Purpose

A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group 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.

Condition

Eligibility

Eligible Ages
Between 35 Years and 80 Years
Eligible Genders
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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
4 arms
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
double blind study

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

P2B001/003 Site Scottsdale
Scottsdale, Arizona 85258
Contact:
Susan Ortega Palacios
susan@movementdisorders.us

P2B001/003 study site Scottsdale
Scottsdale, Arizona 85259
Contact:
Tina Anderson
Anderson.Machiko@mayo.edu

P2B001/003 Study site little Rock
Little Rock, Arkansas 72205
Contact:
Anja Rassmann
arassmann@uams.edu

P2B001 site Los Angeles
Los Angeles, California 90033
Contact:
Gina Barles
gina.barles@med.usc.edu

P2B001 Study site Englewood,
Englewood, Colorado 80113
Contact:
Jessica Jaynes
jaynes@kumarneuro.com

P2B001 Study Vernon
Vernon, Connecticut 06066
Contact:
Sheila Thurlow
thurlow@uchc.edu

P2B001/003 site Boca Raton
Boca Raton, Florida 33431
Contact:
Letty Ginsburg
lginsburg@med.miami.edu

P2B001/003 Site Boca Raton
Boca Raton, Florida 33486
Contact:
Lisbeth Carvajal
lcarvajal@ParkinsonsCenter.org

P2B001/003 study site Jacksonville
Jacksonville, Florida 32209
Contact:
Lisa Smith
lisa.smith@jax.ufl.edu

P2B001/003 site Miami
Miami, Florida 33136
Contact:
Nathalie Padron
npadron@med.miami.edu

P2B001/003 Site Port Charlotte
Port Charlotte, Florida 33980
Contact:
Zachary Lee
research@parkinsonsfl.com

P2B001/003 Site Sarasota
Sarasota, Florida 34243
Contact:
Jillian Chaykin
jchaykin@roskampinstitute.net

P2B001/003 Site Tampa
Tampa, Florida 33613
Contact:
Leigh Harrell
leighharrell@health.usf.edu

P2B001/003 Site Augusta
Augusta, Georgia 30912
Contact:
Buff Farrow
bfarrow@augusta.edu

P2B001/003 study site Honolulu
Honolulu, Hawaii 96819
Contact:
Latona Broadwater
latonia.broadwater@va.gov

P2B001/003 site Chicago
Chicago, Illinois 60612
Contact:
Brian Kelly
Brian_J_Kelly@rush.edu

P2B001/003 Site Winfield
Winfield, Illinois 60190
Contact:
Kathy Hansen
kathy.hansen@nm.org

P2B001/003 site Kansas City
Kansas City, Kansas 66160
Contact:
April Langhammer
alanghammer@kumc.edu

P2B001/003 Site Lexington
Lexington, Kentucky 40536
Contact:
Renee Wagner
renee.wagner@uky.edu

P2B001/003 study site Boston
Boston, Massachusetts 02118
Contact:
Raymond James
rcjames@bu.edu

P2B001/003 Site East Lansing
East Lansing, Michigan 48824
Contact:
Doozie Russell
doozie.russell@ht.msu.edu

P2B001/003 study site west Bloomfield
West Bloomfield, Michigan 48322
Contact:
Pat Kaminsky
pkamins1@hfhs.org

P2B001/003 Site Golden Valley
Golden Valley, Minnesota 55427

P2B001/003 site St. Louis
Saint Louis, Missouri 63110
Contact:
Melissa Ammel
ammelm@neuro.wustl.edu

P2B001/003 study site New Hampshire
Lebanon, New Hampshire 03756
Contact:
Harold Yang
Harold.H.Yang@hitchcock.org

P2B001/003 Study site Camden
Camden, New Jersey 08103
Contact:
Amanda Logan
logan-amanda@cooperhealth.edu

P2B001 Study site Edison
Edison, New Jersey 08820
Contact:
Briana DeCarvalho
Briana.DeCarvalho@hackensackmeridian.org

P2B001/003 Study site Brooklyn
Brooklyn, New York 11203
Contact:
Sofya Glazman
sofya.glazman@downstate.edu

P2B001/003 Site Commack
Commack, New York 11725
Contact:
Nancy Gardella
researchli@parkinsonscenter.org

P2B001/003 New York
New York, New York 10029
Contact:
Mindy Lopez
Mindy.lopez1@mssm.edu

P2B001 Study site Syracuse
Syracuse, New York 13210
Contact:
Jacob Pusey
PuseyJ@upstate.edu

P2B001/003 Study site Williamsville
Williamsville, New York 14221
Contact:
Rachel Shepherd
rlaporta@buffalo.edu

P2B001/003 Site Asheville
Asheville, North Carolina 28806
Contact:
Susan Woodard
research@ashneuro.com

P2B001 study site Cincinnati
Cincinnati, Ohio 45219
Contact:
Erin Neefus
erin.neefus@uc.edu

P2B001/003 Site Toledo
Toledo, Ohio 43614
Contact:
Julia Spears

P2B001/003 Study site Hershey
Hershey, Pennsylvania 17033
Contact:
Samyuktha Ravi
sravi1@pennstatehealth.psu.edu

P2B001/003 Greenville
Greenville, South Carolina 29615
Contact:
Enrique Urrea Mendoza
EUrreamendoza@ghs.org

p2B001/003 Study site Memphis
Memphis, Tennessee 38163
Contact:
Kristen Archbold
archboldkh@gmail.com

P2B001/003 Study site Nashville
Nashville, Tennessee 37232
Contact:
Shelby Ploucher
shelby.ploucher@vanderbilt.edu

P2B001/003 site Bedford
Bedford, Texas 76021
Contact:
Tamara Marshall
tamara@ntmdi.com

P2B001/003 Site Dallas
Dallas, Texas 75390
Contact:
Mina Zilaie
Mina.Zilaie@UTSouthwestern.edu

P2B001/003 Study site Alexandria
Alexandria, Virginia 22042
Contact:
Karlie Smith
karlie.smith@inova.org

P2B001/003 Site Kirkland
Kirkland, Washington 98034
Contact:
Canan Akture
CAkture@evergreenhealth.com

More Details

NCT ID
NCT03329508
Status
Recruiting
Sponsor
Pharma Two B Ltd.

Study Contact

Avigail Glass
89472672
Avigail@pharma2b.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.