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

ID#: NCT05615220

Age: 6 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: January 31, 2023

End Date: December 01, 2024

Contact Information:
Meredith M Miller
773 343 0671
David JB Kim
312 847 1342
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