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NCT06021522
A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder
Conditions: Tourette Syndrome
Sex: All
Ages: 6 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 150
Sponsor: Emalex Biosciences Inc.
Location: Harmonex, Inc. Dothan Alabama
Summary
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 and \=18 years of age) with Tourette's Syndrome (TS).
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
* \2 years prior to Baseline).
* Myocardial infarction within 6 months from Screening.
Source: ClinicalTrials.gov (NCT06021522). StuddyBuddy aggregates publicly available trial information.