Guanfacine in Children With Tic Disorders

This study is currently recruiting participants.
Verified March 2014 by Yale University
Sponsor:
Collaborators:
Mount Sinai School of Medicine
University of South Florida
Shire
New York University
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01547000
First received: March 1, 2012
Last updated: March 19, 2014
Last verified: March 2014

March 1, 2012
March 19, 2014
April 2012
December 2014   (final data collection date for primary outcome measure)
Yale Global Tic Severity Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01547000 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Guanfacine in Children With Tic Disorders
Guanfacine in Children With Tic Disorders: A Multi-site Study

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Tourette Disorder
  • Tourette Syndrome
  • 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
  • Placebo Comparator: Inactive placebo
    Intervention: Drug: placebo
  • Experimental: Extended-release Guanfacine
    Intervention: Drug: extended-release guanfacine (Intuniv)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
6 Years to 17 Years
No
Contact: Lawrence D Scahill, MSN, PhD lawrence.scahill@emory.edu
United States
 
NCT01547000
1004006635
Yes
Yale University
Yale University
  • Mount Sinai School of Medicine
  • University of South Florida
  • Shire
  • New York University
Study Director: Lawrence D Scahill, MSN, PhD Emory University
Principal Investigator: Barbara J Coffey, MD, MS Mount Sinai School of Medicine
Principal Investigator: Tanya Murphy, MD, MS University of South Florida
Principal Investigator: Thomas Fernandez, MD Yale University
Yale University
March 2014

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