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A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), 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

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Trial Profile

A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), 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

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 01 Mar 2017

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At a glance

  • Drugs Safinamide (Primary)
  • Indications Parkinson's disease
  • Focus Therapeutic Use
  • Acronyms SETTLE-extension
  • Sponsors Merck Serono

Most Recent Events

  • 16 Dec 2016 New trial record

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