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Guanfacine in Children With Tic Disorders

NCT01547000 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-08-13

Study results available
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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).

Conditions

  • Tourette Disorder
  • Tourette Syndrome

Interventions

DRUG

placebo

Administered up to 8 weeks.

DRUG

extended-release guanfacine (Intuniv)

1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.

Sponsors & Collaborators

  • Icahn School of Medicine at Mount Sinai

    collaborator OTHER

  • University of South Florida

    collaborator OTHER

  • Shire

    collaborator INDUSTRY

  • New York University

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Lawrence D Scahill, MSN, PhD · Emory University

  • Barbara J Coffey, MD, MS · Icahn School of Medicine at Mount Sinai

  • Tanya Murphy, MD, MS · University of South Florida

  • Thomas Fernandez, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01547000 on ClinicalTrials.gov