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

Running, not enrolling · Phase 3

Conditions studied: Tourette Syndrome

In brief

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).

Key facts

Study ID

NCT06021522

Run by

Emalex Biosciences Inc.

People needed

150

Starts

2023-08-16

Expected to finish

2028-02-01

Last updated by the study team

2026-07-22

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >=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

You may not qualify if…

• 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discontinued the studies PSY-302A, EBS-101-OL-001 or EBS-101-TD-301 due to reasons such as either lost to follow up, withdrawn consent, non-compliant or withdrawn by the discretion of either the site investigator or the sponsor.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.

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Advanced Research Center — Anaheim, California, United States
• CenExel CIT-IE — Bellflower, California, United States
• Cortica Site Network — Glendale, California, United States
• Cortica Site Network - San Rafael — San Rafael, California, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Childrens National Hospital — Washington D.C., District of Columbia, United States
• NW FL Clinical Research Group, LLC — Gulf Breeze, Florida, United States
• Research in Miami Inc — Hialeah, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Florida International Research Center — Miami, Florida, United States
• Medical Research Group of Central Florida — Orange City, Florida, United States
• APG Research, LLC — Orlando, Florida, United States
• University of South Florida — St. Petersburg, Florida, United States
• Pediatric Epilepsy and Neurology Specialists — Tampa, Florida, United States
• Rare Disease Research, LLC — Atlanta, Georgia, United States
• Lurie Children Hospital of Chicago — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Josephson-Wallack-Munshower Neurology — Indianapolis, Indiana, United States
• University of Louisville Research Foundation Inc. — Louisville, Kentucky, United States
• Kennedy Krieger Institute — Baltimore, Maryland, United States
• Mass General Hospital — Boston, Massachusetts, United States
• Boston Childrens Hospital — Boston, Massachusetts, United States
• Umass Chan Medical School — Worcester, Massachusetts, United States
• Harmonex, Inc. — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.