NCT04556656CompletedPhase 3
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
Source: ClinicalTrials.gov · Last updated 12 Mar 2025
Brief summary (registry, in English)
This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 499 (actual)
- First submitted
- 14 Sept 2020
- Start date
- 16 Oct 2020
- Primary completion date
- 14 Mar 2023
- Lead sponsor
- Prilenia
- Diseases
- Huntington's disease
- NCT number
- NCT04556656
- EudraCT number
- 2020-002822-10
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 499
- From 16 Oct 2020 to the primary completion date, 14 Mar 2023
- 58 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of pridopidine within 12 months before the baseline visit.
- Gene therapy at any time
Other illness
- History of epilepsy or seizures within the last 5 years
Lab values
- Any serious medical condition or clinically significant laboratory, or vital sign abnormality that precludes the patient's safe participation in and completion of the study e.g. significant heart disease within 12 weeks before baseline or history of certain cardiac arrhythmias
Other
- Pregnant or breastfeeding, or intention to become pregnant during the study
Who the study is looking for
- Diagnosis of HD based on clinical features and the presence of ≥36 CAG repeats in the huntingtin gene
- Diagnostic confidence level (DCL) of 4
- Adult-onset HD with onset of signs and symptoms ≥18 years of age
- Stage 1 or Stage 2 HD, defined as a UHDRS-TFC score of ≥7, at screening
Age in the registry: 25 years to - · Sex: All · Does not accept healthy volunteers
Sites (58)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prilenia Investigational site (Site 291) Coordinator of this site? Confirm its status | Innsbruck | Austria | Unknown status |
| Prilenia Investigational Site (Site 030) Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Prilenia Investigational Site (Site 232) Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Prilenia Investigational Site (Site 098) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Prilenia Investigational Site (Site 048) Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Prilenia Investigational Site (Site 388) Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Prilenia Investigational Site (Site 234) Coordinator of this site? Confirm its status | Aachen | Germany | Unknown status |
| Prilenia Investigational Site (Site 379) Coordinator of this site? Confirm its status | Bochum | Germany | Unknown status |
| Prilenia Investigational Site (Site 377) Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Prilenia Investigational Site (Site 376) Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Prilenia Investigational site (Site 292) Coordinator of this site? Confirm its status | Taufkirchen | Germany | Unknown status |
| Prilenia Investigational Site (Site 175) Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| Prilenia Investigational Site (Site 380) Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Prilenia Investigational Site (Site 381) Coordinator of this site? Confirm its status | Burgos | Spain | Unknown status |
| Prilenia Investigational Site (Site 176) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Prilenia Investigational Site (Site 382) Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Prilenia Investigational Site (Site 385) Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Prilenia Investigational Site (Site 384) Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Prilenia Investigational Site (Site 392) Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Prilenia Investigational Site (Site 180) Coordinator of this site? Confirm its status | Aberdeen | United Kingdom | Unknown status |
| Prilenia Investigational Site (Site 390) Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Prilenia Investigational Site (Site 378) Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Unknown status |
| Prilenia Investigational Site (Site 249) Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Prilenia Investigational Site (Site 394) Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Prilenia Investigational Site (Site 239) Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Prilenia Investigational Site (Site 393) Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Prilenia Investigational Site (Site 228) Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Prilenia Investigational Site (Site 044) Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| Prilenia Investigational Site (Site 387) Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Prilenia Investigational Site (Site 386) Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Prilenia Investigational Site (Site 244) Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Prilenia Investigational Site (Site 246) Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Prilenia Investigational Site (Site 037) Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Prilenia Investigational Site (Site 032) Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Prilenia Investigational Site (Site 028) Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Prilenia Investigational Site (Site 076) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Prilenia Investigational Site (Site 017) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Prilenia Investigational Site (Site 088) Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Prilenia Investigational Site (Site 089) Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Prilenia Investigational Site (Site 020) Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Prilenia Investigational Site (Site 061) Coordinator of this site? Confirm its status | Davis | United States | Unknown status |
| Prilenia Investigational Site (Site 119) Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Prilenia Investigational Site (Site 343) Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
| Prilenia Investigational Site (Site 160) Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Prilenia Investigational Site (Site 199) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Prilenia Investigational Site (Site 029) Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Prilenia Investigational Site (Site 087) Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Prilenia Investigational Site (Site 031) Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Prilenia Investigational Site (Site 002) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Prilenia Investigational Site (Site 018) Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Prilenia Investigational Site (Site 006) Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Prilenia Investigational Site (Site 326) Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Prilenia Investigational Site (Site 051) Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Prilenia Investigational Site (Site 096) Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Prilenia Investigational Site (Site 027) Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Prilenia Investigational Site (Site 019) Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Prilenia Investigational Site (Site 333) Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Prilenia Investigational Site (Site 083) Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
Related publications
- Antidopaminergic Medications and Clinical Outcomes in Huntington Disease: Evidence From the PROOF-HD Placebo-Controlled Trial.Neurology · 2026 · PMID 42912861
This page is information, not medical advice. Discuss any trial with your doctor.