8. ハンチントン病 Huntington disease Clinical trials / Disease details


臨床試験数 : 229 薬物数 : 193 - (DrugBank : 60) / 標的遺伝子数 : 84 - 標的パスウェイ数 : 158

  
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
Status
Inclusion_
agemin
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agemax
Inclusion_
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PhaseCountries
1EUCTR2020-000105-92-LT
(EUCTR)
02/03/202228/10/2021A study to evaluate the safety, tolerability and efficacy of weekly oral doses of branaplam in patients with Huntington's DiseaseA Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study with Open-Label Extension to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LMI070/branaplam when Administered as Weekly Oral Doses in Participants with Early Manifest Huntington’s Disease Huntington's disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: branaplam
Product Code: LMI070
INN or Proposed INN: BRANAPLAM
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2France;United States;Hungary;Canada;Spain;Belgium;Lithuania;Russian Federation;Germany;United Kingdom;Italy
2EUCTR2020-004556-15-NL
(EUCTR)
01/03/202211/02/2022A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s Disease Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-003
Product Code: WVE-003
INN or Proposed INN: WVE-003
Wave Life Sciences UK LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 1;Phase 2France;Canada;Spain;Poland;Denmark;Australia;Germany;Netherlands;United Kingdom;Switzerland;Italy
3NCT05238701
(ClinicalTrials.gov)
February 28, 20229/1/2022A Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 in Healthy SubjectsA Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 Sustained-release Tablets in Healthy SubjectsHuntington Disease;Tardive DyskinesiaDrug: LPM3770164 sustained release tablet;Drug: LPM3770164 sustained release tablet simulantLuye Pharma Group Ltd.NULLNot yet recruiting18 Years45 YearsAll104Phase 1China
4NCT04478734
(ClinicalTrials.gov)
January 1, 202211/2/2020Trial of the Combined Use of Thiamine and Biotin in Patients With Huntington's DiseaseMulticentric Trial on the Use of Combined Therapy of Thiamine and Biotine in Patients With Huntington´s DiseaseHuntington DiseaseDrug: Moderate doses of Thiamine y Biotin;Drug: High doses of Thiamine y BiotinFundación Pública Andaluza para la gestión de la Investigación en SevillaCiberned (Centro de Investigación Biomédica en Red)Not yet recruiting18 YearsN/AAll24Phase 2Spain
5EUCTR2020-004556-15-IT
(EUCTR)
13/12/202106/10/2021A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s Disease - - Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-003
Product Code: [WVE-003]
INN or Proposed INN: WVE-003
Wave Life Sciences UK LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 1;Phase 2France;Canada;Spain;Poland;Denmark;Australia;Germany;United Kingdom;Italy
6NCT05111249
(ClinicalTrials.gov)
December 8, 202115/10/2021A Dose Range Finding Study With Open-Label Extension to Evaluate the Safety of Oral LMI070/Branaplam in Early Manifest Huntington's DiseaseA Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study With Open-Label Extension to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of LMI070/Branaplam Administered as Weekly Oral Doses in Participants With Early Manifest Huntington's DiseaseEarly Manifest Huntington DiseaseDrug: Branaplam;Drug: PlaceboNovartis PharmaceuticalsNULLRecruiting25 Years75 YearsAll75Phase 2Canada;France;Germany;Hungary;Spain
7EUCTR2020-000105-92-IT
(EUCTR)
26/11/202120/09/2021A study to evaluate the safety, tolerability and efficacy of weekly oral doses of branaplam in patients with Huntington's DiseaseA Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study with Open-Label Extension to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LMI070/branaplam when Administered as Weekly Oral Doses in Participants with Early Manifest Huntington's Disease - - Huntington's disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: branaplam
Product Code: [LMI070]
INN or Proposed INN: BRANAPLAM
Product Name: branaplam
Product Code: [LMI070]
INN or Proposed INN: BRANAPLAM
Product Name: branaplam
Product Code: [LMI070]
INN or Proposed INN: BRANAPLAM
Product Name: branaplam
Product Code: [LMI070]
INN or Proposed INN: BRANAPLAM
Product Name: branaplam
Product Code: [LMI070]
INN or Proposed INN: BRANAPLAM
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2France;United States;Hungary;Canada;Spain;Belgium;Lithuania;Russian Federation;Germany;United Kingdom;Italy
8NCT04713982
(ClinicalTrials.gov)
November 19, 20216/1/2021Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington DiseaseImpact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington DiseaseHuntington DiseaseDrug: DeutetrabenazineVanderbilt University Medical CenterTeva Branded Pharmaceutical Products R&D, Inc.Recruiting18 YearsN/AAll30Phase 2/Phase 3United States
9EUCTR2020-000105-92-FR
(EUCTR)
18/11/202103/09/2021A study to evaluate the safety, tolerability and efficacy of weekly oral doses of branaplam in patients with Huntington's DiseaseA Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study with Open-Label Extension to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LMI070/branaplam when Administered as Weekly Oral Doses in Participants with Early Manifest Huntington’s Disease Huntington's disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: branaplam
Product Code: LMI070
INN or Proposed INN: BRANAPLAM
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2Spain;Belgium;Lithuania;Russian Federation;Germany;United Kingdom;Italy;United States;France;Hungary;Canada
10EUCTR2020-000105-92-ES
(EUCTR)
02/11/202126/08/2021A study to evaluate the safety, tolerability and efficacy of weekly oral doses of branaplam in patients with Huntington's DiseaseA Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study with Open-Label Extension to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LMI070/branaplam when Administered as Weekly Oral Doses in Participants with Early Manifest Huntington’s Disease Huntington's disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: branaplam
Product Code: LMI070
INN or Proposed INN: BRANAPLAM
Novartis Farmacéutica S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2France;United States;Hungary;Canada;Belgium;Spain;Lithuania;Russian Federation;Germany;United Kingdom;Italy
11NCT05107128
(ClinicalTrials.gov)
November 202125/10/2021A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's DiseaseHuntington's DiseaseDrug: SAGE-718;Drug: PlaceboSage TherapeuticsNULLNot yet recruiting25 Years65 YearsAll178Phase 2NULL
12EUCTR2020-000105-92-HU
(EUCTR)
29/10/202124/08/2021A study to evaluate the safety, tolerability and efficacy of weekly oral doses of branaplam in patients with Huntington's DiseaseA Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study with Open-Label Extension to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LMI070/branaplam when Administered as Weekly Oral Doses in Participants with Early Manifest Huntington’s Disease Huntington's disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: branaplam
Product Code: LMI070
INN or Proposed INN: BRANAPLAM
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2France;United States;Hungary;Canada;Spain;Belgium;Lithuania;Russian Federation;Germany;United Kingdom;Italy
13EUCTR2019-004360-22-ES
(EUCTR)
22/10/202110/01/2020Trial on the use of thiamine and biotin in patients with Huntington's disease.MULTI-TECHNICAL TEST ON THE USE OF COMBINED THERAPY OF THEMIN AND BIOTINE IN PATIENTS WITH HUNTINGTON'S DISEASE - Huntiam Huntington´s disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Benerva
Product Name: Benerva
Product Name: Biotina
INN or Proposed INN: BIOTIN
Other descriptive name: Vitamin B7
Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas (Ciberned)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2Spain
14EUCTR2020-000105-92-DE
(EUCTR)
15/10/202118/08/2021A study to evaluate the safety, tolerability and efficacy of weekly oral doses of branaplam in patients with Huntington's DiseaseA Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study with Open-Label Extension to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LMI070/branaplam when Administered as Weekly Oral Doses in Participants with Early Manifest Huntington’s Disease Huntington's disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: branaplam
Product Code: LMI070
INN or Proposed INN: BRANAPLAM
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;France;Hungary;Canada;Spain;Belgium;Lithuania;Russian Federation;Germany;United Kingdom;Italy
15EUCTR2020-001461-36-DE
(EUCTR)
13/09/202130/04/2021Safety and Efficacy of AMT-130 in European Adults with Early Manifest Huntington DiseaseA Phase Ib/II Study to Explore Safety, Tolerability, and Efficacy Signals of Multiple Ascending Doses of Striatally-Administered rAAV5-miHTT Total Huntingtin Gene (HTT) Lowering Therapy (AMT 130) in Early Manifest Huntington Disease - Safety and Efficacy of AMT-130 in European Adults with Early Manifest Huntington Disease Huntington Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: rAAV5-miHTT
Product Code: AMT-130
uniQure biopharma B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Phase 1;Phase 2Poland;Germany
16NCT05032196
(ClinicalTrials.gov)
September 6, 202118/8/2021Study of WVE-003 in Patients With Huntington's DiseaseA Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington's DiseaseHuntington DiseaseDrug: WVE-003Wave Life Sciences Ltd.NULLRecruiting25 Years60 YearsAll36Phase 1/Phase 2Australia;Canada;Denmark;France;Germany;Poland;Spain;United Kingdom
17NCT04826692
(ClinicalTrials.gov)
September 202115/9/2020TEsting METformin Against Cognitive Decline in HDRandomized, Double-blind, Placebo-controlled Study to Assess the Effect of Metformin, an Activator of AMPK, on Cognitive Measures of Progression in Huntington's Disease PatientsHuntington DiseaseDrug: Metformin;Drug: PlaceboInstituto de Investigacion Sanitaria La FeNULLNot yet recruiting21 Years65 YearsAll60Phase 3NULL
18EUCTR2020-004556-15-ES
(EUCTR)
18/08/202123/06/2021A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s Disease Huntington's Disease;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Product Name: WVE-003
Product Code: WVE-003
INN or Proposed INN: WVE-003
Wave Life Sciences UK LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 1;Phase 2France;Canada;Poland;Spain;Denmark;Australia;Germany;United Kingdom;Italy
19EUCTR2020-001461-36-PL
(EUCTR)
30/06/202125/03/2021Safety and Efficacy of AMT-130 in European Adults with Early Manifest Huntington DiseaseA Phase Ib/II Study to Explore Safety, Tolerability, and Efficacy Signals of Multiple Ascending Doses of Striatally-Administered rAAV5-miHTT Total Huntingtin Gene (HTT) Lowering Therapy (AMT 130) in Early Manifest Huntington Disease - Safety and Efficacy of AMT-130 in European Adults with Early Manifest Huntington Disease Huntington Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: rAAV5-miHTT
Product Code: AMT-130
Other descriptive name: ADENO-ASSOCIATED VIRUS SEROTYPE 5 ENCODING A MICRORNA TARGETED TO HUMAN HUNTINGTIN GENE
Product Name: rAAV5-miHTT
Product Code: AMT-130
Other descriptive name: ADENO-ASSOCIATED VIRUS SEROTYPE 5 ENCODING A MICRORNA TARGETED TO HUMAN HUNTINGTIN GENE
uniQure biopharma B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Phase 1;Phase 2Poland;United Kingdom
20EUCTR2020-004556-15-DK
(EUCTR)
21/06/202112/04/2021A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s Disease Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-003
Product Code: WVE-003
INN or Proposed INN: WVE-003
Wave Life Sciences UK LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 1;Phase 2France;Canada;Poland;Australia;Denmark;Germany;United Kingdom
21EUCTR2020-004556-15-FR
(EUCTR)
31/05/202101/04/2021A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s Disease Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-003
Product Code: WVE-003
INN or Proposed INN: WVE-003
Wave Life Sciences UK LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 1;Phase 2France;Canada;Spain;Poland;Denmark;Australia;Germany;United Kingdom
22EUCTR2020-004556-15-PL
(EUCTR)
18/05/202123/02/2021A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s Disease Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-003
Product Code: WVE-003
INN or Proposed INN: WVE-003
Wave Life Sciences UK LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 1;Phase 2France;Canada;Spain;Poland;Denmark;Australia;Germany;Italy;United Kingdom
23EUCTR2020-004556-15-DE
(EUCTR)
12/03/202125/01/2021A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s Disease Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-003
Product Code: WVE-003
INN or Proposed INN: WVE-003
Wave Life Sciences UK LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 1;Phase 2France;Canada;Spain;Poland;Denmark;Australia;Netherlands;Germany;United Kingdom;Switzerland;Italy
24EUCTR2020-002822-10-NL
(EUCTR)
26/02/202124/11/2020A study of Pridopidine in Patients with Early Stage of Huntington DiseaseA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington Disease - PRidopidine Outcome on Function in Huntington Disease (PROOF-HD) Huntington Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: PL101
INN or Proposed INN: PRIDOPIDINE HYDROCHLORIDE
Other descriptive name: Pridiopidine
Prilenia Neurotherapeutics Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3Austria;Czech Republic;Germany;Netherlands
25NCT04421339
(ClinicalTrials.gov)
January 22, 20214/6/2020Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot StudyMelatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot StudyHuntington DiseaseDietary Supplement: Melatonin;Other: PlaceboThe University of Texas Health Science Center, HoustonHuntington's Disease Society of AmericaRecruiting18 Years75 YearsAll20N/AUnited States
