Conditions: Tourette Disorder Tourette Syndrome
Keywords: Tourette Syndrome Tourette Disorder Tics Motor tics Vocal tics Intuniv Guanfacine Medication Drug Placebo Child Children Adolescent
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 34
Healthy volunteers: no

Brief summary:
The goal of this pilot study is to obtain preliminary information on the tolerability and efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette Disorder (TD, also called Tourette syndrome).

Detailed description:
Guanfacine is commonly used for the treatment of tics in children with Tourette Disorder, but neither the immediate release compound nor the new extended release formulation have been evaluated for tics as a primary outcome. This pilot study is not designed to demonstrate efficacy of extended release guanfacine in the treatment of tics in children with TD. Rather, the goal of this trial is to determine whether extended release guanfacine warrants further study in a large scale trial. Immediate-release guanfacine is frequently used in children with TD, but dosing, time to effect and adverse effects with the new extended release guanfacine are unknown. The use of placebo in this trial reduces bias in the measurement of outcomes because it ensures blindness in the parent and clinician ratings.

This is a three-site, investigator-initiated, randomized, double-blind, placebo-controlled, parallel-group study. Subjects who show a positive response to extended release guanfacine in the 8-week double-blind phase will continue on the the drug in an 8-week extension phase. Subjects who are randomly assigned to placebo and do not show improvement will be offered 8-weeks of open-label treatment with Intuniv.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: placebo intervention 2: extended-release guanfacine (Intuniv)
Intervention descriptions: intervention 1: Administered up to 8 weeks. intervention 2: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.

Protocol document: