At a glance
ClinicalIndex Comparison Record- ✓Parkinson's disease meeting UK Brain Bank Criteria with bradykinesia and sequence effect, or prominent motor asymmetry if no rest tremor
- ✓Disease duration less than 3 years since diagnosis
- ✓Hoehn & Yahr stage <3
- ✓MMSE score ≥26
- ✕Atypical parkinsonian syndrome or secondary parkinsonism
- ✕Prior dopamine agonist or levodopa for >4 weeks, or <4 weeks exposure within 2 months of baseline
- ✕Prior MAO-B inhibitor for >4 weeks, or <4 weeks exposure within 3 months of baseline
- ✕Anticholinergic drugs or amantadine for PD for >4 weeks, or <4 weeks exposure within 1 month of baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating P2B001 0.6/0.75 mg, Rasagiline 0.75 mg, and 2 other interventions for Parkinson Disease and Early Parkinson's Disease. Completed, enrolled 544 participants across 72 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
Fixed low dose extended release combination capsule of pramipexole and rasagiline
Rasagiline 0.75 mg oral extended release capsule, component
Pramipexole 0.6 mg oral extended release capsule, component
Marketed Pramipexole ER titrated to optimal dose of 1.5, 3 or 4.5 mg tablet