A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder
Condition(s) studied
Investigational drug(s) / intervention(s)
Ecopipam: Selective dopamine D1 and D5 receptor antagonist
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).
Eligibility
Primary outcome measure(s)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — Baseline up to Month 24
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.
Trial sites (67)
| Facility | City | Region | Status |
|---|---|---|---|
| Harmonex, Inc. | Dothan | Alabama | |
| Arkansas Children's Hospital | Little Rock | Arkansas | |
| Advanced Research Center | Anaheim | California | |
| CenExel CIT-IE | Bellflower | California | |
| Cortica Site Network | Glendale | California | |
| Cortica Site Network - San Rafael | San Rafael | California | |
| Yale School of Medicine | New Haven | Connecticut | |
| Childrens National Hospital | Washington D.C. | District of Columbia | |
| NW FL Clinical Research Group, LLC | Gulf Breeze | Florida | |
| Research in Miami Inc | Hialeah | Florida | |
| University of Miami Miller School of Medicine | Miami | Florida | |
| Florida International Research Center | Miami | Florida | |
| Medical Research Group of Central Florida | Orange City | Florida | |
| APG Research, LLC | Orlando | Florida | |
| University of South Florida | St. Petersburg | Florida | |
| Pediatric Epilepsy and Neurology Specialists | Tampa | Florida | |
| Rare Disease Research, LLC | Atlanta | Georgia | |
| Lurie Children Hospital of Chicago | Chicago | Illinois | |
| Rush University Medical Center | Chicago | Illinois | |
| Josephson-Wallack-Munshower Neurology | Indianapolis | Indiana | |
| University of Louisville Research Foundation Inc. | Louisville | Kentucky | |
| Kennedy Krieger Institute | Baltimore | Maryland | |
| Mass General Hospital | Boston | Massachusetts | |
| Boston Childrens Hospital | Boston | Massachusetts | |
| Umass Chan Medical School | Worcester | Massachusetts | |
| Michigan Clinical research Institute PC | Ann Arbor | Michigan | |
| Neurobahavioral Medicine Group | Bloomfield Hills | Michigan | |
| St. Louis Children's Hospital | St Louis | Missouri | |
| Alivation Research | Lincoln | Nebraska | |
| University of Rochester | Rochester | New York | |
| OnSite Clinical Solutions LLC | Charlotte | North Carolina | |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | |
| National Childrens Hospital - The Ohio State University | Columbus | Ohio | |
| North Star Medical Research, LLC | Middleburg Heights | Ohio | |
| Providence Brain and Spine Institute | Portland | Oregon | |
| Coastal Pediatric Research | Charleston | South Carolina | |
| Access Clinical Trials, Inc. | Nashville | Tennessee | |
| Access Clinical Trials, Inc. | Nashville | Tennessee | |
| Vanderbilt University Medical Center | Nashville | Tennessee | |
| UT Southwestern | Dallas | Texas |
+ 27 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06021522 on ClinicalTrials.gov ↗ ← All trials in Italy