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

• Status: Active, not recruiting
• Trial end date: 2023-04-07
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prilenia

Criteria

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