preparation H (Phenylephrine) on Mitigation of Erythema Severity and Size.Multiple SclerosisOther: No Treatment Arm;Drug: Topical Preparation H armNew York University School of MedicineNULLTerminated18 Years70 YearsAll32Phase 4United States
48NCT02423083
(ClinicalTrials.gov)
April 21, 201521/4/2015Oral Guanabenz for Multiple SclerosisPhase I Study of Oral Guanabenz for Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting;Multiple SclerosisDrug: GuanabenzNational Institute of Neurological Disorders and Stroke (NINDS)NULLTerminated18 Years55 YearsAll2Phase 1United States
49NCT02391961
(ClinicalTrials.gov)
April 1, 20153/3/2015Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple SclerosisStudy and Treatment of Visual Dysfunction and Motor Fatigue in Multiple SclerosisMultiple Sclerosis;Internuclear Ophthalmoplegia;FatigueDrug: Dalfampridine;Drug: PlaceboVA Office of Research and DevelopmentNULLCompleted18 Years65 YearsAll23Phase 2United States
50NCT02428231
(ClinicalTrials.gov)
April 201523/4/2015Tecfidera Slow-Titration StudyA Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients With Multiple SclerosisMultiple SclerosisDrug: dimethyl fumarateBiogenNULLTerminated18 Years65 YearsAll62Phase 3United States;Belgium;Czech Republic;Italy;Australia;Canada;France;Germany;Hungary;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT02939079
(ClinicalTrials.gov)
April 201514/10/2016Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis PatientsEvaluating the Effect of Fingolimod With Fish Oil Compared to Fingolimod With Placebo on Tumor Necrosis Factor-a , Interleukin1b , Interleukin6, and Interferon-gamma in Patients With Relapsing-Remitting Multiple SclerosisMultiple SclerosisDrug: Fingolimod;Dietary Supplement: Fish Oil;Drug: Placebo (for Fish Oil)Isfahan University of Medical SciencesShiraz University of Medical SciencesCompleted18 Years45 YearsAll50Phase 2;Phase 3NULL
52NCT02398461
(ClinicalTrials.gov)
April 201513/3/2015An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a RelapseA Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a RelapseMultiple Sclerosis, Acute RelapsingDrug: rHIgM22;Drug: PlaceboAcorda TherapeuticsPRA Health SciencesCompleted18 Years70 YearsAll27Phase 1United States
53EUCTR2013-002378-26-SE
(EUCTR)
13/11/201415/08/2013Switch To RItuXimab in MS extensionAn extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytesSwitch To RItuXimab in MS extensionAn extension study of STRIX-MS - a phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSext The original trial (EudraCT 2010-023021-38) recruited 74 patients with relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate. This extension study involves the same patients, those that consent to participate in this extension trial.
MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mabthera®
Product Name: Mabthera
Västerbottens Läns LandstingNULLNot RecruitingFemale: yes
Male: yes
74Phase 2Sweden
54NCT02137044
(ClinicalTrials.gov)
July 201422/4/2014Multiple Sclerosis-Collaborative Approach to Rehabilitation Effectiveness StudyImproving the Quality of Care for Pain and Depression in Persons With Multiple SclerosisMultiple Sclerosis;Pain;DepressionBehavioral: Collaborative Care (CC)University of WashingtonPatient-Centered Outcomes Research InstituteCompleted18 YearsN/AAll195N/AUnited States
55EUCTR2013-003126-83-DE
(EUCTR)
23/06/201417/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2013-003126-83-GR
(EUCTR)
27/05/201425/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Denmark;Peru;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
57EUCTR2013-003126-83-ES
(EUCTR)
26/05/201405/03/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-?-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-?-1a in patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3Serbia;Belarus;United States;United Arab Emirates;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
58EUCTR2013-002351-15-ES
(EUCTR)
26/05/201425/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-?-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-?-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3Serbia;Portugal;Belarus;United States;United Arab Emirates;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Peru;Denmark;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden
59EUCTR2013-002351-15-BG
(EUCTR)
21/05/201420/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Interferon-ß-1a
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden
60EUCTR2013-002351-15-HU
(EUCTR)
21/05/201421/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2013-003126-83-HU
(EUCTR)
21/05/201421/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Denmark;Peru;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
62EUCTR2013-002351-15-PT
(EUCTR)
09/05/201425/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Belarus;Portugal;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden
63NCT02579681
(ClinicalTrials.gov)
April 30, 201416/10/2015Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012Single Country Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis Patients Treated With BG00012Multiple Sclerosis, Relapsing-RemittingDrug: dimethyl fumarateBiogenNULLCompleted18 YearsN/AAll221Phase 3Italy
64EUCTR2013-003126-83-BG
(EUCTR)
16/04/201420/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Interferon-ß-1a
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Belarus;Serbia;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
65NCT01892345
(ClinicalTrials.gov)
April 11, 201420/6/2013A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)Neuromyelitis Optica;Neuromyelitis Optica Spectrum DisorderDrug: Eculizumab;Drug: PlaceboAlexion PharmaceuticalsNULLTerminated18 YearsN/AAll143Phase 3United States;Argentina;Australia;Croatia;Czechia;Denmark;Germany;Hong Kong;Italy;Japan;Korea, Republic of;Malaysia;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Canada;Colombia;Czech Republic;France;Singapore
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT02227524
(ClinicalTrials.gov)
April 201420/8/2014Trekking Poles to Aid Multiple Sclerosis Gait ImpairmentTrekking Poles to Aid Multiple Sclerosis Gait ImpairmentMultiple SclerosisOther: No device;Device: Single-point cane (SPC);Device: Four-point cane (FPC);Device: Trekking pole (TP).Rowan UniversityNULLCompleted18 Years64 YearsAll29N/AUnited States
67NCT04256252
(ClinicalTrials.gov)
April 20142/2/2020Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE)Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE): a Prospective, Multicenter, Open-label, Follow-up Clinical TrialNeuromyelitis Optica Spectrum DisorderDrug: RituximabTang-Du HospitalNULLCompleted16 Years75 YearsAll108Phase 4NULL
68NCT02865018
(ClinicalTrials.gov)
April 20149/8/2016Neuromyelitis Optica (NMO) & CetirizineAn Open Label, add-on Trial of Cetirizine for Patients With Neuromyelitis OpticaNeuromyelitis OpticaDrug: cetirizineIcahn School of Medicine at Mount SinaiGuthy Jackson FoundationCompleted18 Years85 YearsBoth16Phase 1;Phase 2United States
69NCT01933802
(ClinicalTrials.gov)
April 201423/8/2013Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Patients With Multiple SclerosisPhase 1 Safety Study of Autologous Bone Marrow-derived Mesenchymal Stem Cell-derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo, Administered Intrathecally in Patients With Multiple SclerosisMultiple SclerosisBiological: intrathecal administration of autologous MSC-NPTisch Multiple Sclerosis Research Center of New YorkNULLCompleted18 Years70 YearsAll20Phase 1United States
70NCT01973517
(ClinicalTrials.gov)
April 201416/10/2013High-Field MRI Iron-Based Contrast-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases7T MRI Ferumoxytol-Enhanced Characterization of Multiple Sclerosis and Demyelinating DiseasesMultiple SclerosisDrug: Feraheme;Drug: Gadolinium-based contrastStanford UniversityNULLWithdrawn18 YearsN/AAll0United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2013-002351-15-AT
(EUCTR)
13/03/201428/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden
72EUCTR2013-002351-15-EE
(EUCTR)
13/03/201418/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden
73EUCTR2013-002351-15-LV
(EUCTR)
03/03/201420/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden
74JPRN-UMIN000012705
2014/01/0707/01/2014The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis Relapsing-remitting multiple sclerosisTocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 2 years.Department of Immunology, National Institute of Neuroscience, NCNPNULLRecruiting20years-old65years-oldMale and Female10Not applicableJapan
75EUCTR2012-004165-41-GB
(EUCTR)
04/11/201319/09/2013Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized StudyHematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - Hematopoietic Stem Cell Therapy for Inflammatory MS Inflammatory Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: natalizumab
Trade Name: Fingolimod
Product Name: Gilenya
INN or Proposed INN: Fingolimod
Trade Name: Tecfidera
Product Name: Tecfidera
Product Code: BG-12 120
INN or Proposed INN: dimethyl fumarate
Northwestern UniversityNULLNot RecruitingFemale: yes
Male: yes
110Phase 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
76NCT03133403
(ClinicalTrials.gov)
November 201321/4/2016Hematopoietic Stem Cell Therapy for Inflammatory Multiple Sclerosis Failing Alternate Approved TherapyHematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized StudyMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: Tecfidera (BG12);Drug: Gilenya;Drug: Tysabri®;Drug: Avonex/Betaseron/Copaxone/Rebif;Procedure: Hematopoietic stem cell transplantation (HSCT)Sheffield Teaching Hospitals NHS Foundation TrustNULLRecruiting18 Years55 YearsAll5Phase 2;Phase 3United Kingdom
77JPRN-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
78NCT03198351
(ClinicalTrials.gov)
April 25, 201322/6/2017An Observational Study on Teriflunomide-exposed PregnanciesTeriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy ProjectMultiple SclerosisDrug: Teriflunomide (HMR1726)SanofiNULLRecruiting16 YearsN/AFemale325United States;Canada
79NCT01767701
(ClinicalTrials.gov)
April 20137/1/2013Raltegravir (Isentress) Pilot Study in Relapsing Multiple SclerosisA Phase II Baseline Versus Treatment Study to Determine the Efficacy of Raltegravir (Isentress) in Preventing Progression of Relapsing Remitting Multiple Sclerosis as Determined by Gadolinium-enhanced MRIRelapsing Remitting Multiple SclerosisDrug: RaltegravirQueen Mary University of LondonMerck Sharp & Dohme Corp.Completed18 Years55 YearsAll23Phase 2United Kingdom
80NCT01888354
(ClinicalTrials.gov)
April 201316/5/2013Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ)Versus ACTHar Gel Five Days SQ for the Treatment of MS ExacerbationsPilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ) Versus ACTHar Gel Five Days SQ for the Treatment of MS ExacerbationsMultiple Sclerosis (MS)Drug: H.P. Acthar Gel (repository corticotropin injection)The University of Texas Health Science Center, HoustonNULLCompleted18 Years55 YearsBoth25Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT01816100
(ClinicalTrials.gov)
April 201325/2/2013The Effect of Exercise on Strength and Mobility and Corresponding CNS Plasticity in Multiple Sclerosis PatientsThe Effect of Exercise on Strength and Mobility and Corresponding CNS Plasticity in Multiple Sclerosis Patients: A Multimodal Neuroimaging InvestigationMultiple SclerosisOther: specifically design 6 month resistance training program;Behavioral: 6 months weight resistance and balance programUniversity of NebraskaBiogenCompleted19 Years65 YearsBoth6N/AUnited States
82NCT01808885
(ClinicalTrials.gov)
April 201312/2/2013Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.A 24-Week, Ph1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, to Assess the Safety Profile of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.Relapsing Remitting Multiple SclerosisDrug: olesoxime (TRO19622);Drug: placeboHoffmann-La RocheHôpital de la Timone;SGS S.A.;STRAGEN ServicesCompleted18 YearsN/ABoth44Phase 1France
83NCT01844232
(ClinicalTrials.gov)
April 201324/4/2013One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With SpasticityA One Year, Open Label, Dose Escalation Study To Evaluate the Long-Term Safety of Arbaclofen Extended Release Tablets (AERT) in Multiple Sclerosis Subjects With SpasticityMultiple Sclerosis;SpasticityDrug: arbaclofenOsmotica Pharmaceutical US LLCNULLCompleted18 Years70 YearsAll150Phase 3United States;Russian Federation;Ukraine
84NCT01738347
(ClinicalTrials.gov)
April 201313/11/2012Assess Safety, Bio-distribution, Radiation Dosimetry and Optimize the Imaging Protocol of GEH120714 (18F) Injection in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS).Assess Safety, Bio-distribution, and Radiation Dosimetry, and Optimize the Imaging Protocol of GEH120714 (18F) Injection, a Marker of Microglial Activation, in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS)Relapsing-remitting Multiple Sclerosis (rrMS)Drug: Arm 1 - GEH120714 (18F) InjectionGE HealthcareCentre for Probe Development and CommercializationCompleted20 Years50 YearsAll30Phase 1Canada;United States
85EUCTR2012-003418-15-AT
(EUCTR)
23/10/201209/11/2012Methylphenidate modified release as treatment of MS-associated fatigue.Methylphenidate modified release as treatment option of MS-associated fatigue. A single-center randomized double-blind placebo-controlled trial. Fatigue is a very common symptom in multiple sclerosis. Its management comprises nonpharmacologic approaches like exercise, cooling procedures and energy conservation programs and as second step pharmacologic therapy. Until now, Amantadine, Modafinil or antidepressants have been used off-label among others, with some success. Until now, methylphenidate has been successfully used to treat fatigue in HIVand parkinson´s disease, data on its efficacy in MS are not available.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Ritalin LA 20mg capsules
Product Name: Methylphenidate modified release 20 mg
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
Trade Name: Ritalin LA 30mg capsules
Product Name: Methylphenidate modified release 30 mg
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
Trade Name: Ritalin LA 40mg capsules
Product Name: Methylphenidate modified release 40 mg
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
Medizinische Universität WienNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2009-017978-21-PL
(EUCTR)
17/08/201206/03/2012Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2175Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
87EUCTR2009-017978-21-PT
(EUCTR)
06/07/201211/08/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2175Phase 3Serbia;United States;United Arab Emirates;Portugal;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
88JPRN-UMIN000009421
2012/06/2828/11/2012Efficacy and safety of rituximab for intractable immunogenic neurological disorder in children neuromyelitis optica (NMO), opsoclonus-myoclonus syndrome (OMS)administration of rituximabDepartment of Pediatrics, Kobe Universtiy Graduate School of MedicineNULLRecruitingNot applicable18years-oldMale and Female10Not applicableJapan
89NCT01623596
(ClinicalTrials.gov)
June 8, 201218/6/2012Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.A 12-month, Prospective, Randomized, Active-controlled, Open-label Study to Evaluate the Patient Retention of Fingolimod vs. Approved First-line Disease Modifying Therapies in Adults With Relapsing Remitting Multiple Sclerosis (PREFERMS)Relapsing Remitting Multiple SclerosisDrug: Fingolimod;Drug: Disease Modifying therapyNovartis PharmaceuticalsNULLCompleted18 Years65 YearsAll881Phase 4United States;Puerto Rico
