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.
Phase of Trial: Phase III
Latest Information Update: 19 Mar 2018
At a glance
- Drugs Safinamide (Primary)
- Indications Parkinson's disease
- Focus Registrational; Therapeutic Use
- Sponsors Newron Pharmaceuticals; Newron Sweden AB
- 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).
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History