Abstract | BACKGROUND AND OBJECTIVES: METHODS: This was a multicenter, randomized, double-blind, placebo-controlled, phase 2b trial. Subjects aged ≥6 to <18 years with a baseline Yale Global Tic Severity Score Total Tic Score of ≥20 were randomly assigned 1:1 to ecopipam (n = 76) or placebo (n = 77). The primary endpoint was mean change over 12 weeks in the Yale Global Tic Severity Score Total Tic Score. The Clinical Global Impression of Tourette Syndrome Severity was the secondary endpoint. Safety and tolerability were evaluated at each study visit. RESULTS: Total tic scores were significantly reduced from baseline to 12 weeks in the ecopipam group compared with placebo (least squares mean differences -3.44, 95% confidence interval -6.09 to -0.79, P = .01). Improvement in Clinical Global Impression of Tourette Syndrome Severity was also greater in the ecopipam group (P = .03). More weight gain was seen in subjects assigned to placebo. No metabolic or electrocardiogram changes were identified. Headache (15.8%), insomnia (14.5%), fatigue (7.9%), and somnolence (7.9%) were the most common adverse events. CONCLUSIONS: Among children and adolescents with TS, ecopipam reduces tics to a greater extent than placebo, without observable evidence of common antipsychotic-associated side effects.
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Authors | Donald L Gilbert, Jordan S Dubow, Timothy M Cunniff, Stephen P Wanaski, Sarah D Atkinson, Atul R Mahableshwarkar |
Journal | Pediatrics
(Pediatrics)
Vol. 151
Issue 2
(02 01 2023)
ISSN: 1098-4275 [Electronic] United States |
PMID | 36628546
(Publication Type: Randomized Controlled Trial, Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- ecopipam
- Antipsychotic Agents
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Topics |
- Adolescent
- Child
- Humans
- Tourette Syndrome
(drug therapy, chemically induced, complications)
- Tics
(chemically induced, complications, drug therapy)
- Treatment Outcome
- Antipsychotic Agents
(adverse effects)
- Double-Blind Method
- Weight Gain
- Severity of Illness Index
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