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This phase 3, multicentre, double-blind, placebo-controlled randomized withdrawal trial evaluated ecopipam, a selective dopamine D1 receptor antagonist, in individuals aged 6 years and older with Tourette syndrome. A total of 216 participants entered the initial 12-week open-label treatment period, during which ecopipam was titrated to a target dose of 1.8 mg/kg/day. Participants who achieved at least a 25% improvement in Yale Global Tic Severity Scale Total Tic Score at weeks 8 and 12 were randomized to continue ecopipam or switch to placebo for another 12 weeks. Among paediatric participants, continued ecopipam significantly reduced the risk of symptom relapse compared with placebo (hazard ratio, 0.47; 95% CI, 0.26–0.84; P=0.008). The effect in adults was directionally similar but not statistically significant. Common adverse events included somnolence, anxiety, headache and insomnia, while drug-induced movement disorders were not observed. The findings suggest that ecopipam can maintain clinically meaningful tic improvement in children and adolescents, although the randomized withdrawal design means the results primarily address maintenance of response among initial responders.
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This phase 3, multicentre, double-blind, placebo-controlled randomized withdrawal trial evaluated ecopipam, a selective dopamine D1 receptor antagonist, in individuals aged 6 years and older with Tourette syndrome. A total of 216 participants entered the initial 12-week open-label treatment period, during which ecopipam was titrated to a target dose of 1.8 mg/kg/day. Participants who achieved at least a 25% improvement in Yale Global Tic Severity Scale Total Tic Score at weeks 8 and 12 were randomized to continue ecopipam or switch to placebo for another 12 weeks. Among paediatric participants, continued ecopipam significantly reduced the risk of symptom relapse compared with placebo (hazard ratio, 0.47; 95% CI, 0.26–0.84; P=0.008). The effect in adults was directionally similar but not statistically significant. Common adverse events included somnolence, anxiety, headache and insomnia, while drug-induced movement disorders were not observed. The findings suggest that ecopipam can maintain clinically meaningful tic improvement in children and adolescents, although the randomized withdrawal design means the results primarily address maintenance of response among initial responders.
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