Efficacy and Safety of Ecopipam for Tourette Syndrome: A Phase 3 Randomized Clinical Trial - PubMed
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- #Clinical Trial
- #Ecopipam
- #Tourette Syndrome
- Ecopipam, a selective dopamine D1 receptor antagonist, was evaluated for Tourette Syndrome (TS) maintenance efficacy and safety over 24 weeks.
- The study was a phase 3 randomized withdrawal trial with a 12-week open-label period and a 12-week double-blind period.
- Pediatric participants showed significantly reduced relapse risk with ecopipam vs placebo (HR 0.47; P = .008).
- Adults showed a similar directional effect but it was not statistically significant.
- Common adverse events included somnolence, anxiety, headache, insomnia, tic, and fatigue.
- No clinically meaningful impacts on weight, metabolic parameters, or psychiatric scales were observed.
- Ecopipam was well tolerated, with adverse events primarily affecting the central nervous system.