CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 34 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
extended-release guanfacine (Intuniv) 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01547000
NCT01547000Phase 4Completed
CompareCT.gov

Guanfacine in Children With Tic Disorders: A Multi-site Study

Yale University·interventional·Posted Mar 7, 2012·Updated Aug 13, 2021

In Brief

A Phase 4 clinical trial evaluating placebo and extended-release guanfacine (Intuniv) for Tourette Disorder and Tourette Syndrome. Completed, enrolled 34 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTourette Disorder, Tourette Syndrome
CountriesUnited States
CollaboratorsIcahn School of Medicine at Mount Sinai, University of South Florida, Shire, New York University

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 7, 2012
Enrollment StartApr 1, 2012
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 14.3 years ago

Interventions

placebodrug

Administered up to 8 weeks.

extended-release guanfacine (Intuniv)drug

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