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Guanfacine in Children With Tic Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01547000
Recruitment Status : Completed
First Posted : March 7, 2012
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Icahn School of Medicine at Mount Sinai
University of South Florida
New York University
Information provided by (Responsible Party):
Yale University

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).

Condition or disease Intervention/treatment Phase
Tourette Disorder Tourette Syndrome Drug: placebo Drug: extended-release guanfacine (Intuniv) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Guanfacine in Children With Tic Disorders: A Multi-site Study
Study Start Date : April 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Inactive placebo Drug: placebo
Administered up to 8 weeks.

Experimental: Extended-release Guanfacine Drug: extended-release guanfacine (Intuniv)
1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.
Other Name: Intuniv

Primary Outcome Measures :
  1. Yale Global Tic Severity Scale (YGTSS) [ Time Frame: 8 weeks ]
    The YGTSS is a clinician-rated scale that begins with a systematic inquiry of tic symptoms in the preceding week. Current motor and phonic tics are rated separately according to number, frequency, intensity, complexity, and interference, each rated on 0 to 5 scale with higher scores indicating greater severity/worse outcome (Leckman et al. 1989). The YGTSS yields a total motor score (0-25), a total phonic score (0-25), a total tic score (sum of total motor and total phonic scores; 0-50), and an impairment score (0-50). Higher scores indicate greater severity/worse outcome.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01547000

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United States, Connecticut
Yale Child Study Center
New Haven, Connecticut, United States, 06510
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Yale University
Icahn School of Medicine at Mount Sinai
University of South Florida
New York University
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Study Director: Lawrence D Scahill, MSN, PhD Emory University
Principal Investigator: Barbara J Coffey, MD, MS Icahn School of Medicine at Mount Sinai
Principal Investigator: Tanya Murphy, MD, MS University of South Florida
Principal Investigator: Thomas Fernandez, MD Yale University
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Responsible Party: Yale University Identifier: NCT01547000    
Other Study ID Numbers: 1004006635
First Posted: March 7, 2012    Key Record Dates
Results First Posted: June 8, 2018
Last Update Posted: June 8, 2018
Last Verified: February 2018
Keywords provided by Yale University:
Tourette Syndrome
Tourette Disorder
Motor tics
Vocal tics
Additional relevant MeSH terms:
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Tourette Syndrome
Tic Disorders
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs