A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Maintenance of Efficacy of Ecopipam in Children, Adolescents and Adults With Tourette's Disorder

EBS-101-TD-301

This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.

2023-01-31

2024-12-01

2024-12-01

Recruiting

Early phase I

196

Inclusion Criteria: * ≥ 6 years of age * ≥ 18 kg (\~ 40 lbs.) * TD diagnosis and both motor and vocal tics that cause impairment with normal routines * Minimum score of 20 on the YGTSS-R Total Tic Score * May not be taking any medications used to treat motor or vocal tics for at least 14 days prior to Baseline. * Effective contraception during the study and 30 days after last study dose for sexually active subjects Exclusion Criteria: * Previous exposure to ecopipam * Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder) * Unstable unstable medical illness or clinically significant lab abnormalities * Risk of suicide * Pregnant or lactating women * Moderate to severe renal insufficiency * Hepatic insufficiency * Positive urine drug screen * Unstable doses for drugs to treat anxiety, depression, Attention Deficit Hyperactivity Disorder * Certain medications that would lead to drug interactions * Recent behavioral therapy

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2024-05-07