Brief Title
Guanfacine in Children With Tic Disorders
Official Title
Guanfacine in Children With Tic Disorders: A Multi-site Study
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Yale Global Tic Severity Scale (YGTSS)
Condition
Tourette Disorder
Intervention
placebo
Study Arms / Comparison Groups
Inactive placebo
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
34
Start Date
April 2012
Completion Date
December 2016
Primary Completion Date
December 2016
Eligibility Criteria
Inclusion Criteria: - Diagnosis of Tourette Disorder or chronic motor or vocal tic disorder. - Between ages 6 yrs 0 mos and 17 years 0 months. - Weight >/= 15 kg (33 lbs). - Ability to swallow pills whole. Exclusion Criteria: - IQ < 80. - Positive pregnancy test. - Positive drug test. - Low blood pressure. - Prior history of hypersensitivity to guanfacine. - Prior failed treatment with an adequate trial of guanfacine in last 2 years. - Concurrent treatment with another psychoactive medication for tics, stimulant medication, or Habit Reversal therapy. - Medication for OCD, anxiety or depression will be allowed if dose is stable for 8 wks with no planned changes; SSRIs are allowed.
Gender
All
Ages
6 Years - 17 Years
Accepts Healthy Volunteers
No
Contacts
Lawrence D Scahill, MSN, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01547000
Organization ID
1004006635
Responsible Party
Sponsor
Study Sponsor
Yale University
Collaborators
Icahn School of Medicine at Mount Sinai
Study Sponsor
Lawrence D Scahill, MSN, PhD, Study Director, Emory University
Verification Date
August 2021