Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults
Key facts
- Where
- Anaheim, Ann Arbor, Atlanta, Bellflower, Bloomfield Hills, Boston, Charleston, Chicago, Cincinnati, Dothan, Draper, Everett, Gainesville, Glendale, Gulf Breeze, Hialeah, Houston, Indianapolis, Irvine, Jensen Beach, Kansas City, Lincoln, Little Rock, Media, Miami, Middleburg Heights, Nashville, New Haven, New York, Orange City, Orlando, Richmond, Rochester, Saint Charles, San Antonio, San Rafael, Santa Ana, St Louis, St. Petersburg, Stony Brook, Tampa, Winston-Salem, Winter Park, and Worcester, United StatesSee the 56 sites
- Phase
- Phase 3
Where in United States
- Advanced Research CenterAnaheim, United StatesNo longer taking part
- Michigan Clinical Research Institute PCAnn Arbor, United StatesNo longer taking part
- Advanced Discovery Research, LlcAtlanta, United StatesNo longer taking part
- Atlanta Behavioral Research, LLCAtlanta, United StatesNo longer taking part
- Rare Disease Research, LLCAtlanta, United StatesNo longer taking part
- CenExel CIT-IEBellflower, United StatesNo longer taking part
- NeuroBehavioral Medicine GroupBloomfield Hills, United StatesNo longer taking part
- Boston Children's HospitalBoston, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Coastal Pediatric ResearchCharleston, United StatesNo longer taking part
- 1725 W. Harrison St., Suite 755Chicago, United StatesNo longer taking part
- Lurie Children Hospital of ChicagoChicago, United StatesNo longer taking part
- The University of Chicago HospitalsChicago, United StatesNo longer taking part
- Cincinnati Childrens Hospital Medical CenterCincinnati, United StatesNo longer taking part
- Harmonex Neuroscience ResearchDothan, United StatesNo longer taking part
- Cedar Clinical ResearchDraper, United StatesNo longer taking part
- Core Clinical ResearchEverett, United StatesNo longer taking part
- University of FloridaGainesville, United StatesNo longer taking part
- Cortica Site NetworkGlendale, United StatesNo longer taking part
- NW FL Clinical Research Group, LLCGulf Breeze, United StatesNo longer taking part
- Research in Miami IncHialeah, United StatesNo longer taking part
- Baylor College of MedicineHouston, United StatesNo longer taking part
- Texas Children's Hospital (TCH)Houston, United StatesNo longer taking part
- The University of Texas Health Science Center at HoustonHouston, United StatesNo longer taking part
- Josephson Wallack Munshower NeurologyIndianapolis, United StatesNo longer taking part
- Amnova Clinical ResearchIrvine, United StatesNo longer taking part
- Emcrown Clinical ResearchJensen Beach, United StatesNo longer taking part
- The Childrens Mercy HospitalKansas City, United StatesNo longer taking part
- Alivation ResearchLincoln, United StatesNo longer taking part
- Arkansas Children's HospitalLittle Rock, United StatesNo longer taking part
- Suburban Research AssociatesMedia, United StatesNo longer taking part
- Care Research CenterMiami, United StatesNo longer taking part
- Florida International Research CenterMiami, United StatesNo longer taking part
- University of Miami Miller School of MedicineMiami, United StatesNo longer taking part
- North Star Medical Research, LLCMiddleburg Heights, United StatesNo longer taking part
- Access Clinical Trials, IncNashville, United StatesNo longer taking part
- Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
- Yale School of MedicineNew Haven, United StatesNo longer taking part
- Mount Sinai School of MedicineNew York, United StatesNo longer taking part
- NYU Child Study CenterNew York, United StatesNo longer taking part
- Medical Research Group of Central FloridaOrange City, United StatesNo longer taking part
- APG Research, LLCOrlando, United StatesNo longer taking part
- Perceptive Pharma Research (PPR)Richmond, United StatesNo longer taking part
- University of RochesterRochester, United StatesNo longer taking part
- Midwest Research GroupSaint Charles, United StatesNo longer taking part
- Road Runner Research, LtdSan Antonio, United StatesNo longer taking part
- Cortica Site Network - San RafaelSan Rafael, United StatesNo longer taking part
- Syrentis Clinical ResearchSanta Ana, United StatesNo longer taking part
- Washington University School of MedicineSt Louis, United StatesNo longer taking part
- University of South FloridaSt. Petersburg, United StatesNo longer taking part
- Stony Brook University Medical CenterStony Brook, United StatesNo longer taking part
- Jedidiah Clinical ResearchTampa, United StatesNo longer taking part
- Pediatric Epilepsy and Neurology SpecialistsTampa, United StatesNo longer taking part
- Wake Forest Baptist Medical Center - PPDSWinston-Salem, United StatesNo longer taking part
- Pediatric Neurology PAWinter Park, United StatesNo longer taking part
- UMass Chan Medical SchoolWorcester, United StatesNo longer taking part
Trial details
- Who runs it
- Emalex Biosciences Inc.
- Trial code
- NCT05615220EU 2023-503494-38-00
- Record updated
- 12 June 2026
- Original description
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period.Read full original descriptionShow less
A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Maintenance of Efficacy of Ecopipam in Children, Adolescents and Adults With Tourette's Disorder
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period.
Inclusion: ≥ 6 years of age; ≥ 18 kg (~ 40 lbs.); TD diagnosis and both motor and vocal tics that cause impairment with normal routines; Minimum score of 20 on the YGTSS-R Total Tic Score; May not be taking any medications used to treat motor or vocal tics for at least 14 days prior to Baseline; Effective contraception during the study and 30 days after last study dose for sexually active subjects.
Exclusion: Previous exposure to ecopipam; Positive urine drug screen; Certain medications that would lead to drug interactions; Recent behavioral therapy; Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder); Unstable medical illness or clinically significant lab abnormalities; Moderate to severe renal insufficiency; Hepatic insufficiency; Unstable doses for drugs to treat anxiety, depression, Attention Deficit Hyperactivity Disorder; Risk of suicide; Pregnant or lactating women.