26EUCTR2020-002822-10-CZ
(EUCTR)
21/01/202110/11/2020A study of Pridopidine in Patients with Early Stage of Huntington DiseaseA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington Disease - PRidopidine Outcome on Function in Huntington Disease (PROOF-HD) Huntington Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: PL101
INN or Proposed INN: PRIDOPIDINE HYDROCHLORIDE
Other descriptive name: Pridiopidine
Prilenia Neurotherapeutics Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3Canada;Austria;Netherlands;Germany;United Kingdom;United States;Czech Republic;European Union
27EUCTR2020-002822-10-AT
(EUCTR)
18/01/202109/11/2020A study of Pridopidine in Patients with Early Stage of Huntington DiseaseA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington Disease - PRidopidine Outcome on Function in Huntington Disease (PROOF-HD) Huntington Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: PL101
INN or Proposed INN: PRIDOPIDINE HYDROCHLORIDE
Other descriptive name: Pridiopidine
Prilenia Neurotherapeutics Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;Czech Republic;European Union;Canada;Austria;Netherlands;Germany;United Kingdom
28EUCTR2018-003898-94-IT
(EUCTR)
30/12/202015/06/2021An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s DiseaseAN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE - NA Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: -
Product Code: [Ro 723-4292/F02]
INN or Proposed INN: tominersen
F. HOFFMANN - LA ROCHE LTD.NULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand
29EUCTR2020-002822-10-DE
(EUCTR)
11/12/202006/11/2020A study of Pridopidine in Patients with Early Stage of Huntington DiseaseA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington Disease - PRidopidine Outcome on Function in Huntington Disease (PROOF-HD) Huntington Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: PL101
INN or Proposed INN: PRIDOPIDINE HYDROCHLORIDE
Other descriptive name: Pridiopidine
Prilenia Neurotherapeutics Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;Czech Republic;European Union;Canada;Austria;Netherlands;Germany;United Kingdom
30EUCTR2018-003898-94-AT
(EUCTR)
10/12/202014/10/2020An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s DiseaseAN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: tominersen
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand
31EUCTR2020-002822-10-IT
(EUCTR)
23/11/202024/05/2021A study of Pridopidine in Patients with Early Stage of Huntington DiseaseA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington Disease - PRidopidine Outcome on Function in Huntington Disease (PROOF-HD) Huntington Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: [PL101]
INN or Proposed INN: PRIDOPIDINE HYDROCHLORIDE
Prilenia Neurotherapeutics LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;Czech Republic;European Union;Canada;Austria;Netherlands;Germany;United Kingdom;Italy
32NCT04556656
(ClinicalTrials.gov)
October 16, 202014/9/2020PRidopidine's Outcome On Function in Huntington Disease, PROOF- HDA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients With Early Stage of Huntington DiseaseHuntington DiseaseDrug: Pridopidine;Drug: PlaceboPrileniaNULLActive, not recruiting25 YearsN/AAll499Phase 3United States;Austria;Canada;Czechia;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom
33EUCTR2018-003898-94-NL
(EUCTR)
01/10/202008/10/2020An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s DiseaseAN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: tominersen
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1050Phase 3United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;New Zealand
34NCT04400331
(ClinicalTrials.gov)
September 18, 202019/5/2020Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington DiseaseOpen-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington DiseaseChorea, HuntingtonDrug: ValbenazineNeurocrine BiosciencesHuntington Study GroupRecruiting18 Years75 YearsAll150Phase 3United States;Canada
35NCT04301726
(ClinicalTrials.gov)
September 1, 202013/2/2020Efficacy of Deutetrabenazine to Control Symptoms of Dysphagia Associated With HDEfficacy of Deutetrabenazine in Huntington's Disease Patients With Dysphagia: A Randomised, Placebo-controlled Pilot StudyHuntington DiseaseDrug: Deutetrabenazine Oral Tablet [Austedo];Drug: Placebo oral tabletFundacion Huntington Puerto RicoNULLNot yet recruiting21 YearsN/AAll48Phase 1NULL
36NCT04514367
(ClinicalTrials.gov)
August 17, 202027/7/2020An Open Label Study of ANX005 in Subjects With, or at Risk for, Manifest Huntington's DiseaseA Phase 2a Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ANX005 in Subjects With, or at Risk for, Manifest Huntington's DiseaseHuntington DiseaseDrug: ANX005Annexon, Inc.NULLActive, not recruiting18 YearsN/AAll28Phase 2United States
37NCT04201834
(ClinicalTrials.gov)
August 13, 202013/12/2019Risperidone for the Treatment of Huntington's Disease Involuntary MovementsRisperidone for the Treatment of Huntington's Disease ChoreaHuntington Disease;ChoreaDrug: Risperidone;Device: BioStamp nPoint deviceUniversity of RochesterNULLRecruiting18 Years65 YearsAll12Phase 2United States
38EUCTR2019-002178-30-DE
(EUCTR)
28/07/202012/06/2020A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients with Huntington’s DiseaseA Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients with Huntington’s Disease Huntington’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120102
Product Code: WVE-120102
INN or Proposed INN: WVE-120102
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: yes
Male: yes
70Phase 2France;Canada;Poland;Denmark;Australia;Germany;United Kingdom
39EUCTR2019-002178-30-FR
(EUCTR)
28/07/202028/04/2020A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients with Huntington’s DiseaseA Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients with Huntington’s Disease Huntington’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120102
Product Code: WVE-120102
INN or Proposed INN: WVE-120102
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: yes
Male: yes
70Phase 2France;Canada;Poland;Denmark;Australia;Germany;United Kingdom
40EUCTR2019-003637-42-DE
(EUCTR)
28/07/202009/06/2020A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120101 in Patients with Huntington’s DiseaseA Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120101 in Patients with Huntington’s Disease Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120101
Product Code: WVE-120101
INN or Proposed INN: WVE-120101
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Canada;Poland;Denmark;Australia;Germany;United Kingdom
41EUCTR2019-003637-42-FR
(EUCTR)
23/07/202005/05/2020A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120101 in Patients with Huntington’s DiseaseA Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120101 in Patients with Huntington’s Disease Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120101
Product Code: WVE-120101
INN or Proposed INN: WVE-120101
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Canada;Poland;Denmark;Australia;Germany;United Kingdom
42EUCTR2019-003637-42-DK
(EUCTR)
06/07/202002/03/2020A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120101 in Patients with Huntington’s DiseaseA Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120101 in Patients with Huntington’s Disease Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.1;Level: LLT;Classification code 10012278;Term: Dementia due to Huntington's disease;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120101
Product Code: WVE-120101
INN or Proposed INN: WVE-120101
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Canada;Poland;Australia;Denmark;Germany;United Kingdom
43NCT04617847
(ClinicalTrials.gov)
April 13, 202030/10/2020Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120101 in Patients With Huntington's DiseaseA Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120101 in Patients With Huntington's DiseaseHuntington DiseaseDrug: WVE-120101Wave Life Sciences Ltd.NULLTerminatedN/AN/AAll27Phase 1/Phase 2Australia;Canada;Denmark;France;Germany;Poland;United Kingdom
44EUCTR2019-003637-42-PL
(EUCTR)
11/04/202019/02/2020A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120101 in Patients with Huntington’s DiseaseA Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120101 in Patients with Huntington’s Disease Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120101
Product Code: WVE-120101
INN or Proposed INN: WVE-120101
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Canada;Poland;Denmark;Australia;Germany;United Kingdom
45NCT04071639
(ClinicalTrials.gov)
March 12, 202026/8/2019Symptomatic Therapy for Patients With Huntington's DiseaseNon-randomized Control Clinical Trial to Evaluate the Efficacy and Safety of Symptomatic Drug Therapy for Mild to Moderate Huntington's Disease PatientsHuntington DiseaseDrug: Haloperidol 2Mg Tab;Drug: Risperidone 1Mg Tab;Drug: Zoloft 50Mg Tablet;Drug: Idebenone;Drug: Deutetrabenazine Oral Tablet [Austedo]Second Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLRecruitingN/AN/AAll60Phase 1China
46NCT04219241
(ClinicalTrials.gov)
February 10, 202011/12/2019Clinical Extension Study for Safety and Efficacy Evaluation of Cellavita-HD Administration in Huntington's Patients.Clinical Extension Study for Assessing the Safety and Efficacy of the Intravenous Administration of Cellavita-HD in Huntington's Disease Patients Who Participated in the ADORE-DH Study.Huntington DiseaseBiological: Cellavita-HDAzidus BrasilCellavita Pesquisa Científica LtdaActive, not recruiting21 Years65 YearsAll35Phase 2/Phase 3Brazil
47EUCTR2019-002178-30-DK
(EUCTR)
22/01/202018/09/2019A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients with Huntington’s DiseaseA Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients with Huntington’s Disease Huntington’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Level: LLT;Classification code 10020469;Term: Huntington's chorea;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120102
Product Code: WVE-120102
INN or Proposed INN: WVE-120102
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: yes
Male: yes
70Phase 2France;Canada;Poland;Australia;Denmark;Germany;United Kingdom
48NCT04701580
(ClinicalTrials.gov)
January 14, 20205/1/2021Synaptic Density and Progression of Huntington's Disease.Longitudinal Measurement of Synaptic Density to Monitor Progression of Huntington's Disease.Huntington DiseaseDiagnostic Test: 11C-UCB-J PET-CT;Diagnostic Test: 18F-FDG PET-MRUniversitaire Ziekenhuizen LeuvenNULLActive, not recruiting20 Years75 YearsAll33N/ABelgium
49NCT04102579
(ClinicalTrials.gov)
November 13, 201923/9/2019Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington DiseaseA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington DiseaseChorea, HuntingtonDrug: Valbenazine;Drug: PlaceboNeurocrine BiosciencesHuntington Study GroupCompleted18 Years75 YearsAll128Phase 3United States;Canada
50EUCTR2019-002178-30-PL
(EUCTR)
29/10/201913/08/2019A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients with Huntington’s DiseaseA Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients with Huntington’s Disease Huntington’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120102
Product Code: WVE-120102
INN or Proposed INN: WVE-120102
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: yes
Male: yes
70Phase 2France;Canada;Poland;Denmark;Australia;Germany;United Kingdom
51NCT04617860
(ClinicalTrials.gov)
September 24, 201930/10/2020Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's DiseaseA Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients With Huntington's DiseaseHuntington DiseaseDrug: WVE-120102Wave Life Sciences Ltd.NULLTerminatedN/AN/AAll36Phase 1/Phase 2Australia;Canada;Denmark;France;Germany;Poland;United Kingdom
52EUCTR2016-005095-10-DE
(EUCTR)
20/09/201904/06/2019A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120101 Administered Intrathecally in Patients with Huntington’s DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120101 Administered Intrathecally in Patients with Huntington’s Disease Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120101
Product Code: WVE-120101
INN or Proposed INN: WVE-120101
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: yes
Male: yes
60Phase 1;Phase 2France;Canada;Poland;Denmark;Australia;Germany;United Kingdom
53NCT04000594
(ClinicalTrials.gov)
September 2, 201926/6/2019A Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 (RG6042) in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's DiseaseAn Open-Label Adaptive Multiple-Dose Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's DiseaseHuntingtons DiseaseDrug: RO7234292 (RG6042)Hoffmann-La RocheNULLCompleted25 Years65 YearsAll12Phase 1Netherlands;United Kingdom
54NCT03854019
(ClinicalTrials.gov)
August 5, 201922/2/2019Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's DiseaseEvaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's DiseaseHuntington Disease;IrritabilityDrug: Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg);Drug: PlaceboThe University of Texas Health Science Center, HoustonCures Within ReachRecruiting18 Years75 YearsAll22Phase 3United States
55EUCTR2018-002987-14-NL
(EUCTR)
23/07/201925/02/2019A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's diseaseA RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: not available
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;New Zealand
56EUCTR2016-005095-10-FR
(EUCTR)
