17. 多系統萎縮症
[臨床試験数:107,薬物数:153(DrugBank:48),標的遺伝子数:59,標的パスウェイ数:104

Searched query = "Multiple system atrophy", "MSA-C", "MSA-P", "Olivopontocerebellar atrophy", "OPCA", "Striatonigral degeneration", "Shy-Drager syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04468919
(ClinicalTrials.gov)
July 1, 20218/7/2020Optimizing BCI-FIT: Brain Computer Interface - Functional Implementation ToolkitOptimizing BCI-FIT: Brain Computer Interface - Functional Implementation ToolkitAmyotrophic Lateral Sclerosis;Brainstem Stroke;Muscular Dystrophies;Parkinson's Disease and Parkinsonism;Multiple System Atrophy;Brain Tumor Adult;Spinal Cord Injuries;Locked-in SyndromeBehavioral: BCI-FIT multi-modal access;Behavioral: BCI-FIT adaptive signal modeling;Behavioral: BCI-FIT active querying;Behavioral: BCI-FIT language modelingOregon Health and Science UniversityNULLNot yet recruiting18 Years75 YearsAll60N/AUnited States
2NCT04616456
(ClinicalTrials.gov)
December 202026/10/2020Effect of Verdiperstat on Microglial Activation in Well-characterized MSA PatientsEffect of Verdiperstat on Microglial Activation in Well-characterized MSA PatientsMultiple System Atrophy;Multiple System Atrophy, Cerebellar Variant;Multiple System Atrophy, Parkinson Variant (Disorder);Multiple System Atrophy (MSA) With Orthostatic HypotensionDrug: [F-18]PBR06;Drug: VerdiperstatBrigham and Women's HospitalBiohaven Pharmaceuticals, Inc.Not yet recruiting18 YearsN/AAll8Early Phase 1United States
3NCT04620382
(ClinicalTrials.gov)
November 9, 202027/10/2020Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure PatientsEffect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure PatientsNeurogenic Orthostatic Hypotension;Autonomic Failure;Pure Autonomic Failure;Multiple System Atrophy;Parkinson DiseaseDrug: Midodrine;Drug: Placebo pill;Device: Abdominal compression;Device: sham compressionVanderbilt University Medical CenterNULLRecruiting40 Years80 YearsAll31Early Phase 1United States
4NCT04250493
(ClinicalTrials.gov)
October 28, 202029/1/2020Insulin Resistance in Multiple System AtrophyInsulin Resistance in Multiple System AtrophyMultiple System AtrophyBiological: Homeostasis Model Assessment of insulin resistance (HOMA);Behavioral: MOntreal Cognitive Assessment (MoCA);Behavioral: Clinical characteristics of AMS patients;Procedure: Brain Magnetic Resonance Imaging (MRI);Biological: Blood samplingUniversity Hospital, BordeauxUniversité de Bordeaux;Labex Brain;Centre National de la Recherche Scientifique, FranceRecruiting30 YearsN/AAll124N/AFrance
5NCT04431713
(ClinicalTrials.gov)
September 16, 202029/5/2020Exenatide Once-weekly as a Treatment for Multiple System AtrophyAn Open Label, Single Site, 48 Week, Randomised Controlled Trial Evaluating the Safety and Efficacy of Exenatide Once-weekly in the Treatment of Patients With Multiple System AtrophyMultiple System AtrophyDrug: Exenatide Pen Injector [Bydureon]University College, LondonNULLRecruiting30 Years80 YearsAll50Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04165486
(ClinicalTrials.gov)
July 7, 202014/11/2019Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB101 Administered to Adults With Multiple System AtrophyA Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB101 Administered Intrathecally to Adults With Multiple System AtrophyMultiple System AtrophyDrug: BIIB101;Drug: PlaceboBiogenNULLRecruiting40 Years70 YearsAll34Phase 1Austria;France;Germany;Portugal;United Kingdom
7NCT04193527
(ClinicalTrials.gov)
July 20202/12/2019A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese PatientsA Multicentre, Phase 3, Clinical Study to Compare the Striatal Uptake of a Dopamine Transporter Radioligand, DaTSCAN™ Ioflupane (123I) Injection, After Intravenous Administration to Chinese Patients With a Diagnosis of Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, or Essential Tremor and to Healthy ControlsParkinsonian Syndrome;Parkinson Disease(PD);Multiple System Atrophy (MSA);Progressive Supranuclear Palsy (PSP)Drug: DaTSCAN™ Ioflupane (123I) InjectionGE HealthcarePPDNot yet recruiting40 Years80 YearsAll172Phase 3China
8ChiCTR2000033282
2020-06-012020-05-26Construction of cohort and prognosis prediction model of multiple system atrophyConstruction of cohort and prognosis prediction model of multiple system atrophy Multiple system atrophyGold Standard:Clinical outcomes.;Index test:Prognosis prediction model of multiple system atrophy;West China Hospital of Sichuan UniversityNULLRecruiting3075BothTarget condition:600;Difficult condition:0China
9EUCTR2020-000122-26-GB
(EUCTR)
11/05/202006/04/2020Exenatide once-weekly as a treatment for Multiple System Atrophy.A Phase IIa, open label, single-site, 48 week randomised controlled trial evaluating the safety and efficacy of Exenatide once-weekly in the treatment of patients with Multiple System Atrophy - Exenatide once-weekly as a treatment for Multiple System Atrophy. Multiple System Atrophy
MedDRA version: 21.1;Level: PT;Classification code 10064060;Term: Multiple system atrophy;System Organ Class: 10029205 - Nervous system disorders
Trade Name: Bydureon
Product Name: Bydureon
INN or Proposed INN: Exenatide
University College London (UCL)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2United Kingdom
10EUCTR2018-003941-41-AT
(EUCTR)
05/03/202019/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04246437
(ClinicalTrials.gov)
February 4, 202025/1/2020[18F]F-DOPA Imaging in Patients With Autonomic Failure[18F]F-DOPA Imaging in Patients With Autonomic FailureAutonomic Failure;Pure Autonomic Failure;Parkinson Disease;Multiple System Atrophy;Dementia With Lewy BodiesDrug: [18F]FDOPA;Drug: Carbidopa 200mg oral dose;Drug: Entacapone 400mg oral doseDaniel ClaassenNULLRecruiting18 YearsN/AAll40Phase 1United States
12EUCTR2018-003941-41-PT
(EUCTR)
03/02/202021/08/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
MedDRA version: 20.0;Level: LLT;Classification code 10021102;Term: Hypotension orthostatic symptomatic;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
13EUCTR2018-003289-15-DE
(EUCTR)
28/01/202008/02/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Denmark;Bulgaria;Germany
