Clinical Trial: A Study of Pridopidine (ACR16) for the Treatment of Patients With Huntington's Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's Disease.

Detailed Summary:
Sponsor: Teva Pharmaceutical Industries

Current Primary Outcome: 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.


Original Primary Outcome: To assess the effects of ACR16 on voluntary motor function in HD subjects. [ Time Frame: At week 4, 5 and 12 ]

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • To assess the effects of ACR16 on clinical global impression of change (CGI-C), cognitive function, behavior and symptoms of depression and anxiety at 12 weeks of treatment [ Time Frame: At 12 weeks of treatment ]
  • To assess the safety and tolerability of ACR16 [ Time Frame: At week 1, 4, 5, 8, 12 and 14 ]


Information By: Teva Pharmaceutical Industries

Dates:
Date Received: July 24, 2008
Date Started: October 2008
Date Completion:
Last Updated: July 20, 2016
Last Verified: July 2016