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COMPLETED
NCT05615220
PHASE3

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

Sponsor: Emalex Biosciences Inc.

View on ClinicalTrials.gov

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 a double-blind, placebo-controlled, randomized withdrawal period.

Official title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Maintenance of Efficacy of Ecopipam in Children, Adolescents and Adults With Tourette's Disorder

Key Details

Gender

All

Age Range

6 Years - Any

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2023-01-31

Completion Date

2025-02-04

Last Updated

2026-06-12

Healthy Volunteers

No

Interventions

DRUG

Ecopipam Hydrochloride

Selective dopamine D1 and D5 receptor antagonist

Locations (95)

Harmonex Neuroscience Research

Dothan, Alabama, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Advanced Research Center

Anaheim, California, United States

CenExel CIT-IE

Bellflower, California, United States

Cortica Site Network

Glendale, California, United States

Amnova Clinical Research

Irvine, California, United States

Cortica Site Network - San Rafael

San Rafael, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

Yale School of Medicine

New Haven, Connecticut, United States

University of Florida

Gainesville, Florida, United States

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, United States

Research in Miami Inc

Hialeah, Florida, United States

Emcrown Clinical Research

Jensen Beach, Florida, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

Florida International Research Center

Miami, Florida, United States

Care Research Center

Miami, Florida, United States

Medical Research Group of Central Florida

Orange City, Florida, United States

APG Research LLC

Orlando, Florida, United States

University of South Florida

St. Petersburg, Florida, United States

Pediatric Epilepsy and Neurology Specialists

Tampa, Florida, United States

Jedidiah Clinical Research

Tampa, Florida, United States

Pediatric Neurology, PA

Winter Park, Florida, United States

Advanced Discovery Research, LLC

Atlanta, Georgia, United States

Rare Disease Research, LLC

Atlanta, Georgia, United States

Atlanta Behavioral Research, LLC.

Atlanta, Georgia, United States

Lurie Children Hospital of Chicago

Chicago, Illinois, United States

1725 W. Harrison St., Suite 755

Chicago, Illinois, United States

The University of Chicago Hospitals

Chicago, Illinois, United States

Josephson-Wallack-Munshower Neurology

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Umass Chan Medical School

Worcester, Massachusetts, United States

Michigan Clinical Research Institute PC

Ann Arbor, Michigan, United States

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, United States

The Childrens Mercy Hospital

Kansas City, Missouri, United States

Midwest Research Group

Saint Charles, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Alivation Research

Lincoln, Nebraska, United States

NYU Child Study Center

New York, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

University of Rochester

Rochester, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Wake Forest Baptist Medical Center - PPDS

Winston-Salem, North Carolina, United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States

North Star Medical Research, LLC

Middleburg Heights, Ohio, United States

Suburban Research Associates

Media, Pennsylvania, United States

Coastal Pediatric Research

Charleston, South Carolina, United States

Access Clinical Trials, Inc.

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

Texas Children's Hospital (TCH)

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Perceptive Pharma Research (PPR)

Richmond, Texas, United States

Road Runner Research Ltd.

San Antonio, Texas, United States

Cedar Clinical Research

Draper, Utah, United States

Core Clinical Research

Everett, Washington, United States

Center Spectar-Plovdiv

Plovdiv, Bulgaria, Bulgaria

ASMP-IP- d-r Kayryakova

Sofia, Sofia-Grad, Bulgaria

Kalimat Medical Center_Sofia

Sofia, Bulgaria

DCC Mladost-M Varna

Varna, Bulgaria

University of Calgary

Calgary, Alberta, Canada

The Kids Clinic Inc

Ajax, Ontario, Canada

Borne og Ungeafdelingen

Herlev, Denmark

CHU Grenoble Alpes - Hopital Couple Enfant

Grenoble, France

Hôpital Fondation Rothschild

Paris, France

CHU Strasbourg-Hopital de Hautepierre

Strasbourg, France

Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen

Munich, Bavaria, Germany

Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School

Hanover, Lower Saxony, Germany

Zentralinstitut fuer Seelische Gesundheit, Mannheim

Mannheim, Germany

Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Gyermek

Szeged, Csongrád megye, Hungary

Vadaskert Gyermek- es Ifjusagpszichiatriai Korhaz es Szakambulancia

Budapest, Hungary

Bethesda Childrens Hospital(Magyarországi Református Egyház Bethesda Gyermekkórháza)

Budapest, Hungary

Istituto Di Ricovero E Cura A Carattere Scientifico IRCCS Eugenio Medea

Bosisio Parini, LC, Italy

IRCCS Istituto Neurologico Carlo Besta

Milan, Milano, Italy

Universita degli Studi di Napoli Federico II

Naples, Napoli, Italy

Ospedale Pediatrico Bambino Gesù

Roma, RM, Italy

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

Catania, Italy

Ospedale Pediatrico Istituto Giannina Gaslini di Genova

Genova, Italy

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

Poznan, Poland, Poland

Gdanskie Centrum Zdrowia Sp z o.o.

Gdansk, Pomeranian Voivodeship, Poland

Wielospecjalistyczna Poradnia Lekarska Synapsis

Katowice, Silesian Voivodeship, Poland

Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie

Krakow, Woj. Malopolskie, Poland

Centrum Medyczne Plejady

Krakow, Poland

Spitalul Clinic de Psihiatrie Prof Dr Al. Obregia Bucureti

Dorobanți, Romania

Institute of Mental Health

Belgrade, Belgrad, Serbia

Clinical Centre Nis Center of Mental Health

Niš, Serbia, Serbia

Clinical Center Vojvodina

Novi Sad, Serbia, Serbia

Clinic of Neurology and Psychiatry for Children and Adolescents

Belgrade, Serbia

Hospital Universitario Fundacion Alcorcon HUFA

Alcorcón, Madrid, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

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

Seville, Sevilla, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital Universitario Virgen Macarena Unidad de Investigacion Neurologia

Seville, Spain