Guanfacine in Children With Tic Disorders
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|ClinicalTrials.gov Identifier: NCT01547000|
Recruitment Status : Completed
First Posted : March 7, 2012
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Tourette Disorder Tourette Syndrome||Drug: placebo Drug: extended-release guanfacine (Intuniv)||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Guanfacine in Children With Tic Disorders: A Multi-site Study|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
|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
- Yale Global Tic Severity Scale (YGTSS) [ Time Frame: 8 weeks ]The YGTSS is a clinician-rated scale that begins with a systematic inquiry of tic symptoms in the preceding week. Current motor and phonic tics are rated separately according to number, frequency, intensity, complexity, and interference, each rated on 0 to 5 scale with higher scores indicating greater severity/worse outcome (Leckman et al. 1989). The YGTSS yields a total motor score (0-25), a total phonic score (0-25), a total tic score (sum of total motor and total phonic scores; 0-50), and an impairment score (0-50). Higher scores indicate greater severity/worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|