Phase 3 Study of Pridopidine to Slow Huntingtons Disease Progression in Adults Aged 23 to 65

What this Trial Is About

Researchers are evaluating pridopidine to see if it can slow the clinical decline of Huntingtons Disease HD in adults aged 23 to 65 who have adult-onset HD. This Phase 3 study compares pridopidine to a placebo to understand its effects on HD progression, including daily functioning, cognition, motor skills, and quality of life. The study also assesses the safety of pridopidine. Participants will take either pridopidine or placebo capsules twice daily for one year, starting with a 2-week period of once-daily dosing and then switching to twice daily. They will have six clinic visits and five safety phone calls during this placebo-controlled year. Afterward, all participants can join a 2-year open-label extension where everyone receives pridopidine, including those who initially took placebo. This extension includes a 2-week retitration period and 102 weeks of twice-daily dosing, with six clinic visits and six phone calls planned. During the trial, participants will be monitored through regular clinic visits and telephone safety calls. Researchers will measure changes in the Composite Unified Huntingtons Disease Rating Scale over one year as the primary outcome. Secondary outcomes include changes in functional capacity, motor function, and cognitive performance. Safety and tolerability will be continuously evaluated throughout both study periods, with a total participation time of three years for those completing both phases.

Pridopidine Phase 3 Study in Huntington's Disease