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Can a dopamine-blocking drug safely control tourette syndrome over years?

NCT ID NCT06021522

Disease control Sponsor: Emalex Biosciences Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial investigates the long-term safety of ecopipam, a drug that blocks dopamine D1 and D5 receptors, in children, adolescents, and adults with Tourette syndrome. Participants who completed a prior study may enroll and receive ecopipam for up to 24 weeks or longer. The main goal is to track side effects and tolerability over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ecopipam tablets, a drug that blocks dopamine D1 and D5 receptors
What this could lead to
If safe and effective, ecopipam could offer a new long-term treatment option for people with Tourette syndrome.
What could go wrong
This is an open-label study with no placebo comparison, so results may be biased. Long-term safety data are still being collected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

brain disorder central nervous system disorder movement disorder nervous system disorder neurodegenerative disease neurodevelopmental disorder psychiatric disorder tic disorder Tourette syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tourette syndrome

Contacts and locations

Locations

  • APG Research, LLC

    Orlando, Florida, 32803, United States

  • ASMP-IP- d-r Kayryakova

    Sofia, Sofia-Grad, 1360, Bulgaria

  • Access Clinical Trials, Inc.

    Nashville, Tennessee, 37203-6502, United States

  • Access Clinical Trials, Inc.

    Nashville, Tennessee, 37203, United States

  • Advanced Research Center

    Anaheim, California, 92805, United States

  • Alivation Research

    Lincoln, Nebraska, 68526, United States

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Azienda Ospedaliero Universitaria " G. Rodolico - San Marco"

    Catania, 95123, Italy

  • Bethesda Childrens Hospital(Magyarországi Református Egyház Bethesda Gyermekkórháza)

    Budapest, 1146, Hungary

  • Boston Childrens Hospital

    Boston, Massachusetts, 02115, United States

  • Cedar Clinical Research

    Draper, Utah, 84020, United States

  • CenExel CIT-IE

    Bellflower, California, 90706, United States

  • Center Spectar-Plovdiv

    Plovdiv, Bulgaria, 4004, Bulgaria

  • Centrum Medyczne Plejady

    Krakow, 30-363, Poland

  • Childrens National Hospital

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Clinic of Neurology and Psychiatry for Children and Adolescents

    Belgrade, Grad Beograd, 1100, Serbia

  • Clinical Centre Nis Center of Mental Health

    Niš, Serbia, 18000, Serbia

  • Clinical Research Center Sp. z o.o. MEDIC-R Sp.k.

    Poznan, Wielkopolska, 61-731, Poland

  • Coastal Pediatric Research

    Charleston, South Carolina, 29414, United States

  • Core Clinical Research

    Everett, Washington, 98201, United States

  • Cortica Site Network

    Glendale, California, 91203, United States

  • Cortica Site Network - San Rafael

    San Rafael, California, 94903, United States

  • Florida International Research Center

    Miami, Florida, 33173, United States

  • Gdanskie Centrum Zdrowia Sp z o.o.

    Gdansk, Pomeranian Voivodeship, 80-542, Poland

  • Harmonex, Inc.

    Dothan, Alabama, 36303, United States

  • Hospital General Universitario Gregorio Maranon

    Madrid, Madrid, 28007, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, Sevilla, 41013, Spain

  • IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133, Italy

  • Institute of Mental Health

    Belgrade, Belgrad, 11120, Serbia

  • Istituto Giannina Gaslini, Universita di Genova

    Genova, GE, 16148, Italy

  • Josephson-Wallack-Munshower Neurology

    Indianapolis, Indiana, 46256, United States

  • Kalimat Medical Center_Sofia

    Sofia, 1680, Bulgaria

  • Kennedy Krieger Institute

    Baltimore, Maryland, 21205, United States

  • Lurie Children Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Mass General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763, United States

  • Michigan Clinical research Institute PC

    Ann Arbor, Michigan, 48105, United States

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, Florida, 32561, United States

  • National Childrens Hospital - The Ohio State University

    Columbus, Ohio, 43205, United States

  • Neurobahavioral Medicine Group

    Bloomfield Hills, Michigan, 48302, United States

  • Neurologia Śląska Centrum Medyczne

    Katowice, Poland, 40-689, Poland

  • North Star Medical Research, LLC

    Middleburg Heights, Ohio, 44130, United States

  • OnSite Clinical Solutions LLC

    Charlotte, North Carolina, 28211, United States

  • Ospedale Pediatrico Bambino Ges

    Roma, RM, 165, Italy

  • Pediatric Epilepsy and Neurology Specialists

    Tampa, Florida, 33609, United States

  • Providence Brain and Spine Institute

    Portland, Oregon, 97225, United States

  • Rare Disease Research, LLC

    Atlanta, Georgia, 30329, United States

  • Research in Miami Inc

    Hialeah, Florida, 33013-3834, United States

  • Road Runner Research, Ltd

    San Antonio, Texas, 78249, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Gyermek-es Ifjusagpszicihatria

    Szeged, Hungary, 6720, Hungary

  • The Kids Clinic Inc

    Ajax, Ontario, L1Z 0M1, Canada

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • UT Southwestern

    Dallas, Texas, 75390, United States

  • Umass Chan Medical School

    Worcester, Massachusetts, 01655, United States

  • Universita degli Studi di Napoli Federico II

    Naples, Napoli, 80131, Italy

  • University of Louisville Research Foundation Inc.

    Louisville, Kentucky, 40202, United States

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of South Florida

    St. Petersburg, Florida, 33701, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-2551, United States

  • Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie

    Krakow, Woj. Malopolskie, 31-503, Poland

  • Yale School of Medicine

    New Haven, Connecticut, 06519, United States

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