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

Emalex Biosciences

Status and phase

Completed

Phase 2

Conditions

Tourette Syndrome in Adolescence

Tourette Syndrome in Children

Treatments

Drug: Ecopipam

Study type

Interventional

Funder types

Industry

Identifiers

NCT04114539

EBS-101-OL-001

Details and patient eligibility

About

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.

Full 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

Enrollment

124 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must have completed the EBS-101-CL-001 study through the Day 14 Follow Up Visit within the last 30 days (or longer with permission of the medical monitor) without a major reportable protocol deviation and must be someone the Investigator feels would benefit from continued participation.

Exclusion criteria

Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder).
Unstable medical illness or clinically significant lab abnormalities.
Risk of suicide.
Pregnant or lactating women.
Moderate to severe renal insufficiency.
Positive urine drug screen.
Certain medications that would lead to drug interactions.