Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults

Last updated: April 28, 2025
Sponsor: Emalex Biosciences Inc.
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Autism

Tic Disorders

Treatment

Ecopipam Hydrochloride

Clinical Study ID

NCT05615220
EBS-101-TD-301
  • Ages > 6
  • All Genders

Study Summary

This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥ 6 years of age

  • ≥ 18 kg (~ 40 lbs.)

  • TD diagnosis and both motor and vocal tics that cause impairment with normalroutines

  • 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 14days prior to Baseline.

  • Effective contraception during the study and 30 days after last study dose forsexually active subjects

Exclusion

Exclusion Criteria:

  • Previous exposure to ecopipam

  • Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder,schizophrenia, major depressive disorder)

  • Unstable 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 DeficitHyperactivity Disorder

  • Certain medications that would lead to drug interactions

  • Recent behavioral therapy

Study Design

Total Participants: 216
Treatment Group(s): 1
Primary Treatment: Ecopipam Hydrochloride
Phase: 3
Study Start date:
January 31, 2023
Estimated Completion Date:
February 04, 2025

Study Description

Following a 28-day Screening period and Baseline visit, eligible subjects will be enrolled into the open-label Stabilization period comprised of a 4-week Titration phase to achieve a target steady-state dose of 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) followed by an 8-week open-label Maintenance phase. Responders to ecopipam will be randomized to ecopipam 1.8 mg/kg/day (2 mg/kg/day ecopipam HCl) or placebo in a 1:1 fashion and enter the double-blind Randomized-Withdrawal (R/WD) period at Week 12. During the 12-week R/WD period, any subject meeting Relapse criteria will be withdrawn from blinded study medication and complete end of study assessments including safety follow up visits.

Connect with a study center

  • ASMP-IP- d-r Kayryakova

    Sofia, Sofia City 1360
    Bulgaria

    Site Not Available

  • Center Spectar-Plovdiv

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • Kalimat Medical Center_Sofia

    Sofia, 1680
    Bulgaria

    Site Not Available

  • DCC Mladost-M Varna

    Varna, 9020
    Bulgaria

    Site Not Available

  • University of Calgary

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • The Kids Clinic Inc

    Ajax, Ontario L1Z 0M1
    Canada

    Site Not Available

  • Center for Pediatric Excellence

    Ottawa, Ontario K2G 1W2
    Canada

    Site Not Available

  • Borne og Ungeafdelingen

    Herlev, 02730
    Denmark

    Site Not Available

  • CHU Grenoble Alpes - Hopital Couple Enfant

    Grenoble, 38000
    France

    Site Not Available

  • Hôpital Fondation Rothschild

    Paris, 75019
    France

    Site Not Available

  • CHU Strasbourg-Hopital de Hautepierre

    Strasbourg, 67098
    France

    Site Not Available

  • Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen

    Muenchen, Bayern 80336
    Germany

    Site Not Available

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

    Hannover, Niedersachsen 30625
    Germany

    Site Not Available

  • Zentralinstitut fuer Seelische Gesundheit, Mannheim

    Mannheim, 68159
    Germany

    Site Not Available

  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Gyermek

    Szeged, Csongrád 6725
    Hungary

    Site Not Available

  • Bethesda Childrens Hospital(Magyarországi Református Egyház Bethesda Gyermekkórháza)

    Budapest, 1146
    Hungary

    Site Not Available

  • Vadaskert Gyermek- es Ifjusagpszichiatriai Korhaz es Szakambulancia

    Budapest, 1021
    Hungary

    Site Not Available

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

    Bosisio Parini, LC 23842
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesù

    Roma, RM 00165
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesù

    P.za Sant'Onofrio, 4, Rome 00165
    Italy

    Site Not Available

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

    Catania, 95123
    Italy

    Site Not Available

  • Ospedale Pediatrico Istituto Giannina Gaslini di Genova

    Genova, 16148
    Italy

    Site Not Available

  • IRCCS Istituto Neurologico Carlo Besta

    Milano, 20133
    Italy

    Site Not Available

  • Universita degli Studi di Napoli Federico II

    Napoli, 80131
    Italy

    Site Not Available

  • AOU Integrata Verona

    Nicolaus, 37124
    Italy

    Site Not Available

  • Gdanskie Centrum Zdrowia Sp z o.o.

    Gdańsk, Pomorskie 80-542
    Poland

    Site Not Available

  • Wielospecjalistyczna Poradnia Lekarska Synapsis

    Katowice, Silesia 42-123
    Poland

    Site Not Available

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

    Krakow, Woj. Malopolskie 31-503
    Poland

    Site Not Available

  • Centrum Medyczne Plejady

    Krakow, 30-363
    Poland

    Site Not Available

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

    Poznań, 61-731
    Poland

    Site Not Available

  • Spitalul Clinic de Psihiatrie Prof Dr Al. Obregia

    Bucureti, Dorobanti 41914
    Romania

    Site Not Available

  • Spitalul Clinic de Psihiatrie Prof Dr Al. Obregia Bucureti

    Dorobanti, 41914
    Romania

    Site Not Available

  • Institute of Mental Health

    Belgrade, Belgrad 11120
    Serbia

    Site Not Available

  • Clinic of Neurology and Psychiatry for Children and Adolescents

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinic of Neurology and Psychiatry for Children and Adolescents

