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

Inclusion criteria

• Male or female patient with idiopathic Parkinson's disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
• Parkinson's disease diagnosed within 5 years.
• Patients 30 years of age or older at the time of diagnosis.
• Modified Hoehn and Yahr stage of 1 to 3.
• Patients receiving pramipexole IR for at least three months prior to baseline visit (randomization visit, V2).
• Pramipexole dose should be optimized (according investigator¿s judgement), greater or equal to 1.5 mg/day, stable and equally divided 3 times per day, for a least 4 weeks prior to baseline visit (V2).
• Patients willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
• Signed informed consent obtained before any study procedures are carried out in accordance with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation).

Exclusion criteria

• Motor complications under levodopa therapy at V1.
• Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
• Dementia, as defined by a Mini-Mental State Exam score < 24 at V1
• Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
• History of psychosis, except history of drug induced hallucinations
• Clinically significant electrocardiogram (ECG) abnormalities at V1.
• Clinically significant hypotension either at screening visit or at baseline visit.
• Malignant melanoma or history of previously treated malignant melanoma.
• Any other clinically significant disease
• Pregnancy or breast-feeding.
• Sexually active female of childbearing potential
• 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).
• Patients with a creatinine clearance < 50 mL/min
• Any dopamine agonist (except pramipexole IR) within three months prior to baseline visit.
• History of discontinuation of treatment with pramipexole IR
• Previous treatment with pramipexole ER.
• 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).
• Any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines.
• Flunarizine within 3 months prior to baseline visit.
• Known hypersensitivity to Pramipexole or its excipients.
• Drug abuse (including alcohol), according to Investigator¿s judgement, within 2 years prior to screening.
• 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.