NCT04007991

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Emalex Biosciences Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Tourette Syndrome

Interventions

Type	Name	Description
DRUG	Ecopipam	Ecopipam HCI tablets administered PO to establish 2 mg/kg/day
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2019-06-28
• Primary completion: 2021-09-23
• Completion: 2021-09-23
• First posted: 2019-07-05
• Last updated: 2023-10-04
• Results posted: 2023-10-04

Locations

70 sites across 5 countries: United States, Canada, France, Germany, Poland

Regulatory

• FDA-regulated drug study