ACTIVE_NOT_RECRUITING

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

Talk to us

Conditions

Tourette SyndromeEcopipamNeurodevelopmental DisordersMental DisordersCentral Nervous System DepressantsNeurodegenerative DiseasesMovement DisordersTic DisordersNervous System DiseasesCentral Nervous System DiseasesBrain Diseases

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-08-16
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06021522

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \>=6 to \>=18 years of age.
  2. * Participants enrolling from the study EBS-101-TD-301; completed all visits through Week 24 and days 7 and 14 safety follow-up, met relapse criteria during the double-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 weeks following the 301 baseline visit or participants who met relapse criteria will be eligible after completing early termination visit, Day 7 and Day 14 follow up visits.
  3. * Participants who completed the studies EBS-101-OL-001 or PSY302A.
  4. * The enrolling participant must have had clinical benefit from ecopipam and would benefit from continued participation.
  5. * Effective contraception during the study and 30 days after last study dose for sexually active participants
  6. * \<18 years of age participants parent/legal guardian must sign a written informed consent and participant must sign a written informed assent.
  7. * Participant must have TD based on Diagnostic and Statistical Manual for Mental Disorders - 5th Edition (DSM-5-TR diagnostic criteria) for TD.
  8. * TD diagnosis and both motor and vocal tics that cause impairment with normal routines
  1. * The participants who discontinued the studies PSY-302A, EBS-101-OL-001 or EBS-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 the sponsor.
  2. * Participants with ongoing or past history of neurological condition (example \[e.g.\], Huntington's disease, Parkinson's disease, Wilson's disease, stroke, Restless Legs Syndrome).
  3. * Any unstable mood disorder (DSM-5-TR criteria), mental illness or clinically significant lab abnormalities, moderate to severe renal or hepatic impairment, a PHQ-9 score \>=10 at screening and history of neuroleptic malignant syndrome at the time of screening or baseline.
  4. * Participants who completed the studies EBS-101-OL-001 or PSY-302A and who had previous exposure to ecopipam and oral neuroleptics within 4 weeks and depot neuroleptics within 3 months prior to screening, 6 months prior to Baseline.
  5. * Participants receiving any other medication to treat motor or vocal tics and anti-depressant or anti-anxiety medications.
  6. * Risk of suicide as per PI judgement
  7. * Pregnant or lactating women
  8. * Certain medications that would have unfavorable drug interactions with ecopipam, e.g., digoxin, fluoxetine, valproic acid, bupropion.
  9. * Current or recent (past 3 months) DSM-5-TR substance use disorder (with the exception of nicotine).
  10. * Recent behavioral therapy
  11. * 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)
  12. * Lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any other psychotic disorder.
  13. * Unable to swallow tablets.
  14. * Known hypersensitivity to any of ecopipam's excipients.
  15. * History of seizures (excluding febrile seizures that occurred \>2 years prior to Baseline).
  16. * Myocardial infarction within 6 months from Screening.

Contacts and Locations

Study Locations (Sites)

Harmonex, Inc.
Dothan, Alabama, 36303
United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
United States
Advanced Research Center
Anaheim, California, 92805
United States
CenExel CIT-IE
Bellflower, California, 90706
United States
Cortica Site Network
Glendale, California, 91203
United States
Cortica Site Network - San Rafael
San Rafael, California, 94903
United States
Yale School of Medicine
New Haven, Connecticut, 06519
United States
Childrens National Hospital
Washington, District of Columbia, 20010
United States
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, 32561
United States
Research in Miami Inc
Hialeah, Florida, 33013-3834
United States
University of Miami Miller School of Medicine
Miami, Florida, 33136
United States
Florida International Research Center
Miami, Florida, 33173
United States
Medical Research Group of Central Florida
Orange City, Florida, 32763
United States
APG Research, LLC
Orlando, Florida, 32803
United States
University of South Florida
St. Petersburg, Florida, 33701
United States
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, 33609
United States
Rare Disease Research, LLC
Atlanta, Georgia, 30329
United States
Lurie Children Hospital of Chicago
Chicago, Illinois, 60611
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Josephson-Wallack-Munshower Neurology
Indianapolis, Indiana, 46256
United States
University of Louisville Research Foundation Inc.
Louisville, Kentucky, 40202
United States
Kennedy Krieger Institute
Baltimore, Maryland, 21205
United States
Mass General Hospital
Boston, Massachusetts, 02114
United States
Boston Childrens Hospital
Boston, Massachusetts, 02115
United States
Umass Chan Medical School
Worcester, Massachusetts, 01655
United States
Michigan Clinical research Institute PC
Ann Arbor, Michigan, 48105
United States
Neurobahavioral Medicine Group
Bloomfield Hills, Michigan, 48302
United States
St. Louis Children's Hospital
St. Louis, Missouri, 63110
United States
Alivation Research
Lincoln, Nebraska, 68526
United States
University of Rochester
Rochester, New York, 14642
United States
OnSite Clinical Solutions LLC
Charlotte, North Carolina, 28211
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
National Childrens Hospital - The Ohio State University
Columbus, Ohio, 43205
United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130
United States
Providence Brain and Spine Institute
Portland, Oregon, 97225
United States
Coastal Pediatric Research
Charleston, South Carolina, 29414
United States
Access Clinical Trials, Inc.
Nashville, Tennessee, 37203-6502
United States
Access Clinical Trials, Inc.
Nashville, Tennessee, 37203
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2551
United States
UT Southwestern
Dallas, Texas, 75390
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
Road Runner Research, Ltd
San Antonio, Texas, 78249
United States
Cedar Clinical Research
Draper, Utah, 84020
United States
Core Clinical Research
Everett, Washington, 98201
United States

Collaborators and Investigators

Sponsor: Emalex Biosciences Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-16
Study Completion Date2027-03

Study Record Updates

Study Start Date2023-08-16
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Ecopipam
  • Neurodevelopmental Disorders
  • Mental Disorders
  • Central Nervous System Depressants
  • Neurodegenerative Diseases
  • Movement Disorders
  • Tic Disorders
  • Nervous System Diseases
  • Central Nervous System Diseases
  • Brain Diseases

Additional Relevant MeSH Terms

  • Tourette Syndrome