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

Launched by EMALEX BIOSCIENCES INC. · Aug 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety of ecopipam tablets in individuals with Tourette's Disorder, which is a condition that causes involuntary movements and sounds called tics. The trial is open to children aged 6 to 12, adolescents aged 12 to 18, and adults aged 18 and older, who have previously participated in certain studies and found ecopipam helpful. Participants must have a diagnosis of Tourette's based on specific guidelines and should have experienced tics that disrupt their daily life.

If you or a loved one are eligible and decide to participate, you can expect to take the ecopipam tablets over an extended period while being closely monitored for any side effects or issues related to the medication. It's important to note that individuals with certain medical conditions or who are taking specific medications may not qualify for the study. Additionally, parents or guardians will need to provide written consent for minors participating in the trial. This study aims to gather important information that could help improve treatment options for Tourette's Disorder in the future.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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.