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

Tourette Syndrome in Adolescence Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04114539
Study type Interventional
Source Emalex Biosciences Inc.
Contact
Status Completed
Phase Phase 2
Start date October 4, 2019
Completion date November 11, 2022
View Details
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