Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria

A Randomized, Double-blind, Placebo-controlled, Flexible Dose Study to Evaluate Efficacy and Safety of Pramipexole Immediate Release (0.125-0.5mg/Day) Versus Placebo for 6 Weeks in Children and Adolescents (Age 6-17 Inclusive) Diagnosed With Tourette Disorder According to DSM IV Criteria.

A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and safety of Pramipexole versus placebo for 6 weeks in children (age 6-17) diagnosed with Tourette Disorder according to DSM IV criteria. The primary efficacy measure will be the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) at 6 weeks.

Inclusion Criteria:

• Male of female patients 6-17 yrs.
• Written informed consent.
• Diagnosed with Tourette's Disorder with a > or equal to 22 on the Total Tic Score at baseline.
• Diagnosed with Tourette's Disorder when administering the Diagnostic Interview Schedule for Children.
• Having at least 1 tic/day.
• Women of childbearing age must have a negative serum pregnancy test at screening and must use a medically accepted contraceptive method.
• Either a newly diagnosed patient or a patient diagnosed with Tourette's Disorder who can safely discontinue treatment.
• Having a body weight of > or equal to 20 kg (44 lbs).

Exclusion Criteria:

• Any women of childbearing age having a positive serum pregnancy test at screening.
• Patients who have clinically significant renal disease or serum creatinine greater than 1.0 mg/dL at screening.
• Lab results at screening: hemoglobin below lower limit of normal which is determined to be clinically significant; Thyroid Stimulating Hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significant; clinically significant abnormalities in labs.
• Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease which would preclude the patient from participating in this study.
• History of Schizophrenia or any psychotic disorder, history of mental disorders or any present Axis I psychiatric disorder according to Diagnostic and Statistic Manual of Mental Disorders Fourth Edition (DSM-IV) requiring any medical therapy except for patients with a diagnosis of attention deficit hyperactivity disorder (ADHD) or obsessive-compulsive disorder (OCD) who are not on therapy.
• History of/or clinical signs of epilepsy or seizures other than fever related seizures in early childhood.
• History of/or clinical signs of any malignant neoplasm.
• Allergic response to pramipexole.
• Had previous treatment with dopamine agonists other than pramipexole within 14 days prior to baseline visit.
• Had any other medical treatment for Tourette's Disorder besides the study medication within 28 days prior to baseline visit.
• Had withdrawal symptoms of any medication at screening or at the baseline visit.
• Having a Kaufman Brief Intelligence Test (KBIT IQ) score <70 at screening.
• Having a children's Yale-Brown obsessive-compulsive scale (CY-BOCS) score of >15 at baseline.
• Patients who meet criteria for Restless Legs Syndrome and or Periodic Limb Movement disorder.
• Patients with severe asthma.
• Patients that have initiated psychotherapy for Tourette's Disorder, OCD or ADHD within 3 mths of starting the trial.
• Patients receiving psychological, cognitive and/or behavioral treatments greater than 3 mths prior to start of trial for Tourette's Disorder, OCD, and/or ADHD who will have changes in treatment plan.