NCT01968460

Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease

A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Pharma Two B Ltd. · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),	Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily
DRUG	Placebo	placebo
DRUG	P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),	Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-05-01
• Completion: 2015-06-01
• First posted: 2013-10-24
• Last updated: 2023-04-07
• Results posted: 2023-04-07

Locations

29 sites across 2 countries: United States, Israel