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Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents — D1AMOND  

Tourette Syndrome Clinical Trial

Official title:
Multicenter, Placebo-Controlled, Double-Blind, Randomized, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Ecopipam in Children and Adolescents With Tourette's Syndrome

Clinical Trial Summary

This study evaluates the effect of ecopipam tablets in children and adolescents in the treatment of Tourette's Syndrome (TS). Half of the participants will receive ecopipam tablets, while the other half will receive matching placebo tablets

Clinical Trial Description

Multicenter, placebo-controlled, double-blind, randomized, parallel-group, Phase 2b study in pediatric subjects (aged greater than equal to 6 to less than 18 years of age) with TS. Following a 28-day Screening period and Baseline visit, eligible subjects will be randomized 1:1 to receive either ecopipam hydrochloride (HCl) or matching placebo for a 12 week treatment period. Doses will be titrated up and down from target dose of 2 mg/kg/day. Follow Up visit will be conducted after the last dose of study medication. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04007991
Study type Interventional
Source Emalex Biosciences Inc.
Contact
Status Completed
Phase Phase 2
Start date June 28, 2019
Completion date September 23, 2021
View Details
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