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
Phase of Trial: Phase III
Latest Information Update: 20 Mar 2018
At a glance
- Drugs Safinamide (Primary)
- Indications Parkinson's disease
- Focus Registrational; Therapeutic Use
- Sponsors Newron Pharmaceuticals; Newron Sweden AB
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History