A Phase III, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Patients 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, and/or an Anticholinergic.

Trial Profile

A Phase III, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Patients 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, and/or an Anticholinergic.

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
  • Sponsors Newron Sweden AB
  • 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
    • 13 Nov 2015 According to a Zambon media release, Xadago (safinamide) was approved as add-on therapy to levodopa (L-dopa) alone or in combination with other PD therapies for patients with Parkinson's disease in mid-to late-stage and motor fluctuations by Swissmedic on November 12, 2015.
    • 23 Jun 2015 Pooled analysis (016 and SETTLE studies) results presented at the 1st Congress of the European Academy of Neurology (n = 1188).
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