90JPRN-UMIN000007866
2012/05/0101/05/2012The safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter Study neuromyelitis opticaTocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 years.Department of Immunology, National Institute of Neuroscience, NCNPDepartment of Neurology, Kinki University Faculty of MediceineComplete: follow-up continuing20years-old65years-oldMale and Female15Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT01491100
(ClinicalTrials.gov)
April 30, 201212/12/2011Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple SclerosisStudy Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon®Multiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted12 Years70 YearsAll1085Albania;Algeria;Argentina;Belgium;Czechia;Egypt;France;Germany;Greece;Hungary;Israel;Kazakhstan;Netherlands;Portugal;Saudi Arabia;Tunisia;Turkey;Bosnia and Herzegovina;Czech Republic;Jordan;Lebanon;Mexico;Poland;Syrian Arab Republic
92NCT01514370
(ClinicalTrials.gov)
April 30, 201217/1/2012Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1aProspeCtive Study to Evaluate Efficacy, Safety and tOlerability of Dietary supplemeNT of Curcumin (BCM95) in Subjects With Active Relapsing MultIple Sclerosis Treated With subcutaNeous Interferon Beta 1a 44 mcg Three Times a Week (TIW)Multiple SclerosisDrug: IFN beta 1a 44 mcg TIW;Drug: Curcumin;Drug: PlaceboMerck KGaA, Darmstadt, GermanyMerck Serono S.P.A., ItalyCompleted18 Years60 YearsAll80Phase 2Italy
93NCT01585298
(ClinicalTrials.gov)
April 29, 201223/4/2012STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)A 1-week, Open-label, Multi-center Study to Explore Conduction Abnormalities During First Dose Administration of Fingolimod in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: FTY720Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll6998Phase 4Germany
94NCT01585766
(ClinicalTrials.gov)
April 24, 20129/4/2012Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple SclerosisA Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple SclerosisMultiple Sclerosis, Relapsing FormsDrug: MEDI-551 30 MG-IV;Drug: MEDI-551 60 MG-SC;Drug: PLACEBO-IV-SC;Drug: MEDI-551 100 MG-IV;Drug: MEDI-551 300 MG-SC;Drug: MEDI-551 600 MG-IVMedImmune LLCNULLCompleted18 Years65 YearsAll56Phase 1United States;Poland;Spain;Ukraine;Czech Republic;United Kingdom
95NCT01480063
(ClinicalTrials.gov)
April 16, 201223/11/2011An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical PracticeA Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In Routine Medical Practice (LIBERATE)Multiple SclerosisDrug: FampridineBiogenNULLCompletedN/AN/AAll4734Argentina;Canada;Czechia;France;Germany;Ireland;Israel;Lebanon;Netherlands;Norway;Portugal;Spain;United Arab Emirates;Australia;Belgium;Czech Republic;Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT01627938
(ClinicalTrials.gov)
April 201230/5/2012Study to Evaluate the Reduction of Cardiac Problems in Multiple Sclerosis Patients With Mitoxantrone and Dexrazoxane in CombinationA Phase II Proof of Concept Study Evaluating the Reduction of Mitoxantrone-induced Cardiotoxicity and Neurological Outcome in the Combined Use of Mitoxantrone and Dexrazoxane (Cardioxane®) in Multiple Sclerosis (MSCardioPro)Multiple SclerosisDrug: Dexrazoxane (DRZ) plus Mitoxantrone (MX);Drug: Placebo plus Mitoxantrone (MX)PD Dr. Andrew ChanNULLActive, not recruiting18 Years55 YearsBoth50Phase 2Germany
97NCT01538225
(ClinicalTrials.gov)
April 201220/2/2012Neurophysiological Study of Sativex in Multiple Sclerosis (MS) SpasticityNeurophysiologic Study on Effects of Sativex® on Spasticity in Progressive Multiple SclerosisMultiple SclerosisDrug: Sativex®;Drug: PlaceboAlmirall, S.A.NULLCompleted18 YearsN/ABoth45Phase 3Italy
98EUCTR2009-017978-21-GR
(EUCTR)
17/01/201208/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Phase 3Serbia;Portugal;United Arab Emirates;United States;Estonia;Saudi Arabia;Taiwan;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
99NCT02280876
(ClinicalTrials.gov)
January 201220/10/2014Efficacy Study of Andrographis Paniculata Purified Standardized Extract (ApE) in Patients With Multiple Sclerosis (MS)Randomized, Comparative, Double Blind Controlled Phase II Clinical Trial, to Evaluate the Efficacy of ApE in Patients With Multiple Sclerosis (MS).Multiple Sclerosis, Relapsing-RemittingDrug: 1 - Andrographis paniculata p/st extract;Drug: 2 - ExcipientsUniversidad Austral de ChileComisión Nacional de Investigación Científica y Tecnológica;University of ChileCompleted18 Years55 YearsBoth30Phase 1;Phase 2Chile
100NCT01500408
(ClinicalTrials.gov)
January 201222/12/2011Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy VolunteersA Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of Interferon Beta-1a Manufactured by Two Different ProcessesMultiple SclerosisDrug: Interferon beta-1a (current approved manufacturing process invloving FBS);Drug: Interferon beta-1a (new process, manufactured without FBS)Biogen IdecNULLCompleted18 Years45 YearsBoth110Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2010-021219-17-DE
(EUCTR)
31/10/201105/07/2011A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosisA 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis - Not applicable Primary progressive or relapse-free secondary progressive multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
AB ScienceNULLNot Recruiting Female: yes
Male: yes
600Phase 3Serbia;United States;Morocco;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;South Africa;Bulgaria;Germany;Tunisia;Bosnia and Herzegovina
102NCT01442194
(ClinicalTrials.gov)
August 1, 201121/8/2011Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying TherapiesLong-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying TherapyMultiple SclerosisDrug: other disease-modifying therapy;Drug: FingolimodNovartis PharmaceuticalsNULLRecruitingN/AN/AAll3620United States;Argentina;Australia;Canada;Chile;Mexico;Puerto Rico
103EUCTR2009-017978-21-LT
(EUCTR)
25/07/201130/03/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
104JPRN-UMIN000005889
2011/07/0108/07/2011The safety and efficacy of tocilizumab in patients with neuromyelitis optica neuromyelitis opticaTocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 months.Department of Immunology, National Institute of Neuroscience, NCNPNULLComplete: follow-up complete20years-old65years-oldMale and Female3Not applicableJapan
105EUCTR2009-017978-21-CZ
(EUCTR)
06/06/201111/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2175Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2009-017978-21-GB
(EUCTR)
03/06/201111/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Phase 3United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
107EUCTR2011-000770-60-IT
(EUCTR)
12/04/201101/09/2011An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - NDAn open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - ND approximately 600 patients with relapsing-remitting MS for whom no suitable therapy exists i.e. where existing therapies have failed.
MedDRA version: 14.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: fingolimod
Product Code: FTY720D
INN or Proposed INN: other nervous system drugs
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
600Italy
108NCT01305837
(ClinicalTrials.gov)
April 201128/2/2011Cyclic Oral Methylprednisolone Trial in Multiple SclerosisCyclic Oral Methylprednisolone Trial in Multiple SclerosisProgressive Multiple SclerosisDrug: methylprednisoloneRigshospitalet, DenmarkNULLCompleted18 Years65 YearsBoth30Phase 2Denmark
109NCT01332019
(ClinicalTrials.gov)
April 201124/3/2011Long-Term Safety and Efficacy Study of Peginterferon Beta-1aA Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: peginterferon beta-1aBiogenNULLCompleted18 Years65 YearsAll1077Phase 3United States;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Estonia;France;Georgia;Germany;Greece;India;Latvia;Mexico;Netherlands;New Zealand;Peru;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
110NCT01407211
(ClinicalTrials.gov)
April 201114/2/2011Impact of Vitamin A on Gene Expression, in Multiple Sclerosis PatientThe Impact of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by CD4+ T Lymphocyte in Multiple Sclerosis PatientsRelapsing Remitting Multiple SclerosisDietary Supplement: vitamin ATehran University of Medical SciencesNULLEnrolling by invitation20 Years45 YearsBoth30Phase 4Iran, Islamic Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2010-023560-40-SE
(EUCTR)
23/03/201121/12/2010Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed.Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST Relapsing-remitting multiple sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Sendoxan
Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE
Trade Name: Thymoglobuline
Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN
Trade Name: Neupogen
Trade Name: Solu-Medrol
Uppsala l?ns landstingNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120United States;Canada;Brazil;Sweden
112EUCTR2010-023021-38-SE
(EUCTR)
23/02/201126/11/2010Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSSwitch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS Relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate
MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Västerbottens läns landstingNULLNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
113NCT01181115
(ClinicalTrials.gov)
April 20105/8/2010Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS)An Open-Label Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Avonex (Interferon Beta-1a) in Chinese Subjects With Relapsing Multiple SclerosisMultiple SclerosisDrug: AvonexBiogen IdecNULLCompleted18 Years55 YearsBoth60Phase 3China
114NCT01071512
(ClinicalTrials.gov)
April 201017/2/2010Tysabri Effects on Cognition and Neurodegeneration in Multiple SclerosisTysabri Effects on Cognition and Neurodegeneration in Multiple SclerosisMultiple SclerosisDrug: TysabriUniversity of ChicagoBiogenCompleted18 Years60 YearsAll20N/AUnited States
115NCT01097668
(ClinicalTrials.gov)
March 201031/3/2010ATX-MS-1467 in Patients With Relapsing Forms of Multiple SclerosisSAFETY AND PROOF OF PRINCIPLE STUDY OF ATX-MS-1467 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS: OPEN LABEL UPWARD TITRATION OVER FIVE DOSE LEVELS AND USING TWO ROUTES OF ADMINISTRATION (INTRADERMAL AND SUBCUTANEOUS).Relapsing Remitting Multiple SclerosisBiological: ATX-MS-1467Apitope Technology (Bristol) Ltd.Aptiv Solutions;ClinStar, LLCCompleted18 Years55 YearsAll43Phase 1Russian Federation;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT01077466
(ClinicalTrials.gov)
March 201026/2/2010Natalizumab Treatment of Progressive Multiple SclerosisNatalizumab Treatment of Progressive Multiple SclerosisPrimary Progressive Multiple Sclerosis;Secondary Progressive Multiple SclerosisDrug: NatalizumabRigshospitalet, DenmarkCopenhagen University Hospital, Hvidovre;Biogen Idec;University of Copenhagen;Signifikans ApSCompleted19 Years55 YearsBoth24Phase 2Denmark
117EUCTR2009-012431-15-CZ
(EUCTR)
21/01/201002/12/2009Možnosti terapeutického ovlivnení neurogenního hyperaktivního detruzoru u pacientu po spinálním poranení a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevrená studie porovnávající efekt aplikace 300 U Botoxu® pri podání do detruzoru mocového mechýre a subsliznicního podání.Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®.Možnosti terapeutického ovlivnení neurogenního hyperaktivního detruzoru u pacientu po spinálním poranení a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevrená studie porovnávající efekt aplikace 300 U Botoxu® pri podání do detruzoru mocového mechýre a subsliznicního podání.Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®. Studie se zabývá lécbou hyperaktivního neurogeního detruzoru u pacientu, kterí trpí príznaky hyperaktivního mocového mechýre jako dusledek spinálního poranení nebo roztroušené sklerózy. K lécbe se pužívá botulinumotoxin. Ve studii se porovnávaní dve ruzné formy aplikace studjiního léku.Trade Name: Botox
Other descriptive name: BOTULINUM TOXIN TYPE A
Krajská nemocnice Liberec, a.s.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Czech Republic
118NCT00914290
(ClinicalTrials.gov)
April 20092/6/2009A Study With IPX056 in Subjects With Spasticity Associated With Multiple SclerosisA Study With IPX056 in Subjects With Spasticity Associated With Multiple SclerosisSpasticity;Multiple SclerosisDrug: IPX056;Drug: Baclofen IR;Drug: Placebo IPX056;Drug: Placebo IRImpax Laboratories, LLCNULLCompleted18 YearsN/AAll23Phase 2United States
119NCT00882999
(ClinicalTrials.gov)
April 200916/4/2009A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: LY2127399;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 Years64 YearsAll245Phase 2United States;Bulgaria;Czechia;France;Germany;Hungary;Israel;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine;Belgium;Canada;Czech Republic;Denmark;Finland;Switzerland
120NCT00883337
(ClinicalTrials.gov)
April 200916/4/2009A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension PeriodMultiple SclerosisDrug: Interferon ß-1a;Drug: TeriflunomideSanofiNULLCompleted18 YearsN/AAll324Phase 3Belgium;Canada;Czech Republic;France;Germany;Greece;Hungary;Italy;Poland;Spain;Switzerland;Tunisia;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT00764413
(ClinicalTrials.gov)
April 20091/10/2008Chronotherapy in Acute Multiple Sclerosis (MS) AttackTreatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment?Multiple SclerosisDrug: methylprednisolone;Drug: Sodium chloridSykehuset Innlandet HFNULLTerminated18 YearsN/ABoth57N/ANorway
122NCT00904826
(ClinicalTrials.gov)
April 200918/5/2009An Open Label Study of the Effects of Eculizumab in Neuromyelitis OpticaAn Open Label Study of the Effects of Eculizumab in Neuromyelitis OpticaNeuromyelitis Optica;Devic's DiseaseDrug: EculizumabMayo ClinicAlexion PharmaceuticalsCompleted18 YearsN/AAll14Phase 1;Phase 2United States
123NCT01567553
(ClinicalTrials.gov)
April 200924/2/2012The Inflammatory Process and the Medical Imaging in Patients With an Inflammatory Disease of the Central Nervous System.Early Neuroinflammatory Changes as a Prognostic Marker in Clinically Isolated Syndromes Patients.Multiple Sclerosis (MS);Inflammatory DiseaseOther: USPIO MRI - Gadolinium MRIRennes University HospitalBayer;BayerTerminated18 Years45 YearsBoth37N/AFrance
124NCT00881205
(ClinicalTrials.gov)
April 200914/4/2009Rivastigmine in Multiple Sclerosis Patients With Cognitive ImpairmentA 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Rivastigmine Patch (10 cm²) on Cognitive Deficits in Patients With Multiple Sclerosis, Followed by a 1-year Open-label Treatment PhaseMultiple Sclerosis;Cognitive ImpairmentDrug: Rivastigmine transdermal patch;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years65 YearsAll86Phase 4Germany
125EUCTR2008-004174-40-FR
(EUCTR)
06/03/200925/11/2008Imagerie de la démyélinisation dans la sclérose en plaques : une étude en tomographie à émission de positons (TEP) avec le 11C-2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (11C-PIB) - SHADOWTEPImagerie de la démyélinisation dans la sclérose en plaques : une étude en tomographie à émission de positons (TEP) avec le 11C-2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (11C-PIB) - SHADOWTEP Groupe I: volontaires sainsGroupe II: patients avec une sclérose en plaques d'évolution rémittente .
