Clinical trial NCT03329508: A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Early Parkinson's Disease
Keywords: Parkinson disease
early Parkinson's Disease
Parkinson's diagnosis
Parkinson's tretment
Parkinson's medications
Lead sponsor: Pharma Two B Ltd.
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 544
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 arms
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160).
timeFrame: baseline to week 12
Secondary outcomes:
measure: Change in Epworth Sleepiness Scale (ESS) Score.
timeFrame: baseline to week 12
measure: Change From Baseline to Week 12 in Total UPDRS III Motor
timeFrame: baseline to week 12
measure: Change From Baseline to Week 12 in Total UPDRS II ADL
timeFrame: Baseline to week 12
measure: Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39
timeFrame: Baseline to week 12
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: P2B001/003 Site Scottsdale
state: Arizona
city: Scottsdale
country: United States
facility: P2B001/003 study site Scottsdale
state: Arizona
city: Little Rock
country: United States
facility: P2B001/003 Study site little Rock
state: Arkansas
city: Los Angeles
country: United States
facility: P2B001 site Los Angeles
state: California
city: Englewood
country: United States
facility: P2B001 Study site Englewood,
state: Colorado
city: Vernon
country: United States
facility: P2B001 Study Vernon
state: Connecticut
city: Boca Raton
country: United States
facility: P2B001/003 site Boca Raton
state: Florida
city: Boca Raton
country: United States
facility: P2B001/003 Site Boca Raton
state: Florida
city: Jacksonville
country: United States
facility: P2B001/003 study site Jacksonville
state: Florida
city: Miami
country: United States
facility: P2B001/003 site Miami
state: Florida
city: Port Charlotte
country: United States
facility: P2B001/003 Site Port Charlotte
state: Florida
city: Sarasota
country: United States
facility: P2B001/003 Site Sarasota
state: Florida
city: Tampa
country: United States
facility: P2B001/003 Site Tampa
state: Florida
city: Augusta
country: United States
facility: P2B001/003 Site Augusta
state: Georgia
city: Honolulu
country: United States
facility: P2B001/003 study site Honolulu
state: Hawaii
city: Chicago
country: United States
facility: P2B001/003 site Chicago
state: Illinois
city: Winfield
country: United States
facility: P2B001/003 Site Winfield
state: Illinois
city: Kansas City
country: United States
facility: P2B001/003 site Kansas City
state: Kansas
city: Lexington
country: United States
facility: P2B001/003 Site Lexington
state: Kentucky
city: Boston
country: United States
facility: P2B001/003 study site Boston
state: Massachusetts
city: East Lansing
country: United States
facility: P2B001/003 Site East Lansing
state: Michigan
city: West Bloomfield
country: United States
facility: P2B001/003 study site west Bloomfield
state: Michigan
city: Golden Valley
country: United States
facility: P2B001/003 Site Golden Valley
state: Minnesota
city: Saint Louis
country: United States
facility: P2B001/003 site St. Louis
state: Missouri
city: Lebanon
country: United States
facility: P2B001/003 study site New Hampshire
state: New Hampshire
city: Camden
country: United States
facility: P2B001/003 Study site Camden
state: New Jersey
city: Edison
country: United States
facility: P2B001 Study site Edison
state: New Jersey
city: Albuquerque
country: United States
facility: P2B001/003 Study site Albuquerque
state: New Mexico
city: Brooklyn
country: United States
facility: P2B001/003 Study site Brooklyn
state: New York
city: Commack
country: United States
facility: P2B001/003 Site Commack
state: New York
city: New York
country: United States
facility: P2B001/003 New York
state: New York
city: Syracuse
country: United States
facility: P2B001 Study site Syracuse
state: New York
city: Williamsville
country: United States
facility: P2B001/003 Study site Williamsville
state: New York
city: Asheville
country: United States
facility: P2B001/003 Site Asheville
state: North Carolina
city: Cincinnati
country: United States
facility: P2B001 study site Cincinnati
state: Ohio
city: Toledo
country: United States
facility: P2B001/003 Site Toledo
state: Ohio
city: Hershey
country: United States
facility: P2B001/003 Study site Hershey
state: Pennsylvania
city: Greenville
country: United States
facility: P2B001/003 Greenville
state: South Carolina
city: Memphis
country: United States
facility: P2B0011/003 Study Veracity Neuroscience
state: Tennessee
city: Memphis
country: United States
facility: p2B001/003 Study site Memphis
state: Tennessee
city: Nashville
country: United States
facility: P2B001/003 Study site Nashville
state: Tennessee
city: Dallas
country: United States
facility: P2B001/003 Site Dallas
state: Texas
city: Alexandria
country: United States
facility: P2B001/003 Study site Alexandria
state: Virginia
city: Falls Church
country: United States
facility: P2B001/003
state: Virginia
city: Kirkland
country: United States
facility: P2B001/003 Site Kirkland
state: Washington
city: Toronto
country: Canada
facility: P2B001/003 study site Toronto
state: Ontario
city: Ulm
country: Germany
facility: P2B001/003 study site Ulm
state: Baden-wuerttemberg
city: Freiburg
country: Germany
facility: P2B001/003 Study site Freiburg
state: Baden-Württemberg
city: Haag
country: Germany
facility: P2B001/003 study site Haag
state: Bayern
city: Haag
country: Germany
facility: P2B001/003 Study site Haag
state: Bayern
city: München
country: Germany
facility: P2B001/003 Study site München
state: Bayern
city: Hanau
country: Germany
facility: P2B001/003 Study site Hanau
state: Hessen
city: Bochum
country: Germany
facility: P2B001/003 Study site Bochum
state: Nordrhein-westfalen
city: Münster
country: Germany
facility: P2B001/003 Study site Münster
state: Nordrhein-westfalen
city: Dresden
country: Germany
facility: P2B001/003 Study site Dresden
state: SaACHSEN
city: Leipzig
country: Germany
facility: P2B001/003 study site Leipzig
state: Sachsen
city: Gera
country: Germany
facility: P2B001/003 study site Gera Germany
state: Thuringen
city: Gera
country: Germany
facility: P2B001/003 Study site Gera
state: Thuringen
city: Berlin
country: Germany
facility: P2B001/003 Study site Berlin
city: Berlin
country: Germany
facility: P2B001/003 Study site Berlin
city: Munich
country: Germany
facility: P2B001/003 site Munich
city: Sant Cugat del Vallés
country: Spain
facility: P2B001/003 Study site Sant Cugat del Vallés
state: Barcelona
city: Mostoles
country: Spain
facility: P2B001/003 study site Mostoles
state: Madridid
city: Pamplona
country: Spain
facility: P2B001/003 Study site Pamplona
state: Navarra
city: Madrid
country: Spain
facility: P2B001/003 Study site La Paz
state: S
city: Barcelona
country: Spain
facility: P2B001/003 Study site Barcelona
city: Barcelona
country: Spain
facility: P2B001/003 Study site Vall d'Hebrón
city: Madrid
country: Spain
facility: P2B001/003 Study site Navarra Madrid
city: Madrid
country: Spain
facility: P2B001/003 study site Madrid
city: Madrid
country: Spain
facility: P2B001/003 Study site Madrid
city: Madrid
country: Spain
facility: P2B0011/003 Study site HM Centro Integral de Neurociencias (CINAC)
city: Majadahonda
country: Spain
facility: P2B001/003 Study site Puerta de Hierro - Majadahonda
Study officials:
affiliation: Pharma2b LTD
name: Pninit Litman
role: STUDY_DIRECTOR
References: