Pivotal Study in Advanced Parkinsons Disease Patients

Exclusion Criteria

• •1. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
• •2. Dementia, as defined by a Mini-Mental State Exam score \< 24 at screening visit
• •3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders 4th edition 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 Electrocardiogram abnormalities at screening visit
• •7. Clinically significant hypotension and/or symptomatic orthostatic hypotension at screening or baseline visit
• •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 for at least one month prior to the screening visit and throughout the study period
• •12. Serum levels of Aspartate Aminotransferase (Serum Glutamic-Oxaloacetic Transaminase), Alanine Aminotransferase (Serum Glutamic Pyruvic Transaminase), alkaline phosphatases or bilirubin \> 2 Upper Limit of Normal
• •13. Patients with a creatinine clearance \< 50 millilitres/minute
• •14. Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit
• •15. Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
• •16. Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines
• •17. Flunarizine within 3 months prior to baseline visit
• •18. Known hypersensitivity to pramipexole or its excipients
• •19. Drug abuse according to investigators judgement, within 2 years prior to screening
• •20. Participation in other investigational drug studies, 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 visit