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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
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.
Details
| Lead sponsor | Pharma Two B Ltd. |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | COMPLETED |
| Enrolment | 149 |
| Start date | 2013-12 |
| Completion | 2015-06 |
Conditions
- Parkinson's Disease
Interventions
- P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),
- Placebo
- P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),
Primary outcomes
- Total UPDRS I, II, III Scores — Week 12
Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 176. High score mean worse outcome.
Countries
United States, Israel