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

NCT04556656 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 499

Last updated 2025-03-12

Study results available
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Summary

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

Conditions

  • Huntington Disease

Interventions

DRUG

Pridopidine

Pridopidine hard gelatin capsule

DRUG

Placebo

Pridopidine-matching placebo hard gelatin capsule

Sponsors & Collaborators

  • Prilenia

    lead INDUSTRY

Principal Investigators

  • Yael Cohen · Prilenia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-16
Primary Completion
2023-03-14
Completion
2024-03-21
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04556656 on ClinicalTrials.gov