A Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER.

1. Subject has Parkinson’s disease consistent with the UK Brain Bank Criteria and must
have bradykinesia with sequence effect. If rest tremor does not exist must have
prominent asymmetry of motor function.

2. Subject with disease duration less than 3 years since diagnosis.

3. Subject has a H&Y stage score of < 3. 4. Subject has a MMSE score ≥ 26. Exclusion Criteria: 1. Subject has an atypical parkinsonian syndrome or secondary parkinsonism 2. Subject has previous exposure to levodopa or a dopamine agonist for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 2 months prior to the baseline visit. 3. Subject has previous exposure to a MAO-B inhibitor for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 3 months prior to the baseline visit. 4. Subject who has taken anticholinergic drugs for PD or amantadine for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 1 month prior to the baseline visit. 5. Subject has moderate (Child-Pugh categorization B, score 7-9) or severe (Child-Pugh categorization C, score 10-15) hepatic impairment.