MedDRA version: 8.1;Level: PT;Classification code 10012300;Term: Demyelinating disease (excl multiple sclerosis)
Product Name: 11C-PIB
INN or Proposed INN: 11C-PIB
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2007-000381-20-BG
(EUCTR)
28/10/200820/10/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3bGermany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
127EUCTR2007-000381-20-GR
(EUCTR)
09/09/200801/04/2008A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1100Phase 3bCzech Republic;Denmark;Estonia;Greece;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom
128EUCTR2007-000381-20-NL
(EUCTR)
29/08/200801/02/2008A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1100Phase 3bPortugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece
129EUCTR2007-006338-32-ES
(EUCTR)
16/07/200828/03/2008Estudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosisEstudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis Esclerosis Múltiple Recurrente-remitente Relapsing remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMab 2H7
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Hoffman La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy
130EUCTR2007-000381-20-LT
(EUCTR)
15/07/200806/06/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3bGermany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131JPRN-UMIN000002725
2008/07/0122/11/2009Efficacy of ramatroban in multiple sclerosis patients Multiple sclerosisAddition of ramatroban to conventional MS therapyIou hospitalNULLComplete: follow-up completeNot applicableNot applicableMale and Female5Not selectedJapan
132EUCTR2007-000381-20-LV
(EUCTR)
29/05/200812/05/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3bUnited States;Portugal;Serbia;Estonia;Saudi Arabia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany
133EUCTR2007-000381-20-EE
(EUCTR)
19/05/200828/12/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3bGermany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
134EUCTR2007-005363-10-FR
(EUCTR)
13/05/200811/12/2007Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement (CIS patients) à haut risque de développer une sclérose en plaques. - USPIO-CISEtude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement (CIS patients) à haut risque de développer une sclérose en plaques. - USPIO-CIS 1. Multiple Sclerosis2. Clinically isolated syndromes (at high risk to develop Multiple Sclerosis)
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive
MedDRA version: 9.1;Classification code 10028246;Term: Multiple sclerosis aggravated
MedDRA version: 9.1;Classification code 10028247;Term: Multiple sclerosis like syndrome
MedDRA version: 9.1;Classification code 10028248;Term: Multiple sclerosis-like syndrome
MedDRA version: 9.1;Classification code 10048393;Term: Multiple sclerosis relapse
MedDRA version: 9.1;Classification code 10053395;Term: Progressive multiple sclerosis
MedDRA version: 9.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis
MedDRA version: 9.1;Classification code 10063401;Term: Primary progressive multiple sclerosis
MedDRA version: 9.1;Classification code 10064137;Term: Progression of multiple sclerosis
MedDRA version: 9.1;Level: PT;Term: Secondary progressive multiple sclerosis
Product Code: SH U 555 CC.H.U. de RENNESNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
135EUCTR2007-000381-20-PT
(EUCTR)
28/04/200815/01/2008A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3bPortugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2007-000381-20-CZ
(EUCTR)
23/04/200814/12/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3bGermany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
137EUCTR2007-000381-20-DK
(EUCTR)
15/04/200805/03/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3bAustralia;United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany
138NCT00642902
(ClinicalTrials.gov)
April 200821/3/2008A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment CourseRelapsing Multiple SclerosisDrug: Atacicept;Drug: Placebo matched to ataciceptEMD SeronoNULLTerminated18 Years60 YearsAll255Phase 2United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom
139NCT00670449
(ClinicalTrials.gov)
April 200828/4/2008An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple SclerosisAn Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple SclerosisMultiple SclerosisDrug: FingolimodNovartisMitsubishi Tanabe Pharma CorporationCompleted18 Years60 YearsAll143Phase 2Japan
140NCT01414816
(ClinicalTrials.gov)
April 200813/7/2011Betaferon® Regulatory Post-Marketing SurveillanceBetaferon® Regulatory Post-Marketing SurveillanceMultiple Sclerosis;Clinically Isolated SystemDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted12 YearsN/ABoth355N/AKorea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT00605215
(ClinicalTrials.gov)
April 20088/1/2008BRAVO Study: Laquinimod Double Blind Placebo Controlled Study in RRMS Patients With a Rater Blinded Reference Arm of Interferon ß-1a (Avonex®)A Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With RRMS to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and a Reference Arm of Interferon ß-1a (Avonex®) in a Rater-blinded Design.Multiple SclerosisDrug: laquinimod;Drug: placebo;Drug: Interferon ß-1a (Avonex®)Teva Pharmaceutical IndustriesNULLCompleted18 Years55 YearsBoth1331Phase 3United States;Bulgaria;Croatia;Czech Republic;Estonia;Georgia;Germany;Israel;Italy;Lithuania;Macedonia, The Former Yugoslav Republic of;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Latvia;Montenegro;Turkey
142EUCTR2007-000381-20-DE
(EUCTR)
17/03/200828/02/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3bUnited States;Portugal;Serbia;Estonia;Saudi Arabia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany
143EUCTR2007-002179-15-FR
(EUCTR)
04/03/200822/11/2007Etude des effets de la méthylprednisolone à fortes doses sur les caractéritiques électrophysiologiques de la fatigabilité à l'effort au cours des poussées de sclérose en plaques - CORTICOFLASHEtude des effets de la méthylprednisolone à fortes doses sur les caractéritiques électrophysiologiques de la fatigabilité à l'effort au cours des poussées de sclérose en plaques - CORTICOFLASH Méthylprednisolone administrée aux patients et contrôles à la dose de 1g/j pendant 3 jours, comme prescrit habituellement dans le cadre de leur pathologie.
MedDRA version: 8.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Methylprednisolone
Product Name: Methylprednisolone
INN or Proposed INN: Methylprednisolone
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
144EUCTR2007-000381-20-BE
(EUCTR)
21/01/200820/12/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Denmark;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany
145EUCTR2006-001152-12-HU
(EUCTR)
09/01/200809/10/2007Not applicableAn international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. - TOPIC Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Teriflunomide
Product Code: HMR1726D
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726D
INN or Proposed INN: Teriflunomide
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
600United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2007-000381-20-AT
(EUCTR)
30/12/200703/01/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3bGermany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
147EUCTR2007-000381-20-FR
(EUCTR)
14/12/200717/10/2007A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Extension trial to Trial 25643: Oral Cladribine in MS Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono International S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3bPortugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece
148EUCTR2006-002982-38-LT
(EUCTR)
30/11/200701/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
149EUCTR2007-000381-20-FI
(EUCTR)
16/11/200715/10/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3bGermany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
150EUCTR2006-003037-32-LT
(EUCTR)
11/09/200727/11/2006A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3bGermany;Estonia;Spain;Italy;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2006-002633-20-LT
(EUCTR)
07/09/200705/07/2007Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRandomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
350Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania
152EUCTR2006-005270-47-GR
(EUCTR)
03/07/200718/06/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
153EUCTR2006-007057-42-DK
(EUCTR)
25/06/200714/05/2007An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrastAn open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast relapsing forms of multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis
Product Name: firategrast (USAN approved name)
Product Code: SB-683699
Other descriptive name: firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
45Czech Republic;Denmark;Sweden
154EUCTR2006-002982-38-PT
(EUCTR)
29/05/200722/02/2007A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
155EUCTR2006-007057-42-BE
(EUCTR)
29/05/200714/02/2007An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrastAn open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast relapsing forms of multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis
Product Name: firategrast (USAN approved name)
Product Code: SB-683699
Other descriptive name: firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
45Czech Republic;Belgium;Denmark;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2006-005270-47-FR
(EUCTR)
22/05/200723/01/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Schering AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
157EUCTR2006-005270-47-SI
(EUCTR)
16/05/200704/04/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering PharmaNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
158EUCTR2006-002982-38-GR
(EUCTR)
08/05/200729/12/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
159EUCTR2006-007057-42-CZ
(EUCTR)
03/05/200716/03/2007An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrastAn open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast relapsing forms of multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis
Product Name: firategrast (USAN approved name)
Product Code: SB-683699
Other descriptive name: firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Czech Republic;Belgium;Denmark;Sweden
160EUCTR2006-005270-47-LV
(EUCTR)
02/05/200703/04/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161EUCTR2006-007057-42-SE
(EUCTR)
02/05/200715/02/2007An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrastAn open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast relapsing forms of multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis
Product Name: firategrast (USAN approved name)
Product Code: SB-683699
Other descriptive name: firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
45Czech Republic;Denmark;Sweden
162EUCTR2006-005270-47-FI
(EUCTR)
23/04/200719/12/2006 International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Schering AGNULLNot Recruiting Female: yes
Male: yes
1880Phase 3Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden
163NCT00548769
(ClinicalTrials.gov)
April 21, 200723/10/2007Firategrast (SB683699) Surface Area Study in Multiple Sclerosis PatientsAn Open-label, Randomised, Four Period Crossover Study to Investigate the Relative Pharmacokinetic Profiles of Tablets From Three Batches of Firategrast With Different Surface Areas and Two Different Tablet Formulations Containing the Same Batch of Firategrast, Given as Single 900mg Doses to Male and Female Subjects With a Diagnosis of Multiple SclerosisMultiple SclerosisDrug: Formulation A;Drug: Formulation B;Drug: Formulation C;Drug: Formulation DGlaxoSmithKlineNULLCompleted18 Years65 YearsAll37Phase 1Czechia;Germany;Poland;Czech Republic
164EUCTR2006-005270-47-HU
(EUCTR)
16/04/200709/03/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering PharmaNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
165EUCTR2006-003037-32-DE
(EUCTR)
13/04/200701/12/2006A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable
Merck Serono SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3bGermany;Estonia;Spain;Italy;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2006-005270-47-BE
(EUCTR)
12/04/200722/12/2006International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bSlovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden
167EUCTR2006-005270-47-NL
(EUCTR)
02/04/200718/04/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Schering AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
168NCT00468182
(ClinicalTrials.gov)
April 200730/4/2007Modulation of Plasmacytoid Dendritic Cell Function in Multiple SclerosisModulation of Plasmacytoid Dendritic Cell Function in Multiple SclerosisMultiple SclerosisDrug: Interferon-beta 1b (Betaseron)Rutgers, The State University of New JerseyBayerCompleted18 Years60 YearsBoth24United States
169NCT00475865
(ClinicalTrials.gov)
April 200718/5/2007Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple SclerosisA Randomized, Multinational, Double-blind, Placebo-controlled, Parallel-group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Glatiramer Acetate in Subjects With Multiple SclerosisMultiple SclerosisDrug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Glatiramer Acetate (GA)SanofiNULLCompleted18 Years55 YearsAll123Phase 2United States;Austria;Canada;Germany;Italy;United Kingdom
170NCT00472797
(ClinicalTrials.gov)
April 200710/5/2007Rebif New Formulation (RNF) Quality of Life (QOL) StudyA Randomized, Multicenter, Two-arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QOL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis (MS) Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF)Relapsing Multiple SclerosisDrug: Rebif New Formulation Non Titrated;Drug: Rebif New Formulation TitratedEMD SeronoNULLCompleted18 Years60 YearsAll232Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2006-002633-20-IT
(EUCTR)
26/03/200705/02/2007Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 - 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRandomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 - 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis Multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Firategrast
Product Code: SB683699
INN or Proposed INN: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
INN or Proposed INN: Firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
350France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;United Kingdom;Italy
172EUCTR2006-002982-38-DE
(EUCTR)
16/03/200710/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
173EUCTR2006-002982-38-EE
(EUCTR)
15/03/200731/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International, a branch of Laboratoires Serono SA An affiliate of Merck KGaANULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
174EUCTR2006-003037-32-EE
(EUCTR)
06/03/200726/01/2007A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3bGermany;Estonia;Spain;Italy;Lithuania
175EUCTR2006-005270-47-SE
(EUCTR)
28/02/200702/02/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer AB, Bayer Health Care, Bayer Schering PharmaNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2006-005270-47-AT
(EUCTR)
22/02/200731/01/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Schering AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bSlovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Germany;Latvia;Netherlands;Sweden
177EUCTR2006-003366-33-ES
(EUCTR)
13/02/200703/03/2010Estudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple ActivaEstudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple Activa Pacientes con esclerosis múltiple activa
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: not applicable
Product Name: Interferon beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
Trade Name: not applicable
Product Name: cladribina oral
Product Code: not applicable
INN or Proposed INN: cladribine
Serono International, S.A.NULLNot RecruitingFemale: yes
Male: yes
290Phase 2Spain;Italy
178EUCTR2006-003037-32-ES
(EUCTR)
09/02/200710/03/2010Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable
Merck Serono International SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3bGermany;Estonia;Spain;Italy;Lithuania
179EUCTR2006-002982-38-SK
(EUCTR)
12/01/200706/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International, a branch of Laboratoires Serono SA An affiliate of Merck KGaANULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
180EUCTR2006-002982-38-FR
(EUCTR)
05/01/200724/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Serono International SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181EUCTR2006-002982-38-DK
(EUCTR)
20/12/200630/11/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Denmark;Belgium;Estonia;Spain;Greece
182EUCTR2006-002982-38-FI
(EUCTR)
19/12/200619/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
183EUCTR2006-002633-20-FI
(EUCTR)
05/12/200604/09/2006Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRandomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
350Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania
184EUCTR2006-002982-38-AT
(EUCTR)
04/12/200629/09/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
185EUCTR2006-002633-20-ES
(EUCTR)
01/12/200613/04/2012Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrenteEstudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente Esclerosis múltiple remitente-recurrente
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
GlaxoSmithKline S.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Germany;Netherlands;France;Norway;Italy;Austria;Australia;Lithuania;Finland;United Kingdom;Russian Federation;Canada;New Zealand;Spain;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186EUCTR2006-002982-38-BE
(EUCTR)
29/11/200614/09/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A.-Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
187EUCTR2006-000606-23-ES
(EUCTR)
23/11/200615/03/2012?Post-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phasePost-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phase - PASS-PD del escalado de dosis de Rebif Not applicalbe
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Rebif 22 y 44 mcg
Product Name: Interferon-beta-1a
Other descriptive name: INTERFERON BETA-1A
Merck, S.L.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase -Spain
188EUCTR2006-002633-20-NL
(EUCTR)
17/11/200610/08/2006Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRandomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
350Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania
189EUCTR2006-002982-38-CZ
(EUCTR)
03/11/200615/09/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
190EUCTR2006-002633-20-DE
(EUCTR)
25/10/200623/08/2006Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRandomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
350France;Finland;Spain;Lithuania;Austria;Netherlands;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
191EUCTR2006-001161-42-SE
(EUCTR)
17/10/200629/05/2006Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - Not applicableMulticentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - Not applicable Multiple sclerosis (MS)Product Name: DACLIZUMAB HYP
Other descriptive name: Daclizumab HYP (DAC HYP)
Biogen Idec Ltd.NULLNot RecruitingFemale: yes
Male: yes
232Hungary;Germany;United Kingdom;Sweden
192EUCTR2004-002567-24-GB
(EUCTR)
09/10/200622/02/2005A Phase 2a Magnetic Resonance Study of the Safety and Efficacy of MLN1202 in Patients with Multiple Sclerosis - Not applicableA Phase 2a Magnetic Resonance Study of the Safety and Efficacy of MLN1202 in Patients with Multiple Sclerosis - Not applicable The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS).