14EUCTR2018-003289-15-PT
(EUCTR)
13/01/202021/08/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
15EUCTR2019-001100-38-DE
(EUCTR)
07/01/202007/10/2019A study to assess whether a drug called BHV-3241 works and is safe to use in people with Multiple System Atrophy (M-STAR Study)Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects with Multiple System Atrophy (M-STAR Study) Multiple System Atrophy
MedDRA version: 21.1;Level: PT;Classification code 10064060;Term: Multiple system atrophy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BHV-3241
INN or Proposed INN: Verdiperstat
Biohaven Pharmaceuticals, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
422Phase 3United States;France;Austria;Germany;United Kingdom;Italy;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03446807
(ClinicalTrials.gov)
January 202020/2/2018Safety and Efficacy of Droxidopa for Fatigue in Patients With ParkinsonismSafety and Efficacy of Droxidopa for Fatigue in Patients With ParkinsonismParkinson Disease;Multiple System Atrophy;Progressive Supranuclear PalsyDrug: Droxidopa;Drug: Placebo Oral TabletLoma Linda UniversityH. Lundbeck A/SNot yet recruiting50 YearsN/AAll32Phase 2United States
17EUCTR2019-001100-38-AT
(EUCTR)
20/12/201929/10/2019A study to assess whether a drug called BHV-3241 works and is safe to use in people with Multiple System Atrophy (M-STAR Study)Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects with Multiple System Atrophy (M-STAR Study) Multiple System Atrophy
MedDRA version: 21.1;Level: PT;Classification code 10064060;Term: Multiple system atrophy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BHV-3241
INN or Proposed INN: Verdiperstat
Biohaven Pharmaceuticals, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
422Phase 3United States;France;Austria;Germany;United Kingdom;Italy;China
18EUCTR2019-001100-38-FR
(EUCTR)
13/12/201903/10/2019A study to assess whether a drug called BHV-3241 works and is safe to use in people with Multiple System Atrophy(M-STAR Study)Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects with Multiple System Atrophy (M-STAR Study) Multiple System Atrophy
MedDRA version: 21.1;Level: PT;Classification code 10064060;Term: Multiple system atrophy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BHV-3241
INN or Proposed INN: Verdiperstat
Biohaven Pharmaceuticals, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
252Phase 3United States;France;Austria;Germany;Italy;United Kingdom
19EUCTR2019-001100-38-GB
(EUCTR)
06/12/201911/10/2019A study to assess whether a drug called BHV-3241 works and is safe to use in people with Multiple System Atrophy(M-STAR Study)Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects with Multiple System Atrophy (M-STAR Study) Multiple System Atrophy
MedDRA version: 21.1;Level: PT;Classification code 10064060;Term: Multiple system atrophy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BHV-3241
INN or Proposed INN: Verdiperstat
Biohaven Pharmaceuticals, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
422Phase 3United States;France;Austria;Germany;Italy;United Kingdom
20EUCTR2018-003941-41-DK
(EUCTR)
29/10/201924/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Denmark;Australia;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2018-003289-15-BG
(EUCTR)
10/10/201924/07/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
22EUCTR2018-003941-41-BG
(EUCTR)
10/10/201926/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
23NCT04184063
(ClinicalTrials.gov)
September 16, 201929/7/2019Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA)A Pilot Exploratory, Randomised, Placebo-controlled, Double Blinded, Cross-over , Phase 2a Study to Explore Efficacy and Safety of NBMI Treatment in Patients With Progressive Supranuclear Palsy (PSP) or Multiple System Atrophy (MSA)Progressive Supranuclear Palsy;Multiple System AtrophyDrug: NBMI;Other: PlaceboEmeraMedNULLRecruiting40 Years85 YearsAll16Phase 2Slovenia
24NCT03753763
(ClinicalTrials.gov)
September 9, 201919/11/2018Safinamide for Multiple System Atrophy (MSA)12-weeks, Multicentre, Randomized, Double-blind, Placebo-controlled, Exploratory, Pilot Study to Evaluate the Safety and Efficacy of Safinamide 200 mg OD, as add-on Therapy, in Patients With Possible or Probable Parkinsonian Variant of MSAMultiple System AtrophyDrug: Safinamide Methanesulfonate;Drug: Safinamide Methanesulfonate matching placeboZambon SpANULLActive, not recruiting30 Years80 YearsAll49Phase 2Italy;Spain
25EUCTR2018-003941-41-PL
(EUCTR)
23/08/201903/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT04004819
(ClinicalTrials.gov)
August 15, 201927/6/2019Rituximab for Multiple System AtrphyRituximab Therapy for the Patients With Multiple Syetem AtrophyMultiple System AtrophyDrug: RituximabFirst Affiliated Hospital of Fujian Medical UniversityNULLRecruiting18 Years80 YearsAll50Phase 2China
27EUCTR2018-003941-41-ES
(EUCTR)
13/08/201911/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
28EUCTR2018-003941-41-GB
(EUCTR)
09/08/201916/05/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
29EUCTR2018-003941-41-HU
(EUCTR)
30/07/201901/08/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
30NCT03952806
(ClinicalTrials.gov)
July 29, 201915/5/2019Study of BHV-3241 in Subjects With Multiple System AtrophyA Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects With Multiple System Atrophy (M-STAR Study)Multiple System AtrophyDrug: Verdiperstat;Drug: PlaceboBiohaven Pharmaceuticals, Inc.NULLActive, not recruiting40 Years80 YearsAll336Phase 3United States;Austria;France;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
31EUCTR2018-004145-16-ES
(EUCTR)
24/07/201911/06/2019A study evaluating the safety and efficacy of safinamide for patients with Multiple System AtrophyA 12-weeks, multicentre, randomized, double-blind, placebo-controlled, exploratory, pilot study to evaluate the safety and efficacy of safinamide 200 mg once daily, as add-on therapy, in patients with possible or probable parkinsonian variant of multiple system atrophy. - Safinamide for Multiple System Atrophy Parkinsonian variant of Multiple System Atrophy
