Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Placebo; Pramipexole
Intervention description: Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.; ER 0.375-4,5 mg
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: 511.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      The general aim of this study is to obtain long-term safety and tolerability data on
      pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have
      previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or
      248.636(NCT00558025) trial).
    

Eligibility criteria:

        Inclusion criteria:

          1. Completion of the double-blind trial 248.524 or 248.636

          2. Male or female patient with early idiopathic Parkinson´s disease (PD), and with a
             Modified Hoehn and Yahr stage of I to III.

          3. Patient willing and able to comply with scheduled visits, treatment plan, laboratory
             tests and other study procedures.

          4. Signed informed consent obtained before any study procedures are carried out (in
             accordance with International Conference on Harmonisation (ICH) - Good Clinical
             Practice (GCP) guidelines and local legislation).

        Exclusion criteria:

          1. Patients prematurely withdrawn from the double-blind trials 248.524 or 248.636.

          2. Atypical parkinsonian syndromes due to drugs,metabolic disorders, encephalitis or
             degenerative diseases.

          3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental
             Disorders, fourth edition (DSM-IV) criteria that could prevent compliance or
             completion of the study and/or put the patient at risk if he/she takes part in the
             study.4.History of psychosis, except history of drug induced hallucinations.

        5. Clinically significant electrocardiogram (ECG) abnormalities at baseline. 6.Clinically
        significant hypotension 7.Malignant melanoma or history of previously treated malignant
        melanoma. 8.Any other clinically significant disease, that could put the patient at risk or
        could prevent compliance or completion of the study. 9. Pregnancy or breast-feeding.

        10. Sexually active female of childbearing potential not using a medically approved method
        of birth control for at least one month prior to the baseline and throughout the study.11
        Serum levels of aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT)
        (SGPT), alkaline phosphatase or bilirubin > 2 upper limit of normal (ULN) at baseline 12.
        Patients with a creatinine clearance < 50 mL/min (estimated by the Cockcroft and Gault
        formula). 13. Motor complications under levodopa therapy (e.g. on-off phenomena,
        dyskinesia) at baseline.

        14. Any medication (including intra-muscular formulations) with central dopaminergic
        antagonist activity within 4 weeks prior to the baseline visit. 15.Any of the following
        drugs within 4 weeks prior to baseline: methylphenidate, cinnarizine, amphetamines. 16.
        Flunarizine within 3 months prior to baseline.

        17. Known hypersensitivity to pramipexole or its excipients. 18. Drug abuse (including
        alcohol), according to investigator´s judgement, within 2 years prior to baseline.

        19. Participation in investigational drug studies other than trials 248.524 and 248.636 or
        use of other investigational drug within one month or five times the half-life of the
        investigational drug prior to baseline.