Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults

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.

Inclusion Criteria:≥ 6 years of age≥ 18 kg (~ 40 lbs.)TD diagnosis and both motor and vocal tics that cause impairment with normal routinesMinimum score of 20 on the YGTSS-R Total Tic ScoreMay 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 subjectsExclusion Criteria:Previous exposure to ecopipamCertain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder)Unstable unstable medical illness or clinically significant lab abnormalitiesRisk of suicidePregnant or lactating womenModerate to severe renal insufficiencyHepatic insufficiencyPositive urine drug screenUnstable doses for drugs to treat anxiety, depression, Attention Deficit Hyperactivity DisorderCertain medications that would lead to drug interactionsRecent behavioral therapy