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Evaluating the long-term safety of ecopipam tablets for Tourette's Disorder

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

PHASE3 · Emalex Biosciences Inc. · NCT06021522

This study is testing if ecopipam tablets are safe for children, teens, and adults with Tourette's Disorder over a long period of time.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment150 (estimated)
Ages6 Years and up
SexAll
SponsorEmalex Biosciences Inc. (industry)
Locations67 sites (Dothan, Alabama and 66 other locations)
Trial IDNCT06021522 on ClinicalTrials.gov

What this trial studies

This study aims to assess the long-term safety and tolerability of ecopipam tablets in children, adolescents, and adults diagnosed with Tourette's Syndrome. Participants will undergo a 4-week titration phase to determine the appropriate dosage, followed by a maintenance period where safety assessments will be conducted at various intervals over 24 months. The study will include regular monitoring of participants to ensure their safety throughout the treatment process.

Who should consider this trial

Good fit: Ideal candidates include children aged 6-12, adolescents aged 12-18, and adults over 18 who have previously shown clinical benefit from ecopipam.

Not a fit: Patients who have not previously responded to ecopipam or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new long-term treatment option for individuals with Tourette's Disorder, improving their quality of life.

How similar studies have performed: Other studies have shown promising results with ecopipam for Tourette's Disorder, indicating potential for success in this long-term evaluation.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Dothan, Alabama and 66 other locations

+17 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Tourette Syndrome, Ecopipam, Neurodevelopmental Disorders, Mental Disorders, Central Nervous System Depressants, Neurodegenerative Diseases, Movement Disorders, Tic Disorders

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.