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A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
NCT03329508 · View on ClinicalTrials.gov ↗
Study Summary
P2B001 is an investigational drug that comprised of low doses of two drugs, pramipexole and rasagiline, which are both approved drugs and routinely used in standard therapy for Parkinson's disease. The two drugs work in two different mechanisms that help each other, so there is a reason to believe that their combined activity will be better than each individual drug, and that lower doses can be used without losing the therapeutic effect. Thus, the development of P2B001 is intended to provide a combination of low doses of these two drugs, in an improved formulation, that is hoped to be more effective in controlling Parkinson's disease symptoms and with less side effects than each of the drugs taken alone or the current available commercial drugs taken together. In a previously completed clinical trial a significant improvement in Parkinson's disease symptoms was seen in patients treated with P2B001 compared to patients that were treated with placebo. In this phase 3 study , the safety and efficacy of P2B001 will be assessed by comparing P2B001 to its individual components pramipexole and rasagiline. This will be done by monitoring the motor and non-motor symptoms, evaluating responses participants provide on questionnaires relating to Parkinson's disease and quality of life that will be completed on every visit. In addition, this study will also compare P2B001 to a marketed drug of pramipexole ER. Approximately 525 patients will participate in this research study and the participation in this study will last between 14 to 18 weeks.
Conditions Studied
Interventions
- DRUG P2B001 0.6/0.75 mg
- DRUG Rasagiline 0.75 mg
- DRUG Pramipexole 0.6 mg
- DRUG Marketed Pramipexole ER
Study Locations (20)
Florida
- P2B001/003 site Boca Raton — Boca Raton
- P2B001/003 Site Boca Raton — Boca Raton
- P2B001/003 study site Jacksonville — Jacksonville
- P2B001/003 site Miami — Miami
- P2B001/003 Site Port Charlotte — Port Charlotte
- P2B001/003 Site Sarasota — Sarasota
- P2B001/003 Site Tampa — Tampa
Arizona
- P2B001/003 Site Scottsdale — Scottsdale
- P2B001/003 study site Scottsdale — Scottsdale
Illinois
- P2B001/003 site Chicago — Chicago
- P2B001/003 Site Winfield — Winfield
Arkansas
- P2B001/003 Study site little Rock — Little Rock
California
- P2B001 site Los Angeles — Los Angeles
Colorado
- P2B001 Study site Englewood, — Englewood
Connecticut
- P2B001 Study Vernon — Vernon
Georgia
- P2B001/003 Site Augusta — Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 544 participants |
| Start Date | 2018-01-19 |
| Est. Completion | 2021-10-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03329508
The ClinicalTrials.gov registry entry for NCT03329508 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 544 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharma Two B, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 4 interventions — of which P2B001 0.6/0.75 mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03329508 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Arizona, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03329508 about?
NCT03329508 is a clinical study titled "A Phase 3 Study With P2B001 in Subjects With Early Parkinson's". P2B001 is an investigational drug that comprised of low doses of two drugs, pramipexole and rasagiline, which are both approved drugs and routinely used in standard therapy for Parkinson's disease. The two drugs work in two different mechanisms that help each other, so there is a reason to believe t...
What is the current status of trial NCT03329508?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 544 participants. The study started on 2018-01-19. Estimated completion is 2021-10-31.
What conditions does trial NCT03329508 study?
This clinical trial studies the following conditions: Parkinson Disease, Early Parkinson's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03329508?
The interventions under investigation include: P2B001 0.6/0.75 mg (DRUG), Rasagiline 0.75 mg (DRUG), Pramipexole 0.6 mg (DRUG), Marketed Pramipexole ER (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03329508?
This trial is sponsored by Pharma Two B, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03329508 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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