Phase
Condition
Autism
Tic Disorders
Treatment
Ecopipam
Clinical Study ID
Ages > 6 All Genders
Study Summary
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who discontinued the studies PSY-302A, EBS-101-OL-001 orEBS-101-TD-301 due to reasons such as either lost to follow up, withdrawn consent,non-compliant or withdrawn by the discretion of either the site investigator or thesponsor.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
Study Description
Connect with a study center
ASMP-IP- d-r Kayryakova
Sofia, Sofia City 1360
BulgariaSite Not Available
Center Spectar-Plovdiv
Plovdiv, 4004
BulgariaSite Not Available
Kalimat Medical Center_Sofia
Sofia, 1680
BulgariaSite Not Available
The Kids Clinic Inc
Ajax, Ontario L1Z 0M1
CanadaSite Not Available
Bethesda Childrens Hospital(Magyarországi Református Egyház Bethesda Gyermekkórháza)
Budapest, 1146
HungarySite Not Available
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Gyermek-es Ifjusagpszicihatria
Szeged, 6720
HungarySite Not Available
Istituto Giannina Gaslini, Universita di Genova
Genova, GE 16148
ItalySite Not Available
Ospedale Pediatrico Bambino Ges
Roma, RM 165
ItalySite Not Available
Azienda Ospedaliero Universitaria " G. Rodolico - San Marco"
Catania, 95123
ItalySite Not Available
IRCCS Istituto Neurologico Carlo Besta
Milano, 20133
ItalySite Not Available
Universita degli Studi di Napoli Federico II
Napoli, 80131
ItalySite Not Available
Gdanskie Centrum Zdrowia Sp z o.o.
Gdańsk, Pomorskie 80-542
PolandSite Not Available
Clinical Research Center Sp. z o.o. MEDIC-R Sp.k.
Poznań, Wielkopolska 61-731
PolandSite Not Available
Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie
Krakow, Woj. Malopolskie 31-503
PolandSite Not Available
Neurologia Śląska Centrum Medyczne
Katowice, 40-689
PolandSite Not Available
Centrum Medyczne Plejady
Kraków, 30-363
PolandSite Not Available
Institute of Mental Health
Belgrade, Belgrad 11120
SerbiaSite Not Available
Clinic of Neurology and Psychiatry for Children and Adolescents
Beograd, Grad Beograd 1100
SerbiaSite Not Available
Clinical Centre Nis Center of Mental Health
Nis, 18000
SerbiaSite Not Available
Hospital Universitario Central de Asturias
Oviedo, Asturias 33011
SpainSite Not Available
Hospital General Universitario Gregorio Maranon
Madrid, 28007
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Universitario Virgen del Rocío
Sevilla, 41013
SpainSite Not Available
Harmonex, Inc.
Dothan, Alabama 36303
United StatesSite Not Available
Arkansas Children's Hospital
Little Rock, Arkansas 72202
United StatesSite Not Available
Advanced Research Center
Anaheim, California 92805
United StatesSite Not Available
CenExel CIT-IE
Bellflower, California 90706
United StatesSite Not Available
Cortica Site Network
Glendale, California 91203
United StatesSite Not Available
Cortica Site Network - San Rafael
San Rafael, California 94903
United StatesSite Not Available
Yale School of Medicine
New Haven, Connecticut 06519
United StatesSite Not Available
Childrens National Hospital
Washington, District of Columbia 20010
United StatesSite Not Available
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida 32561
United StatesSite Not Available
Research in Miami Inc
Hialeah, Florida 33013-3834
United StatesSite Not Available
Florida International Research Center
Miami, Florida 33173
United StatesSite Not Available
University of Miami Miller School of Medicine
Miami, Florida 33136
United StatesSite Not Available
Medical Research Group of Central Florida
Orange City, Florida 32763
United StatesSite Not Available
APG Research, LLC
Orlando, Florida 32803
United StatesSite Not Available
University of South Florida
Saint Petersburg, Florida 33701
United StatesSite Not Available
University of South Florida
St. Petersburg, Florida 33701
United StatesSite Not Available
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida 33609
United StatesSite Not Available
Rare Disease Research, LLC
Atlanta, Georgia 30329
United StatesSite Not Available
Lurie Children Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Josephson-Wallack-Munshower Neurology
Indianapolis, Indiana 46256
United StatesSite Not Available
University of Louisville Research Foundation Inc.
Louisville, Kentucky 40202
United StatesSite Not Available
Kennedy Krieger Institute
Baltimore, Maryland 21205
United StatesSite Not Available
Boston Childrens Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Mass General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Umass Chan Medical School
Worcester, Massachusetts 01655
United StatesSite Not Available
Michigan Clinical research Institute PC
Ann Arbor, Michigan 48105
United StatesSite Not Available
Neurobahavioral Medicine Group
Bloomfield Hills, Michigan 48302
United StatesSite Not Available
St. Louis Children's Hospital
Saint Louis, Missouri 63110
United StatesSite Not Available
St. Louis Children's Hospital
St. Louis, Missouri 63110
United StatesSite Not Available
Alivation Research
Lincoln, Nebraska 68526
United StatesSite Not Available
University of Rochester
Rochester, New York 14642
United StatesSite Not Available
OnSite Clinical Solutions LLC
Charlotte, North Carolina 28211
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesSite Not Available
National Childrens Hospital - The Ohio State University
Columbus, Ohio 43205
United StatesSite Not Available
North Star Medical Research, LLC
Middleburg Heights, Ohio 44130
United StatesSite Not Available
Providence Brain and Spine Institute
Portland, Oregon 97225
United StatesSite Not Available
Coastal Pediatric Research
Charleston, South Carolina 29414
United StatesSite Not Available
Access Clinical Trials, Inc.
Nashville, Tennessee 37203
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232-2551
United StatesSite Not Available
UT Southwestern
Dallas, Texas 75390
United StatesSite Not Available
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United StatesSite Not Available
Road Runner Research, Ltd
San Antonio, Texas 78249
United StatesSite Not Available
Cedar Clinical Research
Draper, Utah 84020
United StatesSite Not Available
Core Clinical Research
Everett, Washington 98201
United StatesSite Not Available
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