CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 153 enrolled
Drug / intervention
Ecopipam +1 moredrug
Likely dose
Ecopipam 2 mg/kgfrom 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/NCT04007991
NCT04007991Phase 2Completed

Multicenter, Placebo-Controlled, Double-Blind, Randomized, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Ecopipam in Children and Adolescents With Tourette's Syndrome

Emalex Biosciences Inc.·interventional·Posted Jul 5, 2019·Updated Oct 4, 2023

In Brief

A Phase 2 clinical trial evaluating Ecopipam and Placebo for Tourette Syndrome. Completed, enrolled 153 participants across 70 sites in 5 countries.

Detailed Summary

This study evaluates the effect of ecopipam tablets in children and adolescents in the treatment of Tourette's Syndrome (TS). Half of the participants will receive ecopipam tablets, while the other half will receive matching placebo tablets

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, France, Germany, Poland, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 5, 2019
Enrollment StartJun 28, 2019
Primary CompletionSep 23, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.0 years ago

Interventions

Ecopipamdrug

Ecopipam HCI tablets administered PO to establish 2 mg/kg/day

Placebodrug

Matching Placebo