MedDRA version: 8.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: MLN1202
Product Code: MLN1202
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Czech Republic;United Kingdom
193EUCTR2006-002633-20-AT
(EUCTR)
05/10/200614/09/2006Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple SclerosisRandomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
Product Name: Firategrast
Product Code: SB683699
Other descriptive name: Firategrast (USAN approved name)
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
350Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania
194EUCTR2005-005751-18-GB
(EUCTR)
07/09/200617/02/2006A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy StudyA multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system of unknown aetiology. It is the commonest cause of disability in young adults. The prevalence in the UK is approximately 125/100,000 of the population with an annual incidence of 6/100,000. Approximately 80,000 individuals are affected with MS in the UK.Trade Name: Rebif 44
Product Name: Rebif 44
Product Code: Interferon beta 1a
INN or Proposed INN: Interferon beta 1a
Trade Name: Rebif 22
Product Name: Rebif 22
Product Code: Interferon beta 1a
INN or Proposed INN: Interferon beta 1a
Product Name: Betaferon 500mcg
Product Code: Betaferon 500mcg
INN or Proposed INN: Interferon beta 1b
UCL Biomedicine R&D UnitNULLNot RecruitingFemale: yes
Male: yes
100United Kingdom
195NCT00261326
(ClinicalTrials.gov)
September 20062/12/2005Simvastatin Treatment of Patients With Acute Optic NeuritisSimvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III TrialOptic Neuritis;Multiple SclerosisDrug: simvastatin;Drug: placeboGlostrup University Hospital, CopenhagenAlpharma ApSActive, not recruiting18 Years59 YearsBoth64Phase 3Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196EUCTR2004-005148-28-LT
(EUCTR)
18/07/200602/05/2006A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
197EUCTR2004-005148-28-LV
(EUCTR)
05/06/200611/01/2007A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
198EUCTR2004-005148-28-SK
(EUCTR)
01/06/200625/04/2006A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Czech Republic;Estonia;Slovakia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom
199EUCTR2004-005148-28-AT
(EUCTR)
22/11/200518/10/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Czech Republic;Estonia;Finland;Lithuania;Denmark;Austria;Latvia;Germany;Italy;United Kingdom
200EUCTR2004-005148-28-DE
(EUCTR)
17/11/200516/05/2006A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International, a branch of Laboratories Serono S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Czech Republic;United Kingdom;Germany;Denmark;Estonia;Italy;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201NCT00273364
(ClinicalTrials.gov)
November 16, 20055/1/2006Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized StudyHematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized StudyMultiple SclerosisProcedure: Hematopoietic Stem Cell Therapy;Drug: Standard treatment with a conventional drugNorthwestern UniversityUppsala University;Sheffield Teaching Hospitals NHS Foundation Trust;University of Sao PauloCompleted18 Years55 YearsAll110Phase 2United States
202EUCTR2005-001008-37-SE
(EUCTR)
01/11/200521/03/2005Analysis of the antibody level against interferon beta before and after increase of dose in MS therapy - Interferon beta dose and antibodyAnalysis of the antibody level against interferon beta before and after increase of dose in MS therapy - Interferon beta dose and antibody Multiple sclerosisTrade Name: Rebif®
Product Name: Rebif®
Product Code: Not applicable
INN or Proposed INN: Interferon beta-1a
Sahlgrenska University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Sweden
203NCT00313976
(ClinicalTrials.gov)
November 200511/4/2006Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)BayerNULLWithdrawn18 YearsN/ABoth0Phase 3Denmark;Sweden
204EUCTR2004-005148-28-EE
(EUCTR)
09/09/200531/05/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
205EUCTR2004-002567-24-HU
(EUCTR)
19/07/200506/04/2005A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not applicableA Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not applicable The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS).Product Name: MLN1202
Product Code: MLN1202
INN or Proposed INN: Not yet available
Other descriptive name: Not yet available
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
160Phase 2aHungary;United Kingdom;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206EUCTR2004-005148-28-CZ
(EUCTR)
14/07/200515/06/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;United Kingdom;Czech Republic;Denmark;Estonia;Italy;Latvia;Lithuania
207EUCTR2004-005148-28-BE
(EUCTR)
14/06/200505/07/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Czech Republic;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom
208EUCTR2004-005148-28-DK
(EUCTR)
02/06/200509/05/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
209NCT00202397
(ClinicalTrials.gov)
June 200512/9/2005Effect of Riluzole as a Symptomatic Approach in Patients With Chronic Cerebellar AtaxiaPhase 2 Study of Riluzole Effects on Patients With Chronic Cerebellar AtaxiaHereditary Ataxia;Multiple Sclerosis;Cerebellar AtaxiaDrug: Riluzole;Other: placeboS. Andrea HospitalNULLCompleted18 Years80 YearsBoth40Phase 2Italy
210EUCTR2004-005148-28-FI
(EUCTR)
26/05/200518/04/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2004-002567-24-CZ
(EUCTR)
04/04/200504/02/2005A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not appilcableA Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not appilcable The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS).Product Name: MLN1202
Product Code: MLN1202
INN or Proposed INN: Not yet available
Other descriptive name: Not yet available
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
160Phase 2aHungary;United Kingdom;Czech Republic
212NCT00109161
(ClinicalTrials.gov)
April 200522/4/2005Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple SclerosisA Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: Daclizumab (Anti-CD25 Humanized Monoclonal Antibody)PDL BioPharma, Inc.NULLCompleted18 Years55 YearsBoth270Phase 2United States;Canada
213NCT00213135
(ClinicalTrials.gov)
April 200513/9/2005A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)Multiple Sclerosis, Relapsing-RemittingDrug: Cladribine 5.25 mg/kg;Drug: Cladribine 3.5 mg/kg;Other: PlaceboEMD SeronoNULLCompleted18 Years65 YearsAll1326Phase 3Canada;Switzerland
214NCT00668343
(ClinicalTrials.gov)
April 200527/4/2008Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to PlaceboRelapsing Remitting Multiple SclerosisDrug: simvastatin;Drug: placeboTehran University of Medical SciencesNULLCompleted15 Years60 YearsBoth80Phase 3Iran, Islamic Republic of
215EUCTR2004-003799-13-LT
(EUCTR)
08/03/200527/12/2004A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot RecruitingFemale: yes
Male: yes
230Phase 3bUnited Kingdom;Spain;Ireland;Sweden;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216EUCTR2004-003799-13-DK
(EUCTR)
24/02/200518/01/2005A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot RecruitingFemale: yes
Male: yes
230Phase 3Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden
217EUCTR2004-004130-14-AT
(EUCTR)
17/02/200513/01/2005A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week).A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week). Male and female subjects with relapsing multiple sclerosis previously treated with interferon beta-1a (22 mcg or 44 mcg, SC three times a week).Product Name: Natalizumab
Product Code: Not Applicable
INN or Proposed INN: natalizumab
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: Interferon beta-1a
Biogen Idec GmbHNULLNot RecruitingFemale: yes
Male: yes
1050Austria
218EUCTR2004-003799-13-ES
(EUCTR)
17/02/200504/11/2005A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3bUnited Kingdom;Ireland;Spain;Lithuania;Sweden
219EUCTR2004-003799-13-SE
(EUCTR)
03/02/200523/12/2004A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot RecruitingFemale: yes
Male: yes
230Phase 3bUnited Kingdom;Spain;Ireland;Lithuania;Sweden
220EUCTR2004-000337-12-HU
(EUCTR)
23/07/200429/09/2004A multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis - EMEA Post Approval Commitment New Clone StudyA multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis - EMEA Post Approval Commitment New Clone Study MS with 2 or more relapses within the last 2 years
MedDRA version: 7.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Rebif
Product Code: Not applicable
INN or Proposed INN: Interferon beta-1a
Other descriptive name: Recombinant human interferon beta
Trade Name: Rebif
Product Name: Rebif
Product Code: Not applicable
INN or Proposed INN: Interferon beta-1a
Other descriptive name: Recombinant human interferon beta
Serono International SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 4Hungary
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221NCT00202995
(ClinicalTrials.gov)
July 200413/9/2005Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMSA Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis PatientsRelapsing Remitting Multiple SclerosisDrug: Glatiramer Acetate;Drug: Betaseron;Drug: RebifTeva Pharmaceutical IndustriesNULLTerminated18 Years50 YearsBoth91Phase 4United States;Canada
222NCT00682929
(ClinicalTrials.gov)
April 14, 200419/5/2008Cannabis for Spasticity in Multiple SclerosisCannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled StudyMultiple SclerosisDrug: Inhaled Cannabis;Drug: Oral THC;Drug: Oral Placebo;Drug: Inhaled placeboUniversity of California, DavisNational Multiple Sclerosis SocietyTerminated21 YearsN/AAll41Phase 1;Phase 2United States
223NCT00086671
(ClinicalTrials.gov)
April 20047/7/2004Safety and Effectiveness of Two Doses of ABT-874 as Compared to Placebo in Subjects With Multiple Sclerosis (MS)A 24-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose Finding, Safety, Tolerability, and Efficacy Study of the Human Anti-IL-12 Antibody ABT-874 in Subjects With Multiple Sclerosis With a 24-Week Double-Blind, Active Extension PhaseMultiple SclerosisDrug: ABT-874/Human monoclonal antibody against IL-12;Drug: PlaceboAbbVie (prior sponsor, Abbott)NULLCompleted18 Years60 YearsBoth215Phase 2United States;Canada;Germany;Netherlands;United Kingdom
224NCT01233245
(ClinicalTrials.gov)
April 200414/10/2010BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus ProgramBetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus ProgramRelapsing Remitting MS (RRMS);Secondary Progressive MS (SPMS)Drug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 YearsN/ABoth1077N/ACzech Republic;France;Germany;Iran, Islamic Republic of;Israel;Italy;Jordan;Korea, Republic of;Lebanon;Netherlands;Portugal;Saudi Arabia;Spain;Taiwan;Turkey
225NCT00217295
(ClinicalTrials.gov)
April 200414/9/2005A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple SclerosisA Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis.Multiple SclerosisDrug: Avonex and TopamaxMultiple Sclerosis InstituteNULLRecruiting18 Years55 YearsBoth30Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226NCT00300716
(ClinicalTrials.gov)
April 20048/3/2006Trial of Memantine for Cognitive Impairment in Multiple SclerosisDouble Blind Placebo Controlled Pilot Trial of Memantine for Cognitive Impairment in Multiple SclerosisMultiple Sclerosis;Cognition DisordersDrug: MemantineOregon Health and Science UniversityForest Laboratories;University of Southern California;University of Texas Southwestern Medical Center;MS-Hub SeattleCompleted18 Years65 YearsAll82Phase 2;Phase 3United States
227NCT00202982
(ClinicalTrials.gov)
August 200312/9/2005A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved DoseA Multi-Center, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy, Tolerability and Safety of 40 mg of Copaxone in the Treatment of Relapsing-Remitting Multiple Sclerosis PatientsRelapse-Remitting Multiple SclerosisDrug: glatiramer acetate 20 mg;Drug: glatiramer acetate 40 mgTeva Pharmaceutical IndustriesNULLCompleted18 Years50 YearsBoth90Phase 2United States
228NCT00053417
(ClinicalTrials.gov)
February 200329/1/2003Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple SclerosisDouble-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple SclerosisMultiple SclerosisDrug: Placebo;Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP);Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP);Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP)Acorda TherapeuticsNULLCompleted18 Years70 YearsAll206Phase 2United States;Canada
229NCT00298662
(ClinicalTrials.gov)
February 20032/3/2006Combination Therapy of Betaseron-Prograf in Multiple SclerosisA Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying AgentsMultiple SclerosisDrug: Interferon beta-1b and TacrolimusClinique de sclérose en plaques et neuromusculaire de l'OutaouaisNULLActive, not recruiting18 Years55 YearsBoth30Phase 2Canada
230NCT00405353
(ClinicalTrials.gov)
April 200228/11/2006Testosterone Treatment for Multiple SclerosisTestosterone Treatment for Multiple Sclerosis: A Preliminary TrialMultiple SclerosisDrug: Androgel 10 grams of gel containing 100 mg of testosteroneUniversity of California, Los AngelesNational Multiple Sclerosis SocietyCompleted18 Years65 YearsMale10Phase 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
