A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
Status:
Active, not recruiting
Trial end date:
2021-10-31
Target enrollment:
Participant gender:
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.