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

A vizsgálat adatai

Ki végzi

Emalex Biosciences Inc.

Azonosító

NCT06021522EU 2023-503545-67-00

A regiszteradat frissítve

2026. július 22.

Eredeti leírás

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 teljes eredeti leírásKevesebb

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

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).

Bevonási feltételek: >=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.

Kizáró feltételek: 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; Certain medications that would have unfavorable drug interactions with ecopipam, e.g., digoxin, fluoxetine, valproic acid, bupropion; 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); History of seizures (excluding febrile seizures that occurred >2 years prior to Baseline); 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; Current or recent (past 3 months) DSM-5-TR substance use disorder (with the exception of nicotine); Lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any other psychotic disorder; Known hypersensitivity to any of ecopipam's excipients; Myocardial infarction within 6 months from Screening; 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; Risk of suicide as per PI judgement; Pregnant or lactating women; Unable to swallow tablets.

ClinicalTrials.gov NCT06021522 · EU CTIS 2023-503545-67-00