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

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emalex Biosciences Inc.
• Treatments: Ecopipam

Criteria

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.