NCT04556656

PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients With Early Stage of Huntington Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 499 (actual)
• Sponsor: Prilenia · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).

Detailed description

This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pridopidine 45 mg BID in patients with early stage HD.

Conditions

• Huntington Disease

Interventions

Type	Name	Description
DRUG	Pridopidine	Pridopidine hard gelatin capsule
DRUG	Placebo	Pridopidine-matching placebo hard gelatin capsule

Timeline

• Start date: 2020-10-16
• Primary completion: 2023-03-14
• Completion: 2024-03-21
• First posted: 2020-09-21
• Last updated: 2025-03-12
• Results posted: 2025-03-12

Locations

58 sites across 11 countries: United States, Austria, Canada, Czechia, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study