Status:
COMPLETED
Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension
Lead Sponsor:
Emalex Biosciences Inc.
Conditions:
Tourette Syndrome in Children
Tourette Syndrome in Adolescence
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief 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 Syndro...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2022
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04114539
Start Date
October 4 2019
End Date
November 11 2022
Last Update
February 1 2024
Active Locations (65)
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1
Harmonex Neuroscience Research
Dothan, Alabama, United States, 36303
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
Advanced Research Center Inc.
Anaheim, California, United States, 92805
4
UCLA
Los Angeles, California, United States, 90095