MedDRA version: 20.0;Level: PT;Classification code 10064060;Term: Multiple system atrophy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Zambon SpANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
48Phase 2Spain
32EUCTR2018-003289-15-PL
(EUCTR)
19/07/201907/05/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine chydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3United States;Portugal;Czechia;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
33EUCTR2018-003941-41-EE
(EUCTR)
04/07/201929/05/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
34EUCTR2018-003289-15-DK
(EUCTR)
02/07/201914/03/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Denmark;Australia;Bulgaria;Germany;New Zealand
35EUCTR2018-003289-15-ES
(EUCTR)
26/06/201927/06/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
188Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Denmark;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36JPRN-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
37EUCTR2018-003289-15-HU
(EUCTR)
04/06/201905/04/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
188Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Denmark;Germany
38EUCTR2018-003289-15-AT
(EUCTR)
15/05/201922/03/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3United States;Portugal;Czechia;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
39EUCTR2018-003289-15-GB
(EUCTR)
08/05/201928/12/2018This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled,Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure - Sequoia study Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
40EUCTR2018-003289-15-EE
(EUCTR)
11/04/201930/01/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
188Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT03901638
(ClinicalTrials.gov)
April 2, 201924/3/2019Tllsh2910 for Ataxia and Gut Microbiota Alteration in Patients of Multiple System AtrophyGut Microbiota Alteration and Improvement of Ataxia in Patients of Multiple System Atrophy Treating With Tllsh2910 - a Randomized, Placebo-controlled, Double-blinded, Cross-over, Single-center Clinical TrialAtaxia, Cerebellar;Multiple System AtrophyDrug: Tllsh2910;Drug: PlaceboNational Taiwan University HospitalNULLRecruiting18 Years80 YearsAll60Phase 3Taiwan
42EUCTR2018-000506-34-SI
(EUCTR)
04/02/201909/03/2018EMERA006 - A pilot, exploratory, randomised, placebo-controlled, double blinded, cross-over, Phase 2a study to explore efficacy and safety of NBMI treatment in patients with Progressive Supranuclear Palsy (PSP) or Multiple System Atrophy (MSA).EMERA006- A pilot, exploratory, randomised, placebo-controlled, double blinded, cross-over, Phase 2a study to explore efficacy and safety of NBMI treatment in patients with Progressive Supranuclear Palsy (PSP) or Multiple System Atrophy (MSA). - EMERA006 PSP or MSA;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]NBMI Science Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
20Phase 2Slovenia
43NCT03648905
(ClinicalTrials.gov)
September 6, 201824/8/2018Clinical Laboratory Evaluation of Chronic Autonomic FailureClinical Laboratory Evaluation of Chronic Autonomic FailureParkinson's Disease;Multiple System Atrophy;Autonomic FailureDrug: 18F-Dopa;Drug: 11C-methylreboxetine;Drug: 13N-Ammonia;Drug: 18F-Dopamne;Drug: Desipramine (DMI)National Institute of Neurological Disorders and Stroke (NINDS)NULLRecruiting18 YearsN/AAll140Phase 1United States
44NCT03589976
(ClinicalTrials.gov)
September 1, 20185/7/2018A Futility Trial of Sirolimus in Multiple System AtrophyA Single Center Randomized,Double Blind, Placebo-controlled Futility Trial to Determine if Sirolimus is of Sufficient Promise to Slow the Progression of Multiple System AtrophyMultiple System AtrophyDrug: Sirolimus 2 MG;Other: PlaceboNYU Langone HealthNational Institute of Neurological Disorders and Stroke (NINDS)Recruiting30 Years80 YearsAll56Phase 2United States
45NCT03403309
(ClinicalTrials.gov)
May 2, 201811/1/2018Inosine 5'-Monophosphate to Raise of Serum Uric Acid Level in Patients With Multiple System Atrophy: a Multi-center, Randomized Controlled, Double Blind, Parallel Assigned Clinical TrialInosine 5'-Monophosphate to Raise of Serum Uric Acid Level in Patients With Multiple System Atrophy: a Multi-center, Randomized Controlled, Double Blind, Parallel Assigned Clinical Trial (IMPROVE MSA Study)Multiple System AtrophyDrug: 1) Inosine 5'-monophosphate;Drug: PlaceboYonsei UniversityNULLCompleted19 Years75 YearsAll43Phase 2Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03265444
(ClinicalTrials.gov)
April 13, 20186/8/2017Safety and Tolerability of CS10BR05 Inj. in Subjects With Multiple System AtrophyA Phase 1 Study to Evaluate the Safety and Tolerability of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Subjects With Multiple System AtrophyMultiple System AtrophyBiological: CS10BR05Corestem, Inc.NULLCompleted30 Years75 YearsAll9Phase 1Korea, Republic of
47NCT03408080
(ClinicalTrials.gov)
December 15, 201717/1/2018An Open Pilot Trial of BHV-4157An Open Pilot Trial of BHV-4157 in Adult Subjects With Cerebellar AtaxiaSpinocerebellar Ataxias;Spinocerebellar Ataxia Type 1;Spinocerebellar Ataxia Type 2;Spinocerebellar Ataxia 3;Spinocerebellar Ataxia Type 6;MSA-CDrug: BHV-4157University of California, Los AngelesNULLActive, not recruiting18 Years75 YearsAll24Phase 3United States
48NCT03174938
(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
49NCT02897063
(ClinicalTrials.gov)
September 20167/9/2016Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic FailureThe Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure Aim 2 of RDCRN (Rare Diseases Clinical Research Network) Project 2Autonomic Failure;Pure Autonomic Failure;Multiple System Atrophy;Parkinson Disease;Orthostatic HypotensionDrug: Droxidopa;Drug: Midodrine;Drug: PlaceboVanderbilt University Medical CenterNULLRecruiting40 Years80 YearsAll34Phase 1United States
50NCT02705755
(ClinicalTrials.gov)
