A Phase 3 Study With P2B001 in Subjects With Early Parkinson's

March 15, 2023 updated by: Pharma Two B Ltd.

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A total of 525 eligible subjects with early untreated Parkinson's disease (PD), will be randomized to 4 treatment groups. Each subject will participate in the study for approximately 18 weeks including a 30 day screening period, 12 week treatment period, and 2 weeks follow-up period. Subjects will be requested to take one capsule and 1-3 tablets of study drug by mouth with a glass of water every day for 13 weeks. The study requires seven visits to the clinic one every 2-4 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
544

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • P2B001/003 study site Toronto
  • Germany
      • Berlin, Germany, 12163
        • P2B001/003 Study site Berlin
      • Berlin, Germany, 12203
        • P2B001/003 Study site Berlin
      • Munich, Germany
        • P2B001/003 site Munich
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
        • P2B001/003 Study site Freiburg
    • Baden-wuerttemberg
      • Ulm, Baden-wuerttemberg, Germany, 89081
        • P2B001/003 study site Ulm
    • Bayern
      • Haag, Bayern, Germany, 83527
        • P2B001/003 Study site Haag
      • Haag, Bayern, Germany
        • P2B001/003 Study site Haag
      • München, Bayern, Germany, 81675
        • P2B001/003 Study site München
    • Hessen
      • Hanau, Hessen, Germany, 63450
        • P2B001/003 Study site Hanau
    • Nordrhein-westfalen
      • Bochum, Nordrhein-westfalen, Germany, 44791
        • P2B001/003 Study site Bochum
      • Münster, Nordrhein-westfalen, Germany, 48149
        • P2B001/003 Study site Münster
    • SaACHSEN
      • Dresden, SaACHSEN, Germany, 01307
        • P2B001/003 Study site Dresden
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • P2B001/003 study site Leipzig
    • Thuringen
      • Gera, Thuringen, Germany, 07551
        • P2B001/003 study site Gera Germany
      • Gera, Thuringen, Germany, 07551
        • P2B001/003 Study site Gera
  • Spain
      • Barcelona, Spain, 08025
        • P2B001/003 Study site Barcelona
      • Barcelona, Spain, 08035
        • P2B001/003 Study site Vall d'Hebrón
      • Madrid, Spain, 28027
        • P2B001/003 Study site Navarra Madrid
      • Madrid, Spain, 28034
        • P2B001/003 Study site Madrid
      • Madrid, Spain, 28040
        • P2B001/003 Study site Madrid
      • Madrid, Spain, 28938
        • P2B0011/003 Study site HM Centro Integral de Neurociencias (CINAC)
      • Majadahonda, Spain, 28222
        • P2B001/003 Study site Puerta de Hierro - Majadahonda
    • Barcelona
      • Sant Cugat del Vallés, Barcelona, Spain, 08190
        • P2B001/003 Study site Sant Cugat del Vallés
    • Madridid
      • Mostoles, Madridid, Spain, 28938
        • P2B001/003 study site Mostoles
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • P2B001/003 Study site Pamplona
    • S
      • Madrid, S, Spain, 28046
        • P2B001/003 Study site La Paz
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • P2B001/003 Site Scottsdale
      • Scottsdale, Arizona, United States, 85259
        • P2B001/003 study site Scottsdale
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • P2B001/003 Study site little Rock
    • California
      • Los Angeles, California, United States, 90033
        • P2B001 Site Los Angeles
    • Colorado
      • Englewood, Colorado, United States, 80113
        • P2B001 Study site Englewood,
    • Connecticut
      • Vernon, Connecticut, United States, 06066
        • P2B001 Study Vernon
    • Florida
      • Boca Raton, Florida, United States, 33431
        • P2B001/003 Site Boca Raton
      • Boca Raton, Florida, United States, 33486
        • P2B001/003 Site Boca Raton
      • Jacksonville, Florida, United States, 32209
        • P2B001/003 study site Jacksonville
      • Miami, Florida, United States, 33136
        • P2B001/003 site Miami
      • Port Charlotte, Florida, United States, 33980
        • P2B001/003 Site Port Charlotte
      • Sarasota, Florida, United States, 34243
        • P2B001/003 Site Sarasota
      • Tampa, Florida, United States, 33613
        • P2B001/003 Site Tampa
    • Georgia
      • Augusta, Georgia, United States, 30912
        • P2B001/003 Site Augusta
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • P2B001/003 study site Honolulu
    • Illinois
      • Chicago, Illinois, United States, 60612
        • P2B001/003 site Chicago
      • Winfield, Illinois, United States, 60190
        • P2B001/003 Site Winfield
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • P2B001/003 site Kansas City
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • P2B001/003 Site Lexington
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • P2B001/003 study site Boston
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • P2B001/003 Site East Lansing
      • West Bloomfield, Michigan, United States, 48322
        • P2B001/003 study site west Bloomfield
    • Minnesota
      • Golden Valley, Minnesota, United States, 55427
        • P2B001/003 Site Golden Valley
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • P2B001/003 site St. Louis
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • P2B001/003 study site New Hampshire
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • P2B001/003 Study site Camden
      • Edison, New Jersey, United States, 08820
        • P2B001 Study site Edison
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • P2B001/003 Study site Albuquerque
    • New York
      • Brooklyn, New York, United States, 11203
        • P2B001/003 Study site Brooklyn
      • Commack, New York, United States, 11725
        • P2B001/003 Site Commack
      • New York, New York, United States, 10029
        • P2B001/003 New York
      • Syracuse, New York, United States, 13210
        • P2B001 Study site Syracuse
      • Williamsville, New York, United States, 14221
        • P2B001/003 Study site Williamsville
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • P2B001/003 Site Asheville
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • P2B001 study site Cincinnati
      • Toledo, Ohio, United States, 43614
        • P2B001/003 Site Toledo
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • P2B001/003 Study site Hershey
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • P2B001/003 Greenville
    • Tennessee
      • Memphis, Tennessee, United States, 38157
        • P2B0011/003 Study Veracity Neuroscience
      • Memphis, Tennessee, United States, 38163
        • p2B001/003 Study site Memphis
      • Nashville, Tennessee, United States, 37232
        • P2B001/003 Study site Nashville
    • Texas
      • Dallas, Texas, United States, 75390
        • P2B001/003 Site Dallas
    • Virginia
      • Alexandria, Virginia, United States, 22311
        • P2B001/003 Study site Alexandria
      • Falls Church, Virginia, United States, 22042
        • P2B001/003
    • Washington
      • Kirkland, Washington, United States, 98034
        • P2B001/003 Site Kirkland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject has Parkinson's disease consistent with the UK Brain Bank Criteria and must have bradykinesia with sequence effect. If rest tremor does not exist must have prominent asymmetry of motor function.
  2. Subject with disease duration less than 3 years since diagnosis.
  3. Subject has a H&Y stage score of < 3.
  4. Subject has a MMSE score ≥ 26.

