Guanfacine in Children With Tic Disorders

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 effects with the new extended release
guanfacine are unknown. The use of placebo in this trial reduces bias in the measurement of
outcomes because it ensures blindness in the parent and clinician ratings.

This is a three-site, investigator-initiated, randomized, double-blind, placebo-controlled,
parallel-group study. Subjects who show a positive response to extended release guanfacine in
the 8-week double-blind phase will continue on the the drug in an 8-week extension phase.
Subjects who are randomly assigned to placebo and do not show improvement will be offered
8-weeks of open-label treatment with Intuniv.

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.