A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder

Last updated: November 13, 2024
Sponsor: Emalex Biosciences Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Autism

Tic Disorders

Treatment

Ecopipam

Clinical Study ID

NCT06021522
EBS-101-TD-391
2023-503545-67-00
  • Ages > 6
  • All Genders

Study Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12 years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age) with Tourette's Syndrome (TS).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • >=6 to >=18 years of age.

  • Participants enrolling from the study EBS-101-TD-301; completed all visits throughWeek 24 and days 7 and 14 safety follow-up, met relapse criteria during thedouble-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 weeksfollowing the 301 baseline visit or participants who met relapse criteria will beeligible after completing early termination visit, Day 7 and Day 14 follow upvisits.

  • Participants who completed the studies EBS-101-OL-001 or PSY302A.

  • The enrolling participant must have had clinical benefit from ecopipam and wouldbenefit from continued participation.

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

  • <18 years of age participants parent/legal guardian must sign a written informedconsent and participant must sign a written informed assent.

  • Participant must have TD based on Diagnostic and Statistical Manual for MentalDisorders - 5th Edition (DSM-5-TR diagnostic criteria) for TD.

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

Exclusion

Exclusion Criteria:

  • The participants who discontinued the studies PSY-302A, EBS-101-OL-001 orEBS-101-TD-301 due to reasons such as either lost to follow up, withdrawn consent,non-compliant or withdrawn by the discretion of either the site investigator or thesponsor.

  • Participants with ongoing or past history of neurological condition (example [e.g.],Huntington's disease, Parkinson's disease, Wilson's disease, stroke, Restless LegsSyndrome).

  • Any unstable mood disorder (DSM-5-TR criteria), mental illness or clinicallysignificant lab abnormalities, moderate to severe renal or hepatic impairment, aPHQ-9 score >=10 at screening and history of neuroleptic malignant syndrome at thetime of screening or baseline.

  • Participants who completed the studies EBS-101-OL-001 or PSY-302A and who hadprevious exposure to ecopipam and oral neuroleptics within 4 weeks and depotneuroleptics within 3 months prior to screening, 6 months prior to Baseline.

  • Participants receiving any other medication to treat motor or vocal tics andanti-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 theexception 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 anyother 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 toBaseline).

  • Myocardial infarction within 6 months from Screening.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Ecopipam
Phase: 3
Study Start date:
August 16, 2023
Estimated Completion Date:
March 31, 2027

Study Description

This study is to evaluate the long-term safety and tolerability of ecopipam tablets in eligible participants. The eligible participants will be entered into a treatment period and start a 4-week titration phase to achieve a target steady-state dose of 1.8 milligram per kilogram per day (mg/kg/day) ecopipam (2 mg/kg/day dose of ecopipam HCl). During the 4-week titration phase ecopipam will be dispensed following weight bands before reaching their respective maintenance dose until end of the treatment. Safety assessment will be conducted at baseline visit and at all treatment visits (Months 1-12, 15, 18, 21 and 24). Safety follow up visits will be conducted 7 and 14 days and a follow up phone call will be conducted 30 days after the last dose of ecopipam.

Connect with a study center

  • ASMP-IP- d-r Kayryakova

    Sofia, Lyulin 1 1360
    Bulgaria

    Active - Recruiting

  • Center Spectar-Plovdiv

    Plovdiv, 4004
    Bulgaria

    Active - Recruiting

  • Kalimat Medical Center_Sofia

    Sofia, 1680
    Bulgaria

    Active - Recruiting

  • The Kids Clinic Inc

    Ajax, Ontario L1Z 0M1
    Canada

    Active - Recruiting

  • Bethesda Childrens Hospital(Magyarországi Református Egyház Bethesda Gyermekkórháza)

    Budapest, 1146
    Hungary

    Active - Recruiting

  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Gyermek-es Ifjusagpszicihatria

    Szeged, 6720
    Hungary

    Active - Recruiting

  • Istituto Giannina Gaslini, Universita di Genova

    Genova, GE 16148
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Ges

    Roma, RM 165
    Italy

    Site Not Available

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

    Catania, 95123
    Italy

    Active - Recruiting

  • IRCCS Istituto Neurologico Carlo Besta

    Milano, 20133
    Italy

    Active - Recruiting

  • Universita degli Studi di Napoli Federico II

    Napoli, 80131
    Italy

    Active - Recruiting

  • Gdanskie Centrum Zdrowia Sp z o.o.

    Gdańsk, Pomorskie 80-542
    Poland

    Active - Recruiting

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

    Poznań, Wielkopolska 61-731
    Poland

    Active - Recruiting

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

    Krakow, Woj. Malopolskie 31-503
    Poland

    Active - Recruiting

  • Neurologia Śląska Centrum Medyczne

    Katowice, 40-689
    Poland

    Active - Recruiting

  • Centrum Medyczne Plejady

    Kraków, 30-363
    Poland

    Active - Recruiting

  • Institute of Mental Health

    Belgrade, Belgrad 11120
    Serbia

    Active - Recruiting

  • Clinic of Neurology and Psychiatry for Children and Adolescents

    Beograd, Grad Beograd 1100
    Serbia

    Active - Recruiting

  • Clinical Centre Nis Center of Mental Health

    Nis, 18000
    Serbia

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Harmonex, Inc.

    Dothan, Alabama 36303
    United States

    Active - Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

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    Anaheim, California 92805
    United States

    Active - Recruiting

  • CenExel CIT-IE

    Bellflower, California 90706
    United States

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  • Cortica Site Network

    Glendale, California 91203
    United States

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  • Cortica Site Network - San Rafael

    San Rafael, California 94903
    United States

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  • Yale School of Medicine

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • Childrens National Hospital

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, Florida 32561
    United States

    Active - Recruiting

  • Research in Miami Inc

    Hialeah, Florida 33013-3834
    United States

    Active - Recruiting

  • Florida International Research Center

    Miami, Florida 33173
    United States

    Active - Recruiting

  • University of Miami Miller School of Medicine

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Medical Research Group of Central Florida

    Orange City, Florida 32763
    United States

    Site Not Available

  • APG Research, LLC

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • University of South Florida

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • Pediatric Epilepsy and Neurology Specialists

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • Rare Disease Research, LLC

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Lurie Children Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Josephson-Wallack-Munshower Neurology

    Indianapolis, Indiana 46256
    United States

    Active - Recruiting

  • 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 Childrens Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Mass General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Umass Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Michigan Clinical research Institute PC

    Ann Arbor, Michigan 48105
    United States

    Active - Recruiting

  • Neurobahavioral Medicine Group

    Bloomfield Hills, Michigan 48302
    United States

    Active - Recruiting

  • St. Louis Children's Hospital

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Alivation Research

    Lincoln, Nebraska 68526
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • OnSite Clinical Solutions LLC

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • 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

  • Coastal Pediatric Research

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Access Clinical Trials, Inc.

    Nashville, Tennessee 37203-6502
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232-2551
    United States

    Active - Recruiting

  • UT Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Road Runner Research, Ltd

    San Antonio, Texas 78249
    United States

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  • Cedar Clinical Research

    Draper, Utah 84020
    United States

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  • Core Clinical Research

    Everett, Washington 98201
    United States

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