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Search / Trial NCT01547000

Guanfacine in Children With Tic Disorders

Launched by YALE UNIVERSITY · Mar 6, 2012

Trial Information

Current as of June 24, 2025

Completed

Keywords

Tourette Syndrome Tourette Disorder Tics Motor Tics Vocal Tics Intuniv Guanfacine Medication Drug Placebo Child Children Adolescent

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

  • 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.

About Yale University

Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.

Locations

Tampa, Florida, United States

New York, New York, United States

New Haven, Connecticut, United States

New York, New York, United States

New Haven, Connecticut, United States

Patients applied

0 patients applied

Trial Officials

Lawrence D Scahill, MSN, PhD

Study Director

Emory University

Barbara J Coffey, MD, MS

Principal Investigator

Icahn School of Medicine at Mount Sinai

Tanya Murphy, MD, MS

Principal Investigator

University of South Florida

Thomas Fernandez, MD

Principal Investigator

Yale University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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