Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This study evaluates the effect of ecopipam tablets in children and adolescents in the
treatment of Tourette's Syndrome (TS). Half of the participants will receive ecopipam
tablets, while the other half will receive matching placebo tablets
Phase
Phase 2
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
Inclusion Criteria:
- ≥ 6 and < 18 years of age
- ≥ 18 kg (~ 40 lbs.)
- TS diagnosis and both motor and vocal tics that cause impairment with normal routines
- Minimum score of 20 on the YGTSS-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:
- Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder,
schizophrenia, major depressive disorder)
- 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