Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease

Exclusion Criteria

• •1. Motor complications under levodopa therapy at V1.
• •2. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
• •3. Dementia, as defined by a Mini-Mental State Exam score \< 24 at V1
• •4. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
• •5. History of psychosis, except history of drug induced hallucinations
• •6. Clinically significant electrocardiogram (ECG) abnormalities at V1.
• •7. Clinically significant hypotension either at screening visit or at baseline visit.
• •8. Malignant melanoma or history of previously treated malignant melanoma.
• •9. Any other clinically significant disease
• •10. Pregnancy or breast-feeding.
• •11. Sexually active female of childbearing potential
• •12. Serum levels of Aspartate Aminotransferase (Serum Glutamic Oxaloacetic Transaminase) (AST (SGOT)), Alanine Aminotransferase (Serum Glutamate Pyruvate Transaminase) (ALT (SGPT)), alkaline phosphatases or bilirubin \> 2 Upper Limit of Normal (ULN) (on screening lab test).
• •13. Patients with a creatinine clearance \< 50 mL/min
• •14. Any dopamine agonist (except pramipexole IR) within three months prior to baseline visit.
• •15. History of discontinuation of treatment with pramipexole IR
• •16. Previous treatment with pramipexole ER.
• •17. Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit (i.e. typical neuroleptics, atypical antipsychotics, reserpine, methyldopa, centrally-active antiemetics, etc).
• •18. Any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines.
• •19. Flunarizine within 3 months prior to baseline visit.
• •20. Known hypersensitivity to Pramipexole or its excipients.
• •21. Drug abuse (including alcohol), according to Investigator¿s judgement, within 2 years prior to screening.
• •22. Participation in other investigational drug studies or use of other investigational drugs within 4 weeks or five times the half-life of the investigational drug (whichever is longer) prior to baseline visit.