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