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

Tourette's Syndrome Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01133353
Study type Interventional
Source Bausch Health Americas, Inc.
Contact
Status Withdrawn
Phase Phase 2
Start date March 2011
Completion date December 2011
View Details
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