- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01547000
Guanfacine in Children With Tic Disorders
Guanfacine in Children With Tic Disorders: A Multi-site Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale Child Study Center
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Florida
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Tampa, Florida, United States, 33612
- University of South Florida
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New York
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New York, New York, United States, 10029
- Mount Sinai School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Inactive placebo
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Administered up to 8 weeks.
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Experimental: Extended-release Guanfacine
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1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Disease
- Tourette Syndrome
- Tic Disorders
- Tics
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Guanfacine
Other Study ID Numbers
- 1004006635
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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