Phase 3 Trial of Ecopipam for Tourette Syndrome: Safety and Efficacy Evaluation
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Summary
This Phase 3 randomized clinical trial evaluates the safety and maintenance of effect of ecopipam, a selective dopamine D1 receptor antagonist, for up to 24 weeks in children, adolescents, and adults with Tourette syndrome. The study includes 216 participants in the open-label period and 104 in the double-blind period (51 ecopipam, 53 placebo), with ages ranging from 6 to 58 years. The trial assesses demographic and baseline characteristics across age groups (6-11, 12-17, and ≥18 years) and includes data on sex, race, and ethnicity distribution among participants.
Source
bskyPhase 3 Trial of Ecopipam for Tourette Syndrome: Safety and Efficacy Evaluationdoi.orgKey quotes
· 3 pulledThis randomized clinical trial evaluates the safety and maintenance of effect of ecopipam, a selective dopamine D1 receptor antagonist, for up to 24 weeks for children, adolescents, and adults with Tourette syndrome.
The study includes 216 participants in the open-label period and 104 in the double-blind period (51 ecopipam, 53 placebo).
Participants ranged in age from 6 to 58 years, with a mean age of 16.3 years in the open-label period.
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