CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 216 enrolled / 216 target
Drug / intervention
Ecopipam Hydrochloridedrug
Likely dose
89.6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05615220
NCT05615220Phase 3CompletedMonitor (5.3/mo)Completion was 17mo ago
CompareCT.gov

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

Emalex Biosciences Inc.·interventional·Posted Nov 14, 2022·Updated Jun 12, 2026

In Brief

A Phase 3 clinical trial evaluating Ecopipam Hydrochloride for Tourette Disorder. Completed, enrolled 216 participants across 95 sites in 12 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTourette Disorder
CountriesBulgaria, Canada, Denmark, France, Germany, Hungary, Italy, Poland, Romania, Serbia, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedNov 14, 2022
Enrollment StartJan 31, 2023
Primary CompletionJan 13, 2025
Study CompletionFeb 4, 2025
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 3.6 years ago

Arms & Interventions

1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl)experimental

Ecopipam 11.2, 22.4, 33.6, 44.8, 67.2 and 89.6 mg tablets (containing 12.5, 25, 37.5, 50, 75 and 100 mg ecopipam HCl, respectively); 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) target dose; oral administration daily in evenings.

Drug: Ecopipam Hydrochloride
Placebo during R/WD Phaseplacebo_comparator

Matching Placebo tablets during R/WD period taken orally in the evening.

Drug: Ecopipam Hydrochloride

Interventions

Ecopipam Hydrochloridedrug

Selective dopamine D1 and D5 receptor antagonist