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

Sponsor
Pharma Two B Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03329508
Collaborator
(none)
525
Enrollment
72
Locations
4
Arms
45
Anticipated Duration (Months)
7.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
525 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
4 arms4 arms
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
double blind study
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jan 29, 2018
Anticipated Primary Completion Date :
Aug 31, 2021
Anticipated Study Completion Date :
Oct 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: P2B001

Fixed dose combination once daily capsule of pramipexole and rasagiline

Drug: P2B001
Fixed dose once daily combination capsule of pramipexole and rasagiline
Other Names:
  • Fixed dose combination of Pramipexole and rasagiline

    		•
    Experimental: rasagiline capsule

    rasagiline Once daily capsule

    Drug: Rasagiline
    Rasagiline oral capsule
    Other Names:
  • rasagiline capsule

    		•
    Experimental: Pramipexole capsule

    Pramipexole once daily capsule

    Drug: Pramipexole
    Pramipexole low dose oral capsule
    Other Names:
  • Pramipexole capsule

    		•
    Active Comparator: Pramipexole Extended Release

    pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg

    Drug: Pramipexole ER
    Pramipexole ER titrated to optimal dose
    Other Names:
  • Pramipexole Extended Release Oral Tablet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change in total Unified Parkinson's Disease Rating Scale (UPDRS) score (defined as sum of parts II and III, scores (0-160). [baseline to week 12]

      Superiority of 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).

    Secondary Outcome Measures

    1. Change in Epworth Sleepiness Scale (ESS) score. [baseline to week 12]

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

    2. change of Total Parkinson's Disease Questionnaire 39 (PDQ39) score. [baseline to week 12]

