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A Phase III, Double-blind, Placebo-controlled, 18-mon Ext Study Long-term Efficacy & Safety of 50 & 100mg/Day Doses of Safinamide, as add-on Therapy, in Idiopathic PD Pts With Motor Fluctuations, Treated With Levodopa, Who May be Receiving DA, and/or Anticholinergic

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Trial Profile

A Phase III, Double-blind, Placebo-controlled, 18-mon Ext Study Long-term Efficacy & Safety of 50 & 100mg/Day Doses of Safinamide, as add-on Therapy, in Idiopathic PD Pts With Motor Fluctuations, Treated With Levodopa, Who May be Receiving DA, and/or Anticholinergic

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Jan 2020

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At a glance

  • Drugs Safinamide (Primary)
  • Indications Parkinson's disease
  • Focus Therapeutic Use
  • Sponsors Newron Pharmaceuticals; Newron Sweden AB

    • Most Recent Events

    • 14 Mar 2018 Results of a new post hoc analysis of the data from this study assessing the long-term (2-year) efficacy of safinamide on parkinsons disease chronic pain, published in the Advances in Therapy Journal.
    • 27 Jun 2017 Results of post-hoc analysis assessing long term efficacy, presented at the 3rd Congress of the European Academy of Neurology.
    • 08 Jun 2017 The effects of safinamide on motor complications and on non-motor symptoms were investigated using the data from studies 016, 018 and SETTLE; results presented at the 21st International Congress of Parkinson's Disease and Movement Disorders

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