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Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults

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Hol
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 és Worcester (Egyesült Államok)Mind a 56 helyszín megnézése
Fázis
3. fázis

Helyszínek itt: Egyesült Államok

  • Advanced Research CenterAnaheim, Egyesült ÁllamokNo longer taking part
  • Michigan Clinical Research Institute PCAnn Arbor, Egyesült ÁllamokNo longer taking part
  • Advanced Discovery Research, LlcAtlanta, Egyesült ÁllamokNo longer taking part
  • Atlanta Behavioral Research, LLCAtlanta, Egyesült ÁllamokNo longer taking part
  • Rare Disease Research, LLCAtlanta, Egyesült ÁllamokNo longer taking part
  • CenExel CIT-IEBellflower, Egyesült ÁllamokNo longer taking part
  • NeuroBehavioral Medicine GroupBloomfield Hills, Egyesült ÁllamokNo longer taking part
  • Boston Children's HospitalBoston, Egyesült ÁllamokNo longer taking part
  • Massachusetts General HospitalBoston, Egyesült ÁllamokNo longer taking part
  • Coastal Pediatric ResearchCharleston, Egyesült ÁllamokNo longer taking part
  • 1725 W. Harrison St., Suite 755Chicago, Egyesült ÁllamokNo longer taking part
  • Lurie Children Hospital of ChicagoChicago, Egyesült ÁllamokNo longer taking part
  • The University of Chicago HospitalsChicago, Egyesült ÁllamokNo longer taking part
  • Cincinnati Childrens Hospital Medical CenterCincinnati, Egyesült ÁllamokNo longer taking part
  • Harmonex Neuroscience ResearchDothan, Egyesült ÁllamokNo longer taking part
  • Cedar Clinical ResearchDraper, Egyesült ÁllamokNo longer taking part
  • Core Clinical ResearchEverett, Egyesült ÁllamokNo longer taking part
  • University of FloridaGainesville, Egyesült ÁllamokNo longer taking part
  • Cortica Site NetworkGlendale, Egyesült ÁllamokNo longer taking part
  • NW FL Clinical Research Group, LLCGulf Breeze, Egyesült ÁllamokNo longer taking part
  • Research in Miami IncHialeah, Egyesült ÁllamokNo longer taking part
  • Baylor College of MedicineHouston, Egyesült ÁllamokNo longer taking part
  • Texas Children's Hospital (TCH)Houston, Egyesült ÁllamokNo longer taking part
  • The University of Texas Health Science Center at HoustonHouston, Egyesült ÁllamokNo longer taking part
  • Josephson Wallack Munshower NeurologyIndianapolis, Egyesült ÁllamokNo longer taking part
  • Amnova Clinical ResearchIrvine, Egyesült ÁllamokNo longer taking part
  • Emcrown Clinical ResearchJensen Beach, Egyesült ÁllamokNo longer taking part
  • The Childrens Mercy HospitalKansas City, Egyesült ÁllamokNo longer taking part
  • Alivation ResearchLincoln, Egyesült ÁllamokNo longer taking part
  • Arkansas Children's HospitalLittle Rock, Egyesült ÁllamokNo longer taking part
  • Suburban Research AssociatesMedia, Egyesült ÁllamokNo longer taking part
  • Care Research CenterMiami, Egyesült ÁllamokNo longer taking part
  • Florida International Research CenterMiami, Egyesült ÁllamokNo longer taking part
  • University of Miami Miller School of MedicineMiami, Egyesült ÁllamokNo longer taking part
  • North Star Medical Research, LLCMiddleburg Heights, Egyesült ÁllamokNo longer taking part
  • Access Clinical Trials, IncNashville, Egyesült ÁllamokNo longer taking part
  • Vanderbilt University Medical CenterNashville, Egyesült ÁllamokNo longer taking part
  • Yale School of MedicineNew Haven, Egyesült ÁllamokNo longer taking part
  • Mount Sinai School of MedicineNew York, Egyesült ÁllamokNo longer taking part
  • NYU Child Study CenterNew York, Egyesült ÁllamokNo longer taking part
  • Medical Research Group of Central FloridaOrange City, Egyesült ÁllamokNo longer taking part
  • APG Research, LLCOrlando, Egyesült ÁllamokNo longer taking part
  • Perceptive Pharma Research (PPR)Richmond, Egyesült ÁllamokNo longer taking part
  • University of RochesterRochester, Egyesült ÁllamokNo longer taking part
  • Midwest Research GroupSaint Charles, Egyesült ÁllamokNo longer taking part
  • Road Runner Research, LtdSan Antonio, Egyesült ÁllamokNo longer taking part
  • Cortica Site Network - San RafaelSan Rafael, Egyesült ÁllamokNo longer taking part
  • Syrentis Clinical ResearchSanta Ana, Egyesült ÁllamokNo longer taking part
  • Washington University School of MedicineSt Louis, Egyesült ÁllamokNo longer taking part
  • University of South FloridaSt. Petersburg, Egyesült ÁllamokNo longer taking part
  • Stony Brook University Medical CenterStony Brook, Egyesült ÁllamokNo longer taking part
  • Jedidiah Clinical ResearchTampa, Egyesült ÁllamokNo longer taking part
  • Pediatric Epilepsy and Neurology SpecialistsTampa, Egyesült ÁllamokNo longer taking part
  • Wake Forest Baptist Medical Center - PPDSWinston-Salem, Egyesült ÁllamokNo longer taking part
  • Pediatric Neurology PAWinter Park, Egyesült ÁllamokNo longer taking part
  • UMass Chan Medical SchoolWorcester, Egyesült ÁllamokNo longer taking part

A vizsgálat adatai

Ki végzi
Emalex Biosciences Inc.
Azonosító
NCT05615220EU 2023-503494-38-00
A regiszteradat frissítve
2026. június 12.
Eredeti leírás
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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: ≥ 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.

Kizáró feltételek: 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.

ClinicalTrials.gov NCT05615220 · EU CTIS 2023-503494-38-00