May 20167/3/2016TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)A Phase 2 Study to Assess the Effect of TD-9855 in Subjects With Neurogenic Orthostatic HypotensionNeurogenic Orthostatic Hypotension;Multiple System Atrophy (MSA) With Orthostatic Hypotension;Pure Autonomic Failure;Parkinson Disease;Hypotension, Orthostatic;Orthostatic Hypotension;Pure Autonomic Failure With Orthostatic Hypotension;Parkinson Disease With Orthostatic HypotensionDrug: TD-9855;Drug: PlaceboTheravance BiopharmaNULLCompleted40 YearsN/AAll34Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT02796209
(ClinicalTrials.gov)
May 20167/6/2016Norepinephrine Transporter Blockade, Autonomic FailurePhase 2 Norepinephrine Transporter Blockade, Autonomic FailureMultiple System Atrophy (MSA)Drug: Atomexetine;Drug: PlaceboNYU Langone HealthVanderbilt University Medical CenterRecruiting40 Years80 YearsAll40Phase 2United States
52NCT02726711
(ClinicalTrials.gov)
April 201628/1/2016Reduction in Splanchnic Capacitance Contributes to Sympathetically Dependent Hypertension in AutonomicReduction in Splanchnic Capacitance Contributes to Sympathetically Dependent Hypertension in Autonomic Aim 1 of Rare Diseases Clinical Research Network (RDCRN) Project 2Multiple System Atrophy;Orthostatic Hypotension;Supine HypertensionDrug: Trimethaphan;Drug: PlaceboVanderbilt UniversityNULLActive, not recruiting40 Years80 YearsAll2Phase 1United States
53NCT02994719
(ClinicalTrials.gov)
March 1, 201621/12/2015Gait Analysis in Neurological DiseaseGait Pattern Analysis in Neurological DiseaseParkinson's Disease;Parkinsonian Disorders;Atypical Parkinson Disease;Progressive Supranuclear Palsy;Multiple System Atrophy;Corticobasal Degeneration;Gait, Frontal;Huntington DiseaseDrug: Anti-Parkinson medication;Device: Deep Brain StimulationBeth Israel Deaconess Medical CenterNULLActive, not recruiting18 Years85 YearsAll120United States
54NCT02591173
(ClinicalTrials.gov)
February 201627/10/2015Blood Pressure Lowering Effects of Angiotensin-(1-7) in Primary Autonomic FailureBlood Pressure Lowering Effects of Angiotensin-(1-7) in Primary Autonomic FailureAutonomic Nervous System Disorders;Pure Autonomic Failure;Shy-Drager Syndrome;Orthostatic Hypotension, DysautonomicDrug: Angiotensin-(1-7);Drug: SalineVanderbilt University Medical CenterNULLRecruiting18 Years80 YearsAll22Early Phase 1United States
55NCT02388295
(ClinicalTrials.gov)
April 27, 20159/3/2015AZD3241 PET MSA Trial, Phase 2, Randomized,12 Week Safety and Tolerability Trial With PET in MSA PatientsA 12-Week, Multicenter, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron Emission Tomography, of AZD3241 in Subjects With Multiple System AtrophyMultiple System Atrophy, MSADrug: AZD3241;Drug: PlaceboAstraZenecaNULLCompleted30 Years80 YearsAll59Phase 2United States;Austria;Finland;France;Italy;Sweden;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2014-004902-13-SE
(EUCTR)
14/04/201502/01/2015Study to assess the effect of AZD3241 in Multiple System AtrophyA 12-Week, Multicenter, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron Emission Tomography, of AZD3241 in Subjects with Multiple System Atrophy Multiple system atrophy (MSA)
MedDRA version: 18.1;Level: PT;Classification code 10064060;Term: Multiple system atrophy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AZD3241 100mg
Product Code: AZD3241
INN or Proposed INN: Not available
Other descriptive name: IUPAC name: 1-(2-Isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d] pyrimidin-4-one
Product Name: AZD3241 300mg
Product Code: AZD3241
INN or Proposed INN: Not available
Other descriptive name: 1-(2-Isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d] pyrimidin-4-one
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
64Phase 2France;United States;Finland;Austria;Italy;United Kingdom;Sweden
57EUCTR2014-004902-13-GB
(EUCTR)
09/04/201524/12/2014Study to assess the effect of AZD3241 in Multiple System AtrophyA 12-Week, Multicenter, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron Emission Tomography, of AZD3241 in Subjects with Multiple System Atrophy Multiple system atrophy (MSA)
MedDRA version: 18.1;Level: PT;Classification code 10064060;Term: Multiple system atrophy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
64Phase 2United States;Finland;United Kingdom;Sweden
58NCT02429557
(ClinicalTrials.gov)
April 201521/4/2015Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic FailureHemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic FailureOrthostatic Hypotension;Pure Autonomic Failure;Multiple System Atrophy;Autonomic FailureOther: Abdominal compression;Other: Sham abdominal compression;Drug: Placebo pill;Drug: midodrineVanderbilt UniversityNULLRecruiting18 Years80 YearsAll20Phase 1United States
59ChiCTR-DPC-15005941
2015-03-012015-01-25Study for the diagnosis and differential diagnosis of multiple system atrophyStudy for the diagnosis and differential diagnosis of multiple system atrophy Multiple system atrophyGold Standard:electrophysiological techniques;Index test:brain MRI;Navy general hospitalNULLCompleted3080BothTarget condition:260;Difficult condition:0China
60EUCTR2014-004902-13-FI
(EUCTR)
11/02/201531/12/2014Study to assess the effect of AZD3241 in Multiple System AtrophyA 12-Week, Multicenter, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron Emission Tomography, of AZD3241 in Subjects with Multiple System Atrophy Multiple system atrophy (MSA)
MedDRA version: 18.1;Level: PT;Classification code 10064060;Term: Multiple system atrophy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AZD3241 100mg
Product Code: AZD3241
INN or Proposed INN: Not available
Other descriptive name: IUPAC name: 1-(2-Isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d] pyrimidin-4-one
Product Name: AZD3241 300mg
Product Code: AZD3241
INN or Proposed INN: Not available
Other descriptive name: 1-(2-Isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d] pyrimidin-4-one
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
64Phase 2United States;France;Finland;Austria;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT02270489
(ClinicalTrials.gov)