231NCT01487096
(ClinicalTrials.gov)
April 20015/12/2011Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With RelapsesA Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With RelapsesMultiple SclerosisDrug: Teriflunomide;Drug: Placebo (placebo for teriflunomide)SanofiNULLCompleted18 Years65 YearsBoth179Phase 2Canada;France
232NCT00017628
(ClinicalTrials.gov)
April 20016/6/2001Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple SclerosisMultiple SclerosisDrug: cyclophosphamide;Drug: filgrastim;Drug: methylprednisolone;Procedure: Autologous Stem Cell TransplantationNorthwestern Memorial HospitalNULLCompletedN/A59 YearsBoth20Phase 1United States
233NCT00040482
(ClinicalTrials.gov)
April 199926/6/2002High Dose Chemo/Radiotherapy and Hematopoietic Stem Cell Transplant for Patients With Multiple SclerosisIntensive Immunosuppression Followed by Rescue With CD34 Selected, T Cell Depleted, Leukopheresis Products in Patients With Multiple SclerosisMultiple SclerosisDrug: Cyclophosphamide;Drug: ATG;Drug: MESNA;Procedure: Radiation therapyBaylor College of MedicineThe Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of MedicineCompleted18 Years60 YearsAll10Phase 2United States
234NCT00006060
(ClinicalTrials.gov)
April 19995/7/2000Diagnostic Study of Quantitative Imaging and Spectroscopy in Patients With Multiple SclerosisMultiple SclerosisDrug: standard gadolinium contrastNational Center for Research Resources (NCRR)University of PennsylvaniaRecruiting20 Years70 YearsBoth100N/AUnited States
235JPRN-JapicCTI-050031
06/09/2005Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval)Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval) [Spinal cord Origin] Spinal cord Injury, Multiple sclerosis, Spinocerebellar degeneration, Circulatory disorder of the spinal, Ossification of the posterior longitudinal ligament [Cerebral Origin] Cerebral palsy, Traumatic head injuryIntervention name : Baclofen
Dosage And administration of the intervention : Intertheacal injection
DAIICHI SANKYO COMPANY, LIMITEDNULLBOTHPhase 4NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236EUCTR2006-005270-47-DE
(EUCTR)
09/02/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering PharmaNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece

299. 嚢胞性線維症 [臨床試験数:1,592,薬物数:1,539(DrugBank:255),標的遺伝子数:81,標的パスウェイ数:162
Searched query = "Cystic fibrosis"
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.
126 / 1,592 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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Inclusion_
gender
Target_
size
PhaseCountries
1NCT04596319
(ClinicalTrials.gov)
December 202015/10/2020Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic FibrosisA Phase 1b/2a, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of AP-PA02 Multi-Phage Therapeutic Candidate for Inhalation in Subjects With Cystic Fibrosis and Chronic Pulmonary Pseudomonas Aeruginosa (Pa) InfectionCystic Fibrosis;Pseudomonas Aeruginosa;Pseudomonas;Lung Infection;Lung Infection PseudomonalBiological: AP-PA02;Other: PlaceboArmata Pharmaceuticals, Inc.Cystic Fibrosis FoundationRecruiting18 YearsN/AAll48Phase 1;Phase 2United States
2NCT04467957
(ClinicalTrials.gov)
October 1, 202019/6/2020Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic FibrosisNon-contrast Lung Perfusion Mapping Applied for New Insights in Cystic FibrosisCystic FibrosisDrug: Initiation of CFTR Modulator;Drug: Hyperpolarized Xenon 129Children's Hospital Medical Center, CincinnatiNULLNot yet recruiting6 Years21 YearsAll26Phase 4NULL
3NCT04058210
(ClinicalTrials.gov)
July 21, 202013/8/2019VX-445/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients Heterozygous for F508del Mutation and a Minimal Function Mutation (F/MF Genotypes)VX-445/TEZ/IVA Triple Combination Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function CFTR MutationCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLApproved for marketing12 YearsN/AAllNULL
4NCT03988816
(ClinicalTrials.gov)
December 6, 201914/6/2019Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With BronchiectasisEffect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Non-cystic Fibrosis Bronchiectasis: a Cross-over, Unicentric, Double-blind and Placebo-controlled StudyBronchiectasis AdultDrug: Roflumilast;Drug: Placebo oral tabletUniversity of Sao Paulo General HospitalFAPESP - Fundação de Apoio à Pesquisa do Estado de São PauloRecruiting18 YearsN/AAll30Phase 2Brazil
5NCT04176328
(ClinicalTrials.gov)
October 25, 20198/11/2019Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis PatientsAn Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis PatientsCystic FibrosisDrug: Teicoplanin Sandoz 200 mg powder and solvent for solution for injection or infusion or oral solution.Neupharma SrlSintesi Research Srl;Aptuit Srl;Pari Pharma GmbHCompleted18 YearsN/AAll12Phase 1Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02748798
(ClinicalTrials.gov)
May 201919/4/2016Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung DisordersDeveloping Optimal Parameters for Hyperpolarized Noble Gas (3He and 129Xe) and Inert Fluorinated Gas Magnetic Resonance Imaging of Lung DisordersLung Transplant;Lung Resection;Lung Cancer;Asthma;Cystic Fibrosis;Chronic Obstructive Pulmonary Disease;Emphysema;Mesothelioma;Asbestosis;Pulmonary Embolism;Interstitial Lung Disease;Pulmonary Fibrosis;Bronchiectasis;Seasonal Allergies;Cold Virus;Lung Infection;Pulmonary Hypertension;Pulmonary Dysplasia;Obstructive Sleep ApneaDrug: HP 3He;Drug: HP 129Xe;Drug: PFP;Drug: SF6;Device: 129Xe Small and Large Human Lung Coil;Device: 3He Human Lung Coil;Device: PFP and SF6 Human Lung CoilThunder Bay Regional Research InstituteThunder Bay Regional Health Sciences Centre;St. Joseph's Care Group;Lakehead UniversityUnknown status18 YearsN/AAll160Early Phase 1Canada
7NCT03912233
(ClinicalTrials.gov)
April 30, 201910/4/2019A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic FibrosisCystic FibrosisDrug: VX-121;Drug: TEZ;Drug: VX-561;Drug: TEZ/IVA;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll87Phase 2United States;Germany;Netherlands;Portugal;United Kingdom
8NCT03911713
(ClinicalTrials.gov)
April 17, 20199/4/2019A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisCystic FibrosisDrug: VX-561;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll77Phase 2United States;Australia;Belgium;Germany;Ireland;Netherlands;United Kingdom
9NCT03795363
(ClinicalTrials.gov)
April 10, 201928/12/2018Orkambi Treatment in 2 to 5 Year Old Children With CFNutritional Impact of Orkambi Treatment in 2 to 5 Year Old Children Homozygous for F508del MutationsCystic FibrosisDrug: OrkambiChildren's Hospital of PhiladelphiaVertex Pharmaceuticals IncorporatedRecruiting2 Years5 YearsAll32United States
10NCT03870841
(ClinicalTrials.gov)
April 3, 201924/10/2018The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic FibrosisAn Open-label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Inhaled PC945 in Adult Cystic Fibrosis (CF) Patients With Persistent Pulmonary Aspergillus Fumigatus InfectionAspergillosis;Cystic FibrosisDrug: PC945Pulmocide LtdNULLTerminated18 YearsN/AAll4Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03710538
(ClinicalTrials.gov)
April 1, 201920/6/2018The Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic FibrosisThe Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic FibrosisCystic FibrosisDietary Supplement: Snack beverage;Behavioral: ExerciseInstitut de Recherches Cliniques de MontrealNULLRecruiting18 YearsN/AAll14N/ACanada
12NCT03724955
(ClinicalTrials.gov)
April 201929/10/2018Pilot E2 for Hypogonadal Women With CFBDPilot Study Evaluating the Effects of Estradiol for Hypogonadal Women With Cystic Fibrosis and OsteopeniaCystic Fibrosis Related Bone DiseaseDrug: Estradiol 2 mg;Other: PlaceboEmory UniversityNULLWithdrawn18 YearsN/AFemale0Phase 4United States
13NCT03624101
(ClinicalTrials.gov)
December 1, 20187/8/2018Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon MutationsNovel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon MutationsCystic FibrosisDrug: Tezacaftor/IvacaftorUniversity of Alabama at BirminghamNULLRecruiting18 YearsN/AAll5Phase 4United States
14NCT03265288
(ClinicalTrials.gov)
October 10, 201821/2/2017Study of LAU-7b in the Treatment of Cystic Fibrosis in AdultsAPPLAUD: A Double-Blind, Randomized, Placebo-Controlled, Phase II Study of the Efficacy and Safety of LAU-7b in the Treatment of Cystic Fibrosis in AdultsCystic FibrosisDrug: LAU-7b;Drug: Placebo oral capsuleLaurent Pharmaceuticals Inc.Cystic Fibrosis FoundationRecruiting18 YearsN/AAll136Phase 2United States;Australia;Canada
15NCT03492567
(ClinicalTrials.gov)
April 25, 20183/4/2018Study of Circulating Blood Cell Monocytes as Predictive Biomarker of Bone Cystic Fibrosis Disease. Impact of CFTR Correctors.Study of Circulating Monocytes as Predictive Biomarker of Osteoclastogenesis in Cystic Fibrosis-related Bone Loss. Impact of CFTR Correctors.Cystic FibrosisBiological: Blood testAssistance Publique - Hôpitaux de ParisVaincre la MucoviscidoseCompleted18 YearsN/AAll25N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03537651
(ClinicalTrials.gov)
April 25, 201815/5/2018A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR MutationA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR MutationCystic FibrosisDrug: TEZ;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting6 YearsN/AAll130Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Poland;Switzerland;United Kingdom
17NCT03527095
(ClinicalTrials.gov)
April 5, 20184/5/2018A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy SubjectsA Phase 1, Open-label, Randomised, Cross Over Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects Following Single DosesCystic FibrosisDrug: FDL169Flatley Discovery Lab LLCNULLCompleted18 Years55 YearsAll11Phase 1United Kingdom
18NCT03489629
(ClinicalTrials.gov)
April 3, 201829/3/2018STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)Cystic FibrosisDrug: Trimethoprim Sulfamethoxazole (TMP/SMX);Drug: Minocycline;Drug: Mupirocin;Drug: Chlorhexidine Gluconate;Behavioral: Environmental DecontaminationUniversity of North Carolina, Chapel HillUniversity of Washington;Cook Children's Medical Center;Indiana University;University of Michigan;University of Texas Southwestern Medical Center;St. Louis Children's HospitalRecruiting2 Years45 YearsAll42Phase 2United States
19EUCTR2017-002181-42-DE
(EUCTR)
27/10/201728/07/2017GLPG2737 on top of Orkambi in subjects with cystic fibrosisA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2737 in Orkambi-treated subjects with cystic fibrosis homozygous for the F508del mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Germany
20NCT03278314
(ClinicalTrials.gov)
August 27, 20176/9/2017Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic FibrosisTezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic FibrosisCystic FibrosisDrug: tezacaftor/ivacaftorVertex Pharmaceuticals IncorporatedNULLApproved for marketing12 YearsN/AAllNULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03277196
(ClinicalTrials.gov)
August 16, 20176/9/2017A Study to Evaluate the Safety of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive MutationA Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive MutationCystic FibrosisDrug: IvacaftorVertex Pharmaceuticals IncorporatedNULLEnrolling by invitationN/A24 MonthsAll75Phase 3United States;Australia;Canada;Germany;Ireland;United Kingdom
22EUCTR2017-001379-21-GB
(EUCTR)
01/08/201720/07/2017A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 3United States;Canada;Ireland;Germany;United Kingdom
23NCT02819856
(ClinicalTrials.gov)
July 21, 201716/6/2016SPI-1005 for Prevention and Treatment of Tobramycin Induced OtotoxicityA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Cystic Fibrosis (CF) Patients With Acute Pulmonary Exacerbation (APE) Receiving IV Tobramycin at Risk for OtotoxicityOtotoxicityDrug: Placebo;Drug: SPI-1005 Ebselen 200mg Capsule x1;Drug: SPI-1005 Ebselen 200mg Capsule x2;Drug: SPI-1005 Ebselen 200mg Capsule x3Sound Pharmaceuticals, IncorporatedMedical University of South Carolina;Cystic Fibrosis FoundationEnrolling by invitation18 YearsN/AAll80Phase 2United States
24EUCTR2016-004477-40-ES
(EUCTR)
31/05/201710/03/2017A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both allelesA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation Cystic Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Serbia;United States;Belgium;Spain;Netherlands;United Kingdom
25EUCTR2016-004477-40-BE
(EUCTR)
08/05/201721/02/2017A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both allelesA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation Cystic Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;Serbia;Spain;Belgium;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03051490
(ClinicalTrials.gov)
April 28, 20179/2/2017RESULT: Reliable, Emergent Solution Using Liprotamase TreatmentA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyExocrine Pancreatic Insufficiency;Cystic FibrosisDrug: Liprotamase;Drug: porcine PERTAnthera PharmaceuticalsNULLUnknown status7 YearsN/AAll140Phase 3United States;Hungary;Israel;Lithuania;Poland;Spain;United Kingdom
27NCT03140527
(ClinicalTrials.gov)
