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

Completed · Phase 2

Conditions studied: Tourette Syndrome in Children, Tourette Syndrome in Adolescence

In brief

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.

Key facts

Study ID

NCT04114539

Run by

Emalex Biosciences Inc.

People needed

124

Starts

2019-10-04

Expected to finish

2022-11-11

Last updated by the study team

2024-02-01

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Advanced Research Center Inc. — Anaheim, California, United States
• UCLA — Los Angeles, California, United States
• PCSD-Feighner Research — San Diego, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Northwest Florida Clinical Research Group, LLC — Gulf Breeze, Florida, United States
• Research in Miami Inc. — Hialeah, Florida, United States
• University of Miami — Miami, Florida, United States
• MedBio Trials — North Miami, Florida, United States
• APG Research LLC — Orlando, Florida, United States
• University of South Florida — St. Petersburg, Florida, United States
• Pediatric Epilepsy and Neurology Specialists — Tampa, Florida, United States
• Pediatric Neurology, PA — Winter Park, Florida, United States
• Rare Disease Research, LLC — Atlanta, Georgia, United States
• Meridian Clinical Research — Savannah, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• The University of Chicago Hospitals — Chicago, Illinois, United States
• AMR - Baber Research Inc. — Naperville, Illinois, United States
• Psychiatric Associates — Overland Park, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Michigan Clinical Research Institute PC — Ann Arbor, Michigan, United States
• Neurobehavioral Medicine Group — Bloomfield Hills, Michigan, United States
• Harmonex Neuroscience Research — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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