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

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).

Conditions

Tourette Syndrome

Study Overview

Study Details

Study overview

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).

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

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

Condition
Tourette Syndrome
Intervention / Treatment

-

Contacts and Locations

Dothan

Harmonex, Inc., Dothan, Alabama, United States, 36303

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202

Anaheim

Advanced Research Center, Anaheim, California, United States, 92805

Bellflower

CenExel CIT-IE, Bellflower, California, United States, 90706

Glendale

Cortica Site Network, Glendale, California, United States, 91203

San Rafael

Cortica Site Network - San Rafael, San Rafael, California, United States, 94903

New Haven

Yale School of Medicine, New Haven, Connecticut, United States, 06519

Washington

Childrens National Hospital, Washington, District of Columbia, United States, 20010

Gulf Breeze

NW FL Clinical Research Group, LLC, Gulf Breeze, Florida, United States, 32561

Hialeah

Research in Miami Inc, Hialeah, Florida, United States, 33013-3834

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * \>=6 to \>=18 years of age.
  • * 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.
  • * Participants who completed the studies EBS-101-OL-001 or PSY302A.
  • * The enrolling participant must have had clinical benefit from ecopipam and would benefit from continued participation.
  • * Effective contraception during the study and 30 days after last study dose for sexually active participants
  • * \<18 years of age participants parent/legal guardian must sign a written informed consent and participant must sign a written informed assent.
  • * Participant must have TD based on Diagnostic and Statistical Manual for Mental Disorders - 5th Edition (DSM-5-TR diagnostic criteria) for TD.
  • * TD diagnosis and both motor and vocal tics that cause impairment with normal routines
  • * 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.
  • * 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).
  • * 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.
  • * 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.
  • * Participants receiving any other medication to treat motor or vocal tics and anti-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 the exception 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 any other 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 to Baseline).
  • * Myocardial infarction within 6 months from Screening.

Ages Eligible for Study

6 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emalex Biosciences Inc.,

Study Record Dates

2027-03