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Clinical Trials in the USA / NCT06021522
Active, not recruiting Phase 3

A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder

NCT06021522 · tracked via the Priya Life Science USA tracker
Sponsor
Emalex Biosciences Inc.
Phase
Phase 3
Started
2023-08-16
Last updated
2026-07-22

Condition(s) studied

Tourette Syndrome

Investigational drug(s) / intervention(s)

Ecopipam

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

Sex
ALL
Min age
6 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * \>=6 to \>=18 years of age. * Participants enrolling from the study EBS-101-TD-301; completed all visits through Week 24 and days 7 and 14 safety follow-up, met relapse criteria during the double-blind randomized (R/WD) period after completing the 301 end of trial (ET) visit, the 7 day and 14 day safety follow up visits, but not before 24 weeks following the 301 baseline visit or participants who met relapse criteria will be eligible after completing early termination visit, Day 7 and Day 14 follow up visits. * Participants who completed the studies EBS-101-OL-001 or PSY302A. * The enrolling participant must have had clinical benefit from ecopipam and would benefit from continued participation. * Effective contraception during the study and 30 days after last study dose for sexually active participants * \<18 years of age participants parent/legal guardian must sign a written informed consent and participant must sign a written informed assent. * Participant must have TD based on Diagnostic and Statistical Manual for Mental Disorders - 5th Edition (DSM-5-TR diagnostic criteria) for TD. * TD diagnosis and both motor and vocal tics that cause impairment with normal routines Exclusion Criteria: * The participants who discontinued the studies PSY-302A, EBS-101-OL-001 or EBS-101-TD-301 due to reasons such as either lost to follow up, withdrawn consent, non-compliant or withdrawn by the discretion of either the site investigator or the sponsor. * Participants with ongoing or past history of neurological condition (example \[e.g.\], Huntington's disease, Parkinson's disease, Wilson's disease, stroke, Restless Legs Syndrome). * Any unstable mood disorder (DSM-5-TR criteria), mental illness or clinically significant lab abnormalities, moderate to severe renal or hepatic impairment, a PHQ-9 score \>=10 at screening and history of neuroleptic malignant syndrome at the time of screening or baseline. * Participants who completed the studies EBS-101-OL-001 or PSY-302A and who had previous exposure to ecopipam and oral neuroleptics within 4 weeks and depot neuroleptics within 3 months prior to screening, 6 months prior to Baseline. * Participants receiving any other medication to treat motor or vocal tics and anti-depressant or anti-anxiety medications. * Risk of suicide as per PI judgement * Pregnant or lactating women * Certain medications that would have unfavorable drug interactions with ecopipam, e.g., digoxin, fluoxetine, valproic acid, bupropion. * Current or recent (past 3 months) DSM-5-TR substance use disorder (with the exception of nicotine). * Recent behavioral therapy * Positive urine drug screen for cocaine, amphetamine, benzodiazepines, barbiturates, phencyclidine (PCP) or opiates at Baseline, except those receiving stable, prescribed treatment for attention deficit/hyperactivity disorder (ADHD) * Lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any other psychotic disorder. * Unable to swallow tablets. * Known hypersensitivity to any of ecopipam's excipients. * History of seizures (excluding febrile seizures that occurred \>2 years prior to Baseline). * Myocardial infarction within 6 months from Screening.

Primary outcome measure(s)

Trial sites (67)

FacilityCityRegionStatus
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.

Other trials for the same condition

Official registry record

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 the USA