April 10, 201727/4/2017Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic FibrosisA Multi-Center, Randomized, Placebo-Controlled, Phase 1, Two-Part Study Designed to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic FibrosisHealthy Volunteer;Cystic FibrosisDrug: PTI-801;Drug: Placebo;Drug: PTI-808Proteostasis Therapeutics, Inc.NULLCompleted18 YearsN/AAll171Phase 1United States;Canada;Denmark;Germany;Sweden;Portugal
28EUCTR2016-004477-40-NL
(EUCTR)
10/04/201714/02/2017A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both allelesA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation Cystic Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Serbia;United States;Belgium;Spain;Netherlands;United Kingdom
29NCT03104855
(ClinicalTrials.gov)
April 3, 201717/2/2017Clearance of 25-hydroxyvitamin D in Cystic FibrosisClearance of 25-hydroxyvitamin D in Cystic FibrosisCystic FibrosisDrug: d6-25-hydroxyvitamin D3University of WashingtonNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 YearsN/AAll10Phase 1United States
30EUCTR2016-002837-31-CZ
(EUCTR)
04/01/201724/10/2016A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
35Phase 2Czech Republic;Belgium;Ireland;Australia;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
31EUCTR2016-002837-31-DE
(EUCTR)
29/12/201624/10/2016A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation - Albatross Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
32EUCTR2016-002837-31-BE
(EUCTR)
16/12/201624/10/2016A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
33EUCTR2016-002837-31-IE
(EUCTR)
02/12/201604/10/2016A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
34EUCTR2015-003291-77-DE
(EUCTR)
25/05/201611/11/2015A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutationA phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation Cystic fibrosis with the G551D mutation
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
32Phase 2Czech Republic;Ireland;Australia;Germany;United Kingdom
35NCT02850692
(ClinicalTrials.gov)
April 18, 201616/6/2016Portal Hypertension and Systemic Endothelial FunctionPortal Hypertension and Systemic Endothelial Function: Investigation of Systemic Endothelial Dysfunction in Case of Portal Hypertension Associated With Cystic Fibrosis.Cystic Fibrosis;Portal HypertensionOther: measure of endothelial function;Biological: Blood sample;Other: Hepatic elastography;Diagnostic Test: Injected abdominal CTHopital FochNULLRecruiting18 YearsN/AAll60N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT02767297
(ClinicalTrials.gov)
April 20165/5/2016Bioavailability and Pharmacokinetics Study of FDL169 in Healthy Subjects and Subjects With Cystic FibrosisA Three-Part Phase 1b Bioavailability and Pharmacokinetics Study of Two Formulations of FDL169 in Healthy Subjects and Subjects With Cystic FibrosisCystic FibrosisDrug: FDL169Flatley Discovery Lab LLCNULLCompleted18 YearsN/ABoth46Phase 1;Phase 2United Kingdom
37NCT02724527
(ClinicalTrials.gov)
April 201611/3/2016Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With IvacaftorA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 for Efficacy and Safety in Patients With CF Heterozygous for F508del-CFTR + Gating Mutation Being Treated With IvacaftorCystic FibrosisDrug: Cavosonstat;Drug: PlaceboNivalis Therapeutics, Inc.NULLActive, not recruiting18 YearsN/ABoth19Phase 2United States
38EUCTR2015-003292-30-NL
(EUCTR)
26/02/201602/12/2015A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutationA phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation. Cystic fibrosis with the S1251N mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
6Phase 2Belgium;Netherlands
39EUCTR2015-003291-77-IE
(EUCTR)
03/02/201603/12/2015A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutationA phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation Cystic fibrosis with the G551D mutation
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
32Phase 2Czech Republic;Ireland;Australia;Germany;United Kingdom
40NCT02840136
(ClinicalTrials.gov)
February 201618/7/2016LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis PatientsOptimisation, Valorisation and Application of UPLC-MS/MS Based Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients - Part 3: Non-blank Sputum Samples for Method Optimisation and ValidationCystic FibrosisDrug: Piperacillin-tazobactam combination product;Drug: Meropenem;Drug: CeftazidimeUniversity GhentKing Baudouin Foundation;Belgische Vereniging voor Strijd tegen MucoviscidoseSuspended12 YearsN/AAll40N/ABelgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2015-003291-77-CZ
(EUCTR)
26/01/201616/11/2015A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutationA phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation Cystic fibrosis with the G551D mutation
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
32Phase 2Czech Republic;Ireland;Australia;Germany;United Kingdom
42EUCTR2015-003292-30-BE
(EUCTR)
18/01/201626/11/2015A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutationA phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation. Cystic fibrosis with the S1251N mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
6Phase 2Belgium;Netherlands
43NCT02449031
(ClinicalTrials.gov)
May 5, 20154/5/2015Observational Study in Cystic Fibrosis Patients Using TOBI® Podhaler™ or Other FDA Approved Inhaled Antipseudomonal Antibacterial DrugsA Prospective Observational Study in Cystic Fibrosis Patients With Chronic Respiratory Pseudomonas Aeruginosa Infection Treated With TOBI® Podhaler™ (Tobramycin Inhalation Powder) or Other FDA Approved Inhaled Antipseudomonal Antibacterial DrugsPseudomonas Aeruginosa in Cystic FibrosisDrug: TOBI Podhaler;Drug: TOBI;Drug: Bethkis;Drug: CaystonMylan Inc.Cystic Fibrosis FoundationActive, not recruiting6 YearsN/AAll260United States
44NCT02343445
(ClinicalTrials.gov)
April 201513/1/2015Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF)A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of P-1037 Solution for Inhalation in Patients With Cystic Fibrosis (CF)Cystic FibrosisDrug: P-1037;Drug: Hypertonic Saline;Drug: SalineParion SciencesVertex Pharmaceuticals IncorporatedCompleted12 Years80 YearsAll142Phase 2United States
45NCT02690064
(ClinicalTrials.gov)
April 201519/2/2016Mechanisms for Vascular Dysfunction and Exercise Tolerance in CFMechanisms for Vascular Dysfunction and Exercise Tolerance in CFCystic FibrosisDietary Supplement: Acute Antioxidant;Dietary Supplement: Chronic Antioxidant;Other: PlaceboAugusta UniversityNULLRecruiting7 YearsN/AAll80N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT02445053
(ClinicalTrials.gov)
April 201511/5/2015Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study)Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study)Cystic FibrosisDrug: ivacaftorVertex Pharmaceuticals IncorporatedNULLCompleted6 YearsN/AAll75Italy;Netherlands;United Kingdom
47EUCTR2014-004519-35-GB
(EUCTR)
23/02/201508/12/2014A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON IR
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATIN (PAncreas Powder)
Trade Name: Kreon 25 000
Product Name: Creon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN (Pancreas Powder)
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
78Phase 2Czech Republic;Hungary;Spain;United Kingdom
48EUCTR2014-004519-35-CZ
(EUCTR)
18/02/201519/11/2014A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON IR
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATIN (PAncreas Powder)
Trade Name: Kreon 25 000
Product Name: Creon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN (Pancreas Powder)
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
78Phase 2Hungary;Czech Republic;Spain;United Kingdom
49EUCTR2014-004519-35-ES
(EUCTR)
30/01/201504/12/2014A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: KREON de Liberación Inmediata
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATINA (Páncreas Polvo
Trade Name: Kreon 25 000
Product Name: Kreon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATINA (Páncreas Polvo)
Abbott Laboratories GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
78Phase 2Czech Republic;Hungary;Spain;United Kingdom
50EUCTR2014-004519-35-HU
(EUCTR)
09/01/201512/11/2014A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON IR
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATIN (Pancreas Powder)
Trade Name: Kreon 25 000
Product Name: Creon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN (Pancreas Powder)
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
78Phase 2Czech Republic;Hungary;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
51NCT02178540
(ClinicalTrials.gov)
August 201424/6/2014Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis PatientsA Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo CapsulesCystic FibrosisDrug: Placebo;Device: Tobi PodhalerNovartis PharmaceuticalsNULLCompleted6 YearsN/AAll45Phase 4United States
52NCT02106832
(ClinicalTrials.gov)
April 30, 20144/4/2014Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.BronchiectasisDrug: Ciprofloxacin (BAYQ3939) dry powder for inhalation;Drug: PlaceboBayerNovartisCompleted18 YearsN/AAll521Phase 3United States;Argentina;Australia;Austria;Brazil;Bulgaria;China;Czechia;Germany;Hong Kong;Korea, Republic of;Latvia;Lithuania;Netherlands;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Taiwan;Thailand;Turkey;Czech Republic
53NCT02088216
(ClinicalTrials.gov)
April 1, 20145/3/2014Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of BronchiectaisisEffect of N-acetylcysteine on Exacerbations of Bronchiectasis (BENE): a Randomized Controlled TrialNon-Cystic Fibrosis BronchiectasisDrug: N-acetylcysteine;Other: On-demand treatmentQilu Hospital of Shandong UniversityNULLCompleted18 Years80 YearsAll161N/AChina
54NCT01991028
(ClinicalTrials.gov)
April 201418/11/2013A Study to Investigate Lung Deposition of Radiolabelled OligoGAn Open Label, Randomised, Two-way Crossover Scintigraphic Study to Investigate Lung Deposition of Radiolabelled OligoG Delivered as a Dry Powder and as a Nebulised Solution in Cystic Fibrosis PatientsCystic FibrosisDrug: Radiolabelled OligoG CF-5/20 DPI;Drug: Radiolabelled OligoG CF-5/20 6% SolutionBio-Images Research LtdAlgiPharma ASCompleted18 YearsN/ABoth10Phase 2United Kingdom
55NCT01515007
(ClinicalTrials.gov)
April 201410/1/2012Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)Non Cystic Fibrosis BronchiectasisDrug: Ciprofloxacin dispersion for inhalation;Drug: PlaceboAradigm CorporationGrifols Therapeutics LLCCompleted18 YearsN/AAll278Phase 3United States;Australia;Canada;Germany;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Poland;Romania;South Africa;Spain;Taiwan;United Kingdom;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT02141958
(ClinicalTrials.gov)
April 201413/5/2014Safety Study of Fenretinide in Adult Patients With Cystic FibrosisAn Adaptive Phase I Intra-patient Dose Escalation Study of Fenretinide in Adult Cystic Fibrosis PatientsCystic FibrosisDrug: Fenretinide;Drug: PlaceboElias MatoukNULLCompleted18 YearsN/ABoth15Phase 1Canada
57NCT02113397
(ClinicalTrials.gov)
April 20149/4/2014Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis LungComparative Evaluation of Bacterial Diversity and Richness in CF Lung in Patients Who Use Cycled Every Other Month Tobramycin Inhalation Powder (TOBI™ Podhaler™) Or Continuous Alternating Therapy With Tobramycin Inhalation Powder (TOBI™ Podhaler™) and Inhaled ColistimethateCystic FibrosisDrug: TOBI™ Podhaler™ 112 mg inhaled twice daily;Drug: Colistimethate 75 mg inhaled two times dailyDartmouth-Hitchcock Medical CenterNovartis PharmaceuticalsTerminated12 Years75 YearsAll1United States
58NCT02104245
(ClinicalTrials.gov)
April 201428/3/2014Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label ExtensionNon Cystic Fibrosis BronchiectasisDrug: Ciprofloxacin dispersion for inhalation;Drug: PlaceboAradigm CorporationGrifols Therapeutics LLCCompleted18 YearsN/AAll304Phase 3United States;Australia;Canada;Former Serbia and Montenegro;France;Georgia;Hungary;Israel;Italy;Korea, Republic of;New Zealand;Peru;Poland;Romania;Spain;United Kingdom;Germany
59NCT02057458
(ClinicalTrials.gov)
April 20144/2/2014Blood Flow and Vascular Function in Cystic FibrosisRole of Blood Flow and Vascular Function on Exercise Capacity in Cystic FibrosisCystic FibrosisDrug: Sildenafil (Acute-1 hour);Drug: Sildenafil (Subchronic-4 weeks);Drug: PlaceboAugusta UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 YearsN/AAll19Phase 2United States
60NCT02084043
(ClinicalTrials.gov)
March 20148/3/2014In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive VentilationIn Vitro Comparison of Continuous and Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation: Analysis of Inhaled and Lost Doses.Respiratory Diseases;Lung Diseases;Cystic Fibrosis;COPD;AsthmaDrug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute);Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute)University Hospital St Luc, BrusselsUniversité Catholique de Louvain;University of Applied Sciences of Western Switzerland;School of Gestion and Engineering Vaud, SwitzerlandCompletedN/AN/ABoth3N/ABelgium;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2013-002819-10-ES
(EUCTR)
26/12/201312/11/2013A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic FibrosisA Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: KREON N 25000
INN or Proposed INN: Not applicable
Other descriptive name: PANCREATIN
Trade Name: Kreon 25000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATINA
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
