Guanfacine in Children With Tic Disorders

Completed · Phase 4 · Has a placebo group

Conditions studied: Tourette Disorder, Tourette Syndrome

In brief

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).

Key facts

Study ID

NCT01547000

Run by

Yale University

People needed

34

Starts

2012-04-01

Expected to finish

2016-12-01

Last updated by the study team

2021-08-13

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Yale Child Study Center — New Haven, Connecticut, United States
• University of South Florida — Tampa, Florida, United States
• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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