NCT01547000

Guanfacine in Children With Tic Disorders

Guanfacine in Children With Tic Disorders: A Multi-site Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tourette Disorder
• Tourette Syndrome

Interventions

Type	Name	Description
DRUG	placebo	Administered up to 8 weeks.
DRUG	extended-release guanfacine (Intuniv)	1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.

Timeline

• Start date: 2012-04-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2012-03-07
• Last updated: 2021-08-13
• Results posted: 2018-06-08

Locations

3 sites across 1 country: United States