NCT02006472

A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease

A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45, 67.5, 90, and 112.5 mg Twice-Daily vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Prilenia · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Huntington's Disease

Interventions

Type	Name	Description
DRUG	Pridopidine	22.5 mg and 45 mg capsules
OTHER	Placebo	Capsules matching drug

Timeline

• Start date: 2014-02-28
• Primary completion: 2015-12-16
• Completion: 2016-07-07
• First posted: 2013-12-10
• Last updated: 2021-07-19
• Results posted: 2021-07-19

Locations

58 sites across 12 countries: United States, Australia, Austria, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Russia, United Kingdom