A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
Public ClinicalTrials.gov record NCT03329508. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03329508
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 544 participants
Conditions and interventions
Conditions
Interventions
- P2B001 0.6/0.75 mg Drug
- Rasagiline 0.75 mg Drug
- Pramipexole 0.6 mg Drug
- Marketed Pramipexole ER Drug
Drug
Eligibility (public fields only)
- Age range
- 35 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 19, 2018 (Actual)
- Primary completion
- Aug 23, 2021 (Actual)
- Completion
- Oct 31, 2021 (Actual)
- Last update posted
- Mar 21, 2023
2018 – 2021
United States locations
- U.S. sites
- 45
- U.S. states
- 27
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| P2B001/003 Site Scottsdale | Scottsdale | Arizona | 85258 | — |
| P2B001/003 study site Scottsdale | Scottsdale | Arizona | 85259 | — |
| P2B001/003 Study site little Rock | Little Rock | Arkansas | 72205 | — |
| P2B001 site Los Angeles | Los Angeles | California | 90033 | — |
| P2B001 Study site Englewood, | Englewood | Colorado | 80113 | — |
| P2B001 Study Vernon | Vernon | Connecticut | 06066 | — |
| P2B001/003 site Boca Raton | Boca Raton | Florida | 33431 | — |
| P2B001/003 Site Boca Raton | Boca Raton | Florida | 33486 | — |
| P2B001/003 study site Jacksonville | Jacksonville | Florida | 32209 | — |
| P2B001/003 site Miami | Miami | Florida | 33136 | — |
| P2B001/003 Site Port Charlotte | Port Charlotte | Florida | 33980 | — |
| P2B001/003 Site Sarasota | Sarasota | Florida | 34243 | — |
| P2B001/003 Site Tampa | Tampa | Florida | 33613 | — |
| P2B001/003 Site Augusta | Augusta | Georgia | 30912 | — |
| P2B001/003 study site Honolulu | Honolulu | Hawaii | 96819 | — |
| P2B001/003 site Chicago | Chicago | Illinois | 60612 | — |
| P2B001/003 Site Winfield | Winfield | Illinois | 60190 | — |
| P2B001/003 site Kansas City | Kansas City | Kansas | 66160 | — |
| P2B001/003 Site Lexington | Lexington | Kentucky | 40536 | — |
| P2B001/003 study site Boston | Boston | Massachusetts | 02118 | — |
| P2B001/003 Site East Lansing | East Lansing | Michigan | 48824 | — |
| P2B001/003 study site west Bloomfield | West Bloomfield | Michigan | 48322 | — |
| P2B001/003 Site Golden Valley | Golden Valley | Minnesota | 55427 | — |
| P2B001/003 site St. Louis | St Louis | Missouri | 63110 | — |
| P2B001/003 study site New Hampshire | Lebanon | New Hampshire | 03756 | — |
| P2B001/003 Study site Camden | Camden | New Jersey | 08103 | — |
| P2B001 Study site Edison | Edison | New Jersey | 08820 | — |
| P2B001/003 Study site Albuquerque | Albuquerque | New Mexico | 87108 | — |
| P2B001/003 Study site Brooklyn | Brooklyn | New York | 11203 | — |
| P2B001/003 Site Commack | Commack | New York | 11725 | — |
| P2B001/003 New York | New York | New York | 10029 | — |
| P2B001 Study site Syracuse | Syracuse | New York | 13210 | — |
| P2B001/003 Study site Williamsville | Williamsville | New York | 14221 | — |
| P2B001/003 Site Asheville | Asheville | North Carolina | 28806 | — |
| P2B001 study site Cincinnati | Cincinnati | Ohio | 45219 | — |
| P2B001/003 Site Toledo | Toledo | Ohio | 43614 | — |
| P2B001/003 Study site Hershey | Hershey | Pennsylvania | 17033 | — |
| P2B001/003 Greenville | Greenville | South Carolina | 29615 | — |
| P2B0011/003 Study Veracity Neuroscience | Memphis | Tennessee | 38157 | — |
| p2B001/003 Study site Memphis | Memphis | Tennessee | 38163 | — |
| P2B001/003 Study site Nashville | Nashville | Tennessee | 37232 | — |
| P2B001/003 Site Dallas | Dallas | Texas | 75390 | — |
| P2B001/003 Study site Alexandria | Alexandria | Virginia | 22311 | — |
| P2B001/003 | Falls Church | Virginia | 22042 | — |
| P2B001/003 Site Kirkland | Kirkland | Washington | 98034 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03329508, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 21, 2023 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03329508 live on ClinicalTrials.gov.