Clinical trial NCT01547000: Guanfacine in Children With Tic Disorders
Official title: Guanfacine in Children With Tic Disorders: A Multi-site Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tourette Disorder
Tourette Syndrome
Keywords: Tourette Syndrome
Tourette Disorder
Tics
Motor tics
Vocal tics
Intuniv
Guanfacine
Medication
Drug
Placebo
Child
Children
Adolescent
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: University of South Florida
name: Shire
name: New York University
First posted: 2012-03-07
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Emory University
name: Lawrence D Scahill, MSN, PhD
role: STUDY_DIRECTOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Barbara J Coffey, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Tanya Murphy, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Thomas Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
References: