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

NCT03329508 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: P2B001/003
• Study Type: interventional
• Target: 544
• Locations: 4 countries
• Sites: 72

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.

Conditions

Parkinson Disease; Early Parkinson's Disease

Keywords

Parkinson disease; early Parkinson's Disease; Parkinson's diagnosis; Parkinson's tretment; Parkinson's medications

Outcome Measures

Primary Outcomes (1)

• Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160).

  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 Outcomes (4)

• Change in Epworth Sleepiness Scale (ESS) Score.

  baseline to week 12

• Change From Baseline to Week 12 in Total UPDRS III Motor

  baseline to week 12

• Change From Baseline to Week 12 in Total UPDRS II ADL

  Baseline to week 12

• Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39

  Baseline to week 12

Study Arms (4)

P2B001 0.6/0.75 mg

EXPERIMENTAL

Fixed dose combination once daily capsule of pramipexole 0.6mg and rasagiline 0.75mg, + matching placebo tablet

Drug: P2B001 0.6/0.75 mg

rasagiline 0.75mg

EXPERIMENTAL

Rasagiline 0.75mg Once daily capsule, component of P2B001, + matching placebo tablet

Drug: Rasagiline 0.75 mg

Pramipexole 0.6mg

EXPERIMENTAL

Pramipexole 0.6mg once daily capsule, component of P2B001 + matching placebo tablet

Drug: Pramipexole 0.6 mg

Pramipexole Extended Release

ACTIVE COMPARATOR

Marketed pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg + matching placebo capsule

Drug: Marketed Pramipexole ER

Interventions

P2B001 0.6/0.75 mg DRUG

Fixed low dose extended release combination capsule of pramipexole and rasagiline

Also known as: P2B001 capsule

P2B001 0.6/0.75 mg

Rasagiline 0.75 mg DRUG

Rasagiline 0.75 mg oral extended release capsule, component

Also known as: RAS 0.75

rasagiline 0.75mg

Pramipexole 0.6 mg DRUG

Pramipexole 0.6 mg oral extended release capsule, component

Also known as: PPX 0.6

Pramipexole 0.6mg

Marketed Pramipexole ER DRUG

Marketed Pramipexole ER titrated to optimal dose of 1.5, 3 or 4.5 mg tablet

Also known as: PramiER

Pramipexole Extended Release

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subject with disease duration less than 3 years since diagnosis.
• Subject has a H\&Y stage score of \< 3.
• Subject has a MMSE score ≥ 26.

You may not qualify if:

• Subject has an atypical parkinsonian syndrome or secondary parkinsonism
• 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.
• 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.
• 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.
• Subject has moderate (Child-Pugh categorization B, score 7-9) or severe (Child-Pugh categorization C, score 10-15) hepatic impairment.

Sponsors & Collaborators

• Pharma Two B Ltd.: lead

Study Sites (72)