40Hungary;Spain;Russian Federation
62EUCTR2013-002819-10-HU
(EUCTR)
29/11/201314/10/2013A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic FibrosisA Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON N 25000
INN or Proposed INN: not applicable
Other descriptive name: PANCREATIN
Trade Name: Creon 25000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
40Hungary;Spain;Russian Federation
63EUCTR2009-012842-21-HU
(EUCTR)
27/06/201310/05/2013Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86Hungary;Bulgaria;Germany;Italy;United Kingdom
64NCT01818544
(ClinicalTrials.gov)
April 20138/3/2013Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) BronchiectasisA Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY85-8501 in Patients With Non-Cystic Fibrosis BronchiectasisBronchiectasisDrug: BAY85-8501;Drug: PlaceboBayerNULLCompleted18 YearsN/ABoth94Phase 2France;Germany;Italy;Spain;United Kingdom
65NCT01807949
(ClinicalTrials.gov)
April 20134/3/2013A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR MutationA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic Fibrosis, Homozygous for the F508del CFTR MutationDrug: Placebo;Drug: Lumacaftor Plus Ivacaftor Combination;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNULLCompleted12 Years65 YearsAll563Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;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
66EUCTR2009-012842-21-BE
(EUCTR)
19/11/201214/05/2012Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREASLIPASE
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86Phase 3Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom
67NCT01641393
(ClinicalTrials.gov)
June 201210/7/2012Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.A Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in the Treatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic FibrosisExocrine Pancreatic Insufficiency: Cystic FibrosisDrug: EUR-1008 25,000 Units;Drug: Kreon 25,000 UnitsAptalis PharmaNULLCompleted12 YearsN/ABoth96Phase 3Belgium;Bulgaria;France;Germany;Italy;Poland;United Kingdom
68NCT01621867
(ClinicalTrials.gov)
May 201214/6/2012Repeated Application of Gene Therapy in CF PatientsA Randomised, Double-blind, Placebo-controlled Phase 2B Clinical Trial of Repeated Application of Gene Therapy in Patients With Cystic FibrosisCystic FibrosisDrug: pGM169/GL67A;Drug: PlaceboImperial College LondonUniversity of Edinburgh;University of Oxford;Royal Brompton & Harefield NHS Foundation TrustCompleted12 YearsN/ABoth130Phase 2United Kingdom
69NCT01572194
(ClinicalTrials.gov)
April 201228/3/2012Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation (MUCO-IRC)Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation.Lung Transplantation;Cystic Fibrosis;Renal FailureBiological: Urinary levels of PIIINP as a marker of changes in renal functionNantes University HospitalNULLTerminated18 YearsN/AAll45N/AFrance
70NCT01270074
(ClinicalTrials.gov)
April 201223/12/2010Prevention of Bronchiectasis in Infants With Cystic FibrosisA Phase 3 Multi-centre Randomised Placebo-controlled Study of Azithromycin in the Primary Prevention of Radiologically-defined Bronchiectasis in Infants With Cystic Fibrosis.Cystic Fibrosis;BronchiectasisDrug: Azithromycin;Drug: Placebo controlThe University of QueenslandTelethon Kids InstituteActive, not recruiting6 Weeks6 MonthsAll132Phase 3Australia;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2011-004761-33-GB
(EUCTR)
08/03/201214/12/2011Repeated application of gene therapy in patients with cystic fibrosisA randomised double-blind placebo-controlled Phase 2B clinical trial of repeated application of gene therapy in patients with cystic fibrosis - Repeated application of gene therapy in patients with CF v01-010204 Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Imperial CollegeNULLNot Recruiting Female: yes
Male: yes
130Phase 2United Kingdom
72NCT01381289
(ClinicalTrials.gov)
June 201122/6/2011VX-770 Expanded Access ProgramVX-770 Expanded Access Program (EAP)Cystic FibrosisDrug: VX-770Vertex Pharmaceuticals IncorporatedNULLApproved for marketing6 YearsN/ABothN/ANULL
73NCT01315665
(ClinicalTrials.gov)
April 201114/3/2011Effect of Sulforaphane in Broccoli Sprouts on Nrf2 ActivationEvaluation of the Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation, Measures of Oxidative Stress, and Neutrophil Migration to Mucosal Surfaces in Healthy and CF SubjectsCystic FibrosisDietary Supplement: Broccoli sproutsUniversity Hospitals Cleveland Medical CenterCystic Fibrosis FoundationCompleted18 Years49 YearsAll15N/AUnited States
74NCT01314716
(ClinicalTrials.gov)
April 201111/3/2011Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis BronchiectasisA Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)BronchiectasisDrug: AZLI;Drug: PlaceboGilead SciencesNULLCompleted18 YearsN/AAll274Phase 3United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
75NCT01337219
(ClinicalTrials.gov)
April 201113/4/2011Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic FibrosisPharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaide® in Patients With Cystic Fibrosis.Cystic FibrosisDrug: TobramycinErempharmaUniversity of Lyon;Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME);Clininfo;Hospices Civils de LyonRecruiting16 YearsN/ABoth36Phase 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
76NCT01347190
(ClinicalTrials.gov)
April 20113/5/2011Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic FibrosisA Double Blind, Randomized, Placebo Controlled, Single Dose, Phase I Study of the Safety and Tolerability of Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects With Cystic FibrosisCystic FibrosisBiological: CR002 Liquid API;Biological: PlaceboCSL BehringNULLCompleted18 Years65 YearsBoth25Phase 1Bulgaria;Hungary;Poland;United Kingdom
77NCT01313624
(ClinicalTrials.gov)
April 201110/3/2011Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis BronchiectasisA Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial InfectionBronchiectasisDrug: AZLI;Drug: PlaceboGilead SciencesNULLCompleted18 YearsN/AAll266Phase 3United States;Australia;Canada
78NCT01349192
(ClinicalTrials.gov)
April 20114/5/2011Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)Cystic Fibrosis;Methicillin-resistant Staphylococcus AureusDrug: Rifampin;Drug: Trimethoprim/Sulfamethoxazole;Drug: Minocycline;Drug: Mupirocin;Drug: chlorhexidine gluconate oral rinse;Drug: 2% Chlorhexidine solution wipes;Behavioral: Environmental DecontaminationUniversity of North Carolina, Chapel HillCF Therapeutics Development Network Coordinating Center;Seattle Children's Hospital;Washington University School of Medicine;University of Washington;University of Colorado, Denver;Baylor College of Medicine;University of Alabama at Birmingham;Cook Children's Medical Center;University of Michigan;University of Florida;University of Texas Southwestern Medical Center;Children's Hospital Medical Center, Cincinnati;St. Louis Children's HospitalTerminated4 Years45 YearsAll47Phase 2United States
79NCT01327703
(ClinicalTrials.gov)
April 201128/3/2011Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic InsufficiencyAn Open-label, Multicenter, Randomized, Cross-over Study to Compare the Safety and Efficacy of PANZYTRAT® 25,000 to KREON® 25,000 in the Control of Steatorrhea in Subjects Aged 7 Years and Older With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)Exocrine Pancreatic Insufficiency;Cystic FibrosisDrug: Panzytrat® 25,000;Drug: Kreon® 25,000Forest LaboratoriesNULLCompleted7 YearsN/AAll87Phase 4Germany;Poland
80EUCTR2009-012842-21-BG
(EUCTR)
24/02/201128/09/2010Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86France;Hungary;Belgium;Spain;Poland;Ireland;Romania;Bulgaria;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
81EUCTR2009-012842-21-DE
(EUCTR)
13/01/201113/07/2010Treatment of Exocrine Pancreatic Insufficiency in Subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86Hungary;Bulgaria;Germany;Italy;United Kingdom
82EUCTR2009-012842-21-GB
(EUCTR)
20/09/201017/06/2010Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Aptalis Pharma US Inc.NULLNot Recruiting Female: yes
Male: yes
86Phase 3Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom
83NCT01131507
(ClinicalTrials.gov)
July 201025/5/2010PR-018: An Open-Label, Safety Extension of Study PR-011A Multicenter, Open-Label, Safety Extension of Study PR-011 Titled: A Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF)Cystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: EUR-1008 (APT-1008)Forest LaboratoriesNULLCompletedN/A12 MonthsAll15Phase 4United States
84NCT01100606
(ClinicalTrials.gov)
June 201031/3/2010A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of AgeA Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF)Cystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: EUR-1008 (APT-1008)Forest LaboratoriesNULLCompleted1 Month12 MonthsAll15Phase 4United States
85NCT01321905
(ClinicalTrials.gov)
April 201023/3/2011Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis5-month Pilot Intervention Study on Vitamin D in Patients With Cystic FibrosisCystic FibrosisDietary Supplement: Supplementation with vitamin D2/D3Karolinska InstitutetStockholm County Council, Sweden;Swedish Cystic Fibrosis AssociationRecruiting6 YearsN/ABoth15Phase 2Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT00763477
(ClinicalTrials.gov)
April 201030/9/2008Ghrelin in Cystic FibrosisThe Effect of Ghrelin on Appetite and Immune Function in Patients With Cystic FibrosisCystic FibrosisBiological: ghrelinPapworth HospitalNULLRecruiting18 Years80 YearsBoth20N/AUnited Kingdom
87NCT01093521
(ClinicalTrials.gov)
April 201024/3/2010A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis PatientsA Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis PatientsCystic FibrosisDrug: 100 mg/m2 dose;Drug: 200 mg/m2 doseUniversity of WashingtonCystic Fibrosis FoundationCompleted18 Years55 YearsAll20Phase 1United States
88NCT01460836
(ClinicalTrials.gov)
April 201025/10/2011Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic FibrosisIndirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic FibrosisCystic FibrosisDrug: Tobramycin solution for inhalation;Drug: Aztreonam lysine for inhalationNovartis PharmaceuticalsNULLCompleted6 YearsN/ABothN/ANULL
89NCT01082367
(ClinicalTrials.gov)
April 20105/3/2010Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 YearsA Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 YearsTreatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis PatientsDrug: TOBI;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted3 Months6 YearsAll50Phase 3Canada;Egypt;France;Germany;Greece;Hungary;Italy;Romania;Russian Federation;Switzerland;Poland;United States
90NCT01499914
(ClinicalTrials.gov)
November 200921/11/2011Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza VaccinationCohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination in Patients With Cystic Fibrosis and, Where Applicable, the Clinical Expression of Influenza A (H1N1)Cystic Fibrosis With Gastrointestinal ManifestationBiological: influenza vaccinationAssistance Publique - Hôpitaux de ParisNULLCompleted6 MonthsN/ABoth439Phase 4France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT00989807
(ClinicalTrials.gov)
September 20092/10/2009Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic FibrosisExpanded Access for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease ProgressionCystic Fibrosis;Pseudomonas AeruginosaDrug: Aztreonam lysineGilead SciencesNULLApproved for marketing6 YearsN/ABothN/ACanada
92ChiCTR-TRC-13003979
2009-05-072013-10-28Application of roxithromycin in patients with bronchiectasis in stable conditionEffect of low-dose, long-term roxithromycin on airway imflammation and remodeling of stable non-cystic fibrosis bronchiectasis BronchietasisRoxithromycin group:The patients received oral roxithromycin in roxithromycin group;Control group:The patients received no drug in control group;First Affiliated Hospital of Guangxi Medical UniversityNULLCompleted1870BothRoxithromycin group:26;Control group:26;China
93NCT00840333
(ClinicalTrials.gov)
April 20095/2/2009Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) PatientsA Phase 1B, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MP-376 Inhalation Solution Given Daily for 14 Days to Stable Pediatric Cystic Fibrosis Patients.Cystic FibrosisDrug: MP-376 (Levofloxacin solution for Inhalation)Horizon Pharma USA, Inc.NULLCompleted6 Years16 YearsAll27Phase 1United States
94NCT00709280
(ClinicalTrials.gov)
April 20091/7/2008Infant Study of Inhaled Saline in Cystic FibrosisInfant Study of Inhaled Saline in Cystic FibrosisCystic FibrosisDrug: 7% Hypertonic Saline (HS);Drug: 0.9% Isotonic Saline (IS)CF Therapeutics Development Network Coordinating CenterCystic Fibrosis Foundation Therapeutics;National Heart, Lung, and Blood Institute (NHLBI)Completed4 Months59 MonthsBoth321N/AUnited States;Canada
95NCT00843817
(ClinicalTrials.gov)
April 200912/2/2009RhDNase and Biodistribution of PMN Serine Proteases in Cystic Fibrosis SputumRhDNase Effect on Biodistribution of PMN Serine Proteases in Cystic Fibrosis SputumCystic FibrosisDrug: PulmozymeUniversity Hospital, ToursNULLCompleted18 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
96NCT00885365
(ClinicalTrials.gov)
