Overview

This trial is active, not recruiting.

Conditions tourette disorder, tourette syndrome
Treatments placebo, extended-release guanfacine (intuniv)
Phase phase 4
Sponsor Yale University
Collaborator Icahn School of Medicine at Mount Sinai
Start date April 2012
End date December 2016
Trial size 42 participants
Trial identifier NCT01547000, 1004006635

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
placebo
Administered up to 8 weeks.
(Experimental)
extended-release guanfacine (intuniv) Intuniv
1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.

Primary Outcomes

Measure
Yale Global Tic Severity Scale
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 6 years up to 17 years old.

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.

Additional Information

Official title Guanfacine in Children With Tic Disorders: A Multi-site Study
Principal investigator Barbara J Coffey, MD, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Yale University.