11/07/201905/03/2019A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120101 Administered Intrathecally in Patients with Huntington’s DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120101 Administered Intrathecally in Patients with Huntington’s Disease Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120101
Product Code: WVE-120101
INN or Proposed INN: WVE-120101
Wave Life Science Ltd.NULLNot RecruitingFemale: yes
Male: yes
48Phase 1;Phase 2United States;France;Canada;Poland;Denmark;Australia;Germany;United Kingdom
57EUCTR2016-005142-39-FR
(EUCTR)
09/07/201921/05/2019A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120102 Administered Intrathecally in Patients with Huntington’s DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120102 Administered Intrathecally in Patients with Huntington’s Disease Huntington’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120102
Product Code: WVE-120102
INN or Proposed INN: WVE-120102
WAVE Life Sciences LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
48 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Canada;Poland;Denmark;Australia;Germany;United Kingdom
58NCT03980938
(ClinicalTrials.gov)
July 8, 20197/6/2019Within Subject Crossover Study of Cognitive Effects of Neflamapimod in Early-Stage Huntington DiseaseA Double-Blind, Placebo-Controlled Two-Period 10-Week Treatment Within-Subject Crossover Study Of Cognitive Effects Of Neflamapimod in Early-Stage Huntington Disease (HD)Huntington DiseaseDrug: neflamapimod;Other: PlaceboEIP Pharma IncVoisin Consulting, Inc.Terminated30 Years70 YearsAll15Phase 2United Kingdom
59EUCTR2018-004840-51-GB
(EUCTR)
26/06/201922/03/2019Study of Neflamapimod in Early-Stage Huntington Disease (HD)A Double-Blind, Placebo-Controlled Two-Period 10-Week Treatment Within-Subject Crossover Study Of Cognitive Effects Of Neflamapimod in Early-Stage Huntington Disease (HD) Early-Stage Huntington Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Neflamapimod
Product Code: VX-745
INN or Proposed INN: Neflamapimod
Other descriptive name: VX-745
EIP Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
16 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
60EUCTR2018-003898-94-ES
(EUCTR)
21/06/201911/06/2019An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s DiseaseAN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: not available
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
Roche Farma S.A(Soc. Unipersonal) que realiza el ensayo en España y actúa como representante de F. Hoffmann-La Roche LTDNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Spain;Austria;Russian Federation;Chile;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand
61NCT03842969
(ClinicalTrials.gov)
April 23, 201911/2/2019An Open-Label Extension Study to Evaluate Long-Term Safety and Tolerability of RO7234292 (RG6042) in Huntington's Disease Participants Who Participated in Prior Roche and Genentech Sponsored StudiesAn Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients With Huntington's DiseaseHuntington DiseaseDrug: RO7234292 (RG6042)Hoffmann-La RocheNULLActive, not recruiting25 YearsN/AAll236Phase 3United States;Australia;Austria;Canada;Germany;Italy;Netherlands;Spain;United Kingdom;Argentina;Chile;Japan;Poland
62EUCTR2018-002987-14-DK
(EUCTR)
11/04/201915/02/2019A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's diseaseA RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: not available
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
800Phase 3United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Denmark;Australia;Netherlands;Germany;China;Japan;New Zealand
63EUCTR2018-002987-14-AT
(EUCTR)
27/03/201922/03/2019A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's diseaseA RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: not available
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand
64EUCTR2018-002987-14-PL
(EUCTR)
19/03/201907/04/2020A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's diseaseA RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: not available
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
801Phase 3United States;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;China;Japan;New Zealand
65EUCTR2018-003898-94-GB
(EUCTR)
07/03/201913/12/2018An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s DiseaseAN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: tominersen
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Spain;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Italy;France;New Zealand;Netherlands;Germany;Denmark;Australia;Poland;Argentina;Canada
66NCT03787758
(ClinicalTrials.gov)
February 28, 201917/12/2018A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part BA Phase 1, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Healthy Adults With an Open-label Cohort of Patients With Huntington's DiseaseHuntington DiseaseDrug: SAGE-718Sage TherapeuticsNULLCompleted18 Years70 YearsAll6Phase 1United States
67EUCTR2018-002987-14-IT
(EUCTR)
27/02/201915/06/2021A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's diseaseA RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE. - A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Pati Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: -
Product Code: [Ro 723-4292/F02]
INN or Proposed INN: -
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
801Phase 3United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;Japan;New Zealand
68EUCTR2016-005095-10-DK
(EUCTR)
26/02/201920/12/2018A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120101 Administered Intrathecally in Patients with Huntington’s DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120101 Administered Intrathecally in Patients with Huntington’s Disease Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120101
Product Code: WVE-120101
INN or Proposed INN: WVE-120101
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: yes
Male: yes
60Phase 1;Phase 2France;Canada;Poland;Australia;Denmark;Germany;United Kingdom
69EUCTR2016-005142-39-DK
(EUCTR)
26/02/201920/12/2018A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120102 Administered Intrathecally in Patients with Huntington’s DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120102 Administered Intrathecally in Patients with Huntington’s Disease Huntington’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120102
Product Code: WVE-120102
INN or Proposed INN: WVE-120102
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: yes
Male: yes
80Phase 1;Phase 2France;United States;Canada;Poland;Australia;United Kingdom;Germany;Denmark
70EUCTR2018-002987-14-GB
(EUCTR)
13/02/201908/02/2019A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's diseaseA RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE Huntington's disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: not available
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand
71NCT03761849
(ClinicalTrials.gov)
January 23, 201930/11/2018A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's DiseaseA Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington's DiseaseHuntingtons DiseaseDrug: RO7234292;Drug: PlaceboHoffmann-La RocheNULLActive, not recruiting25 Years65 YearsAll899Phase 3United States;Argentina;Australia;Austria;Canada;Chile;Denmark;France;Germany;Italy;Japan;Netherlands;New Zealand;Poland;Russian Federation;Spain;Switzerland;United Kingdom;China
72NCT03764215
(ClinicalTrials.gov)
November 15, 201827/11/2018Nilotinib in Huntington's DiseaseAn Open Label, Phase Ib Study to Evaluate the Impact of Low Doses of Nilotinib Treatment on Safety, Tolerability and Biomarkers in Huntington's DiseaseHuntington DiseaseDrug: Nilotinib 150 MGGeorgetown UniversityNULLRecruiting25 Years90 YearsAll10Phase 1United States
73EUCTR2017-002471-25-GB
(EUCTR)
18/10/201804/08/2017An extension study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the study drug, RO7234292 (ISIS 443139), in patients who participated in prior investigational studies of RO7234292AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7234292 (ISIS 443139) IN HUNTINGTON'S DISEASE PATIENTS WHO PARTICIPATED IN PRIOR INVESTIGATIONAL STUDIES OF RO7234292 (ISIS 443139) Early Manifest Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: n.a.
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
46Phase 1;Phase 2Canada;Germany;United Kingdom
74NCT03575676
(ClinicalTrials.gov)
August 8, 201811/6/2018Efficacy and Safety of SOM3355 in Huntington's Disease ChoreaPhase IIa, Double-blind, Randomized, Placebo-controlled Study of the Efficacy and Safety of SOM3355 in Huntington's Disease (HD) Patients With Chorea Movements.Huntington's ChoreaDrug: SOM3355 100mg BID;Drug: SOM3355 200mg BID;Drug: Placebo BIDSOM Biotech SLNULLCompleted18 YearsN/AAll32Phase 2Spain
75EUCTR2016-005142-39-GB
(EUCTR)
02/08/201819/05/2017A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120102 Administered Intrathecally in Patients with Huntington’s DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120102 Administered Intrathecally in Patients with Huntington’s Disease Huntington’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120102
Product Code: WVE-120102
INN or Proposed INN: WVE-120102
Wave Life Sciences UK LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
48 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Poland;Denmark;Australia;Germany;United Kingdom
76EUCTR2016-005095-10-GB
(EUCTR)
02/08/201817/10/2017A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120101 Administered Intrathecally in Patients with Huntington’s DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120101 Administered Intrathecally in Patients with Huntington’s Disease Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120101
Product Code: WVE-120101
INN or Proposed INN: WVE-120101
Wave Life Sciences UK LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Poland;Denmark;Australia;Germany;United Kingdom
77NCT02509793
(ClinicalTrials.gov)
August 1, 201824/7/2015A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)Huntington's DiseaseDrug: TetrabenazineWilliam Ondo, MDH. Lundbeck A/SRecruiting18 Years80 YearsAll20Phase 4United States
78EUCTR2018-000203-16-ES
(EUCTR)
18/06/201821/05/2018Phase IIa, double-blind, randomized, placebo-controlled study of the efficacy and safety of SOM3335 in Huntington`s disease (HD) patients with chorea movements.Phase IIa, double-blind, randomized, placebo-controlled study of the efficacy and safety of SOM3335 in Huntington`s disease (HD) patients with chorea movements. Chorea movements associated with Huntington's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10020469;Term: Huntington's chorea;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Calvan® 100 mg
INN or Proposed INN: BEVANTOLOL HYDROCHLORIDE
SOM BiotechNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain
79NCT03713892
(ClinicalTrials.gov)
May 23, 201817/10/2018CKD-504 in SAD and MAD in Healthy Korean and Caucasian Adult Male and Female SubjectsPhase I Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, PK, PD of CKD-504 in Single SAD and MAD in Healthy Korean and Caucasian Adult Male and Female SubjectsHuntington DiseaseDrug: CKD-504;Drug: PlaceboChong Kun Dang PharmaceuticalNULLRecruiting19 Years45 YearsAll88Phase 1Korea, Republic of
80NCT03252535
(ClinicalTrials.gov)
January 15, 201815/8/2017Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's DiseaseDose-Response Evaluation of the Investigational Product Cellavita HD After Intravenous Administration in Patients With Huntington's DiseaseHuntington DiseaseBiological: Cellavita HD lower dose;Biological: Cellavita HD higher dose;Other: PlaceboAzidus BrasilCellavita Pesquisa Científica LtdaCompleted21 Years65 YearsAll35Phase 2Brazil
81EUCTR2017-002471-25-DE
(EUCTR)
10/01/201807/08/2017An extension study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the study drug, RO7234292 (ISIS 443139), in patients who participated in prior investigational studies of RO7234292An Open-Label Extension Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington’s Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139) Early Manifest Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: Ro 723-4292/F02
INN or Proposed INN: n.a.
Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx
F.Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
46Phase 2Canada;Germany;United Kingdom
82NCT03342053
(ClinicalTrials.gov)
January 2, 201831/10/2017A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)An Open-Label Extension Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)Huntington's DiseaseDrug: RO7234292 (RG6042)Hoffmann-La RocheNULLCompleted25 YearsN/AAll46Phase 2Canada;Germany;United Kingdom
83NCT02728115
(ClinicalTrials.gov)
October 16, 201711/3/2016Safety Evaluation of Cellavita HD Administered Intravenously in Participants With Huntington's DiseaseFirst in Human Study to Evaluate Safety of Cellavita HD Investigational Product After Intravenous Application in Participants With Huntington's DiseaseHuntington DiseaseBiological: Cellavita HD Lower Dose;Biological: Cellavita HD Higher doseAzidus BrasilCellavita Pesquisa Científica Ltda;Azidus Brasil Scientific Research and Development LtdaActive, not recruiting21 Years65 YearsMale6Phase 1Brazil
84NCT03296176
(ClinicalTrials.gov)
October 9, 201715/9/2017Metabolomic Study in Huntington's Disease (METABO-HD)Metabolomic Study in Huntington's DiseaseHuntington DiseaseBiological: blood sampleUniversity Hospital, AngersNULLRecruiting20 Years70 YearsAll150N/AFrance
85NCT03225833
(ClinicalTrials.gov)
July 17, 201717/7/2017Safety and Tolerability of WVE-120101 in Patients With Huntington's DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120101 Administered Intrathecally in Patients With Huntington's DiseaseHuntington's DiseaseDrug: WVE-120101;Drug: PlaceboWave Life Sciences Ltd.NULLTerminated25 Years65 YearsAll61Phase 1/Phase 2Australia;Canada;Denmark;France;Germany;Poland;United Kingdom