Exclusion Criteria:

  1. Subject has an atypical parkinsonian syndrome or secondary parkinsonism
  2. Subject has previous exposure to levodopa or a dopamine agonist for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 2 months prior to the baseline visit.
  3. Subject has previous exposure to a MAO-B inhibitor for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 3 months prior to the baseline visit.
  4. Subject who has taken anticholinergic drugs for PD or amantadine for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 1 month prior to the baseline visit.
  5. Subject has moderate (Child-Pugh categorization B, score 7-9) or severe (Child-Pugh categorization C, score 10-15) hepatic impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: P2B001 0.6/0.75 mg
Fixed dose combination once daily capsule of pramipexole 0.6mg and rasagiline 0.75mg, + matching placebo tablet
Drug: P2B001 0.6/0.75 mg
Fixed low dose extended release combination capsule of pramipexole and rasagiline
Other Names:
  • P2B001 capsule
Experimental: rasagiline 0.75mg
Rasagiline 0.75mg Once daily capsule, component of P2B001, + matching placebo tablet
Drug: Rasagiline 0.75 mg
Rasagiline 0.75 mg oral extended release capsule, component
Other Names:
  • RAS 0.75
Experimental: Pramipexole 0.6mg
Pramipexole 0.6mg once daily capsule, component of P2B001 + matching placebo tablet
Drug: Pramipexole 0.6 mg
Pramipexole 0.6 mg oral extended release capsule, component
Other Names:
  • PPX 0.6
Active Comparator: Pramipexole Extended Release
Marketed pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg + matching placebo capsule
Drug: Marketed Pramipexole ER
Marketed Pramipexole ER titrated to optimal dose of 1.5, 3 or 4.5 mg tablet
Other Names:
  • PramiER

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160).
Time Frame: baseline to week 12

Differences between P2B 0.6/0.75 mg as compared to its individual components in the change of total UPDRS score (defined as sum of parts II and III, scores (0-160).

UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 160.

High score mean worse outcome.
baseline to week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Epworth Sleepiness Scale (ESS) Score.
Time Frame: baseline to week 12

Differences between P2B 0.6/0.75 mg as compared to pramipexole ER tablets in the change of Epworth Sleepiness Scale (ESS) score.

Scale is 0-24 , when 24 is worse outcome
baseline to week 12
Change From Baseline to Week 12 in Total UPDRS III Motor
Time Frame: baseline to week 12

Differences between P2B 0.6/0.75 mg as compared to its individual components in the change of Motor UPDRS score (UPDRS Part III ).

UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome)
baseline to week 12
Change From Baseline to Week 12 in Total UPDRS II ADL
Time Frame: Baseline to week 12
Differences between of P2B 0.6/0.75 mg as compared to its individual components in the change of ADL UPDRS score (UPDRS part II) Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome)
Baseline to week 12
Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39
Time Frame: Baseline to week 12

The efficacy of P2B 0.6/0.75 mg as compared to Pramipexole ER tablet titrated to optimal dose.

ADL PDQ39- Activity of daily life part in Parkinson's Disease Questionaries' 39 Score 0-100 when 100 is the worse outcome
Baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pharma Two B Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pninit Litman, Pharma2b LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P2B001/003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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