pramipexole pilot phase ii study in children and adolescents with tourette disorder according to dsm-iv criteria

Conditions: Tourette Syndrome

Summary: 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.


Eligibility criteria:
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.