Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients

Inclusion Criteria

• Male or female patient with idiopathic Parkinsons disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
• Parkinsons 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 requiring additional therapy/ introduction of therapy (for de novo patients) to treat their parkinsonian symptoms at the time of enrollment (screening visit, V1) according to the investigators judgement.

Exclusion Criteria

• Atypical parkinsonian syndromes due to drugs (e.g., metoclopramide, flunarizine), metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy).
• Dementia, as defined by a Mini-Mental State Exam score 2 Upper Limit of Normal (ULN)
• Patients with a creatinine clearance < 50 mL/min
• Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit, or L-Dopa within 8 weeks prior to baseline visit.
• Total cumulative duration of prior exposure to Levodopa of more than 3 months.
• Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
• 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 Investigators judgement, within 2 years prior to screening.
• 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