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
Overview
- Phase
- Phase 3
- Intervention
- Pridopidine
- Conditions
- Huntington Disease
- Sponsor
- Prilenia
- Enrollment
- 499
- Locations
- 58
- Primary Endpoint
- Change From Baseline in the Unified Huntington Disease Rating Scale-Total Functional Capacity (UHDRS-TFC) Score (mITT)
- Status
- Completed
- Last Updated
- last year
Overview
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).
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Pridopidine
45 mg pridopidine twice daily (BID)
Intervention: Pridopidine
Placebo
Matching placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in the Unified Huntington Disease Rating Scale-Total Functional Capacity (UHDRS-TFC) Score (mITT)
Time Frame: From baseline to Week 65
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.
Change From Baseline to Week 65 in the UHDRS TFC Score (ITT)
Time Frame: From baseline to Week 65.
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.
Secondary Outcomes
- Change From Baseline to Week 65 in Composite UHDRS (cUHDRS) Total Score (mITT)(From baseline to Week 65)