NCT05615220

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

A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Maintenance of Efficacy of Ecopipam in Children, Adolescents and Adults With Tourette's Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Emalex Biosciences Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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 a double-blind, placebo-controlled, randomized withdrawal period.

Detailed description

Following a 28-day Screening period and Baseline visit, eligible subjects will be enrolled into the open-label Stabilization period comprised of a 4-week Titration phase to achieve a target steady-state dose of 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) followed by an 8-week open-label Maintenance phase. Responders to ecopipam will be randomized to ecopipam 1.8 mg/kg/day (2 mg/kg/day ecopipam HCl) or placebo in a 1:1 fashion and enter the double-blind Randomized-Withdrawal (R/WD) period at Week 12. During the 12-week R/WD period, any subject meeting Relapse criteria will be withdrawn from blinded study medication and complete end of study assessments including safety follow up visits.

Conditions

• Tourette Disorder

Interventions

Type	Name	Description
DRUG	Ecopipam Hydrochloride	Selective dopamine D1 and D5 receptor antagonist

Timeline

• Start date: 2023-01-31
• Primary completion: 2025-01-13
• Completion: 2025-02-04
• First posted: 2022-11-14
• Last updated: 2025-11-25
• Results posted: 2025-11-25

Locations

95 sites across 12 countries: United States, Bulgaria, Canada, Denmark, France, Germany, Hungary, Italy, Poland, Romania, Serbia, Spain

Regulatory

• FDA-regulated drug study