NCT04114539

Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Emalex Biosciences Inc. · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was an international, multicenter, open-label, long term extension study to evaluate the safety of ecopipam tablets for the treatment of pediatric subjects (aged ≥6 to ≤18 years at Baseline) with Tourette Syndrome. Participants who completed the Phase 2b, randomized, double-blind, efficacy and safety study (EBS-101-CL-001) without major reportable protocol deviations, and who met all the inclusion/exclusion criteria for this study were eligible to participate in this study. All participants were titrated to a target dose of 2 mg/kg/day as participants rolled over from the Phase 2b double-blind efficacy and safety study were tapered off study drug to maintain the blind from that study. Participants were to complete study visits every month for 1 year. Follow-up visits were conducted 7 and 14 days after the last dose of the study drug and a follow-up phone call was conducted 30 days after the last dose of study drug

Conditions

• Tourette Syndrome in Children
• Tourette Syndrome in Adolescence

Interventions

Type	Name	Description
DRUG	Ecopipam	Ecopipam HCl 12.5-, 37.5-. 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings.

Timeline

• Start date: 2019-10-04
• Primary completion: 2022-11-11
• Completion: 2022-11-11
• First posted: 2019-10-03
• Last updated: 2024-02-01
• Results posted: 2023-12-01

Locations

65 sites across 5 countries: United States, Canada, France, Germany, Poland

Regulatory

• FDA-regulated drug study