      The efficacy of P2B 0.6/0.75 mg as compared to its individual components in the change of Total PDQ39 score.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 P2B001/003 Site Scottsdale Scottsdale Arizona United States 85258
    2 P2B001/003 study site Scottsdale Scottsdale Arizona United States 85259
    3 P2B001/003 Study site little Rock Little Rock Arkansas United States 72205
    4 P2B001 site Los Angeles Los Angeles California United States 90033
    5 P2B001 Study site Englewood, Englewood Colorado United States 80113
    6 P2B001 Study Vernon Vernon Connecticut United States 06066
    7 P2B001/003 site Boca Raton Boca Raton Florida United States 33431
    8 P2B001/003 Site Boca Raton Boca Raton Florida United States 33486
    9 P2B001/003 study site Jacksonville Jacksonville Florida United States 32209
    10 P2B001/003 site Miami Miami Florida United States 33136
    11 P2B001/003 Site Port Charlotte Port Charlotte Florida United States 33980
    12 P2B001/003 Site Sarasota Sarasota Florida United States 34243
    13 P2B001/003 Site Tampa Tampa Florida United States 33613
    14 P2B001/003 Site Augusta Augusta Georgia United States 30912
    15 P2B001/003 study site Honolulu Honolulu Hawaii United States 96819
    16 P2B001/003 site Chicago Chicago Illinois United States 60612
    17 P2B001/003 Site Winfield Winfield Illinois United States 60190
    18 P2B001/003 site Kansas City Kansas City Kansas United States 66160
    19 P2B001/003 Site Lexington Lexington Kentucky United States 40536
    20 P2B001/003 study site Boston Boston Massachusetts United States 02118
    21 P2B001/003 Site East Lansing East Lansing Michigan United States 48824
    22 P2B001/003 study site west Bloomfield West Bloomfield Michigan United States 48322
    23 P2B001/003 Site Golden Valley Golden Valley Minnesota United States 55427
    24 P2B001/003 site St. Louis Saint Louis Missouri United States 63110
    25 P2B001/003 study site New Hampshire Lebanon New Hampshire United States 03756
    26 P2B001/003 Study site Camden Camden New Jersey United States 08103
    27 P2B001 Study site Edison Edison New Jersey United States 08820
    28 P2B001/003 Study site Albuquerque Albuquerque New Mexico United States 87108
    29 P2B001/003 Study site Brooklyn Brooklyn New York United States 11203
    30 P2B001/003 Site Commack Commack New York United States 11725
    31 P2B001/003 New York New York New York United States 10029
    32 P2B001 Study site Syracuse Syracuse New York United States 13210
    33 P2B001/003 Study site Williamsville Williamsville New York United States 14221
    34 P2B001/003 Site Asheville Asheville North Carolina United States 28806
    35 P2B001 study site Cincinnati Cincinnati Ohio United States 45219
    36 P2B001/003 Site Toledo Toledo Ohio United States 43614
    37 P2B001/003 Study site Hershey Hershey Pennsylvania United States 17033
    38 P2B001/003 Greenville Greenville South Carolina United States 29615
    39 P2B0011/003 Study Veracity Neuroscience Memphis Tennessee United States 38157
    40 p2B001/003 Study site Memphis Memphis Tennessee United States 38163
    41 P2B001/003 Study site Nashville Nashville Tennessee United States 37232
    42 P2B001/003 Site Dallas Dallas Texas United States 75390
    43 P2B001/003 Study site Alexandria Alexandria Virginia United States 22311
    44 P2B001/003 Falls Church Virginia United States 22042
    45 P2B001/003 Site Kirkland Kirkland Washington United States 98034
    46 P2B001/003 study site Toronto Toronto Ontario Canada M5T 2S8
    47 P2B001/003 study site Ulm Ulm Baden-wuerttemberg Germany 89081
    48 P2B001/003 Study site Freiburg Freiburg Baden-Württemberg Germany 79106
    49 P2B001/003 study site Haag Haag Bayern Germany 83527
    50 P2B001/003 Study site Haag Haag Bayern Germany
    51 P2B001/003 Study site München München Bayern Germany 81675
    52 P2B001/003 Study site Hanau Hanau Hessen Germany 63450
    53 P2B001/003 Study site Bochum Bochum Nordrhein-westfalen Germany 44791
    54 P2B001/003 Study site Münster Münster Nordrhein-westfalen Germany 48149
    55 P2B001/003 Study site Dresden Dresden SaACHSEN Germany 01307
    56 P2B001/003 study site Leipzig Leipzig Sachsen Germany 04103
    57 P2B001/003 study site Gera Germany Gera Thuringen Germany 07551
    58 P2B001/003 Study site Gera Gera Thuringen Germany 07551
    59 P2B001/003 Study site Berlin Berlin Germany 12163
    60 P2B001/003 Study site Berlin Berlin Germany 12203
    61 P2B001/003 site Munich Munich Germany
    62 P2B001/003 Study site Sant Cugat del Vallés Sant Cugat del Vallés Barcelona Spain 08190
    63 P2B001/003 study site Mostoles Mostoles Madridid Spain 28938
    64 P2B001/003 Study site Pamplona Pamplona Navarra Spain 31008
    65 P2B001/003 Study site La Paz Madrid S Spain 28046
    66 P2B001/003 Study site Barcelona Barcelona Spain 08025
    67 P2B001/003 Study site Vall d'Hebrón Barcelona Spain 08035
    68 P2B001/003 Study site Navarra Madrid Madrid Spain 28027
    69 P2B001/003 study site Madrid Madrid Spain 28034
    70 P2B001/003 Study site Madrid Madrid Spain 28040
    71 P2B0011/003 Study site HM Centro Integral de Neurociencias (CINAC) Madrid Spain 28938
    72 P2B001/003 Study site Puerta de Hierro - Majadahonda Majadahonda Spain 28222

    Sponsors and Collaborators

    • Pharma Two B Ltd.

    Investigators

    • Study Director: Pninit Litman, Pharma2b LTD

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pharma Two B Ltd.
    ClinicalTrials.gov Identifier:
    NCT03329508
    Other Study ID Numbers:
    • P2B001/003
    First Posted:
    Nov 6, 2017
    Last Update Posted:
    May 21, 2021
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pharma Two B Ltd.
    Parkinson disease
    early Parkinson's Disease
    Parkinson's diagnosis
    Parkinson's tretment
    Parkinson's medications
    Additional relevant MeSH terms:
    Parkinson Disease
    Pramipexole
    Rasagiline

    Study Results

    No Results Posted as of May 21, 2021