Conditions: Huntington's Disease
Keywords: Huntington's Disease Pridopidine Pride-HD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 408
Healthy volunteers: no

Brief summary:
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).

Detailed description:
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.

Arms:
arm 1: Twice daily arm 2: Twice daily arm 3: Twice daily arm 4: Twice daily arm 5: Twice daily

Interventions: intervention 1: Pridopidine intervention 2: Placebo
Intervention descriptions: intervention 1: 22.5 mg and 45 mg capsules intervention 2: Capsules matching drug

Protocol document: