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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05615220
Other study ID # EBS-101-TD-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 31, 2023
Est. completion date December 2024

Study information

Verified date June 2024
Source Emalex Biosciences Inc.
Contact Meredith M Miller
Phone 773 343 0671
Email mmiller@emalexbiosciences.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 During the 12-week R/WD period, any subject meeting Relapse criteria will be withdrawn from blinded study medication and complete end of study assessments including safety follow up visits.


Recruitment information / eligibility

Status Recruiting
Enrollment 196
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years and older
Eligibility 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 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ecopipam Hydrochloride
Selective dopamine D1 and D5 receptor antagonist

Locations

Country Name City State
Bulgaria Center Spectar-Plovdiv Plovdiv
Bulgaria ASMP-IP- d-r Kayryakova Sofia Lyulin 1
Bulgaria Kalimat Medical Center_Sofia Sofia
Bulgaria DCC Mladost-M Varna Varna
Canada The Kids Clinic Inc Ajax Ontario
Canada University of Calgary Calgary Alberta
Canada Center for Pediatric Excellence Ottawa Ontario
Denmark Borne og Ungeafdelingen Herlev
France CHU Grenoble Alpes - Hopital Couple Enfant Grenoble
France Hôpital Fondation Rothschild Paris
France CHU Strasbourg-Hopital de Hautepierre Strasbourg
Germany Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School Hannover Niedersachsen
Germany Zentralinstitut fuer Seelische Gesundheit, Mannheim Mannheim
Germany Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen Muenchen Bayern
Hungary Bethesda Childrens Hospital(Magyarországi Református Egyház Bethesda Gyermekkórháza) Budapest
Hungary Vadaskert Gyermek- es Ifjusagpszichiatriai Korhaz es Szakambulancia Budapest
Hungary Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Gyermek Szeged Csongrád
Italy Istituto Di Ricovero E Cura A Carattere Scientifico IRCCS Eugenio Medea Bosisio Parini LC
Italy Azienda Ospedaliera Vittorio Emanuele Policlinico // Azienda Ospedaliera Policlinico San Marco Catania
Italy Ospedale Pediatrico Istituto Giannina Gaslini di Genova Genova
Italy IRCCS Istituto Neurologico Carlo Besta Milano
Italy Universita degli Studi di Napoli Federico II Napoli
Poland Gdanskie Centrum Zdrowia Sp z o.o. Gdansk Pomorskie
Poland Wielospecjalistyczna Poradnia Lekarska Synapsis Katowice Silesia
Poland Centrum Medyczne Plejady Krakow
Poland Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie Krakow Woj. Malopolskie
Poland Clinical Research Center Sp. z o.o. MEDIC-R Sp.k. Poznan
Romania Spitalul Clinic de Psihiatrie Prof Dr Al. Obregia Bucureti Dorobanti
Serbia Clinic of Neurology and Psychiatry for Children and Adolescents Belgrade
Serbia Institute of Mental Health Belgrade Belgrad
Serbia Clinical Centre Nis Center of Mental Health Nis
Serbia Clinical Center Vojvodina Novi Sad
Spain Hospital Universitario Fundacion Alcorcon HUFA Alcorcón Madrid
Spain Hospital Clínic de Barcelona Barcelona
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Central de Asturias Oviedo Asturias
Spain Hospital Universitario Virgen del Rocío, C/Antonio Maura Montaner, s/n, edificio IBiS Sevilla
Spain Hospital Universitario Virgen Macarena Unidad de Investigacion Neurologia Sevilla
United States Advanced Research Center Anaheim California
United States Michigan Clinical Research Institute PC Ann Arbor Michigan
United States Advanced Discovery Research, LLC Atlanta Georgia
United States Atlanta Behavioral Research, LLC. Atlanta Georgia
United States Rare Disease Research, LLC Atlanta Georgia
United States Kennedy Krieger Institute Baltimore Maryland
United States CenExel CIT-IE Bellflower California
United States Neurobehavioral Medicine Group Bloomfield Hills Michigan
United States Boston Children's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Coastal Pediatric Research Charleston South Carolina
United States OnSite Clinical Solutions LLC Charlotte North Carolina
United States 1725 W. Harrison St., Suite 755 Chicago Illinois
United States Chicago Research Center Chicago Illinois
United States Lurie Children Hospital of Chicago Chicago Illinois
United States The University of Chicago Hospitals Chicago Illinois
United States Cincinnati Childrens Hospital Medical Center Cincinnati Ohio
United States National Childrens Hospital - The Ohio State University Columbus Ohio
United States UT Southwestern Dallas Texas
United States Harmonex Neuroscience Research Dothan Alabama
United States Cedar Clinical Research Draper Utah
United States Core Clinical Research Everett Washington
United States University of Florida Gainesville Florida
United States Cortica Site Network Glendale California
United States NW FL Clinical Research Group, LLC Gulf Breeze Florida
United States Research in Miami Inc Hialeah Florida
United States Med Research Associates, Inc Hollywood Florida
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 Josephson-Wallack-Munshower Neurology Indianapolis Indiana
United States Amnova Clinical Research Irvine California
United States Emcrown Clinical Research Jensen Beach Florida
United States The Childrens Mercy Hospital Kansas City Missouri
United States Alivation Research Lincoln Nebraska
United States Arkansas Children's Hospital Little Rock Arkansas
United States University of Louisville Research Foundation Inc. Louisville Kentucky
United States Suburban Research Associates Media Pennsylvania
United States Care Research Center Miami Florida
United States Florida International Research Center Miami Florida
United States IM Medical Research Center LLC Miami Florida
United States University of Miami Miller School of Medicine Miami Florida
United States North Star Medical Research, LLC Middleburg Heights Ohio
United States Access Clinical Trials, Inc. Nashville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee
United States Yale School of Medicine New Haven Connecticut
United States Mount Sinai School of Medicine New York New York
United States NYU Child Study Center New York New York
United States Medical Research Group of Central Florida Orange City Florida
United States APG Research LLC Orlando Florida
United States Phoenix Children's Hospital Phoenix Arizona
United States Providence Brain and Spine Institute Portland Oregon
United States University of Rochester Rochester New York
United States Midwest Research Group Saint Charles Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States University of South Florida Saint Petersburg Florida
United States Road Runner Research Ltd. San Antonio Texas
United States Cortica Site Network - San Rafael San Rafael California
United States Syrentis Clinical Research Santa Ana California
United States Stony Brook University Medical Center Stony Brook New York
United States Jedidiah Clinical Research Tampa Florida
United States Pediatric Epilepsy and Neurology Specialists Tampa Florida
United States Childrens National Hospital Washington District of Columbia
United States Wake Forest Baptist Medical Center - PPDS Winston-Salem North Carolina
United States Pediatric Neurology, PA Winter Park Florida
United States Umass Chan Medical School Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Emalex Biosciences Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Denmark,  France,  Germany,  Hungary,  Italy,  Poland,  Romania,  Serbia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Yale Global Tic Severity Scale (YGTSS) Clinician-completed rating scale with score ranging from 0 to 50 (0=none to 50=severe) Screening up to Week 24
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