Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults — D1AMOND  

Tourette Disorder Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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 During the 12-week R/WD period, any subject meeting Relapse criteria will be withdrawn from blinded study medication and complete end of study assessments including safety follow up visits. ;

Related Conditions & MeSH terms

• Tourette Disorder
• Tourette Syndrome

• NCT number: NCT05615220
• Study type: Interventional
• Source: Emalex Biosciences Inc.
• Contact: Meredith M Miller
• Phone: 773 343 0671
• Email: mmiller@emalexbiosciences.com
• Status: Recruiting
• Phase: Phase 3
• Start date: January 31, 2023
• Completion date: December 2024