86NCT03225846
(ClinicalTrials.gov)
July 17, 201717/7/2017Safety and Tolerability of WVE-120102 in Patients With Huntington's DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120102 Administered Intrathecally in Patients With Huntington's DiseaseHuntington's DiseaseDrug: WVE-120102;Drug: PlaceboWave Life Sciences Ltd.NULLTerminated25 Years65 YearsAll88Phase 1/Phase 2Australia;Canada;Denmark;France;Germany;Poland;United Kingdom
87NCT03515213
(ClinicalTrials.gov)
April 27, 20172/8/2017Safety and Efficacy of Fenofibrate as a Treatment for Huntington's DiseaseA Phase IIa, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Fenofibrate as a Treatment for Huntington's DiseaseHuntington DiseaseDrug: Fenofibrate;Drug: PlaceboUniversity of California, IrvineNULLActive, not recruiting18 YearsN/AAll20Phase 2United States
88NCT03019289
(ClinicalTrials.gov)
April 19, 20173/1/2017A Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's DiseaseA Phase I, Open-Label, Single-Dose, Adaptive (S)-(-)-[18F]Fluspidine and [18F]Fallypride Positron Emission Tomography Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's DiseaseHealth Volunteers, Huntington DiseaseDrug: pridopidine (90 mg)PrileniaNULLCompleted25 YearsN/AMale23Phase 1Germany
89EUCTR2016-003730-25-NL
(EUCTR)
14/02/201709/01/2017A study to assess the safety and efficacy of a new medicine SBT-020 in patients with Early Stage Huntington’s Disease.A Two Part Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of SBT-020 in Patients with Early Stage Huntington’s Disease. - SBT-020 in HD Huntington's Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: SBT-020
Product Code: SBT-020
INN or Proposed INN: SBT-020
Other descriptive name: SS-20
Stealth Bio Therapeutics IncNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Netherlands
90NCT02507284
(ClinicalTrials.gov)
May 10, 201622/7/2015Tolerability, Safety, and Activity of SRX246 in Irritable Subjects With Huntington's DiseaseAn Exploratory Phase II Study to Determine the Tolerability, Safety, and Activity of a Novel Vasopressin 1a Receptor Antagonist (SRX246) in Irritable Subjects With Huntington's Disease (HD)Irritable Mood;Huntington's DiseaseDrug: SRX246;Drug: PlaceboAzevan PharmaceuticalsNational Institute of Neurological Disorders and Stroke (NINDS);NeuroNEXT NetworkCompleted18 YearsN/AAll106Phase 2United States
91NCT02994719
(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
92NCT02907294
(ClinicalTrials.gov)
March 20168/3/2016Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF-999 After Multiple Oral Doses in Healthy VolunteersRandomized, Double Blind, Placebo Controlled, Parallel Groups Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF-999 (160 mg and 320 mg) After Multiple Oral Doses in Healthy VolunteersHuntington DiseaseDrug: PBF-999 / 160 mg;Drug: PBF-999 / 320 mg;Drug: PlaceboPalobiofarma SLFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauTerminated18 Years45 YearsBoth8Phase 1Spain
93EUCTR2015-000904-24-NL
(EUCTR)
15/02/201617/02/2016A study testing if pridopidine is safe and efficacious in patients with Huntington's DiseaseA Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients with Huntington’s Disease - Open PRIDE-HD Huntington's disease
MedDRA version: 19.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;United States;Canada;Poland;Denmark;Austria;Australia;Russian Federation;Germany;Netherlands;Italy;United Kingdom
94EUCTR2014-005112-42-NL
(EUCTR)
11/12/201507/08/2015A comparative phase2 study assessing the efficacy of triheptanoin, an anaplerotic therapy in Huntington's Disease (TRIHEP 3)A comparative phase2 study assessing the efficacy of triheptanoin, an anaplerotic therapy in Huntington's Disease (TRIHEP 3) Huntington's disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Product Name: Triheptanoin
Product Code: UX007
INSERMNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;Netherlands
95EUCTR2015-000904-24-DE
(EUCTR)
03/12/201504/08/2015A study testing if pridopidine is safe and efficacious in patients with Huntington's DiseaseA Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients with Huntington’s Disease - Open PRIDE-HD Huntington's disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Poland;Austria;Australia;France;United States;Canada;Russian Federation;Netherlands;Germany;Italy;United Kingdom
96EUCTR2015-000904-24-AT
(EUCTR)
18/11/201515/09/2015A study testing if pridopidine is safe and efficacious in patients with Huntington's DiseaseA Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients with Huntington’s Disease - Open PRIDE-HD Huntington's disease
MedDRA version: 19.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;United States;Canada;Poland;Denmark;Australia;Austria;Russian Federation;Netherlands;Germany;Italy;United Kingdom
97EUCTR2015-000904-24-GB
(EUCTR)
13/11/201518/08/2015A study testing if pridopidine is safe and efficacious in patients with Huntington's DiseaseA Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients with Huntington’s Disease - Open PRIDE-HD Huntington's disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Poland;Austria;Australia;Russian Federation;Netherlands;Germany;Italy;United Kingdom
98EUCTR2014-000418-75-NL
(EUCTR)
04/11/201515/10/2014A clinical study in subjects with Huntington's Disease to assess the efficacy and safety of three oral doses of laquinimod, either 0.5 mg/day, 1.0 mg/day or 1.5 mg/day (experimental drug)A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) Huntington's Disease (HD)
MedDRA version: 18.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: 5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium
Teva Branded Pharmaceutical Products R&D, Inc.NULLNot RecruitingFemale: yes
Male: yes
330Phase 2Portugal;United States;Czech Republic;Canada;Spain;Russian Federation;Germany;Netherlands;Italy;United Kingdom
99NCT02494778
(ClinicalTrials.gov)
September 24, 20157/7/2015A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's DiseaseA Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD)Huntington's DiseaseDrug: PridopidinePrileniaNULLTerminated21 YearsN/AAll248Phase 2United States;Australia;Austria;Canada;France;Germany;Italy;Netherlands;Poland;Russian Federation;United Kingdom;Denmark
100EUCTR2015-000904-24-IT
(EUCTR)
15/09/201523/02/2018A study testing if pridopidine is safe and efficacious in patients with Huntington's DiseaseA Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients with Huntington's Disease - Open PRIDE-HD Huntington's disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidina
Product Code: TV-7820
INN or Proposed INN: Pridopidina
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidina
Product Code: TV-7820
INN or Proposed INN: Pridopidina
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INCNULLNot RecruitingFemale: yes
Male: yes
400Phase 2France;United States;Canada;Poland;Denmark;Austria;Australia;Russian Federation;Netherlands;Germany;United Kingdom;Italy
101NCT02519036
(ClinicalTrials.gov)
August 6, 20151/8/2015Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 443139 in Participants With Early Manifest Huntington's DiseaseA Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of Intrathecally Administered ISIS 443139 in Patients With Early Manifest Huntington's DiseaseHuntington's DiseaseDrug: ISIS 443139 10 mg;Drug: ISIS 443139 30 mg;Drug: ISIS 443139 60 mg;Drug: ISIS 443139 90 mg;Drug: ISIS 443139 120 mg;Other: PlaceboIonis Pharmaceuticals, Inc.NULLCompleted25 Years65 YearsAll46Phase 1/Phase 2Canada;Germany;United Kingdom
102NCT02481674
(ClinicalTrials.gov)
July 201519/6/2015A Study in Subjects With Late Prodromal and Early Manifest Huntington's Disease (HD) to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Pepinemab (VX15/2503)A Phase 2, Multi-center, Randomized, Double-blind, Placebo Controlled Study in Subjects With Late Prodromal and Early Manifest Huntington's Disease (HD) to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of VX15/2503Huntington's DiseaseDrug: VX15/2503;Drug: PlaceboVaccinex Inc.Huntington Study GroupCompleted21 YearsN/AAll301Phase 2United States;Canada
103NCT02336633
(ClinicalTrials.gov)
July 20158/1/2015Resveratrol and Huntington DiseaseMetabolic Intervention Using Resveratrol in Patients With Huntington DiseaseHuntington DiseaseDietary Supplement: Resveratrol;Other: PlaceboAssistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/AAll102N/AFrance
104NCT02453061
(ClinicalTrials.gov)
June 29, 201512/5/2015A Comparative Phase 2 Study Assessing the Efficacy of Triheptanoin, an Anaplerotic Therapy in Huntington's DiseaseA Comparative Phase 2 Study Assessing the Efficacy of Triheptanoin, an Anaplerotic Therapy in Huntington's DiseaseHuntington DiseaseDrug: Triheptanoin oil;Drug: PlaceboInstitut National de la Santé Et de la Recherche Médicale, FranceUltragenyx Pharmaceutical IncCompleted18 YearsN/AAll100Phase 2France;Netherlands
105EUCTR2014-005112-42-FR
(EUCTR)
22/06/201522/06/2015A comparative phase2 study assessing the efficacy of triheptanoin, an anaplerotic therapy in Huntington's Disease (TRIHEP 3)A comparative phase2 study assessing the efficacy of triheptanoin, an anaplerotic therapy in Huntington's Disease (TRIHEP 3) Huntington's disease
MedDRA version: 18.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Name: Triheptanoin
Product Code: UX007
INSERMNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2France;Netherlands
106EUCTR2014-004900-31-DE
(EUCTR)
27/05/201513/02/2015AN OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY, TOLERABILITY AND EFFICACY OF PF-02545920 IN SUBJECTS WITH HUNTINGTON’S DISEASE WHO PREVIOUSLY COMPLETED STUDY A8241021AN OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY, TOLERABILITY AND EFFICACY OF PF-02545920 IN SUBJECTS WITH HUNTINGTON’S DISEASE WHO PREVIOUSLY COMPLETED STUDY A8241021 HUNTINGTON'S DISEASE
MedDRA version: 17.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PF-02545920
INN or Proposed INN: not available
Other descriptive name: PF-02545920
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
260Phase 2United States;Canada;Poland;Germany;United Kingdom
107EUCTR2014-001291-56-GB
(EUCTR)
24/04/201521/07/2014A PHASE 2, RANDOMIZED, PLACEBO CONTROLLED, DOUBLE BLIND PROOF-OF-CONCEPT STUDY OF THE EFFICACY AND SAFETY OF PF-02545920 IN SUBJECTS WITH HUNTINGTON’S DISEASEA PHASE 2, RANDOMIZED, PLACEBO CONTROLLED, DOUBLE BLIND PROOF-OF-CONCEPT STUDY OF THE EFFICACY AND SAFETY OF PF-02545920 IN SUBJECTS WITH HUNTINGTON’S DISEASE HUNTINGTON’S DISEASE
MedDRA version: 17.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.0;Level: LLT;Classification code 10020469;Term: Huntington's chorea;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PF-02545920
INN or Proposed INN: not available
Other descriptive name: PF-02545920
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
260 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom;Germany;Poland;Canada;United States
108EUCTR2013-001888-23-DK
(EUCTR)
13/04/201508/01/2015A study testing different doses of pridopidine (45 mg, 67.5 mg, 90 mg, 112.5 mg twice-daily) against placebo to establish which one works best and is safe when treating certain symptoms of patients with Huntington´s Disease.A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease Huntington’s disease
MedDRA version: 17.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Denmark;Australia;Germany;Netherlands
109NCT02342548
(ClinicalTrials.gov)
February 25, 201515/1/2015Open Label Extension Study To Investigate Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Completed Study A8241021An Open Label Extension Study To Investigate The Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Previously Completed Study A8241021Huntington's DiseaseDrug: 20 mg BID of PF-02545920PfizerNULLTerminated30 Years66 YearsAll188Phase 2United States;Canada;Germany;Poland;United Kingdom
110EUCTR2014-000418-75-GB
(EUCTR)
30/01/201524/09/2014A clinical study in subjects with Huntington's Disease to assess the efficacy and safety of three oral doses of laquinimod, either 0.5 mg/day, 1.0 mg/day or 1.5 mg/day (experimental drug)A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) Huntington's Disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: 5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium
Teva Branded Pharmaceutical Products R&D, Inc.NULLNot Recruiting Female: yes
Male: yes
330 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Czech Republic;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom
111EUCTR2014-000418-75-DE
(EUCTR)
06/01/201525/09/2014A clinical study in subjects with Huntington's Disease to assess the efficacy and safety of three oral doses of laquinimod, either 0.5 mg/day, 1.0 mg/day or 1.5 mg/day (experimental drug)A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) Huntington's Disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: 5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium
Teva Branded Pharmaceutical Products R&D, Inc.NULLNot RecruitingFemale: yes
Male: yes
330Phase 2Portugal;United States;Czech Republic;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom
112EUCTR2014-000418-75-CZ
(EUCTR)
05/01/201525/09/2014A clinical study in subjects with Huntington's Disease to assess the efficacy and safety of three oral doses of laquinimod, either 0.5 mg/day, 1.0 mg/day or 1.5 mg/day (experimental drug)A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) Huntington's Disease (HD)
MedDRA version: 19.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: 5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium
