A Study of Pridopidine (ACR16) for the Treatment of Patients With Huntington's Disease (HART)
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|ClinicalTrials.gov Identifier: NCT00724048|
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : July 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Huntington Disease||Drug: ACR16 10 mg Drug: ACR16 22.5 mg Drug: ACR16 45 mg Other: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||227 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A 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)|
|Study Start Date :||October 2008|
|Primary Completion Date :||June 2011|
|Study Completion Date :||June 2011|
Experimental: ACR16 10 mg
Participants receive one ACR16 10mg twice daily:
First four weeks - ACR16 10mg qd - one active 10mg capsule daily. After four weeks - ACR16 10mg bid - two active 10mg capsules taken as two separate doses (20mg ACR16 per day).
Drug: ACR16 10 mg
ACR16 capsules: 10mg twice daily
Other Name: pridopidine
Experimental: ACR16 22.5 mg
Participants receive one ACR16 22.5mg capsule twice daily:
First four weeks - ACR16 22.5mg qd - one active 22.5mg capsule daily. After four weeks - ACR16 22.5mg bid - two active 22.5mg capsules taken as two separate doses (45mg ACR16 per day).
Drug: ACR16 22.5 mg
ACR16 capsules: 22.5mg twice daily
Experimental: ACR16 45 mg
Participants receive one ACR16 45mg capsule twice daily:
First four weeks - ACR16 45mg qd - one active 45mg capsule daily. After four weeks - ACR16 45mg bid - two active 45mg capsule taken as two separate doses (90mg ACR16 per day).
Drug: ACR16 45 mg
ACR16 capsules: 45mg twice daily
Placebo Comparator: Placebo
Weeks 1-4, Participants receive a one placebo capsule once daily for four weeks.
Weeks 5-26, Participants receive a one placebo capsule taken twice daily as two separate doses.
- Sum score of items 4-10 and 13-15 of the UHDRS motor assessment [ Time Frame: 26 Weeks ]The primary objective is to assess the effects of ACR16 on voluntary motor function in HD patients, as defined as the sum score of items 4-10 and 13-15 of the UHDRS motor assessment (a modified motor score in MS) at 26 weeks of treatment.
- Clinical Global Impressions (CGI) [ Time Frame: At 4, 8, 12 and 26 weeks ]The effects of ACR16 on CGI, cognitive function, behaviour and symptoms of depression and anxiety. CGI has two components—the CGI-Severity, which rates illness severity, and the CGI-Improvement, which rates change from the initiation (baseline) of treatment.
- Adverse event profile [ Time Frame: 30 weeks ]Safety and tolerability assessed from adverse event profile
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724048
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|Study Director:||Joakim Tedroff, MD||NeuroSearch A/S|