A Phase III, Double-Blind, Placebo-Controlled Randomised Trial 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 Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist.
Phase of Trial: Phase III
Latest Information Update: 21 Mar 2017
At a glance
- Drugs Safinamide (Primary)
- Indications Parkinson's disease
- Focus Registrational; Therapeutic Use
- Acronyms MOTION
- Sponsors Newron Sweden AB
- 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.
- 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.
- 30 Sep 2015 According to a Newron Pharmaceuticals media release, late-cycle review meeting for the New Drug Application for safinamide has been completed with the U.S. Food and Drug Administration and the review time has been extended by the standard period of 3 months to review the late submission of additional financial disclosure forms for the MOTION and SETTLE clinical studies. This extends the PDUFA date to March 29, 2016.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History