Trial intelligence / Profile preview

Tetrabenazine MR in Children with Tourette's Syndrome

NCT01133353Phase 2

Key facts

Status: Withdrawn
Start: Mar 2011
Primary completion: Nov 2011
Sponsor: Valeant Pharmaceuticals
Modality: Small Molecules

Drugs: tetrabenazine
Conditions: Tourette syndrome (TS)

Overview

Phase 2, randomised, double-blind trial in Tourette syndrome (TS) comparing Tetrabenazine MR with Placebo (2 arms). Primary endpoint: Yale Global Tic Severity Scale Total Tic Score. Planned start Mar 2011; status: withdrawn.

Design

2 arms

Study design: RandomizedDouble-blind

Tetrabenazine MR
Tetrabenazine MR tablets, dose-escalating up to 150 mg/day
Placebo
Placebo tablets matching Tetrabenazine MR

Who it enrols

Children aged 5-17 with Tourette's Syndrome and a total tic score >= 22, weighing >= 15 kg. Excludes patients with major depressive disorder, suicidal ideation, renal/hepatic impairment, or prior treatment with > 7 doses of tetrabenazine.

Endpoints

Primary

Yale Global Tic Severity Scale Total Tic ScoreDays 0 to 84

Secondary

Cognitive Measures for Safety and TolerabilityDays 0 and 84
Assessment of DepressionDays 0 to 84
Assessment of SuicidalityDays 0 to 91
Full Yale Global Tic Severity ScaleDays 0 to 84
Patient Global Impression of ChangeDays 0 to 84
Clinical Global Impression of SeverityDays 0 to 84

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