Status:
COMPLETED
A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
Lead Sponsor:
Pharma Two B Ltd.
Conditions:
Parkinson Disease
Early Parkinson's Disease
Eligibility:
All Genders
35-80 years
Phase:
PHASE3
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. Th...
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 includin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
544 Patients enrolled
Trial Details
Trial ID
NCT03329508
Start Date
January 19 2018
End Date
October 31 2021
Last Update
March 21 2023
Active Locations (72)
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1
P2B001/003 Site Scottsdale
Scottsdale, Arizona, United States, 85258
2
P2B001/003 study site Scottsdale
Scottsdale, Arizona, United States, 85259
3
P2B001/003 Study site little Rock
Little Rock, Arkansas, United States, 72205
4
P2B001 site Los Angeles
Los Angeles, California, United States, 90033