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

ID#: NCT04114539

Age: 6 - 18 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: October 04, 2019

End Date: November 01, 2022

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.

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.