A Study of Pridopidine (ACR16) for the Treatment of Patients With Huntington's Disease (HART)
|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
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|