PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD
Sponsor
Prilenia (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04556656
Collaborator
(none)
499
58
2
29.7
8.6
0.3
Study Details
Study Description
Brief Summary
This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Eligible patients who completed the Main Study (65 to 78 weeks) will have the option to enroll into an open-label extension.
Study Design
Study Type:
Interventional
Actual Enrollment
:
499 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date
:
Oct 16, 2020
Anticipated Primary Completion Date
:
Mar 3, 2023
Anticipated Study Completion Date
:
Apr 7, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pridopidine 45 mg pridopidine twice daily (BID) |
Drug: Pridopidine
Pridopidine hard gelatin capsule
|
| Placebo Comparator: Placebo Matching placebo |
Drug: Placebo
Pridopidine-matching placebo hard gelatin capsule
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in the Unified Huntington Disease Rating Scale-Total functional capacity (UHDRS-TFC) score [Baseline, 65 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
25 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
INCLUSION CRITERIA MAIN STUDY
-
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
EXCLUSION CRITERIA
-
Use of pridopidine within 12 months before the baseline visit.
-
Gene therapy at any time
-
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
-
History of epilepsy or seizures within the last 5 years
-
Pregnant or breastfeeding, or intention to become pregnant during the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Prilenia Investigational Site (Site 061) | Davis | California | United States | 95616 |
| 2 | Prilenia Investigational Site (Site 051) | San Diego | California | United States | 92093 |
| 3 | Prilenia Investigational Site (Site 343) | Englewood | Colorado | United States | 80113 |
| 4 | Prilenia Investigational Site (Site 333) | Washington | District of Columbia | United States | 20057 |
| 5 | Prilenia Investigational Site (Site 160) | Gainesville | Florida | United States | 32611 |
| 6 | Prilenia Investigational Site (Site 019) | Tampa | Florida | United States | 33620 |
| 7 | Prilenia Investigational Site (Site 032) | Atlanta | Georgia | United States | 30322 |
| 8 | Prilenia Investigational Site (Site 088) | Chicago | Illinois | United States | 60611 |
| 9 | Prilenia Investigational Site (Site 029) | Kansas City | Kansas | United States | 66103 |
| 10 | Prilenia Investigational Site (Site 083) | Wichita | Kansas | United States | 67226 |
| 11 | Prilenia Investigational Site (Site 087) | Louisville | Kentucky | United States | 40292 |
| 12 | Prilenia Investigational Site (Site 028) | Baltimore | Maryland | United States | 21218 |
| 13 | Prilenia Investigational Site (Site 017) | Boston | Massachusetts | United States | 02114 |
| 14 | Prilenia Investigational Site (Site 076) | Boston | Massachusetts | United States | 02215 |
| 15 | Prilenia Investigational Site (Site 027) | Saint Louis | Missouri | United States | 63130 |
| 16 | Prilenia Investigational Site (Site 037) | Albany | New York | United States | 12208 |
| 17 | Prilenia Investigational Site (Site 002) | New York | New York | United States | 10027 |
| 18 | Prilenia Investigational Site (Site 119) | Durham | North Carolina | United States | 27708 |
| 19 | Prilenia Investigational Site (Site 089) | Cincinnati | Ohio | United States | 45221 |
| 20 | Prilenia Investigational Site (Site 020) | Columbus | Ohio | United States | 43210 |
| 21 | Prilenia Investigational Site (Site 006) | Portland | Oregon | United States | 97239 |
| 22 | Prilenia Investigational Site (Site 018) | Philadelphia | Pennsylvania | United States | 19104 |
| 23 | Prilenia Investigational Site (Site 031) | Nashville | Tennessee | United States | 37232 |
| 24 | Prilenia Investigational Site (Site 199) | Houston | Texas | United States | 77004 |
| 25 | Prilenia Investigational Site (Site 326) | Richmond | Virginia | United States | 23284 |
| 26 | Prilenia Investigational Site (Site 096) | Seattle | Washington | United States | 98195 |
| 27 | Prilenia Investigational site (Site 291) | Innsbruck | Austria | ||
| 28 | Prilenia Investigational Site (Site 030) | Calgary | Alberta | Canada | AB T2N 1N4 |
| 29 | Prilenia Investigational Site (Site 048) | Vancouver | British Columbia | Canada | BC V6T 1Z4 |
| 30 | Prilenia Investigational Site (Site 098) | Montréal | Quebec | Canada | QC H2X 3E4 |
| 31 | Prilenia Investigational Site (Site 232) | Halifax | Canada | NS B3S 1L8 | |
| 32 | Prilenia Investigational Site (Site 388) | Prague | Czechia | ||
| 33 | Prilenia Investigational Site (Site 385) | Lille | France | ||
| 34 | Prilenia Investigational Site (Site 384) | Marseille | France | ||
| 35 | Prilenia Investigational Site (Site 392) | Paris | France | ||
| 36 | Prilenia Investigational Site (Site 234) | Aachen | Germany | ||
| 37 | Prilenia Investigational Site (Site 379) | Bochum | Germany | ||
| 38 | Prilenia Investigational Site (Site 377) | Lübeck | Germany | ||
| 39 | Prilenia Investigational Site (Site 376) | Münster | Germany | ||
| 40 | Prilenia Investigational site (Site 292) | Taufkirchen | Germany | ||
| 41 | Prilenia Investigational Site (Site 175) | Ulm | Germany | ||
| 42 | Prilenia Investigational Site (Site 249) | Bari | Italy | ||
| 43 | Prilenia Investigational Site (Site 394) | Bologna | Italy | ||
| 44 | Prilenia Investigational Site (Site 239) | Milano | Italy | ||
| 45 | Prilenia Investigational Site (Site 393) | Napoli | Italy | ||
| 46 | Prilenia Investigational Site (Site 228) | Roma | Italy | ||
| 47 | Prilenia Investigational Site (Site 044) | Leiden | Netherlands | ||
| 48 | Prilenia Investigational Site (Site 387) | Maastricht | Netherlands | ||
| 49 | Prilenia Investigational Site (Site 386) | Gdańsk | Poland | ||
| 50 | Prilenia Investigational Site (Site 244) | Kraków | Poland | ||
| 51 | Prilenia Investigational Site (Site 246) | Warsaw | Poland | ||
| 52 | Prilenia Investigational Site (Site 380) | Barcelona | Spain | ||
| 53 | Prilenia Investigational Site (Site 381) | Burgos | Spain | ||
| 54 | Prilenia Investigational Site (Site 176) | Madrid | Spain | ||
| 55 | Prilenia Investigational Site (Site 382) | Valencia | Spain | ||
| 56 | Prilenia Investigational Site (Site 180) | Aberdeen | United Kingdom | ||
| 57 | Prilenia Investigational Site (Site 390) | Cardiff | United Kingdom | ||
| 58 | Prilenia Investigational Site (Site 378) | Newcastle | United Kingdom |
Sponsors and Collaborators
- Prilenia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Prilenia
ClinicalTrials.gov Identifier:
NCT04556656
Other Study ID Numbers:
- PL101-HD301
- 2020-002822-10
First Posted:
Sep 21, 2020
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prilenia
Additional relevant MeSH terms: