drugset / Trial / NCT05615220

Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults

NCT05615220

Phase 3 Completed 216 enrolled Emalex Biosciences Inc.
RandomizedSequentialTriple-blindTreatment

Summary

This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period.

Timeline

Start
2023-01-31
Primary completion
2025-01-13
Completion
2025-02-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ecopipam Small molecule 1.8 mg/kg Oral

Indications