Guanfacine for Children with Tic Disorders: A Multi-Site Study

Primary Investigator: Thomas Fernandez, MD

The Yale Child Study Center is recruiting subjects for a study of a new extended-release form of guanfacine (Intuniv®) in the treatment of tics in children with a Chronic Tic Disorder.

Purpose of the Study

This pilot study, funded by Shire Pharmaceuticals, will occur at three sites across the United States. The sites include Yale University Child Study Center, Mount Sinai School of Medicine, and University of South Florida.

Study participants will be randomly assigned (like the flip of a coin) to the active treatment (guanfacine) or an inactive placebo (sugar pill).  Neither the participant nor the study doctor will know which treatment has been assigned. The assigned treatment will be provided free of charge for 8 weeks. During this 8-week period, participants will be return to the clinic every two weeks to meet with the study doctors.  Participants will be closely monitored for side effects and the medication dose may be reduced or discontinued at any time if necessary.

At the end of the initial 8-week period, the study doctors will make a judgment about whether the assigned treatment was helpful in reducing tic severity.  Participants who received guanfacine and had a decrease in tic severity will be offered an additional 8 weeks of treatment with guanfacine.   Participants who received placebo and had no change in tic severity will be given the option of trying the active medication for 8 weeks. Participation in this extension period requires 2-4 additional visits with the study doctors.

There are no costs associated with participation in this study.  Participants will be offered a small payment to help offset the cost of travel.

Eligible Children:

-              Children between 6 and 17 years old

-              Diagnosis of Tourette Disorder or a Chronic Tic Disorder (Chronic Motor Tic, Chronic Vocal Tic)

-              Not currently taking any stimulant medications or any medications for tics.

If you are interested in participating in this study or have further questions, please contact:

Thomas Fernandez          

Tel: (203) 677-0842