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Study identifier: NCT06021522 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Active Not Recruiting

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

Condition: Tourette Syndrome  ·  Sponsor: Emalex Biosciences Inc.

PhasePhase 3
Planned participants150
Who can joinAll sexes, 6 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where67 locations · 8 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (67)

Harmonex, Inc.Dothan, Alabama, United States
Arkansas Children's HospitalLittle Rock, Arkansas, United States
Advanced Research CenterAnaheim, California, United States
CenExel CIT-IEBellflower, California, United States
Cortica Site NetworkGlendale, California, United States
Cortica Site Network - San RafaelSan Rafael, California, United States
Yale School of MedicineNew Haven, Connecticut, United States
Childrens National HospitalWashington D.C., District of Columbia, United States
NW FL Clinical Research Group, LLCGulf Breeze, Florida, United States
Research in Miami IncHialeah, Florida, United States
University of Miami Miller School of MedicineMiami, Florida, United States
Florida International Research CenterMiami, Florida, United States

+ 55 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

DothanLittle RockAnaheimBellflower

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