Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: pramipexole 0.125 mg BID; pramipexole 0.0625 mg QD; pramipexole 0.125 mg TID; pramipexole 0.25 mg BID; pramipexole 0.0625 mg BID
Intervention description: titrated dose for those patients whose symptoms were not controlled on the 0.0625 mg BID dose; dose down titrated for those patients unable to tolerate the 0.0625 mg BID dosing; titrated up for those patients whose symptoms were not adequately controlled on 0.125 mg BID dose; titrated for those patients whose symptoms were not adequately controlled on 0.125 mg TID dose; 0.0625 mg BID given for first 4 wks of treatment
Intervention MeSH terms: Pramipexole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The primary objective of this open-label, flexible dose study is to assess the safety and
      efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years
      inclusive) diagnosed with Tourette Syndrome according to Diagnostic and Statistical Manual of
      Mental Disorders, 4th Edition (DSM-IV) criteria and who have completed either Study 248.641
      (NCT 00681863) or 248.644 (NCT 00558467).
    

Eligibility criteria:

        Inclusion criteria

          1. Male or female patients aged 6-17 years at the time of enrollment into study 248.641
             or 248.644 and who have completed study 248.641 or 248.644.

          2. Written informed consent provided by the patient's parent (or legal guardian) and
             assent provided by the patient consistent with International Conference on
             Harmonization (ICH) Good Clinical Practice (GCP) and local Institutional Review Board
             (IRB) requirements for children obtained prior to any study procedures being
             performed.

          3. Ability and willingness to comply with study treatment regimen and to complete study
             assessments.

          4. Females of childbearing potential having a negative serum pregnancy test at Visit 1.

          5. Females of childbearing potential must be using a medically accepted contraceptive
             method throughout the study. Acceptable methods of birth control are limited to:
             Intra-Uterine Device (IUD), oral, implantable, injectable contraceptives or estrogen
             patch, double barrier method (spermicide + diaphragm), or abstinence at the discretion
             of the investigator

        Exclusion criteria

          1. Breastfeeding females.

          2. Development of any clinical condition in the preceding trial that in the
             investigator's opinion could be worsened by treatment with pramipexole.

          3. Clinically significant renal disease or serum creatinine out of this range: 0.3 1.0
             mg/dL for patients aged 3-12 years and 0.5-1.4 mg/dL for patients aged 13+ years.

          4. Any of the following lab results at screening:

             Hemoglobin (Hgb) below lower limit of normal (LLN) which is determined to be
             clinically significant Basal thyroid stimulating hormone (TSH), triiodothyronine (T3)
             or thyroxine (T4) clinically significant (at the investigator's discretion) out of
             normal range at screening (if not caused by substitution therapy according the
             investigator's opinion) Patients with any clinically significant abnormalities in
             laboratory parameters at screening at the investigator's discretion.

          5. Other clinically significant metabolic-endocrine, hematological, gastrointestinal
             disease, or pulmonary disease (such as severe asthma) in the opinion of the
             investigator that would preclude the patient from participating in this study.

          6. History or presence of schizophrenia or any psychotic disorder. History or presence of
             any psychiatric disorder requiring medical therapy with the exception for patients
             with a diagnosis of Tourette Syndrome (TS), Attention Deficit Hyperactivity Disorder
             (ADHD) or Obsessive Compulsive Disorder (OCD) who are not on therapy other than
             pramipexole.

          7. History or presence of clinical signs of epilepsy or seizures other than fever-related
             seizures in early childhood.

          8. History or presence of clinical signs of any malignant neoplasm including suspicious
             undiagnosed skin lesion (which may be melanoma), melanoma, or a history of melanoma.

          9. History of any other medical treatment for TS besides the study medication within 28
             days prior to the baseline visit (14 days prior to baseline for guanfacine, 14 days
             prior to baseline for dopamine agonists, 14 days prior to baseline for L-Dopa, 35 days
             prior to baseline for fluoxetine).

         10. Patients receiving psychotherapy are excluded unless they started the treatment at
             least 3 months prior to starting the trial and no changes in treatment are planned for
             the duration of the study.

         11. Allergic response to pramipexole or the inactive ingredients in its tablet
             formulation.

         12. Non-compliance with study medication (defined as less than 80% or more than 120%)
             during the preceding Study 248.641 or 248.644.

         13. Concurrent participation in another clinical trial using any investigational drug
             since completion of the preceding Study 248.641 or 248.644.

         14. Any other conditions, that in the opinion of the investigator, would interfere with
             the evaluation of the results or constitute a health hazard for the patient.