Guanfacine in Children With Tic Disorders

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-12-31

Brief Summary

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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).

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Detailed Description

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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

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Tourette Disorder Tourette Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Inactive placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Administered up to 8 weeks.

Extended-release Guanfacine

Group Type EXPERIMENTAL

extended-release guanfacine (Intuniv)

Intervention Type DRUG

1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.

Interventions

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placebo

Administered up to 8 weeks.

Intervention Type DRUG

extended-release guanfacine (Intuniv)

1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.

Intervention Type DRUG

Other Intervention Names

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Intuniv

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No