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
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Tracking Information | |||||||||||||
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First Submitted Date ICMJE | March 1, 2012 | ||||||||||||
First Posted Date ICMJE | March 7, 2012 | ||||||||||||
Results First Submitted Date ICMJE | January 15, 2018 | ||||||||||||
Results First Posted Date ICMJE | June 8, 2018 | ||||||||||||
Last Update Posted Date | June 8, 2018 | ||||||||||||
Study Start Date ICMJE | April 2012 | ||||||||||||
Actual Primary Completion Date | December 2016 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Yale Global Tic Severity Scale [ Time Frame: 8 weeks ] | ||||||||||||
Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | 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. |
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Phase 4 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||
Actual Enrollment ICMJE |
34 | ||||||||||||
Original Estimated Enrollment ICMJE |
42 | ||||||||||||
Actual Study Completion Date ICMJE | December 2016 | ||||||||||||
Actual Primary Completion Date | December 2016 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Years to 17 Years (Child) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
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 ICMJE | Not Provided | ||||||||||||
Responsible Party | Yale University | ||||||||||||
Study Sponsor ICMJE | Yale University | ||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Yale University | ||||||||||||
Verification Date | February 2018 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |