Trial Information

Summary: A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and safety of Pramipexole IR (0.125-0.5 mg/day) versus placebo for 6 weeks in children and adolescents (age 6-17 inclusive) diagnosed with Tourette's Disorder according to DSM IV criteria

The purpose of this research study is to see if a medication called pramipexole (also called Mirapex®) is safe and helpful for children suffering from TD. Although pramipexole (PPX) is approved by the FDA for the treatment of Parkinson's disease as well as moderate to severe Restless Leg Syndrome (RLS) in adults, it has never been tested for the treatment of children and adults diagnosed with TD. The study will last up to 10 weeks and will consist of a screening period of up to four weeks to see if the study is appropriate for your child, followed by six weeks of treatment with PPX or placebo (pills without medication), and a taper period of three days to gradually stop the medication. There is a one out of three chance your child will receive placebo instead of PPX. This means that for every three children who get medication, one of these children will get the placebo. Neither you, your child, nor the study doctor will know whether your child is receiving PPX or placebo until the study is over (possibly the end of year 2008). However, the information is available if there is a medical emergency, and the information is necessary for your child's medical care. There will be four different daily doses tested in this study: 0.125, 0.25, 0.375, and 0.5 mg. Your child will start on 0.0625 mg twice a day, and from there the study doctor may increase or decrease the dose between those options depending on how your child feels. Transportation expenses will be reimbursed. Additionally, as a follow-up to the study, all participants will receive three months of standard treatment for TD at no cost.

Patient Inclusion Criteria:

• Able to understand the study and follow study procedures
• Children and adolescents ages of 6-17
• In good physical health and have a weight of at least 44 pounds
• Sexually active females of childbearing potential who are using a medically acceptable form of birth control
• Diagnosis of TD or experiencing symptoms (motor and/or vocal tics) regularly for at least one year
• If receiving psychotherapy, participants should have been doing so for more than three consecutive months

Patient Exclusion Criteria:

• Medical conditions that would contraindicate participation
• Psychiatric disorders or symptoms that would contraindicate participation
• Using medications prohibited in study
• Pregnant or nursing females

If you would like to learn more about participating in this study, please send an e-mail message using the form below.