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.

Trial Profile

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.

Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2017

At a glance

  • Drugs Pramipexole/rasagiline (Primary)
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Pharma Two B
  • Most Recent Events

    • 30 Oct 2017 Status changed from planning to not yet recruiting.
    • 30 Jun 2015 According to a Pharma Two B media release, based on the positive results of the Phase IIb pivotal study (see profile 700238244), the company can now move forward to immediately initiate this trial needed for registration, via the 505(b)(2) pathway.
    • 06 Mar 2015 New trial record
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