Phase 3Recruiting
Pridopidine Phase 3 Study in Huntington's Disease (PRECISE-HD)
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Huntington's Disease (HD)
- Sponsor
- Prilenia (Industry)
- Enrolment
- 400 planned
- Conditions
- Huntington Disease
- Interventions
- Pridopidine; Placebo
- Ages
- adults, older adults
- Registry
- NCT07609108, CTIS2026-526093-16-00
Full record on ClinicalTrials.gov
From the registry
The goal of this clinical trial is to learn if pridopidine can slow the clinical decline of Huntington's Disease (HD) in adult participants. It will also inform about the safety of pridopidine. The main questions the study aims to answer are: Does pridopidine slow the overall worsening of HD over 1 year? Does pridopidine slow the worsening of specific aspects of HD over 1 year, namely the clinical progression, the ability to perform daily life activities (functional capacity), the mind's ability to process information (cognition), working of the muscles (motor function), and quality of life? Researchers will compare the drug pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works better than placebo to treat HD. During the first year of the study, participants will have the same chance to receive either pridopidine or placebo. Participants will: Take 1 pridopidine or placebo capsule twice daily for 12 months. Visit the clinic 6 times within 1 year for checkups and tests. All participants who complete this 1-year placebo-controlled…
Primary outcomes
- Change in Composite Unified Huntington's Disease Rating Scale (cUHDRS)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered