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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Nov 2023

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At a glance

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

    • Most Recent Events

    • 09 Nov 2023 Results presented in a Pharma Two B Media Release.
    • 27 Oct 2023 Results assessing determine if P2B001 (a fixed, low-dose, extended-release [ER] combination of pramipexole 0.6 mg and rasagiline 0.75 mg) is superior to each of its components and compare its safety and efficacy to optimized treatment with marketed doses of pramipexole-ER published in the Movement Disorders
    • 28 Aug 2023 According to Pharma Two B Media Release, sub group analysis data from this study were presented at the 2023 The International Parkinson and Movement Disorder Society annual meeting, August 27-31, in Copenhagen, Denmark. Results are being presented as a poster presentation.
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