At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 124 enrolled
Drug / intervention
Ecopipamdrug
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.
A Multicenter, Open-Label, Extension Study Intended to Evaluate the Long-term Safety of Ecopipam Tablets in Children and Adolescent Subjects With Tourette's Syndrome
In Brief
A Phase 2 clinical trial evaluating Ecopipam for Tourette Syndrome in Children and Tourette Syndrome in Adolescence. Completed, enrolled 124 participants across 65 sites in 5 countries.
Detailed Summary
This study was an international, multicenter, open-label, long term extension study evaluating the safety of ecopipam tablets for the treatment of children and adolescent subjects with Tourette Syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, France, Germany, Poland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartOct 2019
Primary CompletionNov 2022
TodayJul 2026
First PostedOct 3, 2019
Enrollment StartOct 4, 2019
Primary CompletionNov 11, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.7 years ago
Interventions
Ecopipamdrug
Ecopipam HCl 12.5-, 37.5-. 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings.