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NCT01968460 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
A Phase 2 study of Parkinson's Disease, sponsored by Pharma Two B.
- Completed
- Registry status
- Phase 2
- Development phase
- 149
- Enrollment target
- 20
- Study locations
NCT01968460: Completed Phase 2 study of Parkinson's Disease, sponsored by Pharma Two B.
NCT01968460 is a Phase 2 study of Parkinson's Disease that has completed, run by Pharma Two B. The registered enrollment target is 149 participants, below the 634-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01968460, a Phase 2 study of Parkinson's Disease, has completed, sponsored by Pharma Two B.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 149 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),
- DRUG P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),
Study Locations (20)
Florida
- P2B001 Site Boca Raton - Boca Raton
- P2B001 Site Port Charlotte - Port Charlotte
- P2B001 Site Tampa - Tampa
Connecticut
- P2B001 Manchester - Manchester
- P2B001 Site New Haven - New Haven
New Jersey
- P2B001 Site Camden - Camden
- P2B001 Site New Brunswick - New Brunswick
New York
- P2B001 site Commack - Commack
- P2B001 Site New York - New York
Alabama
- P2B001 Site Birmingham - Birmingham
California
- P2B001 Site Los Angeles - Los Angeles
Colorado
- P2B001 Site Aurora - Aurora
Georgia
- P2B001 Site Augusta - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
What the finished NCT01968460 record still lists
NCT01968460 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, below the 634-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01968460 names 20 study sites across 15 states, led by Florida, Connecticut, New Jersey.
Frequently Asked Questions
What is clinical trial NCT01968460 about?
NCT01968460 is a clinical study titled "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 ar...
What is the current status of trial NCT01968460?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 149 participants. The study started on 2013-12. Estimated completion is 2015-06.
What conditions does trial NCT01968460 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT01968460?
The interventions under investigation include: Placebo (DRUG), P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), (DRUG), P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), (DRUG).
Who is sponsoring clinical trial NCT01968460?
This trial is sponsored by Pharma Two B, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01968460 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Parkinson's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01968460's enrollment target sits among peer trials
149 45th of 158 higher than 114 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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