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NCT06021522 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder
A Phase 3 study of Tourette Syndrome, sponsored by Emalex Biosciences.
- Active
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT06021522: Active Phase 3 study of Tourette Syndrome, sponsored by Emalex Biosciences.
NCT06021522 is a Phase 3 study of Tourette Syndrome that is active but no longer recruiting, run by Emalex Biosciences. The registered enrollment target is 150 participants, above the 82-participant average among 33 other Tourette Syndrome trials with a reported enrollment target (83% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06021522, a Phase 3 study of Tourette Syndrome, is active but no longer recruiting, sponsored by Emalex Biosciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to \[\>=\] 6 and less than \[\<\] 12 years of age), adolescents (\>=12 and \<18 years of age), and adults (\>=18 years of age) with Tourette's Syndrome (TS).
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a subject administered a study drug and which does not necessarily have a causal relationship with this treatment. A TEAE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product.
Conditions Studied
Interventions
- DRUG Ecopipam
Study Locations (20)
Florida
- NW FL Clinical Research Group, LLC - Gulf Breeze
- Research in Miami Inc - Hialeah
- University of Miami Miller School of Medicine - Miami
- Florida International Research Center - Miami
- Medical Research Group of Central Florida - Orange City
- APG Research, LLC - Orlando
- University of South Florida - St. Petersburg
- Pediatric Epilepsy and Neurology Specialists - Tampa
California
- Advanced Research Center - Anaheim
- CenExel CIT-IE - Bellflower
- Cortica Site Network - Glendale
- Cortica Site Network - San Rafael - San Rafael
Illinois
- Lurie Children Hospital of Chicago - Chicago
- Rush University Medical Center - Chicago
Alabama
- Harmonex, Inc. - Dothan
Arkansas
- Arkansas Children's Hospital - Little Rock
Connecticut
- Yale School of Medicine - New Haven
District of Columbia
- Childrens National Hospital - Washington D.C.
Georgia
- Rare Disease Research, LLC - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-08-16 |
| Est. Completion | 2027-03 |
| Phase | Phase 3 |
What the registry record for NCT06021522 still lists
NCT06021522 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 82-participant average among 33 other Tourette Syndrome trials with a reported enrollment target (83% higher).
The record links to 1 condition, with Tourette Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Ecopipam is the first listed.
NCT06021522 names 20 study sites across 9 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT06021522 about?
NCT06021522 is a clinical study titled "A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder". The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to \[\>=\] 6 and less than \[\<\] 12 years of age), adolescents (\>=12 and \<18 years of age), and adults (\>=18 years of age) with Tourette's Syndrome (TS)...
What is the current status of trial NCT06021522?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2023-08-16. Estimated completion is 2027-03.
What conditions does trial NCT06021522 study?
This clinical trial studies the following conditions: Tourette Syndrome.
What interventions are being tested in trial NCT06021522?
The interventions under investigation include: Ecopipam (DRUG).
Who is sponsoring clinical trial NCT06021522?
This trial is sponsored by Emalex Biosciences, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06021522 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tourette Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06021522's enrollment target sits among peer trials
150 7th of 33 higher than 26 of 33 other Tourette Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tourette Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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