December 11, 20144/9/2014Study Assessing Safety and Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early MSAA Randomized, Placebo-controlled, Parallel Group, Patient-blind, Phase I Study Assessing the Safety and Exploring the Immunogenicity/Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early Multiple System AtrophyMultiple System Atrophy;Neurodegenerative DiseasesBiological: AFFITOPE® PD01A + Adjuvant;Biological: AFFITOPE® PD03A + Adjuvant;Biological: Adjuvant without active componentAffiris AGUniversity Hospital, Bordeaux;Institut National de la Santé Et de la Recherche Médicale, France;Forschungszentrum Juelich;University Hospital, ToulouseCompleted30 Years75 YearsAll30Phase 1France
62NCT02149901
(ClinicalTrials.gov)
October 201426/5/2014Water and Sudafed in Autonomic FailureEffect of Drinking Water on the Pressor Response to Pseudoephedrine in Patients With Autonomic FailureShy-Drager Syndrome;Multiple System AtrophyDrug: Pseudoephedrine + 480 ml water;Drug: Pseudoephedrine + 50 ml water;Other: Placebo + 480 ml water (optional);Other: Placebo + 50 ml water (optional)Vanderbilt UniversityNational Heart, Lung, and Blood Institute (NHLBI);National Center for Advancing Translational Science (NCATS)Active, not recruiting18 Years80 YearsAll35Early Phase 1United States
63EUCTR2012-005539-10-DE
(EUCTR)
29/04/201418/12/2013Clinical study to investigate the efficacy and safety of two dose levels of NT 201 versus placebo in treating chronic troublesome sialorrhea in various neurological conditions.Prospective, 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 conditions - SIAXI – Sialorrhea in Adults Xeomin Investigation Chronic troublesome sialorrhea resulting from neurological conditions in adults with Parkinson's disease or atypical parkinsonism (multiple system atrophy, corticobasal degeneration or progressive supranuclear palsy), or after stroke or traumatic brain injury.
MedDRA version: 18.1;Level: PT;Classification code 10039424;Term: Salivary hypersecretion;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Xeomin
INN or Proposed INN: NT 101
Other descriptive name: BOTULINUM TOXIN TYPE A
Trade Name: Xeomin
INN or Proposed INN: NT 101
Other descriptive name: BOTULINUM TOXIN TYPE A
Merz Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Poland;Germany
64NCT02064166
(ClinicalTrials.gov)
February 201413/2/2014Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.A Double-blinded Placebo-controlled Single-center Study to Evaluate the Efficacy of Intranasal Insulin 40 International Units Day as Treatment for Subjects With Parkinson Disease and Multiple System AtrophyParkinson Disease;Multiple System AtrophyDrug: Intranasal InsulinPeter NovakNULLCompleted18 YearsN/AAll15Phase 2United States
65NCT02071459
(ClinicalTrials.gov)
January 21, 201421/2/2014Efficacy of L-threo DOPS on Orthostatic Hypotension Symptoms and Other Non-motor Symptoms in Patients With MSAEvaluate the Long-term (3 Months) Efficacy of L-threo DOPS (DroxiDopa) on Orthostatic Hypotension Symptoms and Other Non-motor Symptoms in Patients With Multiple System Atrophy (MSA). Comparative Study Versus PlaceboMultiple System AtrophyDrug: L-Threo DOPS;Drug: placeboUniversity Hospital, ToulouseNULLCompleted30 Years80 YearsAll107Phase 2;Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT02008721
(ClinicalTrials.gov)
January 20148/12/2013Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-ApproachDouble-blind, Randomised, Placebo-controlled Parallel Group Study to Investigate the Effect of EGCG Supplementation on Disease Progression of Patients With Multiple System Atrophy (MSA)Multiple System AtrophyDrug: EGCG as putative neuroprotective agent;Drug: PlaceboDr. Johannes LevinGerman Center for Neurodegenerative Diseases (DZNE);Deutsche Parkinson Vereinigung;Deutsche Stiftung Neurologie;ParkinsonFonds Deutschland gGmbHCompleted18 YearsN/ABoth92Phase 3Germany
67EUCTR2012-000928-18-DE
(EUCTR)
21/11/201328/06/2013Double blind, randomised, prospective placebo controlled parallel group phase III study to investigate the Effect of EGCG supplementation on disease progression of patients with Multiple System Atrophy (MSA)Double blind, randomised, prospective placebo controlled parallel group phase III study to investigate the Effect of EGCG supplementation on disease progression of patients with Multiple System Atrophy (MSA) - Progression Rate of MSA under EGCG Supplementation as anti-Aggregation-Approach Progression of patients with Multiple System Atrophy (MSA);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Sunphenon EGCg
INN or Proposed INN: EGCG
Other descriptive name: GREEN TEA LEAF
Hospital of the Ludwig-Maximilians-University of MunichNULLNot RecruitingFemale: yes
Male: yes
86Phase 3Germany
68JPRN-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
69JPRN-UMIN000010712
2013/05/2015/05/2013Ubiquinol for patients with multiple system atrophy Patients with multiple system atrophyPatients with administration of ubiquinolDepartment of Neurology, the University of Tokyo HospitalNULLComplete: follow-up complete30years-old80years-oldMale and Female1Not selectedJapan
70JPRN-UMIN000008959
2012/11/0116/10/2012Trial of molecular hydrogen water in Multiple system atrophy and Progressive supranuclear palsy Multiple system atrophy(MSA)Progressive supranuclear palsy (PSP)hydrogen water
pseudo-water (nitrogen filling water)
Juntendo University School of Medicine, Department of NeurologyNULLComplete: follow-up complete20years-old80years-oldMale and Female40Phase 1Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT02315027
(ClinicalTrials.gov)
October 201231/10/2014Mesenchymal Stem Cell Therapy in Multiple System AtrophyIntrathecal Autologous Mesenchymal Stem Cell Therapy in Multiple System Atrophy (MSA) - Effect of Dose and Natural HistoryMSABiological: autologous mesenchymal stem cellsMayo ClinicNULLActive, not recruiting30 Years80 YearsAll30Phase 1United States
72NCT01577992
(ClinicalTrials.gov)
December 20117/11/2011Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System AtrophyEvaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System AtrophyPain Threshold;Multiple System AtrophyDrug: Levodopa test;Procedure: determination of objective and subjective pain thresholdUniversity Hospital, ToulouseFondation de FranceCompleted50 Years80 YearsBoth42N/AFrance