April 200920/4/2009A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas AeruginosaCystic FibrosisDrug: tobramycin / Bramitob;Drug: tobramycin / TOBIChiesi Farmaceutici S.p.A.NULLCompleted6 YearsN/AAll324Phase 3Czechia;France;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine;Czech Republic
97NCT00880100
(ClinicalTrials.gov)
April 20099/4/2009Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)Efficacy and Safety of Ultrase MT12 in the Control of Steatorrhea in Cystic Fibrosis (CF) and Pancreatic Insufficient (PI) Children Aged 2 to 6 Years OldCystic Fibrosis;Pancreatic InsufficiencyDrug: Ultrase® MT12Forest LaboratoriesNULLCompleted2 Years6 YearsAll49Phase 3United States
98NCT00775528
(ClinicalTrials.gov)
April 200917/10/2008Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic FibrosisAn Open Label, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic FibrosisCystic Fibrosis;Pancreatic Exocrine InsufficiencyDrug: Pancrelipase Delayed ReleaseSolvay PharmaceuticalsNULLCompleted1 Month6 YearsAll19Phase 3United States
99NCT01091025
(ClinicalTrials.gov)
March 200918/3/2010Comparing Two Different Approaches in the Screening of Cystic Fibrosis Related DiabetesA Comparative Analysis of the Clinical Efficacy of Two Approaches in the Screening for Cystic Fibrosis Related Diabetes in Adult With Cystic Fibrosis: i) a Selective Approach; ii) an Unselected Annual Oral Glucose Tolerance TestScreening of Cystic Fibrosis Related DiabetesOther: Glucose profile for 2 weeksImperial College LondonRoyal Brompton & Harefield NHS Foundation TrustCompleted16 YearsN/AAll100N/AUnited Kingdom
100NCT01759342
(ClinicalTrials.gov)
April 200821/12/2012Comprehensive Exercise Training Program During Hospitalization for an Acute CF ExacerbationThe Efficacy of a Standardized Exercise Protocol in Inpatient Care of Patients With Cystic FibrosisCystic FibrosisBehavioral: Aerobic exercise;Behavioral: Resistance exercise;Behavioral: Flexibility and postural exercise;Behavioral: Balance exerciseUniversity of Alabama at BirminghamNULLCompleted6 Years21 YearsBoth23N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT01323101
(ClinicalTrials.gov)
April 200815/2/2011Doxycycline Effects on Inflammation in Cystic FibrosisEffect of Doxycycline on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Patients With Cystic Fibrosis.Cystic FibrosisDrug: Doxycycline;Other: No doxycyclineUniversity of Southern CaliforniaNULLCompleted18 YearsN/AAll21Phase 4United States
102NCT00700050
(ClinicalTrials.gov)
April 200816/6/2008Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis AirwaysModulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways - A Pilot StudyCystic FibrosisDrug: Hypertonic salineThe Hospital for Sick ChildrenNULLRecruitingN/A22 YearsBoth32Phase 3Canada
103NCT00476281
(ClinicalTrials.gov)
April 200818/5/2007Nutritional, Metabolic and Respiratory Status in Cystic FibrosisMulticenter Prospective Study of Abnormalies Tolerance Glucose by the Continuous Measurement of Glucose of Nutritional Status and Breathing in the Patient With Cystic FibrosisCystic Fibrosis;DiabetesProcedure: Urinary collect;Procedure: Continuous Glucose Monitoring System (CGMS)University Hospital, Strasbourg, FranceAssociation d'Aide aux Insuffisants Respiratoires d'Alsace LorraineCompleted10 YearsN/AAll114N/AFrance
104EUCTR2006-001254-27-FR
(EUCTR)
30/11/200625/08/2006Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitusOpen randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus Patients atteints de mucoviscidose, chez lesquels un diagnostic de diabète a été fait par hyperglycémie provoquée orale (HGPO)
MedDRA version: 8.1;Level: PT;Classification code 10012594;Term: DIABETES
Trade Name: NovoNorm 0.5 mg
Product Name: NovoNorm 0.5 mg
INN or Proposed INN: Répaglinide
Trade Name: Actrapid Penfill 100UI/ml
Product Name: Actrapid Penfill 100UI/ml
INN or Proposed INN: Insuline humaine recombinante
Trade Name: NovoNorm 1 mg
Product Name: NovoNorm 1 mg
INN or Proposed INN: Répaglinide
Trade Name: NovoNorm 2 mg
Product Name: NovoNorm 2 mg
INN or Proposed INN: Répaglinide
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
105NCT00572975
(ClinicalTrials.gov)
August 200611/12/2007Malabsorption Blood Test:Toward a Novel Approach to Quantify SteatorrheaMALABSORPTION BLOOD TEST: Toward a Novel Approach to Quantify SteatorrheaCystic Fibrosis;Pancreatic InsufficiencyOther: Pentadecanoic acid (PA) and Triheptadecanoin (THA)Children's Hospital of PhiladelphiaSolvay PharmaceuticalsCompleted8 YearsN/ABoth9Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT00297167
(ClinicalTrials.gov)
May 200627/2/2006Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic InsufficiencyA Randomized, Double-Blind, Placebo-Controlled, Two-Treatment, Crossover Study to Evaluate the Safety and Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients With Cystic Fibrosis and Exocrine Pancreatic InsufficiencyCystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: EUR-1008 (APT-1008);Drug: PlaceboForest LaboratoriesNULLCompleted7 YearsN/AAll34Phase 3United States
107NCT00981214
(ClinicalTrials.gov)
May 200621/9/2009Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic InsufficiencyAn Open-Label Study to Evaluate the Efficacy and Safety of Pancreatic Enzyme Product (PEP) Microtabs in Pediatric Patients With Cystic Fibrosis and Exocrine Pancreatic InsufficiencyCystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: EUR-1008 (APT-1008)Forest LaboratoriesNULLCompletedN/A7 YearsAll19Phase 3United States
108NCT00420836
(ClinicalTrials.gov)
April 200610/1/2007Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic StudyCrossover Pharmacokinetic Study of Tobramycin Administered for Inhalation by PARI eFlow® Rapid Electronic Nebulizer (no Compressor) vs. PARI LC PLUSTM Jet Nebulizer (With Compressor) in Cystic Fibrosis SubjectsCystic FibrosisDrug: TobramycinNovartisNULLCompleted6 YearsN/ABoth20Phase 1NULL
109NCT00322868
(ClinicalTrials.gov)
April 20064/5/2006Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung DiseaseA Pilot Study Assessing the Safety and Efficacy of Pioglitazone as an Anti-inflammatory Agent for the Treatment of CF Lung Disease in Patients With Cystic FibrosisCystic FibrosisDrug: pioglitazoneUniversity Hospitals Cleveland Medical CenterCystic Fibrosis FoundationCompleted18 YearsN/AAll21N/AUnited States
110EUCTR2005-003837-42-GB
(EUCTR)
26/09/200524/08/2005CIPROFLOXACIN-INDUCED PHOTOTOXICITY IN PATIENTS WITH CYSTIC FIBROSIS - ciprofloxacin phototoxicity cystic fibrosisCIPROFLOXACIN-INDUCED PHOTOTOXICITY IN PATIENTS WITH CYSTIC FIBROSIS - ciprofloxacin phototoxicity cystic fibrosis infection - ciprofloxacin is used to treat various infections, for example respiratory tract infections, ear, nose and throat infections, eye infections, urinary tract infections. The main indication that is relevant to this application is its use in the treatment of chest infections in patients with cystic fibrosis. I have included the ICD classification for chest infection below.Belfast City Hospital TrustNULLNot Recruiting Female: yes
Male: yes
60Phase 4United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT00219882
(ClinicalTrials.gov)
April 200516/9/2005Safety Study of Orally Administered Curcuminoids in Adult Subjects With Cystic FibrosisA Phase I Safety and Dose Finding Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis Who Are Homozygous for Delta F508 Cystic Fibrosis Transmembrane Conductance Regulator (?F508 CFTR) MutationCystic FibrosisDrug: standardized turmeric root extractRamsey, Bonnie, MDSeer Pharmaceuticals;CF Therapeutics Development Network Coordinating Center;Cystic Fibrosis Foundation TherapeuticsCompleted18 Years40 YearsBoth11Phase 1United States
112NCT00198289
(ClinicalTrials.gov)
April 20059/9/2005Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their LungsA Phase IIa Dose Escalation Study to Assess Safety and Pharmacokinetics of Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their LungsStaphylococcus AureusDrug: Aurexis® (tefibazumab)Bristol-Myers SquibbNULLCompleted7 YearsN/ABoth30Phase 2United States
113NCT00730509
(ClinicalTrials.gov)
April 20044/8/2008Effects of 5-Methyltetrahydrofolate and Vitamin B12 Supplemetation on Red Cell Membrane in Children With Cystic FibrosisPreliminary Evidences of Active Form of Folic Acid and Vitamin B12 Supplementation to Ameliorate Cell Membrane in Children With Cystic FibrosisCystic FibrosisDietary Supplement: 5-methyltetrahydrofolate and vitamin B12Universita di VeronaNULLCompleted3 Years8 YearsBoth31N/AItaly
114NCT00499720
(ClinicalTrials.gov)
October 20039/7/2007Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway InfectionExpanded Access Program for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease ProgressionCystic Fibrosis;Pseudomonas Aeruginosa Airway InfectionDrug: Aztreonam Lysine for InhalationGilead SciencesNULLApproved for marketing6 YearsN/ABothN/AUnited States;Puerto Rico
115NCT00056147
(ClinicalTrials.gov)
April 20036/3/2003Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung DiseaseMulti-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects With Mild to Moderate Cystic Fibrosis Lung DiseaseCystic FibrosisDrug: denufosol tetrasodium (INS37217)Merck Sharp & Dohme Corp.Cystic Fibrosis Foundation TherapeuticsCompleted8 Years50 YearsBoth90Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT00222521
(ClinicalTrials.gov)
April 200314/9/2005Insulin Glargine Vs Standard Insulin TherapyComparison of Insulin Glargine Vs Standard Insulin Therapy in CFRD Without Fasting HyperglycemiaCystic Fibrosis Related DiabetesDrug: Glargine insulinUniversity of Minnesota - Clinical and Translational Science InstituteSanofi;Moran, Antoinette, M.D.Completed12 YearsN/ABoth20Phase 3United States
117NCT00376428
(ClinicalTrials.gov)
January 200313/9/2006Interest of Gentamicin-induced Readthrough in Cystic Fibrosis PatientsApplication of Functional Electrophysiological Tests to Evaluate Pharmacological Treatments in Patients With Cystic FibrosisCystic FibrosisDrug: GentamicinAssistance Publique - Hôpitaux de ParisNULLTerminatedN/AN/ABoth20Phase 2France
118NCT00043342
(ClinicalTrials.gov)
April 20027/8/2002Study of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic FibrosisA Phase I/II Study of Interferon Gamma-1b by Subcutaneous Injection for the Treatment of Patients With Cystic FibrosisCystic FibrosisDrug: interferon gamma-1bInterMuneNULLCompleted6 YearsN/ABoth51Phase 1;Phase 2United States
119NCT02269189
(ClinicalTrials.gov)
April 200216/10/2014Safety, Tolerability and Pharmacokinetics of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis (CF) PatientsA Randomized, Double-blind Within Dose, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeated Oral Doses (15-day Dosing) of BIIL 284 BS in Adult (300 mg) and Pediatric (150 mg) Cystic Fibrosis PatientsCystic FibrosisDrug: BIIL 284 BS, high dose;Drug: BIIL 284 BS, low dose;Drug: PlaceboBoehringer IngelheimNULLCompleted6 YearsN/ABoth36Phase 1NULL
120NCT00005112
(ClinicalTrials.gov)
April 200015/4/2000Growth Hormone Use in Cystic Fibrosis - a Multicenter StudyCystic FibrosisDrug: Human recombinant growth hormoneNational Center for Research Resources (NCRR)Genentech, Inc.Completed5 Years12 YearsBothPhase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT00005110
(ClinicalTrials.gov)
April 200013/4/2000A Multi-Centered Study of the Long-Term Effect of Salmeterol and Albuterol in Cystic FibrosisCystic FibrosisDrug: Salmeterol;Drug: AlbuterolNational Center for Research Resources (NCRR)NULLSuspended5 Years45 YearsBothN/AUnited States
122EUCTR2018-002624-16-FR
(EUCTR)
21/11/2018NA Validation of respiratory epithelial functional assessment to predict clinical efficacy of Orkambi®. Pathway to personalized therapy in Cystic Fibrosis PREDICT-CF - PREDICT-CF Homozygous F508del patient aged 12 years or older
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
ASSISTANC-PUBLIQUE-HOPITAUX DE PARIS (AP-HP)NULLNA Female: yes
Male: yes
104Phase 4France
123EUCTR2017-001379-21-IE
(EUCTR)
26/07/2017A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
75Phase 3United States;Canada;Ireland;Germany;United Kingdom
124EUCTR2016-001840-20-Outside-EU/EEA
(EUCTR)
18/05/2016Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis PatientsA Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules. cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI PodhalerNovartis Pharmaceuticals CorporationNULLNAFemale: yes
Male: yes
45Phase 4United States
125EUCTR2017-001379-21-DE
(EUCTR)
01/08/2017A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
75Phase 3United States;Canada;Ireland;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
126EUCTR2008-002673-13-DE
(EUCTR)
27/08/2008Anti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and PlaceboAnti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo Deficiency of the Cftr-molecule results in accumulation of ceramide in respiratory epithelial cells. Ceramide triggers a pro-inflammatory and -apoptotic status in cystic fibrosis patients. Amitriptyline reduces ceramide levels in the lung tissue, normalises the activity of cytokines and prevents constitutive cell death of epithelial cells. Amitriptyline prevents pulmonary infections of CF-mice with P. aeruginosa. Amitriptyline may result in an improved lung function of cystic fibrosis patients.Trade Name: Amitriptylin-CT
Product Name: Amitriptyline
INN or Proposed INN: Amitriptyline
PSKSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Germany