This is a multicenter, multinational, randomized, parallel-group, double-blind, placebo-controlled, dose range finding study to compare the efficacy and safety of different doses of pridopidine versus placebo in the treatment of motor impairment in Huntington's Disease (HD).
Originally, the study was designed to assess the effect of pridopidine on motor function at 26 weeks. Due to the recognition that the primary target of pridopidine is the Sigma-1 receptor, the trial was extended from 26 to 52 weeks to evaluate the effect of pridopidine on Total Functional Capacity (TFC). A minimum of 52 weeks are needed for the placebo group to decline and allow a window to assess an effect on TFC (a prespecified endpoint). Approximately 20% of patients completed 26 weeks of the study before IRB approvals for this extension, and did not continue into the 2nd treatment period up to 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
408
22.5 mg and 45 mg capsules
Capsules matching drug
Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at Week 26
TMS was defined as the sum of all UHDRS motor domains ratings. The motor section of the UHDRS assesses motor features of Huntington's Disease (HD) with standardized ratings of oculo-motor function, dysarthria, chorea, dystonia, gait, and postural stability. Each of 15 assessments is rated on a scale of 0 (normal) to 4 (marked impairment) for a TMS range of 0-124. Negative change from baseline values indicate improvement.
Time frame: 26 weeks
Number of Patients With Adverse Events
Time frame: 52 weeks
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Investigational Site 12199
La Jolla, California, United States
Investigational Site 12204
Los Angeles, California, United States
Investigational Site 12201
Englewood, Colorado, United States
Investigational Site 12196
Washington D.C., District of Columbia, United States
Investigational Site 12207
Chicago, Illinois, United States
Investigational Site 12202
Baltimore, Maryland, United States
Investigational Site 12206
Baltimore, Maryland, United States
Investigational Site 12200
Manhasset, New York, United States
Investigational Site 12203
New York, New York, United States
Investigational Site 12198
Rochester, New York, United States
...and 48 more locations