73NCT01287221
(ClinicalTrials.gov)
March 201128/1/2011Study of Rifampicin in Multiple System AtrophyDouble-Blind, Placebo-Controlled Study of Rifampicin in Multiple System AtrophyMultiple System AtrophyDrug: Rifampicin;Drug: placeboPhillip LowNational Institute of Neurological Disorders and Stroke (NINDS);Vanderbilt University;Rare Disease Research Network Autonomic ConsortiumTerminated30 Years80 YearsAll100Phase 3United States
74NCT01292694
(ClinicalTrials.gov)
March 20118/2/2011Contribution of Angiotensin II to Supine Hypertension in Autonomic FailureContribution of Angiotensin II to Supine Hypertension in Autonomic FailureHypertension;Pure Autonomic Failure;Multiple System AtrophyDrug: Losartan;Drug: Captopril;Drug: PlaceboVanderbilt UniversityNULLTerminated18 Years85 YearsAll12Phase 1United States
75EUCTR2009-018157-23-GB
(EUCTR)
30/11/201016/06/2010A Phase IIa, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group 12-Month Treatment, Adaptive Design Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD3241 in Patients with Multiple System AtrophyA Phase IIa, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group 12-Month Treatment, Adaptive Design Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD3241 in Patients with Multiple System Atrophy Multiple system atrophy
MedDRA version: 12.1;Level: LLT;Classification code 10064060;Term: Multiple system atrophy
Product Name: AZD3241
Product Code: AZD3241
Product Name: AZD3241
Product Code: AZD3241
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
135Phase 2aUnited Kingdom;Spain;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2009-018157-23-AT
(EUCTR)
11/11/201007/07/2010A Phase IIa, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, 12-Month Treatment, Adaptive Design Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD3241 in Patients with Multiple System AtrophyA Phase IIa, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, 12-Month Treatment, Adaptive Design Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD3241 in Patients with Multiple System Atrophy Multiple system atrophy
MedDRA version: 12.1;Level: LLT;Classification code 10064060;Term: Multiple system atrophy
Product Name: AZD3241
Product Code: AZD3241
Product Name: AZD3241
Product Code: AZD3241
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2aUnited Kingdom;Spain;Austria
77EUCTR2009-018157-23-ES
(EUCTR)
14/09/201023/06/2010A Phase IIa, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group 12-Month Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD3241 in Patients with Multiple System AtrophyEstudio de fase IIa, multicéntrico, doble ciego, aleatorizado, controlado con placebo, de gruposparalelos, de 12 meses de duración para evaluar la eficacia, la seguridad, la tolerabilidad y lafarmacocinética de AZD3241 en pacientes con atrofia multisistémicaA Phase IIa, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group 12-Month Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD3241 in Patients with Multiple System AtrophyEstudio de fase IIa, multicéntrico, doble ciego, aleatorizado, controlado con placebo, de gruposparalelos, de 12 meses de duración para evaluar la eficacia, la seguridad, la tolerabilidad y lafarmacocinética de AZD3241 en pacientes con atrofia multisistémica Multiple system atrophyAtrofia Multisistémica
MedDRA version: 12.1;Level: LLT;Classification code 10064060;Term: Multiple system atrophy
Product Name: AZD3241
Product Code: AZD3241
Product Name: AZD3241
Product Code: AZD3241
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
110Phase 2aUnited Kingdom;Spain;Austria
78NCT01119417
(ClinicalTrials.gov)
May 20104/5/2010The Role of Endothelin in the Supine Hypertension of Autonomic FailureThe Role of Endothelin in the Supine Hypertension of Autonomic FailureHypertension;Pure Autonomic Failure;Multiple System AtrophyDrug: BQ123;Drug: Bq123;Drug: SalineVanderbilt UniversityNULLEnrolling by invitation18 Years85 YearsAll12Phase 1United States
79NCT01136213
(ClinicalTrials.gov)
April 201026/5/2010Investigation of the Serotoninergic System in Multiple System Atrophy: a Positron Emission Tomography (PET) StudyMorphological and Functional Investigation of the Serotoninergic System in Multiple System Atrophy: a 18F-MPPF PET StudyMultiple System AtrophyRadiation: PET (Positron Emission Tomography) Study;Other: Brain MRI (magnetic resonance imaging);Drug: Fluoxétine / PlaceboUniversity Hospital, BordeauxNULLCompleted30 Years80 YearsAll53N/AFrance
80EUCTR2009-014644-11-AT
(EUCTR)
10/03/201021/10/2009A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P) Multiple System Atrophy of the Parkinsonian Subtype
MedDRA version: 12.0;Level: PT;Classification code 10064060;Term: Multiple system atrophy
Trade Name: AZILECT
INN or Proposed INN: Rasagiline
Other descriptive name: Rasagiline mesylate
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
140Portugal;Hungary;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2009-014644-11-NL
(EUCTR)
11/02/201029/10/2009A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P) Multiple System Atrophy of the Parkinsonian Subtype
MedDRA version: 12.0;Level: PT;Classification code 10064060;Term: Multiple system atrophy
Trade Name: AZILECT
INN or Proposed INN: Rasagiline
Other descriptive name: Rasagiline mesylate
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
243Portugal;Hungary;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria
82EUCTR2009-014644-11-PT
(EUCTR)
05/02/201011/01/2010A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P) Multiple System Atrophy of the Parkinsonian Subtype
MedDRA version: 12.0;Level: PT;Classification code 10064060;Term: Multiple system atrophy
Trade Name: AZILECT
INN or Proposed INN: Rasagiline
Other descriptive name: Rasagiline mesylate
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
140Hungary;Portugal;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria
83EUCTR2009-014644-11-GB
(EUCTR)
25/01/201004/08/2010A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P) Multiple System Atrophy of the Parkinsonian Subtype