P2B001/003 Site Scottsdale

Scottsdale, Arizona, 85258, United States

Location

P2B001/003 study site Scottsdale

Scottsdale, Arizona, 85259, United States

Location

P2B001/003 Study site little Rock

Little Rock, Arkansas, 72205, United States

Location

P2B001 site Los Angeles

Los Angeles, California, 90033, United States

Location

P2B001 Study site Englewood,

Englewood, Colorado, 80113, United States

Location

P2B001 Study Vernon

Vernon, Connecticut, 06066, United States

Location

P2B001/003 site Boca Raton

Boca Raton, Florida, 33431, United States

Location

P2B001/003 Site Boca Raton

Boca Raton, Florida, 33486, United States

Location

P2B001/003 study site Jacksonville

Jacksonville, Florida, 32209, United States

Location

P2B001/003 site Miami

Miami, Florida, 33136, United States

Location

P2B001/003 Site Port Charlotte

Port Charlotte, Florida, 33980, United States

Location

P2B001/003 Site Sarasota

Sarasota, Florida, 34243, United States

Location

P2B001/003 Site Tampa

Tampa, Florida, 33613, United States

Location

P2B001/003 Site Augusta

Augusta, Georgia, 30912, United States

Location

P2B001/003 study site Honolulu

Honolulu, Hawaii, 96819, United States

Location

P2B001/003 site Chicago

Chicago, Illinois, 60612, United States

Location

P2B001/003 Site Winfield

Winfield, Illinois, 60190, United States

Location

P2B001/003 site Kansas City

Kansas City, Kansas, 66160, United States

Location

P2B001/003 Site Lexington

Lexington, Kentucky, 40536, United States

Location

P2B001/003 study site Boston

Boston, Massachusetts, 02118, United States

Location

P2B001/003 Site East Lansing

East Lansing, Michigan, 48824, United States

Location

P2B001/003 study site west Bloomfield

West Bloomfield, Michigan, 48322, United States

Location

P2B001/003 Site Golden Valley

Golden Valley, Minnesota, 55427, United States

Location

P2B001/003 site St. Louis

St Louis, Missouri, 63110, United States

Location

P2B001/003 study site New Hampshire

Lebanon, New Hampshire, 03756, United States

Location

P2B001/003 Study site Camden

Camden, New Jersey, 08103, United States

Location

P2B001 Study site Edison

Edison, New Jersey, 08820, United States

Location

P2B001/003 Study site Albuquerque

Albuquerque, New Mexico, 87108, United States

Location

P2B001/003 Study site Brooklyn

Brooklyn, New York, 11203, United States

Location

P2B001/003 Site Commack

Commack, New York, 11725, United States

Location

P2B001/003 New York

New York, New York, 10029, United States

Location

P2B001 Study site Syracuse

Syracuse, New York, 13210, United States

Location

P2B001/003 Study site Williamsville

Williamsville, New York, 14221, United States

Location

P2B001/003 Site Asheville

Asheville, North Carolina, 28806, United States

Location

P2B001 study site Cincinnati

Cincinnati, Ohio, 45219, United States

Location

P2B001/003 Site Toledo

Toledo, Ohio, 43614, United States

Location

P2B001/003 Study site Hershey

Hershey, Pennsylvania, 17033, United States

Location

P2B001/003 Greenville

Greenville, South Carolina, 29615, United States

Location

P2B0011/003 Study Veracity Neuroscience

Memphis, Tennessee, 38157, United States

Location

p2B001/003 Study site Memphis

Memphis, Tennessee, 38163, United States

Location

P2B001/003 Study site Nashville

Nashville, Tennessee, 37232, United States

Location

P2B001/003 Site Dallas

Dallas, Texas, 75390, United States

Location

P2B001/003 Study site Alexandria

Alexandria, Virginia, 22311, United States

Location

P2B001/003

Falls Church, Virginia, 22042, United States

Location

P2B001/003 Site Kirkland

Kirkland, Washington, 98034, United States

Location

P2B001/003 study site Toronto

Toronto, Ontario, M5T 2S8, Canada

Location

P2B001/003 Study site Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

P2B001/003 study site Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

P2B001/003 study site Haag

Haag, Bavaria, 83527, Germany

Location

P2B001/003 Study site Haag

Haag, Bavaria, Germany

Location

P2B001/003 Study site München

München, Bavaria, 81675, Germany

Location

P2B001/003 Study site Hanau

Hanau, Hesse, 63450, Germany

Location

P2B001/003 Study site Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

Location

P2B001/003 Study site Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

P2B001/003 Study site Dresden

Dresden, SaACHSEN, 01307, Germany

Location

P2B001/003 study site Leipzig

Leipzig, Saxony, 04103, Germany

Location

P2B001/003 study site Gera Germany

Gera, Thuringia, 07551, Germany

Location

P2B001/003 Study site Gera

Gera, Thuringia, 07551, Germany

Location

P2B001/003 Study site Berlin

Berlin, 12163, Germany

Location

P2B001/003 Study site Berlin

Berlin, 12203, Germany

Location

P2B001/003 site Munich

Munich, Germany

Location

P2B001/003 Study site Sant Cugat del Vallés

Sant Cugat Del Vallés, Barcelona, 08190, Spain

Location

P2B001/003 study site Mostoles

Móstoles, Madridid, 28938, Spain

Location

P2B001/003 Study site Pamplona

Pamplona, Navarre, 31008, Spain

Location

P2B001/003 Study site La Paz

Madrid, S, 28046, Spain

Location

P2B001/003 Study site Barcelona

Barcelona, 08025, Spain

Location

P2B001/003 Study site Vall d'Hebrón

Barcelona, 08035, Spain

Location

P2B001/003 Study site Navarra Madrid

Madrid, 28027, Spain

Location

P2B001/003 study site Madrid

Madrid, 28034, Spain

Location

P2B001/003 Study site Madrid

Madrid, 28040, Spain

Location

P2B0011/003 Study site HM Centro Integral de Neurociencias (CINAC)

Madrid, 28938, Spain

Location

P2B001/003 Study site Puerta de Hierro - Majadahonda

Majadahonda, 28222, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline; Pramipexole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pninit Litman study director
• Organization: Pharma 2B LTD

pninit@pharma2b.com

+972 8 9472672

Study Officials

• Pninit Litman

  Pharma2b LTD

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 4 arms

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: January 19, 2018
• Primary Completion: August 23, 2021
• Study Completion: October 31, 2021
• Last Updated: March 21, 2023
• Results First Posted: March 21, 2023

Record last verified: 2022-06

Locations

CA (1); ES (11); DE (15); US (45)