Clinical Trial: A Study of Treatment With Pridopidine (ACR16) in Patients With Huntington's Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicentre, Multinational, Randomized, Double-blind, Parallel-group Study Comparing ACR16 Versus Placebo for the Symptomatic Treatment of Huntington's 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: The primary objective in the present study is to confirm whether ACR16 is efficacious in improving voluntary motor function in Huntington's disease, symptoms that seem to be most important for the functional disability associated with the disorder. To achieve this, patients are randomised to ACR16 45mg qd, ACR16 45mg bd, or placebo treatment in equal proportions in a parallel design for treatment duration of 26 weeks.
Sponsor: Teva Pharmaceutical Industries
Current Primary Outcome: 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 mMS) at 26 weeks of treatment. [ Time Frame: last timepoint at which outcome is assessed is after 26 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety and tolerability assessed from adverse event profile. [ Time Frame: After 1, 4, 5, 8, 12, 26 and 30 weeks ]
- The effects of ACR16 on CGI, cognitive function, behaviour and symptoms of depression and anxiety. [ Time Frame: At 4, 8, 12 and 26 weeks ]
Original Secondary Outcome: Safety and tolerability assessed from adverse event profile [ Time Frame: After 1, 4, 5, 8, 12, 26 and 30 weeks ]
Information By: Teva Pharmaceutical Industries
Dates:
Date Received: April 22, 2008
Date Started: April 2008
Date Completion:
Last Updated: July 19, 2016
Last Verified: July 2016