    Beograd, 11000
    Serbia

    Site Not Available

  • Clinical Centre Nis Center of Mental Health

    Nis, 18000
    Serbia

    Site Not Available

  • Clinical Center Vojvodina

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Alcorcon HUFA

    Alcorcón, Madrid 28922
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    C/Antonio Maura Montaner, S/n, Edificio IBiS, Sevilla 41013
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, 8036
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena Unidad de Investigacion Neurologia

    Sevilla, 41009
    Spain

    Site Not Available

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

    Sevilla, 41013
    Spain

    Site Not Available

  • Harmonex Neuroscience Research

    Dothan, Alabama 36303
    United States

    Site Not Available

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Advanced Research Center

    Anaheim, California 92805
    United States

    Site Not Available

  • CenExel CIT-IE

    Bellflower, California 90706
    United States

    Site Not Available

  • Cortica Site Network

    Glendale, California 91203
    United States

    Site Not Available

  • Amnova Clinical Research

    Irvine, California 92604
    United States

    Site Not Available

  • Cortica Site Network - San Rafael

    San Rafael, California 94903
    United States

    Site Not Available

  • Syrentis Clinical Research

    Santa Ana, California 92705
    United States

    Site Not Available

  • Yale School of Medicine

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Childrens National Hospital

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32608
    United States

    Site Not Available

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, Florida 32561
    United States

    Site Not Available

  • Research in Miami Inc

    Hialeah, Florida 33013-3834
    United States

    Site Not Available

  • Med Research Associates, Inc

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Emcrown Clinical Research

    Jensen Beach, Florida 34957
    United States

    Site Not Available

  • Care Research Center

    Miami, Florida 33175
    United States

    Site Not Available

  • Florida International Research Center

    Miami, Florida 33173
    United States

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  • IM Medical Research Center LLC

    Miami, Florida 33144
    United States

    Site Not Available

  • University of Miami Miller School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • Medical Research Group of Central Florida

    Orange City, Florida 32763
    United States

    Site Not Available

  • APG Research LLC

    Orlando, Florida 32803
    United States

    Site Not Available

  • University of South Florida

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • University of South Florida

    St. Petersburg, Florida 33701
    United States

    Site Not Available

  • Jedidiah Clinical Research

    Tampa, Florida 33617
    United States

    Site Not Available

  • Pediatric Epilepsy and Neurology Specialists

    Tampa, Florida 33609-4181
    United States

    Site Not Available

  • Pediatric Neurology, PA

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Advanced Discovery Research, LLC

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Atlanta Behavioral Research, LLC.

    Atlanta, Georgia 30338
    United States

    Site Not Available

  • Rare Disease Research, LLC

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • 1725 W. Harrison St., Suite 755

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Chicago Research Center

    Chicago, Illinois 60634
    United States

    Site Not Available

  • Lurie Children Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • The University of Chicago Hospitals

    Chicago, Illinois 60637-1447
    United States

    Site Not Available

  • Josephson-Wallack-Munshower Neurology

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • University of Louisville Research Foundation Inc.

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Kennedy Krieger Institute

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Umass Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Michigan Clinical Research Institute PC

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Neurobehavioral Medicine Group

    Bloomfield Hills, Michigan 48302-1952
    United States

    Site Not Available

  • The Childrens Mercy Hospital

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Midwest Research Group

    Saint Charles, Missouri 63304
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Alivation Research

    Lincoln, Nebraska 68526
    United States

    Site Not Available

  • Alivation Research, LLC

    Lincoln, Nebraska 68526
    United States

    Active - Recruiting

  • Mount Sinai School of Medicine

    New York, New York 10029-6504
    United States

    Site Not Available

  • NYU Child Study Center

    New York, New York 10016-5815
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • Stony Brook University Medical Center

    Stony Brook, New York 11794
    United States

    Site Not Available

  • OnSite Clinical Solutions LLC

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • Wake Forest Baptist Medical Center - PPDS

    Winston Salem, North Carolina 27157-0001
    United States

    Site Not Available

  • Wake Forest Baptist Medical Center - PPDS

    Winston-Salem, North Carolina 27157-0001
    United States

    Site Not Available

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio 45229-3026
    United States

    Site Not Available

  • National Childrens Hospital - The Ohio State University

    Columbus, Ohio 43205
    United States

    Site Not Available

  • North Star Medical Research, LLC

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Providence Brain and Spine Institute

    Portland, Oregon 97225
    United States

    Site Not Available

  • Suburban Research Associates

    Media, Pennsylvania 19063
    United States

    Site Not Available

  • Coastal Pediatric Research

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Access Clinical Trials, Inc.

    Nashville, Tennessee 37203-6502
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232-7610
    United States

    Site Not Available

  • UT Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Children's Hospital (TCH)

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Perceptive Pharma Research (PPR)

    Richmond, Texas 77407
    United States

    Site Not Available

  • Road Runner Research Ltd.

    San Antonio, Texas 78249-3539
    United States

    Site Not Available

  • Cedar Clinical Research

    Draper, Utah 84020
    United States

    Site Not Available

  • Core Clinical Research

    Everett, Washington 98201
    United States

    Site Not Available

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