Guanfacine in Children With Tic Disorders
|Tourette Disorder Tourette Syndrome||Drug: placebo Drug: extended-release guanfacine (Intuniv)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Guanfacine in Children With Tic Disorders: A Multi-site Study|
- Yale Global Tic Severity Scale [ Time Frame: 8 weeks ]
|Study Start Date:||April 2012|
|Study Completion Date:||December 2016|
|Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Inactive 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547000
|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|
|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|