Teva Branded Pharmaceutical Products R&D, Inc.NULLNot RecruitingFemale: yes
Male: yes
330Phase 2Portugal;United States;Czech Republic;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom
113EUCTR2014-000418-75-IT
(EUCTR)
18/11/201425/08/2014A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) Huntington's Disease (HD)
MedDRA version: 17.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: 5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium
Teva Branded Pharmaceutical Products R&D, Inc.NULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Portugal;France;Czech Republic;Canada;Spain;Netherlands;Germany;United Kingdom;Italy
114EUCTR2014-000418-75-PT
(EUCTR)
31/10/201425/09/2014A clinical study in subjects with Huntington's Disease to assess the efficacy and safety of three oral doses of laquinimod, either 0.5 mg/day, 1.0 mg/day or 1.5 mg/day (experimental drug)A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) Huntington's Disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: 5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium
Teva Branded Pharmaceutical Products R&D, Inc.NULLNot Recruiting Female: yes
Male: yes
330 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Portugal;Czech Republic;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom
115NCT02215616
(ClinicalTrials.gov)
October 28, 201412/8/2014A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of LaquinimodA Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/Day) as Treatment in Patients With Huntington's DiseaseHuntington's DiseaseDrug: Laquinimod;Drug: PlaceboTeva Branded Pharmaceutical Products R&D, Inc.NULLCompleted21 Years55 YearsAll352Phase 2United States;Canada;Czechia;Germany;Italy;Netherlands;Portugal;Russian Federation;Spain;United Kingdom;Czech Republic;France;India;Israel
116EUCTR2014-001291-56-DE
(EUCTR)
27/10/201418/07/2014A PHASE 2, RANDOMIZED, PLACEBO CONTROLLED, DOUBLE BLIND PROOF-OF-CONCEPT STUDY OF THE EFFICACY AND SAFETY OF PF-02545920 IN SUBJECTS WITH HUNTINGTON’S DISEASEA PHASE 2, RANDOMIZED, PLACEBO CONTROLLED, DOUBLE BLIND PROOF-OF-CONCEPT STUDY OF THE EFFICACY AND SAFETY OF PF-02545920 IN SUBJECTS WITH HUNTINGTON’S DISEASE HUNTINGTON’S DISEASE
MedDRA version: 19.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 19.0;Level: LLT;Classification code 10020469;Term: Huntington's chorea;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PF-02545920
INN or Proposed INN: not available
Other descriptive name: PF-02545920
Pfizer Inc, 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
260Phase 2United States;Canada;Poland;Germany;United Kingdom
117EUCTR2014-000418-75-ES
(EUCTR)
23/10/201416/10/2014A clinical study in subjects with Huntington's Disease to assess the efficacy and safety of three oral doses of laquinimod, either 0.5 mg/day, 1.0 mg/day or 1.5 mg/day (experimental drug)A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) Huntington's Disease (HD)
MedDRA version: 17.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: 5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium
Teva Branded Pharmaceutical Products R&D, Inc.NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Portugal;France;United States;Czech Republic;Canada;Spain;Netherlands;Germany;Italy;United Kingdom
118NCT02231580
(ClinicalTrials.gov)
September 1, 20142/9/2014Study Exploring Safety, Pharmacokinetic and Pharmacodynamic of BN82451 in Male Huntington's Disease PatientsA Dose Escalation, Proof of Concept, Phase IIa Study to Investigate the Safety and Tolerability, the Pharmacokinetic and the Pharmacodynamic of BN82451B, Administered Twice Daily Over 4 Weeks, in Male Patients With Huntington's DiseaseHuntington's DiseaseDrug: BN82451B;Drug: PlaceboIpsenNULLTerminated20 Years70 YearsMale17Phase 2Germany
119NCT01834053
(ClinicalTrials.gov)
September 201411/4/2013Safety and Efficacy of Bone Marrow Derived MNCs for Treatment of Cells for the Treatment of Hunting Tons Chorea.Safety and Efficacy of Bone Marrow Derived MNCs for the Treatment of Huntingtons Chorea. It is Self Funded (Patients' Own Funding) Clinical TrialHuntington DiseaseBiological: autologous Stem CellChaitanya Hospital, PuneNULLRecruiting35 Years44 YearsBoth50Phase 1/Phase 2India
120NCT02208934
(ClinicalTrials.gov)
September 20144/8/2014Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 in Healthy Young Male VolunteersStudy To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 ( 5 mg, 10 mg, 20 mg and 40 mg ) in Healthy Young Male VolunteersHuntington's DiseaseDrug: PBF-999;Drug: PlaceboFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauPalo Biofarma, S.LCompleted18 Years45 YearsMale32Phase 1Spain
121NCT02197130
(ClinicalTrials.gov)
September 201416/7/2014Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's DiseaseA Phase 2, Randomized, Placebo Controlled, Double Blind Proof-of-concept Study Of The Efficacy And Safety Of Pf-02545920 In Subjects With Huntington's DiseaseHuntington's DiseaseDrug: PF-02545920;Other: PlaceboPfizerNULLCompleted30 Years65 YearsAll272Phase 2United States;Canada;Germany;Poland;United Kingdom
122EUCTR2013-001888-23-PL
(EUCTR)
23/07/201414/05/2014A study testing different doses of pridopidine (45 mg, 67.5 mg, 90 mg, 112.5 mg twice-daily) against placebo to establish which one works best and is safe when treating certain symptoms of patients with Huntington´s Disease.A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease Huntington’s disease
MedDRA version: 19.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Australia;Denmark;Germany;Netherlands
123EUCTR2013-001888-23-AT
(EUCTR)
01/07/201408/01/2014A study testing different doses of pridopidine (45 mg, 67.5 mg, 90 mg, 112.5 mg twice-daily) against placebo to establish which one works best and is safe when treating certain symptoms of patients with Huntington´s Disease.A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease Huntington’s disease
MedDRA version: 19.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Australia;Denmark;Germany;Netherlands
124EUCTR2013-002899-41-DE
(EUCTR)
28/04/201424/01/2014Study to assess the effects of BN82451B and how it is absorbed, distributed and eliminated in the body, when it is given for 4 weeks to men suffering from Hungtington's diseaseA dose escalation, proof of concept, phase IIa study to investigate the safety and tolerability, the pharmacokinetic and thepharmacodynamic of BN82451B, administered twice daily over 4 weeks, in male patients with Huntington’s disease Huntington's disease
MedDRA version: 18.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BN8251B
INN or Proposed INN: N/A
Other descriptive name: BN82451B
Product Name: BN8251B
INN or Proposed INN: N/A
Other descriptive name: BN82451B
Ipsen PharmaNULLNot RecruitingFemale: no
Male: yes
Phase 2Germany
125EUCTR2013-001888-23-NL
(EUCTR)
07/04/201420/12/2013A study testing different doses of pridopidine (45 mg, 67.5 mg, 90 mg, 112.5 mg twice-daily) against placebo to establish which one works best and is safe when treating certain symptoms of patients with Huntington´s Disease.A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease Huntington’s disease
MedDRA version: 19.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Australia;Denmark;Netherlands;Germany
126EUCTR2013-001888-23-DE
(EUCTR)
25/03/201410/12/2013A study testing different doses of pridopidine (45 mg, 67.5 mg, 90 mg, 112.5 mg twice-daily) against placebo to establish which one works best and is safe when treating certain symptoms of patients with Huntington´s Disease.A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease Huntington’s disease
MedDRA version: 19.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Australia;Denmark;Germany;Netherlands
127EUCTR2013-001888-23-IT
(EUCTR)
13/03/201411/12/2013A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease Huntington’s disease
MedDRA version: 14.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Netherlands;United States;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Australia;Denmark;Germany
128NCT02006472
(ClinicalTrials.gov)
February 28, 20145/12/2013A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's DiseaseA Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45, 67.5, 90, and 112.5 mg Twice-Daily vs Placebo for Symptomatic Treatment in Patients With Huntington's DiseaseHuntington's DiseaseDrug: Pridopidine;Other: PlaceboPrileniaEuropean Huntington's Disease Network;Huntington Study GroupCompleted21 YearsN/AAll408Phase 2United States;Australia;Austria;Canada;Denmark;France;Germany;Italy;Netherlands;Poland;Russian Federation;United Kingdom
129EUCTR2013-001888-23-GB
(EUCTR)
22/01/201427/11/2013A study testing different doses of pridopidine (45 mg, 67.5 mg, 90 mg, 112.5 mg twice-daily) against placebo to establish which one works best and is safe when treating certain symptoms of patients with Huntington´s Disease.A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease Huntington’s disease
MedDRA version: 17.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2United States;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Australia;Denmark;Germany;Netherlands
130EUCTR2013-002545-10-SE
(EUCTR)
08/01/201411/11/2013An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy.An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy. - OSU6162Open1309 Parkinsons diseaseHuntingtons diseaseMultiple sclerosBrain traumaStrokeMyalgic encephalomyelitisNarcolepsy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: OSU6162 similar to (-)-OSU 6162A. Carlsson Research ABNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Sweden
131NCT02074410
(ClinicalTrials.gov)
January 201421/2/2014Safety and Efficacy of OMS643762 in Subjects With Huntington's DiseasePhase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of OMS643762 in Subjects With Huntington's DiseaseHuntington's DiseaseDrug: OMS643762;Drug: PlaceboOmeros CorporationNULLTerminated18 Years65 YearsAll22Phase 2United States
132NCT01897896
(ClinicalTrials.gov)
November 12, 201314/6/2013Alternatives for Reducing Chorea in Huntington DiseaseAn Open-Label, Long Term Safety Study of SD-809 ER in Subjects With Chorea Associated With Huntington DiseaseChorea Associated With Huntington DiseaseDrug: SD-809Auspex Pharmaceuticals, Inc.NULLCompleted18 YearsN/AAll119Phase 3United States;Australia;Canada
133NCT01806896
(ClinicalTrials.gov)
September 20136/3/2013Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's DiseaseA Phase 2, Double-blind Randomized, Sequential Treatment Group, Placebo-controlled Study To Evaluate The Safety, Tolerability And Brain Cortico-striatal Function Of 2 Doses Of Pf-02545920 In Subjects With Early Huntington's DiseaseHuntington's DiseaseDrug: PF-02545920;Drug: PlaceboPfizerNULLCompleted18 Years70 YearsAll37Phase 2France
134NCT01795859
(ClinicalTrials.gov)
August 5, 201320/2/2013First Time Use of SD-809 in Huntington DiseaseA Randomized Double-Blind, Placebo-Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington DiseaseChoreaDrug: SD-809;Drug: PlaceboTeva Pharmaceutical IndustriesNULLCompleted18 YearsN/AAll90Phase 3United States;Australia;Canada
135NCT01882062
(ClinicalTrials.gov)
May 201318/6/2013Proof of Concept of an Anaplerotic Study Using Brain Phosphorus Magnetic Resonance Spectroscopy in Huntington DiseaseHuntington DiseaseDrug: Triheptanoin 1g/kg/dayInstitut National de la Santé Et de la Recherche Médicale, FranceNULLCompleted18 YearsN/AAll10Phase 2France
136NCT01834911
(ClinicalTrials.gov)
March 201315/4/2013Effect of Tetrabenazine on Stroop Interference in HDEffect of Tetrabenazine on Stroop Interference in Huntington DiseaseHuntington DiseaseDrug: Tetrabenazine withdrawalNew York Medical CollegeNULLCompleted18 YearsN/AAll2Phase 4United States
137NCT01696708
(ClinicalTrials.gov)
December 6, 201220/9/2012Utilization of 31P-Nuclear Magnetic Resonance Spectroscopy to Monitor Brain Energy Deficit in Huntington DiseaseStudy of the Brain Energy Profile Evolution, Using 31Phosphorus-Nuclear Magnetic Resonance Spectroscopy, at Different Stages of Huntington DiseaseHuntington DiseaseOther: 31-Phosphorus RMN SpectroscopyInstitut National de la Santé Et de la Recherche Médicale, FranceNULLCompleted18 YearsN/AAll50N/AFrance
138NCT01914965
(ClinicalTrials.gov)
June 201231/7/2013Apathy Cure Through Bupropion in Huntington's DiseaseA Randomized, Double-blind, Placebo-controlled Prospective Crossover Trial Investigating the Efficacy and Safety of the Treatment With Bupropion in Patients With Apathy in Huntington's DiseaseApathy;Huntington's DiseaseDrug: Bupropion;Drug: PlaceboCharite University, Berlin, GermanyUniversity of Ulm;Ruhr University of Bochum;University Hospital MuensterCompleted25 Years75 YearsBoth40Phase 2Germany
139NCT01590888
(ClinicalTrials.gov)
April 201218/4/2012Effect of PBT2 in Patients With Early to Mid Stage Huntington DiseaseA Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability, and Efficacy of PBT2 in Patients With Early to Mid-stage Huntington DiseaseHuntington DiseaseDrug: PBT2;Drug: PlaceboPrana Biotechnology LimitedNULLCompleted25 YearsN/AAll109Phase 2United States;Australia
140NCT01573819
(ClinicalTrials.gov)
November 24, 201116/2/2012A Repeat Dose Study in Healthy Volunteers Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK356278A Randomised, Placebo Controlled, Ascending, Repeat Dose Study in Healthy Volunteers Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK356278Huntington DiseaseDrug: GSK356278;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 Years65 YearsAll36Phase 1Netherlands
141NCT01602900
(ClinicalTrials.gov)
