NCT01133353

A Study of the Effectiveness and Safety of Tetrabenazine MR in Pediatric Subjects With Tourette's Syndrome

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tetrabenazine MR in Subjects Aged 5 up to 17 Years With Tourette's Syndrome

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to study the therapeutic effect of tetrabenazine MR in children with Tourette's Syndrome, as measured by the improvement in total tic score of the Yale Global Tic Severity Scale (YGTSS).

Detailed description

Tourette's Syndrome (TS) is typically diagnosed in early childhood (6-7 years) or before the age of 21 years and is characterized by chronic, intermittent motor and phonic tics. There is a body of evidence, mostly from the clinical experience data, suggesting the efficacy of tetrabenazine in TS patients with tics, including patients who were unresponsive to other treatment options. These publications consistently report the usefulness of tetrabenazine as an alternative to conventional neuroleptics for the treatment of TS.

Conditions

• Tourette's Syndrome

Interventions

Type	Name	Description
DRUG	Tetrabenazine MR	Modified-Release (MR) tablets containing 15 mg or 30 mg tetrabenazine, dose-escalating up to a maximum of 150 mg depending on weight, once per day for 12 weeks
DRUG	Placebo	1 to 5 tablets once per day depending on weight for 12 weeks

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2010-05-28
• Last updated: 2019-11-29