Huntington Disease Clinical Trial
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
| Verified date | November 2023 |
| Source | Prilenia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).
| Status | Active, not recruiting |
| Enrollment | 499 |
| Est. completion date | March 14, 2024 |
| Est. primary completion date | March 14, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 25 Years and older |
| Eligibility | INCLUSION CRITERIA MAIN STUDY 1. Diagnosis of HD based on clinical features and the presence of =36 CAG repeats in the huntingtin gene 2. Diagnostic confidence level (DCL) of 4 3. Adult-onset HD with onset of signs and symptoms =18 years of age 4. Stage 1 or Stage 2 HD, defined as a UHDRS-TFC score of =7, at screening EXCLUSION CRITERIA 1. Use of pridopidine within 12 months before the baseline visit. 2. Gene therapy at any time 3. 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 4. History of epilepsy or seizures within the last 5 years 5. Pregnant or breastfeeding, or intention to become pregnant during the study |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Prilenia Investigational site (Site 291) | Innsbruck | |
| Canada | Prilenia Investigational Site (Site 030) | Calgary | Alberta |
| Canada | Prilenia Investigational Site (Site 232) | Halifax | |
| Canada | Prilenia Investigational Site (Site 098) | Montréal | Quebec |
| Canada | Prilenia Investigational Site (Site 048) | Vancouver | British Columbia |
| Czechia | Prilenia Investigational Site (Site 388) | Prague | |
| France | Prilenia Investigational Site (Site 385) | Lille | |
| France | Prilenia Investigational Site (Site 384) | Marseille | |
| France | Prilenia Investigational Site (Site 392) | Paris | |
| Germany | Prilenia Investigational Site (Site 234) | Aachen | |
| Germany | Prilenia Investigational Site (Site 379) | Bochum | |
| Germany | Prilenia Investigational Site (Site 377) | Lübeck | |
| Germany | Prilenia Investigational Site (Site 376) | Münster | |
| Germany | Prilenia Investigational site (Site 292) | Taufkirchen | |
| Germany | Prilenia Investigational Site (Site 175) | Ulm | |
| Italy | Prilenia Investigational Site (Site 249) | Bari | |
| Italy | Prilenia Investigational Site (Site 394) | Bologna | |
| Italy | Prilenia Investigational Site (Site 239) | Milano | |
| Italy | Prilenia Investigational Site (Site 393) | Napoli | |
| Italy | Prilenia Investigational Site (Site 228) | Roma | |
| Netherlands | Prilenia Investigational Site (Site 044) | Leiden | |
| Netherlands | Prilenia Investigational Site (Site 387) | Maastricht | |
| Poland | Prilenia Investigational Site (Site 386) | Gdansk | |
| Poland | Prilenia Investigational Site (Site 244) | Kraków | |
| Poland | Prilenia Investigational Site (Site 246) | Warsaw | |
| Spain | Prilenia Investigational Site (Site 380) | Barcelona | |
| Spain | Prilenia Investigational Site (Site 381) | Burgos | |
| Spain | Prilenia Investigational Site (Site 176) | Madrid | |
| Spain | Prilenia Investigational Site (Site 382) | Valencia | |
| United Kingdom | Prilenia Investigational Site (Site 180) | Aberdeen | |
| United Kingdom | Prilenia Investigational Site (Site 390) | Cardiff | |
| United Kingdom | Prilenia Investigational Site (Site 378) | Newcastle | |
| United States | Prilenia Investigational Site (Site 037) | Albany | New York |
| United States | Prilenia Investigational Site (Site 032) | Atlanta | Georgia |
| United States | Prilenia Investigational Site (Site 028) | Baltimore | Maryland |
| United States | Prilenia Investigational Site (Site 017) | Boston | Massachusetts |
| United States | Prilenia Investigational Site (Site 076) | Boston | Massachusetts |
| United States | Prilenia Investigational Site (Site 088) | Chicago | Illinois |
| United States | Prilenia Investigational Site (Site 089) | Cincinnati | Ohio |
| United States | Prilenia Investigational Site (Site 020) | Columbus | Ohio |
| United States | Prilenia Investigational Site (Site 061) | Davis | California |
| United States | Prilenia Investigational Site (Site 119) | Durham | North Carolina |
| United States | Prilenia Investigational Site (Site 343) | Englewood | Colorado |
| United States | Prilenia Investigational Site (Site 160) | Gainesville | Florida |
| United States | Prilenia Investigational Site (Site 199) | Houston | Texas |
| United States | Prilenia Investigational Site (Site 029) | Kansas City | Kansas |
| United States | Prilenia Investigational Site (Site 087) | Louisville | Kentucky |
| United States | Prilenia Investigational Site (Site 031) | Nashville | Tennessee |
| United States | Prilenia Investigational Site (Site 002) | New York | New York |
| United States | Prilenia Investigational Site (Site 018) | Philadelphia | Pennsylvania |
| United States | Prilenia Investigational Site (Site 006) | Portland | Oregon |
| United States | Prilenia Investigational Site (Site 326) | Richmond | Virginia |
| United States | Prilenia Investigational Site (Site 027) | Saint Louis | Missouri |
| United States | Prilenia Investigational Site (Site 051) | San Diego | California |
| United States | Prilenia Investigational Site (Site 096) | Seattle | Washington |
| United States | Prilenia Investigational Site (Site 019) | Tampa | Florida |
| United States | Prilenia Investigational Site (Site 333) | Washington | District of Columbia |
| United States | Prilenia Investigational Site (Site 083) | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Prilenia |
United States, Austria, Canada, Czechia, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in the Unified Huntington Disease Rating Scale-Total functional capacity (UHDRS-TFC) score | Baseline, 65 weeks |
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