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

Bausch Health Americas, Inc.0 sitesMarch 2011

ConditionsTourette's Syndrome

InterventionsTetrabenazine MR Placebo

DrugsTetrabenazine MR Placebo

Overview

Phase: Phase 2
Intervention: Tetrabenazine MR
Conditions: Tourette's Syndrome
Sponsor: Bausch Health Americas, Inc.
Primary Endpoint: Improvement in total tic score as measured by the Yale Global Tic Severity Score (YGTSS)
Status: Withdrawn
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

December 2011

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bausch Health Americas, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must meet all of the following criteria:
•Children aged 5 to up to 17 years
•Subjects must be capable of providing informed consent or assent, if applicable, and parents/legal guardian must be capable of providing informed consent/permission and complying with study procedures
•Subject and parents/legal guardian must be able to communicate effectively with Investigator and study coordinator
•Diagnosed with Tourette's Syndrome, according to DSM-IV-TR and using K-SADS-PL to aid diagnosis, and requiring drug therapy
•Total tic score ≥ 22 as measured by YGTSS at screening and baseline
•Total body weight ≥ 15 kg (33 lbs.)
•Tics are causing distress or impairment, as determined by parent/legal guardian or subject and by the Investigator, despite current treatment regimen
•Able to swallow whole tablets without difficulty
•Non-pregnant status:

Exclusion Criteria

•Subjects are not eligible if any of the following criteria are met:
•Subjects with history or current major depressive disorder
•Prior treatment with \> 7 doses of tetrabenazine
•Prior treatment with reserpine
•Subjects with impaired renal function (defined as having a creatinine level of ≥ 1.5 times the upper limit of age-appropriate normal value)
•Subjects with current or any history of suicidal ideation
•Participation in an investigational medication trial within the 3 months prior to the Screening visit, except for study BVF-018-102
•Use of Botox® (botulinum toxin) within the 4 months prior to the Screening visit
•Immediate families of site Investigators or sponsor employees
•Excluding conditions related directly to the disease under study, subject has a history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.

Arms & Interventions

Tetrabenazine MR

Intervention: Tetrabenazine MR

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Improvement in total tic score as measured by the Yale Global Tic Severity Score (YGTSS)

Time Frame: Days 0 to 84

Secondary Outcomes

To explore the therapeutic effects of tetrabenazine using the full YGTSS(Days 0 to 84)
To evaluate the safety and tolerability of tetrabenazine using cognitive measures(Days 0 and 84)
To evaluate the safety and tolerability of tetrabenazine using an assessment of depression(Days 0 to 84)
To evaluate the safety and tolerability of tetrabenazine using an assessment of suicidality(Days 0 to 91)
To explore the therapeutic effects of tetrabenazine using the Patient Global Impression of Change scale (PGI-C)(Days 0 to 84)
To explore the therapeutic effects of tetrabenazine using the Clinical Global Impression of Severity scale (CGI-S)(Days 0 to 84)