A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
- Conditions
- Parkinson DiseaseEarly Parkinson's Disease
- Interventions
- Drug: P2B001 0.6/0.75 mg
- Registration Number
- NCT03329508
- Lead Sponsor
- Pharma Two B Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 544
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description P2B001 0.6/0.75 mg P2B001 0.6/0.75 mg Fixed dose combination once daily capsule of pramipexole 0.6mg and rasagiline 0.75mg, + matching placebo tablet Pramipexole 0.6mg Pramipexole 0.6 mg Pramipexole 0.6mg once daily capsule, component of P2B001 + matching placebo tablet Pramipexole Extended Release Marketed Pramipexole ER Marketed pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg + matching placebo capsule rasagiline 0.75mg Rasagiline 0.75 mg Rasagiline 0.75mg Once daily capsule, component of P2B001, + matching placebo tablet
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method Change in Epworth Sleepiness Scale (ESS) Score. 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 outcomeChange From Baseline to Week 12 in Total UPDRS III Motor 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)Change From Baseline to Week 12 in Total UPDRS II ADL 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)
Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39 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
Trial Locations
- Locations (71)
P2B001/003 site Boca Raton
🇺🇸Boca Raton, Florida, United States
P2B001/003 Study site little Rock
🇺🇸Little Rock, Arkansas, United States
P2B001/003 Site Scottsdale
🇺🇸Scottsdale, Arizona, United States
P2B001/003 study site Scottsdale
🇺🇸Scottsdale, Arizona, United States
P2B001/003 Site Boca Raton
🇺🇸Boca Raton, Florida, United States
P2B001 Study Vernon
🇺🇸Vernon, Connecticut, United States
P2B001/003 study site Jacksonville
🇺🇸Jacksonville, Florida, United States
P2B001 site Los Angeles
🇺🇸Los Angeles, California, United States
P2B001/003 Study site Berlin
🇩🇪Berlin, Germany
P2B001/003 Study site Sant Cugat del Vallés
🇪🇸Sant Cugat del Vallés, Barcelona, Spain
P2B001/003 Study site Pamplona
🇪🇸Pamplona, Navarra, Spain
P2B001/003 Study site Vall d'Hebrón
🇪🇸Barcelona, Spain
P2B001/003 Study site Gera
🇩🇪Gera, Thuringen, Germany
P2B001/003 study site Mostoles
🇪🇸Mostoles, Madridid, Spain
P2B0011/003 Study site HM Centro Integral de Neurociencias (CINAC)
🇪🇸Madrid, Spain
P2B001/003 Study site Barcelona
🇪🇸Barcelona, Spain
P2B001/003 site Munich
🇩🇪Munich, Germany
P2B001/003 study site Madrid
🇪🇸Madrid, Spain
P2B001/003 Study site La Paz
🇪🇸Madrid, S, Spain
P2B001/003 Study site Puerta de Hierro - Majadahonda
🇪🇸Majadahonda, Spain
P2B001/003 Study site Navarra Madrid
🇪🇸Madrid, Spain
P2B001/003 Study site Madrid
🇪🇸Madrid, Spain
P2B001/003 site Chicago
🇺🇸Chicago, Illinois, United States
P2B001/003 study site Boston
🇺🇸Boston, Massachusetts, United States
P2B001 study site Cincinnati
🇺🇸Cincinnati, Ohio, United States
P2B001/003 Study site Nashville
🇺🇸Nashville, Tennessee, United States
P2B001/003 Site Tampa
🇺🇸Tampa, Florida, United States
P2B001/003 Site Sarasota
🇺🇸Sarasota, Florida, United States
P2B001/003 Site Lexington
🇺🇸Lexington, Kentucky, United States
P2B001/003 study site Honolulu
🇺🇸Honolulu, Hawaii, United States
P2B001/003 Site Winfield
🇺🇸Winfield, Illinois, United States
P2B001/003 Site Augusta
🇺🇸Augusta, Georgia, United States
P2B001/003 Site East Lansing
🇺🇸East Lansing, Michigan, United States
P2B001/003 study site west Bloomfield
🇺🇸West Bloomfield, Michigan, United States
P2B001/003 Site Golden Valley
🇺🇸Golden Valley, Minnesota, United States
P2B001 Study site Edison
🇺🇸Edison, New Jersey, United States
P2B001/003 study site New Hampshire
🇺🇸Lebanon, New Hampshire, United States
P2B001/003 site St. Louis
🇺🇸Saint Louis, Missouri, United States
P2B001/003 Site Commack
🇺🇸Commack, New York, United States
P2B001/003 New York
🇺🇸New York, New York, United States
P2B001 Study site Syracuse
🇺🇸Syracuse, New York, United States
P2B001/003 Study site Hershey
🇺🇸Hershey, Pennsylvania, United States
P2B001/003 Study site Williamsville
🇺🇸Williamsville, New York, United States
P2B001/003 Site Asheville
🇺🇸Asheville, North Carolina, United States
P2B001/003 Greenville
🇺🇸Greenville, South Carolina, United States
P2B001/003 Site Dallas
🇺🇸Dallas, Texas, United States
P2B001/003
🇺🇸Falls Church, Virginia, United States
p2B001/003 Study site Memphis
🇺🇸Memphis, Tennessee, United States
P2B001/003 Study site Freiburg
🇩🇪Freiburg, Baden-Württemberg, Germany
P2B001/003 Study site Alexandria
🇺🇸Alexandria, Virginia, United States
P2B001/003 Site Kirkland
🇺🇸Kirkland, Washington, United States
P2B001/003 study site Haag
🇩🇪Haag, Bayern, Germany
P2B001/003 Study site Hanau
🇩🇪Hanau, Hessen, Germany
P2B001/003 Study site Haag
🇩🇪Haag, Bayern, Germany
P2B001/003 Study site Bochum
🇩🇪Bochum, Nordrhein-westfalen, Germany
P2B001/003 Study site Dresden
🇩🇪Dresden, SaACHSEN, Germany
P2B001/003 study site Leipzig
🇩🇪Leipzig, Sachsen, Germany
P2B001/003 study site Gera Germany
🇩🇪Gera, Thuringen, Germany
P2B001/003 site Miami
🇺🇸Miami, Florida, United States
P2B001 Study site Englewood,
🇺🇸Englewood, Colorado, United States
P2B001/003 Site Port Charlotte
🇺🇸Port Charlotte, Florida, United States
P2B001/003 Study site Albuquerque
🇺🇸Albuquerque, New Mexico, United States
P2B001/003 Study site Brooklyn
🇺🇸Brooklyn, New York, United States
P2B001/003 site Kansas City
🇺🇸Kansas City, Kansas, United States
P2B0011/003 Study Veracity Neuroscience
🇺🇸Memphis, Tennessee, United States
P2B001/003 Study site Camden
🇺🇸Camden, New Jersey, United States
P2B001/003 study site Ulm
🇩🇪Ulm, Baden-wuerttemberg, Germany
P2B001/003 Site Toledo
🇺🇸Toledo, Ohio, United States
P2B001/003 study site Toronto
🇨🇦Toronto, Ontario, Canada
P2B001/003 Study site München
🇩🇪München, Bayern, Germany
P2B001/003 Study site Münster
🇩🇪Münster, Nordrhein-westfalen, Germany