Guanfacine in Children With Tic Disorders

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: Icahn School of Medicine at Mount Sinai; New York University; Shire; University of South Florida
• Treatments: Guanfacine

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.