Summary:
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 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
Qualified Participants May Receive:
Compensation for time and travel upon meeting qualifications into the study