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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.

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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.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2023

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At a glance

  • Drugs Safinamide (Primary) ; Levodopa
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms SETTLE
  • Sponsors Merck Serono; Newron Pharmaceuticals

    • Most Recent Events

    • 09 Dec 2023 Results of post hoc analysis of SETTLE and XINDI trial assessing the effects of safinamide in chinese and non-chinese patients with parkinson's disease (440 non-Chinese and 109 Chinese patients in the SETTLE study, and 305 Chinese patients in the XINDI trial ) published in the Advances in Therapy.
    • 18 Sep 2022 Results of post hoc analysis evaluating the efficacy and safety outcomes of safinamide as a levodopa adjunct therapy, presented at the 26th International Congress of Parkinson's Disease and Movement Disorders
    • 30 Jul 2022 This trial has been completed in Netherlands, according to European Clinical Trials Database record (29 Mar 2012).
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