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

2014-08-27 03:13:20 | BioPortfolio

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).

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Tourette's Syndrome

Intervention

Tetrabenazine MR, Placebo

Status

Not yet recruiting

Source

Biovail Laboratories International SRL

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:20-0400

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Medical and Biotech [MESH] Definitions

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Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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