Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
Recruitment status was: Active, not recruiting
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.
|Parkinson's Disease||Drug: Pramipexole / Rasagiline Mesylate once daily Drug: Placebo||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Total UPDRS I, II, III scores [ Time Frame: 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 ADL (part II) [ Time Frame: Week 12 ]Change from baseline in individual UPDRS ADL (part II)
- CGI-S [ Time Frame: 12 weeks ]Change from baseline in individual Clinical Global Impression - Severity
- UPDRS Motor (part III) [ Time Frame: 12 weeks ]Change from baseline in individual UPDRS motor (part III)
- PDQ39 [ Time Frame: 12 weeks ]Change from baseline in individual Parkinson's Disease Questionnaire - 39
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
|Experimental: P2B001 Treatment A||Drug: Pramipexole / Rasagiline Mesylate once daily|
|Experimental: P2B001 Treatment B||Drug: Pramipexole / Rasagiline Mesylate once daily|
|Placebo Comparator: Placebo||Drug: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01968460
Show 29 Study Locations
|Study Director:||pninit litman, Ph.D||Pharma Two B Ltd.|