Guanfacine in Children With Tic Disorders

This study has been completed.

Sponsor:

Collaborators:

Icahn School of Medicine at Mount Sinai

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: January 23, 2017

Last verified: January 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

March 1, 2012

Last Updated Date

January 23, 2017

Start Date ^ICMJE

April 2012

Primary Completion Date

December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Yale Global Tic Severity Scale [ Time Frame: 8 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01547000 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

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

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

Enrollment ^ICMJE

Completion Date

December 2016

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

Sexes Eligible for Study:

All

Ages

6 Years to 17 Years (Child)

Accepts Healthy Volunteers

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

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

January 2017

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

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