Guanfacine in Children With Tic Disorders

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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