November 22, 20111/12/2011Healthy Volunteer Positron Emission Tomography (PET) Brain Occupancy Study of a Phosphodiesterase 4 (PDE4) Inhibitor in Huntington's DiseaseAn Open Label Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain PDE4 Engagement, Pharmacokinetics and Safety of Single Oral Doses of GSK356278, Using 11C-(R)-Rolipram as a PET Ligand(s)Huntington DiseaseDrug: GSK356278;Drug: RolipramGlaxoSmithKlineNULLCompleted22 Years55 YearsMale8Phase 1United Kingdom
142NCT01485965
(ClinicalTrials.gov)
November 201129/11/2011A Open-label Food Effect Study With SEN0014196 in Subjects With Huntington DiseaseA Phase 1b, Open-label, Parallel-group Study in Subjects With Huntington Disease to Assess the Safety, Tolerability, and Fed/Fasted Pharmacokinetics of Repeated Oral Doses of SEN0014196Huntington's DiseaseDrug: SEN0014196Siena Biotech S.p.A.NULLCompleted25 Years65 YearsBoth26Phase 1United States
143NCT01521585
(ClinicalTrials.gov)
November 201126/1/2012A Phase II Safety and Tolerability Study With SEN0014196A Double-blind, Placebo-controlled Study in Huntington's Disease Patients to Determine the Safety and Tolerability of SEN0014196Huntington's DiseaseDrug: SEN0014196;Drug: PlaceboSiena Biotech S.p.A.NULLCompleted30 Years70 YearsBoth144Phase 2Germany
144EUCTR2011-001131-23-GB
(EUCTR)
24/10/201118/07/2011A study to determine how safe and tolerable the study drug is, when given to patients with Huntingtons Disease.A double-blind, placebo-controlled study in Huntington’s Disease patients to determine the safety and tolerability of SEN0014196 - N/A Huntington's disease
MedDRA version: 14.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: SEN0014196
Product Code: SEN0014196
INN or Proposed INN: selisistat
Product Name: SEN0014196
Product Code: SEN0014196
INN or Proposed INN: selisistat
Siena Biotech SpANULLNot RecruitingFemale: yes
Male: yes
144Germany;Italy;United Kingdom
145EUCTR2011-001131-23-IT
(EUCTR)
20/10/201122/11/2011A study to determine how safe and tolerable the study drug is, when given to patients with Huntingtons Disease.A double-blind, placebo-controlled study in Huntington's Disease patients to determine the safety and tolerability of SEN0014196 Huntington's disease
MedDRA version: 14.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.0;Level: LLT;Classification code 10020469;Term: Huntington's chorea;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: SEN0014196
Product Code: SEN0014196
INN or Proposed INN: selisistat
Product Name: SEN0014196
Product Code: SEN0014196
INN or Proposed INN: selisistat
SIENA BIOTECH SPANULLNot RecruitingFemale: yes
Male: yes
144Germany;United Kingdom;Italy
146EUCTR2011-001131-23-DE
(EUCTR)
21/09/201127/06/2011A study to determine how safe and tolerable the study drug is, when given to patients with Huntingtons Disease.A double-blind, placebo-controlled study in Huntington’s Disease patients to determine the safety and tolerability of SEN0014196 - N/A Huntington's disease
MedDRA version: 14.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: SEN0014196
Product Code: SEN0014196
INN or Proposed INN: selisistat
Product Name: SEN0014196
Product Code: SEN0014196
INN or Proposed INN: selisistat
Siena Biotech SpANULLNot RecruitingFemale: yes
Male: yes
144Germany;Italy;United Kingdom
147NCT01458470
(ClinicalTrials.gov)
September 201120/10/2011A Trial of Memantine as Symptomatic Treatment for Early Huntington DiseaseA Trial of Memantine as Symptomatic Treatment for Early Huntington Disease; a Phase IIb StudyHuntington DiseaseDrug: Memantine;Other: PlaceboUniversity of British ColumbiaHuntington Society of Canada;Huntington Study GroupCompleted18 Years75 YearsAll19Phase 2Canada
148NCT01357681
(ClinicalTrials.gov)
September 201119/5/2011Effects of EGCG (Epigallocatechin Gallate) in Huntington's Disease (ETON-Study)Effects of EGCG (Epigallocatechin Gallate) in Huntington's Disease The ETON-Study - A Randomized, Double-blind, Stratified, Placebo-controlled Prospective Investigator Initiated Multicenter Trial -Huntington DiseaseDrug: (2)-epigallocatechin-3-gallate (EGCG);Drug: PlaceboCharite University, Berlin, GermanyNULLCompleted18 YearsN/ABoth54Phase 2Germany
149NCT01502046
(ClinicalTrials.gov)
September 201129/12/2011Neuroprotection by Cannabinoids in Huntington's DiseaseA Double Blind, Randomized, Cross Over, Placebo Controlled Phase 2 Clinical Trial to Asses Neuroprotection by Cannabinoids in Huntington's DiseaseHuntington's DiseaseDrug: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD);Drug: PlaceboFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalGW Pharmaceuticals Ltd.Completed18 YearsN/ABoth25Phase 2Spain
150NCT01306929
(ClinicalTrials.gov)
March 1, 201128/2/2011Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington DiseaseA Multi-Center, North American, Open-Label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington's Disease (Open-HART).Huntington DiseaseDrug: pridopidinePrileniaNULLCompletedN/AN/AAll235Phase 2United States;Canada
151NCT01485952
(ClinicalTrials.gov)
March 201129/11/2011An Exploratory Clinical Trial in Early Stage Huntington's Disease Patients With SEN0014196An Exploratory Clinical Trial in Early Stage Huntington's Disease Patients to Assess Pharmacokinetics, Candidate Pharmacodynamic Measures of Target Engagement and Disease Modulation as Well as Acute Phenotypical Effects Following Multiple Oral Doses of SEN0014196.Huntington DiseaseDrug: SEN0014196 (Low Dose);Drug: SEN0014196 (High Dose);Drug: PlaceboSiena Biotech S.p.A.Seventh Framework Programme;European Huntington's Disease NetworkCompleted18 Years70 YearsBoth55Phase 1Germany
152NCT02101957
(ClinicalTrials.gov)
October 201025/3/2014Multicentric Trial of the Treatment of Huntington's Disease by Cysteamine (RP103)Huntington's DiseaseDrug: RP103;Drug: PlaceboUniversity Hospital, AngersNULLActive, not recruiting18 Years65 YearsBoth96Phase 2/Phase 3France
153EUCTR2009-018123-32-SE
(EUCTR)
30/09/201010/06/2010HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-PlusHORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus Huntington disease
MedDRA version: 12.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Medivation, IncNULLNot RecruitingFemale: yes
Male: yes
350United Kingdom;Germany;Netherlands;Denmark;Italy;Sweden
154EUCTR2009-018123-32-NL
(EUCTR)
23/08/201014/04/2010HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-PlusHORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus Huntington disease
MedDRA version: 12.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Medivation, IncNULLNot RecruitingFemale: yes
Male: yes
350United Kingdom;Germany;Netherlands;Denmark;Italy;Sweden
155EUCTR2009-018123-32-IT
(EUCTR)
28/07/201015/07/2010HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease(Protocol DIM20EXT) - Horizon-PlusHORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease(Protocol DIM20EXT) - Horizon-Plus Huntington`s Corea
MedDRA version: 9.1;Level: LLT;Classification code 10020469
Product Name: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Product Name: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
MEDIVATION, INC.NULLNot RecruitingFemale: yes
Male: yes
350United Kingdom;Germany;Netherlands;Denmark;Italy;Sweden
156EUCTR2009-018119-14-GB
(EUCTR)
23/07/201018/06/2010Huntington's Disease Rilmenidine Safety Trial - Huntington's Disease Rilmenidine studyHuntington's Disease Rilmenidine Safety Trial - Huntington's Disease Rilmenidine study Huntington's Disease
MedDRA version: 14.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: Hyperium
Product Name: Rilmenidine
INN or Proposed INN: Rilmenidine
Cambridge University Hospitals NHS Foundation Trust and University of CambridgeNULLNot Recruiting Female: yes
Male: yes
16 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
157EUCTR2010-019444-39-FR
(EUCTR)
18/06/201004/05/2010Essai multicentrique de traitement de la maladie de Huntington par la cystéamine - CYST-HDEssai multicentrique de traitement de la maladie de Huntington par la cystéamine - CYST-HD Maladie de Huntington.
MedDRA version: 12.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: Cysteamine Bitartrate
Product Code: RP 103
Centre Hospitalier Universitaire d'AngersNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
158EUCTR2009-018123-32-DE
(EUCTR)
07/06/201002/03/2010HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-PlusHORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus Huntington disease
MedDRA version: 12.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Medivation, IncNULLNot RecruitingFemale: yes
Male: yes
350Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
159EUCTR2009-018123-32-GB
(EUCTR)
14/05/201018/03/2010HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-PlusHORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus Huntington disease
MedDRA version: 12.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Medivation, IncNULLNot RecruitingFemale: yes
Male: yes
350Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden
160EUCTR2009-018123-32-DK
(EUCTR)
23/04/201016/03/2010HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-PlusHORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus Huntington disease
MedDRA version: 12.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Medivation, IncNULLNot RecruitingFemale: yes
Male: yes
350United Kingdom;Germany;Netherlands;Denmark;Italy;Sweden
161NCT01411163
(ClinicalTrials.gov)
April 20104/8/2011Premanifest Huntington's Disease Extension Study II: Creatine Safety & TolerabilityPremanifest Huntington's Disease Extension Study II: Creatine Safety & TolerabilityHuntington's DiseaseDrug: Creatine monohydrateMassachusetts General HospitalNational Institutes of Health (NIH)Completed26 YearsN/ABoth24Phase 2United States
162NCT01085266
(ClinicalTrials.gov)
February 201010/3/2010An Extension of the HORIZON Protocol Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington DiseaseHORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington DiseaseHuntington DiseaseDrug: Dimebon (latrepirdine)Medivation, Inc.Pfizer;PfizerTerminated30 YearsN/ABoth362Phase 3NULL
163NCT00920699
(ClinicalTrials.gov)
February 20109/6/2009Study in PRE-manifest Huntington's Disease of Coenzyme Q10 (UbiquinonE) Leading to Preventive Trials (PREQUEL)A Multi-Center, Double-Blind, Randomized, Parallel Group Tolerability Study of Coenzyme Q10 (UbiquinonE)in PRE-manifest Huntington's DiseaseHuntington's DiseaseDrug: CoQ10Johns Hopkins UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed18 YearsN/AAll90Phase 2United States
164EUCTR2009-011800-44-NL
(EUCTR)
20/01/201028/09/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZONA Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZON Huntington disease
MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Medivation, IncNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden
165EUCTR2009-011800-44-IT
(EUCTR)
22/12/200904/11/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease Version 2.0 08 May 2009 - DIM20A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease Version 2.0 08 May 2009 - DIM20 Patients with Mild-to-Moderate Huntington Disease
MedDRA version: 12.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: Dimebon
Product Name: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
MEDIVATION, INC.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden
166EUCTR2009-011743-39-GB
(EUCTR)
15/12/200921/08/2009A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose titration Proof of Concept study in patients with Huntington's disease to assess the efficacy, safety and tolerability of AFQ056 in reducing choreaA multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose titration Proof of Concept study in patients with Huntington's disease to assess the efficacy, safety and tolerability of AFQ056 in reducing chorea Huntington's disease
MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
64Germany;United Kingdom
167EUCTR2009-011800-44-SE
(EUCTR)
14/12/200923/09/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZONA Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZON Huntington disease
MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Medivation, IncNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden
168NCT01019473
(ClinicalTrials.gov)
November 200919/11/2009Efficacy, Safety and Tolerability of AFQ056 in Patients With Huntington's Disease in Reducing ChoreaA Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Titration Proof of Concept Study in Patients With Huntington's Disease to Assess the Efficacy, Safety and Tolerability of AFQ056 in Reducing ChoreaHuntington's Disease;ChoreaDrug: AFQ056;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated30 Years85 YearsBoth44Phase 2Germany;United Kingdom
169EUCTR2009-011800-44-DE
(EUCTR)
07/10/200906/07/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZONA Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZON Huntington disease
MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Medivation, IncNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
170EUCTR2009-011800-44-GB
(EUCTR)
07/10/200905/06/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZONA Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZON Huntington disease
MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Medivation, IncNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden
171NCT00988624
(ClinicalTrials.gov)
October 20091/10/2009A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)A Phase 1, Randomized, Open-Label, Single Dose Cross-Over Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)Alzheimer's Disease;Huntington DiseaseDrug: Dimebon IR Tablet;Drug: Dimebon MR1;Drug: Dimebon MR2;Drug: Dimebon MR3;Drug: Dimebon MR4PfizerMedivation, Inc.Completed18 Years55 YearsBoth20Phase 1United States
172NCT00975481
(ClinicalTrials.gov)
