Conditions: Parkinson's Disease
Keywords: Parkinson's Disease, Rasagiline, Pramipexole
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 149
Healthy volunteers: no

Brief summary:
This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and rasagiline for the treatment of early Parkinson's disease.

Animal studies support the therapeutic advantage of combining low doses of rasagiline and pramipexole and suggest further improvement when both are administered in a sustained fashion. Both rasagiline and pramipexole are well known marketed drugs for Parkinson's disease with a good safety profile. combining the drugs in low doses and controlled release may provide better symptom management than the existing drugs alone or together.

Detailed description:

Arms:
arm 1: Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily. arm 2: Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily arm 3: Placebo once daily for 12 weeks.

Interventions: intervention 1: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), intervention 2: Placebo intervention 3: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),
Intervention descriptions: intervention 1: Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily intervention 2: placebo intervention 3: Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily

Protocol document: