Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome
Intervention: pramipexole immediate release (IR); Placebo
Intervention MeSH terms: Pramipexole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

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.