Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
Purpose: This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and rasagiline for the treatment of early Parkinson's disease.
Duration: 12 weeks
Study design: Randomized, double-blind, placebo-controlled
Subject is male or female ≥35 years of age to ≤75 years of age at the time of enrollment.
Subject has idiopathic Parkinson's disease consistent with the UK Brain Bank Criteria
Subject with disease duration no longer than 3 years and 0 months.
Subject has a Hoehn & Yahr (H&Y) stage score of < 3.
Subject has a MMSE score ≥ 26.
Subject has an atypical parkinsonian syndrome or secondary parkinsonism.
Subject has a history of psychosis or hallucinations within the previous 12 months.
Subject who is taking anticholinergic drugs.
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.
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.