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

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emalex Biosciences Inc.
• Treatments: Ecopipam

Criteria

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