Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Pramipexole; Placebo
Intervention description: Pramipexole ER 0.375 -4.5 mg; Placebo tablets identical to Pramipexole ER tablets
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: 391.0
Sex: All
Minimum age: 32 Years
Healthy volunteers: No

Summary:

      The general aim of this study is to obtain long-term safety and tolerability data on
      pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in
      patients who have previously completed a pramipexole double-blind study in advanced
      Parkinson's disease (PD) (248.525 trial).
    

Eligibility criteria:

        Inclusion criteria:

          1. Completion of the double-blind trial 248.525

          2. Male or female patient with advanced idiopathic Parkinson's disease (PD), with a
             Modified Hoehn and Yahr stage of 2 to 4 at on-time, and a concomitant treatment with
             standard or controlled release L-Dopa+, or a combination of L-Dopa+ and entacapone.

          3. Patient willing and able to comply with scheduled visits, treatment plan, laboratory
             tests and other study procedures. In particular the patient should be able to
             recognise the off-time and on-time periods during waking hours and the patient (or a
             family member or a guardian) should be able to record them accurately in the patient
             diary.

          4. Signed informed consent obtained before any study procedures are carried out (in
             accordance with International Conference of Harmonization - Good Clinical Practice
             (ICH-GCP) guidelines and local legislation).

        Exclusion criteria:

          1. Patients prematurely withdrawn from the double-blind trial 248.525

          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 (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. History of deep brain stimulation

          6. Clinically significant ECG abnormalities at baseline

          7. Clinically significant hypotension and/or symptomatic orthostatic hypotension at
             baseline

          8. Malignant melanoma or history of previously treated malignant melanoma

          9. Any other clinically significant disease, whether treated or not, that could put the
             patient at risk or could prevent compliance or completion of the study

         10. Pregnancy or breast-feeding

         11. Sexually active female of childbearing potential not using a medically approved method
             of birth control

         12. Serum levels of aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase
             (SGOT)), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase) (SGPT)),
             alkaline phosphatase (AP) or bilirubin > 2 upper limit normal (ULN) at baseline

         13. Patients with a creatinine clearance < 50 mL/min at baseline

         14. Any medication 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 visit: methylphenidate,
             cinnarizine, amphetamines

         16. Flunarizine within 3 months prior to baseline

         17. Known hypersensitivity to pramipexole or its excipients

         18. Drug abuse, according to investigators judgement, within 2 years prior to baseline

         19. Participation in investigational drug studies other than the trial 248.525, or use of
             other investigational drugs within one month or five times the half-life of the
             investigational drug (whichever is longer) prior to baseline