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NCT04556656 · ClinicalTrials.gov registry record · Phase 3
PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD
A Phase 3 study, sponsored by Prilenia.
- Completed
- Registry status
- Phase 3
- Development phase
- 499
- Enrollment target
NCT04556656: Completed Phase 3 study, sponsored by Prilenia.
NCT04556656 is a Phase 3 study that has completed, run by Prilenia. The registered enrollment target is 499 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04556656, a Phase 3 study, has completed, sponsored by Prilenia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 499 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).
Primary Outcome
The primary efficacy endpoint for this study was the change from baseline to Week 65 in the TFC (defined as the sum of all TFC 5-items ratings \[domestic chores, activities of daily living, finances, care level, and occupation\]). The TFC is the standard and well-accepted clinical scale for staging and tracking the progression of HD using functional capacity. Scores range from 0 to 13, with 13 as the least affected and 0 as complete incapacity.
Interventions
- DRUG Placebo
- DRUG Pridopidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 499 participants |
| Start Date | 2020-10-16 |
| Est. Completion | 2024-03-21 |
| Phase | Phase 3 |
What the finished NCT04556656 record still lists
NCT04556656 is an interventional study that assigns participants to a tested intervention. The registered 499 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04556656 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04556656 about?
NCT04556656 is a clinical study titled "PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD". This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).
What is the current status of trial NCT04556656?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 499 participants. The study started on 2020-10-16. Estimated completion is 2024-03-21.
What interventions are being tested in trial NCT04556656?
The interventions under investigation include: Placebo (DRUG), Pridopidine (DRUG).
Who is sponsoring clinical trial NCT04556656?
This trial is sponsored by Prilenia, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04556656's enrollment target sits among peer trials
499 775th of 2000 higher than 1,226 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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