MedDRA version: 12.0;Level: PT;Classification code 10064060;Term: Multiple system atrophy
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
140Phase 2Portugal;France;Hungary;Spain;Austria;Netherlands;Germany;Italy;United Kingdom
84NCT01044693
(ClinicalTrials.gov)
January 20106/1/2010Nebivolol in the Supine Hypertension of Autonomic FailureEffect of Nebivolol on Blood Pressure in a Model of Hypertension Sensitive to Potentiation of Nitric Oxide BioactivityHypertension;Pure Autonomic Failure;Multiple System AtrophyDrug: Placebo;Drug: Nebivolol 5 mg;Drug: metoprolol tartrate 50 mg;Drug: Sildenafil25 mgVanderbilt UniversityForest LaboratoriesCompleted18 Years80 YearsAll20N/AUnited States
85EUCTR2009-014644-11-IT
(EUCTR)
10/12/200922/12/2009A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P) - NDA Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P) - ND Multiple System Atrophy of the Parkinsonian subtype (MSA-P)
MedDRA version: 12.1;Level: LLT;Classification code 10064060;Term: Multiple system atrophy
Trade Name: AZILECT
INN or Proposed INN: Rasagiline
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
140Portugal;Hungary;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2009-014644-11-DE
(EUCTR)
08/12/200915/09/2009A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P) Multiple System Atrophy of the Parkinsonian Subtype
MedDRA version: 12.0;Level: PT;Classification code 10064060;Term: Multiple system atrophy
Trade Name: AZILECT
INN or Proposed INN: Rasagiline
Other descriptive name: Rasagiline mesylate
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
140Portugal;France;Hungary;Spain;Austria;Netherlands;Germany;United Kingdom;Italy
87NCT00977665
(ClinicalTrials.gov)
December 200915/9/2009Clinical Trial to Assess Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)Multiple System AtrophyDrug: rasagiline mesylate;Drug: placeboTeva Pharmaceutical IndustriesH. Lundbeck A/SCompleted30 YearsN/AAll174Phase 2United States;Austria;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Spain;United Kingdom
88EUCTR2009-014644-11-FR
(EUCTR)
17/11/200922/09/2009A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P) Multiple System Atrophy of the Parkinsonian Subtype
MedDRA version: 12.0;Level: PT;Classification code 10064060;Term: Multiple system atrophy
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
140Phase 2Portugal;France;Hungary;Spain;Austria;Netherlands;Germany;United Kingdom;Italy
89EUCTR2009-016377-15-IT
(EUCTR)
26/10/200926/10/2009DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED TRIAL TO TEST THE EFFICACY, SAFETY AND TOLERABILITY OF LITHIUM IN MULTIPLE SYSTEM ATROPHY - Lithium in MSADOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED TRIAL TO TEST THE EFFICACY, SAFETY AND TOLERABILITY OF LITHIUM IN MULTIPLE SYSTEM ATROPHY - Lithium in MSA Muliple system atrophy
MedDRA version: 9.1;Level: HLT;Classification code 10008028
Trade Name: LITIO CARBONATO
INN or Proposed INN: LITHIUM CARBONATE
UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO IINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
90EUCTR2009-014644-11-ES
(EUCTR)
22/10/200924/09/2009 A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P). Ensayo multicéntrico, randomizado, doble ciego, controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad de mesilato de rasagilina 1 mg en pacientes con Atrofia Multisistémica del subtipo parkinsoniano (MSA-P) A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P). Ensayo multicéntrico, randomizado, doble ciego, controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad de mesilato de rasagilina 1 mg en pacientes con Atrofia Multisistémica del subtipo parkinsoniano (MSA-P) Pacientes con Atrofia Multisistémica del subtipo parkinsoniano (MSA-P)
MedDRA version: 12.0;Level: PT;Classification code 10064060;Term: Multiple system atrophy
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
140Phase 2Portugal;France;Hungary;Spain;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
91EUCTR2009-014644-11-HU
(EUCTR)
19/10/200925/09/2009A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P) Multiple System Atrophy of the Parkinsonian Subtype
MedDRA version: 12.0;Level: PT;Classification code 10064060;Term: Multiple system atrophy
Trade Name: AZILECT
INN or Proposed INN: Rasagiline
Other descriptive name: Rasagiline mesylate
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
140Portugal;Hungary;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria
92NCT00997672
(ClinicalTrials.gov)
October 200916/10/2009Lithium in Multiple System AtrophyA Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess Efficacy, Safety and Tolerability of Lithium in Multiple System Atrophy.Multiple System AtrophyDrug: Lithium Carbonate;Drug: PlaceboFederico II UniversityNULLTerminated18 Years80 YearsAll10Phase 2Italy
93EUCTR2007-004890-24-PT
(EUCTR)
07/10/200825/06/2008A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHNA Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN Neurogenic orthostatic hypotension in patients with multiple system atrophy or Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
MedDRA version: 9.1;Classification code 10064060;Term: Multiple system atrophy
Product Name: Fipamezole hydrochloride 90 mg oral disintegrating tablets
Product Code: JP-1730/F01
INN or Proposed INN: Fipamezole hydrochloride
Product Name: Fipamezole hydrochloride 60 mg oral disintegrating tablets
Product Code: JP-1730/F02
INN or Proposed INN: Fipamezole hydrochloride
Product Name: Fipamezole hydrochloride 30 mg oral disintegrating tablets
Product Code: JP-1730/F03
INN or Proposed INN: Fipamezole hydrochloride
Juvantia Pharma LtdNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Portugal;France
94NCT00758849
(ClinicalTrials.gov)
September 200824/9/2008Fipamezole in Neurogenic Orthostatic HypotensionA Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients With Multiple System Atrophy or Parkinson's DiseaseSymptomatic Neurogenic Orthostatic Hypotension (NOH);Parkinson's Disease;Multiple System AtrophyDrug: Placebo;Drug: FipamezoleJuvantia Pharma LtdSanthera PharmaceuticalsNot yet recruiting30 Years80 YearsBoth24Phase 2France;Portugal
95NCT00750867
(ClinicalTrials.gov)
June 20089/9/2008Treatment of Multiple System Atrophy Using Intravenous ImmunoglobulinsTreatment of Multiple System Atrophy Using Intravenous ImmunoglobulinsMultiple System AtrophyDrug: intravenous immunoglobulin (IVIg)University of Massachusetts, WorcesterNULLCompleted18 YearsN/AAll9Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT00822913
(ClinicalTrials.gov)
June 200814/1/2009Botulinum A Toxin in Patients With Parkinson's DiseaseThe Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity.Parkinson's Disease;Multiple System Atrophy;Detrusor OveractivityDrug: Intravesical injection of Botulinum A toxinUniversity Of PerugiaUniversity of Roma La SapienzaEnrolling by invitation18 Years80 YearsBoth20Phase 4NULL
97EUCTR2007-004890-24-FR
(EUCTR)
07/05/200809/05/2008A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHNA Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN Neurogenic orthostatic hypotension in patients with multiple system atrophy or Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
MedDRA version: 9.1;Classification code 10064060;Term: Multiple system atrophy
Product Name: Fipamezole hydrochloride 90 mg oral disintegrating tablets
Product Code: JP-1730/F01
INN or Proposed INN: Fipamezole hydrochloride
Product Name: Fipamezole hydrochloride 60 mg oral disintegrating tablets
Product Code: JP-1730/F02
INN or Proposed INN: Fipamezole hydrochloride
Product Name: Fipamezole hydrochloride 30 mg oral disintegrating tablets
Product Code: JP-1730/F03
INN or Proposed INN: Fipamezole hydrochloride
Juvantia Pharma LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2Portugal;France
98NCT01146548
(ClinicalTrials.gov)
May 200816/6/2010Fluoxetine in Multiple System Atrophy PatientsAssessment of Fluoxetine's Effect in Patients With Multiple System Atrophy : a Double Blind Placebo-controlled Randomized TrialMultiple System AtrophyDrug: FLUOXETINEUniversity Hospital, ToulouseClinical Research Center, ToulouseCompleted30 Years80 YearsBoth87Phase 2France
99NCT00911365
(ClinicalTrials.gov)
May 200826/5/2009Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System AtrophyA Double-blind Placebo-controlled Randomized Clinical Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System AtrophyMultiple System AtrophyBiological: autologous mesenchymal stem cells;Biological: normal salineYonsei UniversityNULLCompletedN/A75 YearsBoth27Phase 2Korea, Republic of
100EUCTR2007-004922-26-FR
(EUCTR)
12/02/200831/01/2008Evaluation de l’effet de la fluoxétine chez le patient atteint d’atrophie multi-systématisée : Etude randomisée en double-insu versus placebo. - Etude MSA-fluoxétineEvaluation de l’effet de la fluoxétine chez le patient atteint d’atrophie multi-systématisée : Etude randomisée en double-insu versus placebo. - Etude MSA-fluoxétine atrophie multisystématisée
MedDRA version: 9.1;Level: LLT;Classification code 10064060;Term: Multiple system atrophy
Trade Name: PROZACCHU ToulouseNULLAuthorised-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
101NCT00738062
(ClinicalTrials.gov)
January 200819/8/2008Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)An Open-label Study, to Assess the Long-term Safety and Clinical Benefit of Droxidopa in Subjects With PAF, Dopamine Beta Hydroxylase Deficiency or Non-diabetic Neuropathy and Symptomatic Neurogenic Orthostatic HypotensionNeurogenic Orthostatic Hypotension;Non-Diabetic Autonomic Neuropathy;Multiple System Atrophy;Dopamine Beta Hydroxylase DeficiencyDrug: Droxidopa;Drug: PlaceboChelsea TherapeuticsNULLCompleted18 YearsN/AAll103Phase 3United States;Australia;Canada;New Zealand
102NCT00547911
(ClinicalTrials.gov)
October 200719/10/2007Augmenting Effects of L-DOPS With Carbidopa and EntacaponeL-Dihydroxyphenylserine (L-DOPS) for Norepinephrine Deficiency: Interactions With Carbidopa and EntacaponeParkinson Disease;Multiple System Atrophy;Autonomic Nervous System DiseasesDrug: Droxidopa;Drug: Carbidopa;Drug: EntacaponeNational Institute of Neurological Disorders and Stroke (NINDS)NULLTerminated18 YearsN/AAll14Phase 1;Phase 2United States
103NCT00103597
(ClinicalTrials.gov)
January 200511/2/2005Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System AtrophyEfficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System AtrophyParkinson's Disease;Multiple System Atrophy;Orthostatic HypotensionDrug: Fludrocortisone;Drug: Domperidone;Behavioral: Conservative Measures for Orthostatic HypotensionRoyal Brisbane and Women's HospitalNULLCompleted40 Years95 YearsBoth50Phase 1Australia
104NCT00179023
(ClinicalTrials.gov)
April 200313/9/2005The Autonomic Nervous System and ObesityThe Autonomic Nervous System and ObesityOBESITY;HYPERTENSION;PURE AUTONOMIC FAILURE;SHY-DRAGER SYNDROMEDrug: Trimethaphan;Drug: PseudoephedrineVanderbilt UniversityNULLCompleted18 Years80 YearsAll128Phase 1United States
105NCT01044992
(ClinicalTrials.gov)
May 20026/1/2010Motor Activation in Multiple System Atrophy and Parkinson Disease: a Positron Emission Tomography (PET) StudyMotor Activation in Patients With Multi Systemic Atrophy and Comparison With Parkinson Disease and Dopaminergic ChallengeMultisystemic AtrophyRadiation: H215O PET;Drug: LevodopaUniversity Hospital, ToulouseNULLCompleted40 Years75 YearsBoth38N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT00211224
(ClinicalTrials.gov)
April 200013/9/2005Neuroprotection and Natural History in Parkinson's Plus Syndromes (NNIPPS)Phase 3 Study of Riluzole in Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP) (Parkinson's Plus Syndromes)Multiple System Atrophy;Progressive Supranuclear PalsyDrug: RiluzoleKing's College LondonAssistance Publique - Hôpitaux de Paris;University of Ulm;Aventis PharmaceuticalsTerminated30 Years80 YearsBoth800Phase 3United Kingdom
107NCT00004478
(ClinicalTrials.gov)
March 199918/10/1999Droxidopa in Treating Patients With Neurogenic HypotensionStudy of Droxidopa in Patients With Neurologic HypotensionShy-Drager Syndrome;Orthostatic HypotensionDrug: droxidopaMount Sinai School of MedicineNULLCompleted20 YearsN/ABothN/AUnited States