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A Phase III, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of a Low (50-100 mg/Day) and High (150-200 mg/Day) Dose Range of Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist

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Trial Profile

A Phase III, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of a Low (50-100 mg/Day) and High (150-200 mg/Day) Dose Range of Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2021

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At a glance

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

    • Most Recent Events

    • 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 (009, 015 and MOTION) Efficacy benefits results presented at the 1st Congress of the European Academy of Neurology.
    • 18 Jun 2015 Pooled analysis (009, 015, Motion) results presented at the 19th International Congress of Parkinson's Disease and Movement Disorders.

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