Guanfacine in Children With Tic Disorders

This study is ongoing, but not recruiting participants.
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: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Tourette Disorder
Tourette Syndrome
Drug: placebo
Drug: extended-release guanfacine (Intuniv)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Guanfacine in Children With Tic Disorders: A Multi-site Study

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Yale Global Tic Severity Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547000

Locations
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
Mount Sinai School of Medicine
University of South Florida
Shire
New York University
Investigators
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
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01547000     History of Changes
Other Study ID Numbers: 1004006635
Study First Received: March 1, 2012
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Yale University:
Tourette Syndrome
Tourette Disorder
Tics
Motor tics
Vocal tics
Intuniv
Guanfacine
Medication
Drug
Placebo
Child
Children
Adolescent

Additional relevant MeSH terms:
Disease
Syndrome
Tic Disorders
Tourette Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Mental Disorders Diagnosed in Childhood
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Pathologic Processes
Guanfacine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014