A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
Parkinson Disease, Early Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, early Parkinson's Disease, Parkinson's diagnosis, Parkinson's tretment, Parkinson's medications
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- P2B001/003 Site Scottsdale
- P2B001/003 study site Scottsdale
- P2B001/003 Study site little Rock
- P2B001 site Los Angeles
- P2B001 Study site Englewood,
- P2B001 Study Vernon
- P2B001/003 site Boca Raton
- P2B001/003 Site Boca Raton
- P2B001/003 study site Jacksonville
- P2B001/003 site Miami
- P2B001/003 Site Port Charlotte
- P2B001/003 Site Sarasota
- P2B001/003 Site Tampa
- P2B001/003 Site Augusta
- P2B001/003 study site Honolulu
- P2B001/003 site Chicago
- P2B001/003 Site Winfield
- P2B001/003 site Kansas City
- P2B001/003 Site Lexington
- P2B001/003 study site Boston
- P2B001/003 Site East Lansing
- P2B001/003 study site west Bloomfield
- P2B001/003 Site Golden Valley
- P2B001/003 site St. Louis
- P2B001/003 study site New Hampshire
- P2B001/003 Study site Camden
- P2B001 Study site Edison
- P2B001/003 Study site Albuquerque
- P2B001/003 Study site Brooklyn
- P2B001/003 Site Commack
- P2B001/003 New York
- P2B001 Study site Syracuse
- P2B001/003 Study site Williamsville
- P2B001/003 Site Asheville
- P2B001 study site Cincinnati
- P2B001/003 Site Toledo
- P2B001/003 Study site Hershey
- P2B001/003 Greenville
- P2B0011/003 Study Veracity Neuroscience
- p2B001/003 Study site Memphis
- P2B001/003 Study site Nashville
- P2B001/003 Site Dallas
- P2B001/003 Study site Alexandria
- P2B001/003
- P2B001/003 Site Kirkland
- P2B001/003 study site Toronto
- P2B001/003 study site Ulm
- P2B001/003 Study site Freiburg
- P2B001/003 study site Haag
- P2B001/003 Study site Haag
- P2B001/003 Study site München
- P2B001/003 Study site Hanau
- P2B001/003 Study site Bochum
- P2B001/003 Study site Münster
- P2B001/003 Study site Dresden
- P2B001/003 study site Leipzig
- P2B001/003 study site Gera Germany
- P2B001/003 Study site Gera
- P2B001/003 Study site Berlin
- P2B001/003 Study site Berlin
- P2B001/003 site Munich
- P2B001/003 Study site Sant Cugat del Vallés
- P2B001/003 study site Mostoles
- P2B001/003 Study site Pamplona
- P2B001/003 Study site La Paz
- P2B001/003 Study site Barcelona
- P2B001/003 Study site Vall d'Hebrón
- P2B001/003 Study site Navarra Madrid
- P2B001/003 study site Madrid
- P2B001/003 Study site Madrid
- P2B0011/003 Study site HM Centro Integral de Neurociencias (CINAC)
- P2B001/003 Study site Puerta de Hierro - Majadahonda
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
P2B001 0.6/0.75 mg
rasagiline 0.75mg
Pramipexole 0.6mg
Pramipexole Extended Release
Fixed dose combination once daily capsule of pramipexole 0.6mg and rasagiline 0.75mg, + matching placebo tablet
Rasagiline 0.75mg Once daily capsule, component of P2B001, + matching placebo tablet
Pramipexole 0.6mg once daily capsule, component of P2B001 + matching placebo tablet
Marketed pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg + matching placebo capsule