October 200910/9/2009A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug UsersA Randomized, Double-Blind, Placebo- And Active-Controlled Single-Dose, Crossover Study To Evaluate The Abuse Potential Of Single Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug UsersAlzheimer's Disease;Huntington's DiseaseDrug: dimebon;Drug: placebo;Drug: alprazolamPfizerMedivation, Inc.Completed18 Years55 YearsAll36Phase 1Canada
173NCT01521832
(ClinicalTrials.gov)
October 200913/1/2012Escalating Dose Study in Healthy Volunteers With SEN0014196A Phase I, Randomised, Double-Blind, Placebo-Controlled, Two-Part Study Consisting of Single and Multiple Oral Dose Escalation to Determine, Safety, Tolerability and Pharmacokinetics of SEN0014196Huntington's DiseaseDrug: SEN0014196Siena Biotech S.p.A.NULLCompleted18 Years65 YearsBoth88Phase 1United Kingdom
174NCT00990613
(ClinicalTrials.gov)
October 20096/10/2009A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The SkinA Phase 1, Fixed Sequence, Cross-Over Study To Investigate The Single Dose Pharmacokinetics Of A Dimebon (Latrepirdine) Transdermal Solution Relative To The Immediate Release Formulation In Older AdultsAlzheimer's Disease;Huntington's DiseaseDrug: Dimebon IR;Drug: Dimebon TransdermalPfizerMedivation, Inc.Completed50 Years85 YearsBoth19Phase 1United States
175EUCTR2009-011743-39-DE
(EUCTR)
18/09/200920/08/2009Efficacy, Safety and Tolerability of AFQ056 in Patients with Huntington's Disease in Reducing ChoreaA multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose titration Proof of Concept study in patients with Huntington's disease to assess the efficacy, safety and tolerability of AFQ056 in reducing chorea Huntington's disease
MedDRA version: 13.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60United States;Germany;United Kingdom
176EUCTR2009-011800-44-DK
(EUCTR)
11/09/200904/08/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZONA Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZON Huntington disease
MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Product Name: Dimebon
Product Code: Dimebon
INN or Proposed INN: Dimebon dihydrochloride
Other descriptive name: Dimebon dihydrochloride
Medivation, IncNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden
177NCT00712426
(ClinicalTrials.gov)
September 20098/7/2008Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)Huntington's DiseaseDrug: Creatine Monohydrate;Drug: PlaceboMassachusetts General HospitalUniversity of Rochester;National Center for Complementary and Integrative Health (NCCIH)Terminated18 YearsN/ABoth553Phase 3United States;Australia;Canada;New Zealand
178NCT00980694
(ClinicalTrials.gov)
September 200917/9/2009Bioavailability of Ubiquinol in Huntington DiseaseBioavailability of Ubiquinol in Huntington DiseaseHuntington DiseaseDietary Supplement: ubiquinolUniversity of RochesterKaneka CorporationCompleted18 YearsN/ABoth6Phase 1United States
179NCT00931073
(ClinicalTrials.gov)
July 20091/7/2009A Phase I Study To Estimate The Effect Of Ketoconazole And Omeprazole On The Pharmacokinetics Of Dimebon In Healthy Subjects Who Are Normal Or Poor CYP2D6 MetabolizersA Phase I, Open-Label, Three-Period, Fixed-Sequence Study To Estimate The Steady-State Effect Of Ketoconazole And Omeprazole On The Single-Dose Pharmacokinetics Of Dimebon [PF-01913539] In Healthy CYP2D6 EM And PM SubjectsAlzheimer's Disease;Huntington's DiseaseDrug: Dimebon alone;Drug: Dimebon + Ketoconazole;Drug: Dimebon + OmeprazolePfizerMedivation, Inc.Completed18 Years55 YearsBoth24Phase 1United States
180NCT00920946
(ClinicalTrials.gov)
July 200912/6/2009A Safety and Efficacy Study of Dimebon in Patients With Huntington DiseaseA Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington DiseaseHuntington DiseaseDrug: Dimebon;Other: PlaceboMedivation, Inc.Pfizer;PfizerCompleted30 YearsN/ABoth403Phase 3United States;Australia;Canada;Denmark;Germany;Sweden;United Kingdom
181NCT00970229
(ClinicalTrials.gov)
July 200931/8/2009Evaluation of [123I]MNI-420 and SPECT as a Marker of the Adenosine A2a Receptor in PD, HD and Healthy Subjects.Evaluation of [123I]MNI-420 and SPECT as a Marker of the Adenosine A2a Receptor in Subjects With Parkinson Disease, Huntington Disease, and Healthy ControlsParkinson Disease;Huntington DiseaseDrug: [123I]MNI-420Institute for Neurodegenerative DisordersNULLCompleted18 YearsN/AAll19Phase 1United States
182NCT00907595
(ClinicalTrials.gov)
May 200920/5/2009Treating Sleep/Wake Cycle Disturbances in Basal Ganglia Disorders With RamelteonTreating Sleep Wake Cycle Disturbances in Basal Ganglia Neurodegenerative Disorder Subjects With Ramelteon- A Double Blind, Placebo Controlled TrialHuntington's Disease;Parkinson's Disease;Dementia With Lewy Bodies;Sleep Disorders;Circadian DysregulationDrug: Ramelteon;Drug: PlaceboMassachusetts General HospitalNULLWithdrawn20 Years90 YearsBoth0N/AUnited States
183NCT01411150
(ClinicalTrials.gov)
May 20094/8/2011Premanifest Huntington's Disease: Creatine Safety & Tolerability Extension StudyPremanifest Huntington's Disease: Creatine Safety & Tolerability Extension StudyHuntington's DiseaseDrug: Creatine MonohydrateMassachusetts General HospitalNational Institutes of Health (NIH)Completed26 YearsN/ABoth38Phase 2United States
184EUCTR2007-004988-22-AT
(EUCTR)
02/04/200919/02/2008A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008)A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008) Huntington's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: ACR16
Product Code: ACR16
NeuroSearch Sweden ABNULLNot RecruitingFemale: yes
Male: yes
420Portugal;Germany;United Kingdom;Belgium;France;Spain;Italy;Austria
185NCT00632645
(ClinicalTrials.gov)
April 200929/2/2008Neuroleptic and Huntington Disease Comparison of : Olanzapine, la Tetrabenazine and TiaprideNeuroleptic and Huntington Disease. Comparison of : Olanzapine, la Tetrabenazine and Tiapride. A Multicentric, Randomised, Controlled Study.Huntington DiseaseDrug: Olanzapine;Drug: Xenazine;Drug: TiapridalAssistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/AAll180Phase 3France
186NCT00870974
(ClinicalTrials.gov)
March 200926/3/2009A PET Brain Imaging Study of mGluR5 in Subjects With Neuropsychiatric ConditionsEvaluation of [18F]PEB and Positron Emission Tomography (PET) as a Marker of mGluR5 in Subjects w/ Neuropsychiatric ConditionsParkinson Disease;Huntington Disease;Autistic Spectrum Disorders;Fragile X Syndrome;Alzheimer Disease;Mild Cognitive ImpairmentDrug: [18F]FPEBInstitute for Neurodegenerative DisordersNULLCompleted18 Years85 YearsAll48Phase 1United States
187NCT00824590
(ClinicalTrials.gov)
February 200912/1/2009A Phase 1, Non-Randomized, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF 01913539] In Subjects With Severely-Impaired And Normal Renal FunctionA Phase 1, Non-Randomized, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF 01913539] In Subjects With Severely-Impaired And Normal Renal FunctionAlzheimer's Disease;Huntington's DiseaseDrug: DimebonPfizerMedivation, Inc.Completed18 Years75 YearsBoth20Phase 1United States
188NCT00825084
(ClinicalTrials.gov)
February 200912/1/2009A Phase 1 Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy SubjectsA Phase 1, Randomized, Subject- And Investigator-Blind, Sponsor-Open, Placebo-Controlled, Parallel-Cohort, Single-Dose Escalation, And Multiple-Dose Titration Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy SubjectsAlzheimer's Disease;Huntington's DiseaseDrug: DimebonPfizerMedivation, Inc.Completed18 Years55 YearsBoth45Phase 1United States
189NCT00831506
(ClinicalTrials.gov)
February 200927/1/2009Dimebon (PF-01913539)-Digoxin Drug-Drug Interaction Study In Healthy SubjectsA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF-01913539) On The Safety, Tolerability, And Steady-State Pharmacokinetics Of Digoxin In Healthy SubjectsAlzheimer Disease;Huntington DiseaseDrug: digoxin;Drug: dimebonPfizerMedivation, Inc.Completed18 Years55 YearsBoth12Phase 1United States
190NCT00827034
(ClinicalTrials.gov)
February 200920/1/2009A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF 01913539) On The Single-Dose Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy SubjectsA Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF 01913539) On The Single-Dose Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy SubjectsAlzheimer's Disease;Huntington's DiseaseDrug: Warfarin;Drug: DimebonPfizerMedivation, Inc.Completed18 Years55 YearsAll14Phase 1United States
191NCT00788047
(ClinicalTrials.gov)
November 20087/11/2008A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of DextromethorphanA Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon [PF-01913539] On The Single-Dose Pharmacokinetics Of The CYP2D6 Substrate Dextromethorphan In Healthy SubjectsHuntington Disease;Alzheimer DiseaseDrug: Dextromethorphan;Drug: Dimebon + DextromethorphanPfizerMedivation, Inc.Completed18 Years55 YearsBoth14Phase 1United States
192NCT00724048
(ClinicalTrials.gov)
October 200824/7/2008A Study of Pridopidine (ACR16) for the Treatment of Patients With Huntington's DiseaseA Multi-center, North American, Randomized, Double-blind, Parallel Group Study Comparing Three Doses of ACR16 Versus Placebo for the Symptomatic Treatment of Huntington Disease (HART)Huntington DiseaseDrug: ACR16 10 mg;Drug: ACR16 22.5 mg;Drug: ACR16 45 mg;Other: PlaceboTeva Pharmaceutical IndustriesNULLCompleted30 YearsN/ABoth227Phase 2/Phase 3United States;Canada
193EUCTR2007-002977-30-FR
(EUCTR)
02/09/200828/08/2008Essai multicentrique évaluant l'effet de la cystéamine sur le BDNF sérique dans la maladie de Huntington. - BDNF-HDEssai multicentrique évaluant l'effet de la cystéamine sur le BDNF sérique dans la maladie de Huntington. - BDNF-HD Maladie de Huntigton (MH): maladie neurodégénérative d’origine génétique. Elle associe des troubles moteurs, psychiatriques et cognitifs (dégénérescence neuronale dans le striatum). Aucun traitement validé n’existe à ce jour.
MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Trade Name: CYSTAGON
Product Name: CYSTAGON
Centre Hospitalier Universitaire d'AngersNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
194EUCTR2007-004988-22-IT
(EUCTR)
26/08/200829/07/2008A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington?s Disease - NDA multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington?s Disease - ND Huntington's DiseaseProduct Code: ACR16NEUROSEARCH SWEDEN ABNULLNot RecruitingFemale: yes
Male: yes
420Portugal;Germany;United Kingdom;Belgium;France;Spain;Italy;Austria
195EUCTR2007-004988-22-PT
(EUCTR)
06/06/200814/02/2008A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008)A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008) Huntington's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: ACR16
Product Code: ACR16
NeuroSearch Sweden ABNULLNot RecruitingFemale: yes
Male: yes
420Austria;Italy;Spain;France;Belgium;United Kingdom;Germany;Portugal
196EUCTR2007-004988-22-ES
(EUCTR)
03/06/200811/02/2008Un estudio multicentro, internacional, aleatorizado, doble ciego y de grupos paralelos que compara la administración de ACR16 45 mg una o dos veces al día frente al placebo, para el tratamiento sintomático de la Enfermedad de Huntington.(A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease) - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008)Un estudio multicentro, internacional, aleatorizado, doble ciego y de grupos paralelos que compara la administración de ACR16 45 mg una o dos veces al día frente al placebo, para el tratamiento sintomático de la Enfermedad de Huntington.(A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease) - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008) Enfermedad de Huntington (Huntington's Disease)
MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: ACR16
Product Code: ACR16
NeuroSearch Sweden ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Portugal;Germany;United Kingdom;Belgium;France;Spain;Italy;Austria
197EUCTR2007-004988-22-FR
(EUCTR)
23/05/200808/01/2008A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008)A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008) Huntington's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: ACR16
Product Code: ACR16
NeuroSearch Sweden ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Portugal;Germany;United Kingdom;Belgium;France;Spain;Italy;Austria
198NCT00665223
(ClinicalTrials.gov)
April 200822/4/2008A Study of Treatment With Pridopidine (ACR16) in Patients With Huntington's DiseaseA Multicentre, Multinational, Randomized, Double-blind, Parallel-group Study Comparing ACR16 Versus Placebo for the Symptomatic Treatment of Huntington's DiseaseHuntington's DiseaseDrug: ACR16;Drug: PlaceboTeva Pharmaceutical IndustriesNULLCompleted30 YearsN/ABoth437Phase 3Austria;Belgium;France;Germany;Italy;Portugal;Spain;United Kingdom
199NCT00608881
(ClinicalTrials.gov)
March 20084/2/2008Coenzyme Q10 in Huntington's Disease (HD)Coenzyme Q10 in Huntington's Disease (HD)Huntington's DiseaseDrug: coenzyme Q10;Other: placeboMassachusetts General HospitalNational Institute of Neurological Disorders and Stroke (NINDS);University of RochesterTerminated16 YearsN/AAll609Phase 3United States;Australia;Canada
200EUCTR2007-004988-22-DE
(EUCTR)
22/02/200826/10/2007A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008)A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008) Huntington's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: ACR16
Product Code: ACR16
NeuroSearch Sweden ABNULLNot RecruitingFemale: yes
Male: yes
420Portugal;France;Spain;Belgium;Austria;Germany;Italy;United Kingdom
201EUCTR2007-004988-22-GB
(EUCTR)
11/01/200816/10/2007A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008)A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008) Huntington's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: ACR16
