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Guanfacine in Children With Tic Disorders

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ClinicalTrials.gov Identifier: NCT01547000
Recruitment Status : Completed
First Posted : March 7, 2012
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
University of South Florida
Shire
New York University
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE March 1, 2012
First Posted Date  ICMJE March 7, 2012
Results First Submitted Date  ICMJE January 15, 2018
Results First Posted Date  ICMJE June 8, 2018
Last Update Posted Date June 8, 2018
Study Start Date  ICMJE April 2012
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2012)
Yale Global Tic Severity Scale [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Guanfacine in Children With Tic Disorders
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Tourette Disorder
  • Tourette Syndrome
Intervention  ICMJE
  • Drug: placebo
    Administered up to 8 weeks.
  • Drug: extended-release guanfacine (Intuniv)
    1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.
    Other Name: Intuniv
Study Arms  ICMJE
  • Placebo Comparator: Inactive placebo
    Intervention: Drug: placebo
  • Experimental: Extended-release Guanfacine
    Intervention: Drug: extended-release guanfacine (Intuniv)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2017)
34
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2012)
42
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01547000
Other Study ID Numbers  ICMJE 1004006635
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE
  • Icahn School of Medicine at Mount Sinai
  • University of South Florida
  • Shire
  • New York University
Investigators  ICMJE
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
PRS Account Yale University
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP