A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson's Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.

Trial Profile

A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson's Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jun 2017

At a glance

  • Drugs Safinamide (Primary)
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms SETTLE
  • Sponsors Newron Pharmaceuticals
  • Most Recent Events

    • 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
    • 21 Mar 2017 According to a Newron Pharmaceuticals media release, the Food and Drug Administration (FDA) has approved the use of Xadago (safinamide) for the treatment of Parkinsons disease as add-on therapy to levodopa/carbidopa, based on the data from MOTION and SETTLE studies.
    • 12 Dec 2016 Results published in the JAMA Neurology
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