Product Code: ACR16
NeuroSearch Sweden ABNULLNot RecruitingFemale: yes
Male: yes
420Portugal;Germany;United Kingdom;Belgium;France;Spain;Italy;Austria
202EUCTR2007-004988-22-BE
(EUCTR)
04/01/200830/10/2007A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008)A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease - A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008) Huntington's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: ACR16
Product Code: ACR16
NeuroSearch Sweden ABNULLNot RecruitingFemale: yes
Male: yes
420Portugal;Germany;United Kingdom;Belgium;France;Spain;Italy;Austria
203NCT00592995
(ClinicalTrials.gov)
December 200728/12/2007Creatine Safety and Tolerability in Premanifest HD: PRECRESTCreatine Safety and Tolerability in Premanifest HD: PRECRESTHuntington DiseaseDrug: Creatine monohydrate;Drug: PlaceboMassachusetts General HospitalNULLCompleted26 YearsN/ABoth64Phase 2United States
204EUCTR2007-003293-25-GB
(EUCTR)
20/11/200726/07/2007A MULTI-CENTER, PHASE 2 RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY OF DIMEBON IN SUBJECTS WITH HUNTINGTON’S DISEASE - DIMONDA MULTI-CENTER, PHASE 2 RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY OF DIMEBON IN SUBJECTS WITH HUNTINGTON’S DISEASE - DIMOND Huntington's disease
MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea
Product Name: Dimebon
Product Code: Dimebon
Other descriptive name: Dimebon Dihydrochloride
Medivation, Inc.NULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
205NCT00514774
(ClinicalTrials.gov)
August 20078/8/2007Ursodiol in Huntington's DiseaseUrsodiol in Huntington's DiseaseHuntington DiseaseDrug: ursodiol;Drug: placeboOregon Health and Science UniversityHuntington Study Group;Huntington Society of CanadaActive, not recruiting18 YearsN/ABoth21Phase 1United States
206NCT00497159
(ClinicalTrials.gov)
July 20073/7/2007A Study of the Novel Drug Dimebon in Patients With Huntington's DiseaseA Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's DiseaseHuntington's DiseaseOther: Placebo;Drug: DimebonMedivation, Inc.Huntington Study GroupCompleted29 YearsN/ABoth90Phase 2United States
207NCT00387270
(ClinicalTrials.gov)
October 200610/10/2006Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's DiseaseA Multicenter, Phase 1-2A, Open-Label, Dosage-Escalation and Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's DiseaseHuntington's DiseaseDrug: DimebonMedivation, Inc.Huntington Study GroupCompleted18 YearsN/ABoth9Phase 1/Phase 2United States
208EUCTR2005-002088-98-PT
(EUCTR)
07/06/200616/03/2006Full title of the trial : A multicentre, multi-national, double-blind, randomised, parallel group placebo-controlled trial of ethyl-EPA (ethyl-icosapent) in patients with Huntington’s DiseaseFull title of the trial : A multicentre, multi-national, double-blind, randomised, parallel group placebo-controlled trial of ethyl-EPA (ethyl-icosapent) in patients with Huntington’s Disease HUNTINGTON’S DISEASE
MedDRA version: 8.0;Level: LLT;Classification code 10010331
Product Name: Ethyl-EPA
Product Code: LAX-101
INN or Proposed INN: Ethyl Icosapent
Other descriptive name: Ethyl-EPA
Amarin Neuroscience LtdNULLNot RecruitingFemale: yes
Male: yes
Portugal;Germany;United Kingdom;Spain;Italy
209NCT00277355
(ClinicalTrials.gov)
April 200612/1/2006Pilot Study of Minocycline in Huntington's DiseaseA Multi-Center, Double-Blind, Pilot Study of Minocycline in Huntington's DiseaseHuntington DiseaseDrug: minocycline;Drug: Matching placeboMerit CudkowiczFDA Office of Orphan Products DevelopmentCompleted18 YearsN/AAll114Phase 2/Phase 3United States;Canada
210EUCTR2005-002088-98-ES
(EUCTR)
29/12/200504/10/2005Full title of the trial : Estudio multicentrico, multinacional aleatorizado doble ciego con grupos paralelos y controlado con placebo de etil-EPA (etil eicosapentanoato) en pacientes con enfermedad de Huntington.Full title of the trial : Estudio multicentrico, multinacional aleatorizado doble ciego con grupos paralelos y controlado con placebo de etil-EPA (etil eicosapentanoato) en pacientes con enfermedad de Huntington. HUNTINGTON’S DISEASE
MedDRA version: 8.0;Level: llt;Classification code 10010331
Product Name: Ethyl-EPA
Product Code: LAX-101
Amarin Neuroscience LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Portugal;Germany;United Kingdom;Spain;Italy
211EUCTR2005-002088-98-AT
(EUCTR)
01/12/200527/10/2005Full title of the trial : A multicentre, multi-national, double-blind, randomised, parallel group placebo-controlled trial of ethyl-EPA (ethyl-icosapent) in patients with Huntington’s DiseaseFull title of the trial : A multicentre, multi-national, double-blind, randomised, parallel group placebo-controlled trial of ethyl-EPA (ethyl-icosapent) in patients with Huntington’s Disease HUNTINGTON’S DISEASE
MedDRA version: 8.0;Level: LLT;Classification code 10010331
Product Name: Ethyl-EPA
Product Code: LAX-101
INN or Proposed INN: Ethyl-Icosapent
Amarin Neuroscience LtdNULLNot RecruitingFemale: yes
Male: yes
240Portugal;Spain;Austria;Germany;Italy;United Kingdom
212EUCTR2005-002088-98-GB
(EUCTR)
07/11/200518/08/2005Full title of the trial : A multicentre, multi-national, double-blind, randomised, parallel group placebo-controlled trial of ethyl-EPA (ethyl-icosapent) in patients with Huntington’s DiseaseFull title of the trial : A multicentre, multi-national, double-blind, randomised, parallel group placebo-controlled trial of ethyl-EPA (ethyl-icosapent) in patients with Huntington’s Disease HUNTINGTON’S DISEASE
MedDRA version: 8.0;Level: LLT;Classification code 10010331
Product Name: Ethyl-EPA
Product Code: LAX-101
Amarin Neuroscience LtdNULLNot RecruitingFemale: yes
Male: yes
Portugal;Germany;United Kingdom;Spain;Italy
213NCT00368849
(ClinicalTrials.gov)
November 200524/8/2006Atomoxetine and Huntington's DiseaseAtomoxetine for Attention Deficits in Adults With Mild HD: A Randomized, Placebo-Controlled Crossover StudyHuntington Disease;ChoreaDrug: atomoxetine;Drug: Matching PlaceboUniversity of IowaEli Lilly and CompanyCompleted18 Years65 YearsAll20Phase 2United States
214NCT00271596
(ClinicalTrials.gov)
November 200530/12/2005Citalopram to Enhance Cognition in HDA Randomized, Placebo-Controlled Pilot Study in Huntington's Disease (CIT-HD)Huntington Disease;Chorea;Executive DysfunctionDrug: 20mg daily citalopram;Drug: PlaceboUniversity of IowaNational Institute of Neurological Disorders and Stroke (NINDS);Cure Huntington's Disease Initiative (CHDI);University of Rochester;Mayo ClinicCompleted18 Years75 YearsAll33Phase 2United States
215NCT00146211
(ClinicalTrials.gov)
September 20052/9/2005TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's DiseaseA Multicenter, Double Blind, Randomized, Parallel Group, Placebo-Controlled Trial of Ethyl-EPA (Miraxion™) in Subjects With Mild to Moderate Huntington's DiseaseHuntington DiseaseDrug: Ethyl-EPA (Miraxion™)Amarin Neuroscience LtdHuntington Study GroupCompleted35 YearsN/ABoth300Phase 3United States;Canada
216NCT00212316
(ClinicalTrials.gov)
August 200519/9/2005Safety and Tolerability Study of Phenylbutyrate in Huntington's Disease (PHEND-HD)Phenylbutyrate Development for Huntington's Disease (PHEND-HD): A Multi-Center, Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up to Determine the Safety and Tolerability of Phenylbutyrate in Subjects With Huntington's DiseaseHuntington's DiseaseDrug: sodium phenylbutyrateUniversity of RochesterHP Therapeutics Foundation;Massachusetts General Hospital;Columbia University;University of Iowa;University of California, San Diego;University of Kansas;University of Alabama at Birmingham;Johns Hopkins UniversityCompleted18 YearsN/ABoth60Phase 2United States
217NCT01412151
(ClinicalTrials.gov)
April 20055/8/2011Creatine Safety & Tolerability in Huntington's DiseaseCreatine Safety & Tolerability in Huntington's Disease (CREST-X): A Single-Center, Open-Label, Long-Term Safety & Tolerability Extension Study of Creatine in Subjects With HDHuntington's Disease (HD)Drug: Creatine monohydrateMassachusetts General HospitalNULLCompleted18 YearsN/AAll10Phase 2United States
218NCT00652457
(ClinicalTrials.gov)
November 23, 200431/3/2008Study of Memantine to Treat Huntington's DiseaseA Pilot Study of Memantine for Cognitive and Behavioral Dysfunction in Huntington's DiseaseHuntington's DiseaseDrug: MemantineJody Corey-Bloom, MD, PhDForest LaboratoriesCompleted18 YearsN/AAll60Phase 4United States
219EUCTR2004-000394-60-DK
(EUCTR)
05/10/200417/08/2004A randomised phase II multicentre, double blind, parallel group, placebo controlled study of ACR16 50 mg once daily for the symptomatic treatment of Huntington diseaseA randomised phase II multicentre, double blind, parallel group, placebo controlled study of ACR16 50 mg once daily for the symptomatic treatment of Huntington disease ACR16 belongs to a new class of CNS active agents called dopaminergic stabilizers. Dopaminergic stabilizers are compounds that can both enhance and counteract dopamine dependent functions in the CNS, depending on the initial level of dopaminergic activity. The stabilizing feature of such compounds is illustrated by their interaction with dopaminergic agonists.Product Name: ACR16
Product Code: ACR16
A. Carlsson Research ABNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Denmark;Sweden
220NCT00095355
(ClinicalTrials.gov)
October 20042/11/2004Effects of Lithium and Divalproex`on Brain-Derived Neurotrophic Factor in Huntington's DiseaseStimulation of Tyrosine Kinase and ERK Signaling Pathways in Huntington's DiseaseHuntington's DiseaseDrug: Lithium;Drug: DivalproexNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth35Phase 2United States
221EUCTR2004-000394-60-SE
(EUCTR)
30/06/200413/05/2004A randomised phase II multicentre, double blind, parallel group, placebo controlled study of ACR16 50 mg once daily for the symptomatic treatment of Huntington diseaseA randomised phase II multicentre, double blind, parallel group, placebo controlled study of ACR16 50 mg once daily for the symptomatic treatment of Huntington disease ACR16 belongs to a new class of CNS active agents called dopaminergic stabilizers. Dopaminergic stabilizers are compounds that can both enhance and counteract dopamine dependent functions in the CNS, depending on the initial level of dopaminergic activity. The stabilizing feature of such compounds is illustrated by their interaction with dopaminergic agonists.Product Name: ACR16
Product Code: ACR16
A. Carlsson Research ABNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Denmark;Sweden
222NCT00190450
(ClinicalTrials.gov)
January 200215/9/2005MIG-HD: Multicentric Intracerebral Grafting in Huntington's DiseaseMulticentric Intracerebral Grafting in Huntington's DiseaseHuntington DiseaseBiological: graft intracerebral of foetal neuronsAssistance Publique - Hôpitaux de ParisNULLCompleted18 Years65 YearsAll54Phase 2France
223NCT00026988
(ClinicalTrials.gov)
October 200115/11/2001Creatine Therapy for Huntington's DiseaseCreatine Therapy for Huntington's DiseaseHuntington's DiseaseDrug: CreatineNational Center for Complementary and Integrative Health (NCCIH)NULLCompleted18 YearsN/ABoth64Phase 1/Phase 2United States
224NCT00029874
(ClinicalTrials.gov)
September 200124/1/2002Minocycline in Patients With Huntington's DiseaseMinocycline Dosing and Safety in Huntington's DiseaseHuntington's DiseaseDrug: MinocyclineFDA Office of Orphan Products DevelopmentNULLCompleted18 YearsN/ABoth63Phase 1/Phase 2United States
225NCT00219804
(ClinicalTrials.gov)
January 200014/9/2005Efficacy and Safety of Tetrabenazine in ChoreaA Randomized, Double-Blind, Placebo-Controlled Study of Tetrabenazine for the Treatment of Huntington's ChoreaHuntington's DiseaseDrug: tetrabenazine or placeboPrestwick PharmaceuticalsNULLCompleted18 YearsN/ABothPhase 3NULL
226NCT00277602
(ClinicalTrials.gov)
November 199913/1/2006Riluzole in Huntington's DiseaseA Phase III Multicenter, Double-Blind, Parallel-Group, Placebo Controlled Study to Measure the Effect of Riluzole 50 mg b.i.d. Over a Period of Three Years on the Progression of Huntington's DiseaseHuntington DiseaseDrug: RiluzoleSanofiNULLCompleted25 Years65 YearsBoth537Phase 3NULL
227NCT00001930
(ClinicalTrials.gov)
April 19993/11/1999Treatment of Huntington's Chorea With AmantadineNMDA-Receptor Blockade in Huntington's ChoreaChorea;Huntington's DiseaseDrug: AmantadineNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth25Phase 2United States
228EUCTR2005-002088-98-DE
(EUCTR)
28/11/2006Full title of the trial : A multicentre, multi-national, double-blind, randomised, parallel group placebo-controlled trial of ethyl-EPA (ethyl-icosapent) in patients with Huntington’s DiseaseFull title of the trial : A multicentre, multi-national, double-blind, randomised, parallel group placebo-controlled trial of ethyl-EPA (ethyl-icosapent) in patients with Huntington’s Disease HUNTINGTON’S DISEASE
MedDRA version: 8.0;Level: LLT;Classification code 10010331
Product Name: Ethyl-EPA
Product Code: LAX-101
INN or Proposed INN: Ethyl-Icosapent
Amarin Neuroscience LtdNULLNot RecruitingFemale: yes
Male: yes
240Portugal;United Kingdom;Germany;Spain;Italy
229EUCTR2016-005142-39-DE
(EUCTR)
04/06/2019A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120102 Administered Intrathecally in Patients with Huntington’s DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120102 Administered Intrathecally in Patients with Huntington’s Disease Huntington’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: WVE-120102
Product Code: WVE-120102
INN or Proposed INN: WVE-120102
Wave Life Sciences UK LimitedNULLNot RecruitingFemale: yes
Male: yes
80Phase 1;Phase 2France;United States;Canada;Poland;Denmark;Australia;Germany;United Kingdom