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New drug ecopipam shows promise for Tourette's tics in Late-Stage trial

NCT ID NCT05615220

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 study tested whether ecopipam can safely maintain tic control in 216 people with Tourette's disorder, ages 6 and up. Participants first received open-label ecopipam, then those who responded were randomly switched to placebo or continued ecopipam to see if benefits lasted. The goal is to offer a new treatment option for tics that interfere with daily life.

What this could mean

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

Active substance
ecopipam
What this could lead to
If successful, ecopipam could offer a new option to help control tics in people with Tourette's disorder.
What could go wrong
This is a Phase 3 trial, but it's a withdrawal study—meaning it tests if benefits last after initial response. The drug may not work for everyone, and side effects are possible.

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

216 people

The number who actually took part.

Started

Jan 2023

Finished

Feb 2025

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 years of age * ≥ 18 kg (\~ 40 lbs.) * TD diagnosis and both motor and vocal tics that cause impairment with normal routines * Minimum score of 20 on the YGTSS-R Total Tic Score * May not be taking any medications used to treat motor or vocal tics for at least 14 days prior to Baseline. * Effective contraception during the study and 30 days after last study dose for sexually active subjects Exclusion Criteria: * Previous exposure to ecopipam * Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder) * Unstable medical illness or clinically significant lab abnormalities * Risk of suicide * Pregnant or lactating women * Moderate to severe renal insufficiency * Hepatic insufficiency * Positive urine drug screen * Unstable doses for drugs to treat anxiety, depression, Attention Deficit Hyperactivity Disorder * Certain medications that would lead to drug interactions * Recent behavioral therapy

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Conditions

The condition(s) this trial relates to.

Tourette syndrome

As listed by the trial registrant

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

Tourette disorder

Contacts and locations

Locations

  • 1725 W. Harrison St., Suite 755

    Chicago, Illinois, 60612, United States

  • 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

  • Advanced Discovery Research, LLC

    Atlanta, Georgia, 30318, United States

  • Advanced Research Center

    Anaheim, California, 92805, United States

  • Alivation Research

    Lincoln, Nebraska, 68526, United States

  • Amnova Clinical Research

    Irvine, California, 92604, United States

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Atlanta Behavioral Research, LLC.

    Atlanta, Georgia, 30338, United States

  • Azienda Ospedaliera Vittorio Emanuele Policlinico // Azienda Ospedaliera Policlinico San Marco

    Catania, 95123, Italy

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Bethesda Childrens Hospital(Magyarországi Református Egyház Bethesda Gyermekkórháza)

    Budapest, 1146, Hungary

  • Borne og Ungeafdelingen

    Herlev, 02730, Denmark

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • CHU Grenoble Alpes - Hopital Couple Enfant

    Grenoble, 38000, France

  • CHU Strasbourg-Hopital de Hautepierre

    Strasbourg, 67098, France

  • Care Research Center

    Miami, Florida, 33175, 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

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio, 45229-3026, United States

  • Clinic of Neurology and Psychiatry for Children and Adolescents

    Belgrade, 11000, Serbia

  • Clinical Center Vojvodina

    Novi Sad, Serbia, 21000, Serbia

  • Clinical Centre Nis Center of Mental Health

    Niš, Serbia, 18000, Serbia

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

    Poznan, Poland, 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

  • DCC Mladost-M Varna

    Varna, 9020, Bulgaria

  • Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School

    Hanover, Lower Saxony, 30625, Germany

  • Emcrown Clinical Research

    Jensen Beach, Florida, 34957, 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 Neuroscience Research

    Dothan, Alabama, 36303, United States

  • Hospital Clínic de Barcelona

    Barcelona, 8036, Spain

  • 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 Fundacion Alcorcon HUFA

    Alcorcón, Madrid, 28922, Spain

  • Hospital Universitario Virgen Macarena Unidad de Investigacion Neurologia

    Seville, 41009, Spain

  • Hospital Universitario Virgen del Rocío, C/Antonio Maura Montaner, s/n, edificio IBiS

    Seville, Sevilla, 41013, Spain

  • Hôpital Fondation Rothschild

    Paris, 75019, France

  • IRCCS Istituto Neurologico Carlo Besta

    Milan, Milano, 20133, Italy

  • Institute of Mental Health

    Belgrade, Belgrad, 11120, Serbia

  • Istituto Di Ricovero E Cura A Carattere Scientifico IRCCS Eugenio Medea

    Bosisio Parini, LC, 23842, Italy

  • Jedidiah Clinical Research

    Tampa, Florida, 33617, United States

  • Josephson-Wallack-Munshower Neurology

    Indianapolis, Indiana, 46256, United States

  • Kalimat Medical Center_Sofia

    Sofia, 1680, Bulgaria

  • Lurie Children Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Massachusetts 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

  • Midwest Research Group

    Saint Charles, Missouri, 63304, United States

  • Mount Sinai School of Medicine

    New York, New York, 10029-6504, United States

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, Florida, 32561, United States

  • NYU Child Study Center

    New York, New York, 10016-5815, United States

  • Neurobehavioral Medicine Group

    Bloomfield Hills, Michigan, 48302-1952, United States

  • North Star Medical Research, LLC

    Middleburg Heights, Ohio, 44130, United States

  • Ospedale Pediatrico Bambino Gesù

    Roma, RM, 00165, Italy

  • Ospedale Pediatrico Istituto Giannina Gaslini di Genova

    Genova, 16148, Italy

  • Pediatric Epilepsy and Neurology Specialists

    Tampa, Florida, 33609-4181, United States

  • Pediatric Neurology, PA

    Winter Park, Florida, 32789, United States

  • Perceptive Pharma Research (PPR)

    Richmond, Texas, 77407, United States

  • Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen

    Munich, Bavaria, 80336, Germany

  • 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, 78249-3539, United States

  • Spitalul Clinic de Psihiatrie Prof Dr Al. Obregia Bucureti

    Dorobanți, 41914, Romania

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794, United States

  • Suburban Research Associates

    Media, Pennsylvania, 19063, United States

  • Syrentis Clinical Research

    Santa Ana, California, 92705, United States

  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Gyermek

    Szeged, Csongrád megye, 6725, Hungary

  • Texas Children's Hospital (TCH)

    Houston, Texas, 77030, United States

  • The Childrens Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • The Kids Clinic Inc

    Ajax, Ontario, L1Z 0M1, Canada

  • The University of Chicago Hospitals

    Chicago, Illinois, 60637-1447, United States

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • Umass Chan Medical School

    Worcester, Massachusetts, 01655, United States

  • Universita degli Studi di Napoli Federico II

    Naples, Napoli, 80131, Italy

  • University of Calgary

    Calgary, Alberta, T2N 4Z6, Canada

  • University of Florida

    Gainesville, Florida, 32608, 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

  • Vadaskert Gyermek- es Ifjusagpszichiatriai Korhaz es Szakambulancia

    Budapest, 1021, Hungary

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-7610, United States

  • Wake Forest Baptist Medical Center - PPDS

    Winston-Salem, North Carolina, 27157-0001, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Wielospecjalistyczna Poradnia Lekarska Synapsis

    Katowice, Silesian Voivodeship, 42-123, Poland

  • 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

  • Zentralinstitut fuer Seelische Gesundheit, Mannheim

    Mannheim, 68159, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.