Title: Assessment of Safety and Efficacy of Safinamide as a Levodopa Adjunct in Patients With Parkinson Disease and Motor Fluctuations

Authors: Schapira, A. MD, DSc, FRCP, Fox, S. MBChB, MRCP(UK), PhD2; Hauser, R. A. MD, et al


What You Need to Know:

Safinamide, an oral aminoamide derivative with dopaminergic and nondopaminergic actions, improved “on” time (relief of parkinsonian motor features) without dyskinesia and reduced wearing off in levodopa-treated Parkinson’s disease (PD) patients with motor fluctuations.

Trial Design:

  • Double-blind study from March 2009 to February 2012
  • 549 idiopathic PD patients with “off” time greater than 1.5 hours/day; medications: oral levodopa plus benserazide or carbidopa (stable regimen for 4 weeks or longer)
  • Patients received either safinamide (n=274), starting dose 50mg with increase to 100mg at Day 14 if no tolerability issues or placebo (n=275); 12 in safinamide group and 10 in placebo group discontinued prematurely (due to adverse events)
  • Primary endpoint: mean change from baseline to 24 weeks in daily “on” time without troublesome dyskinesia (assessed from diary data)

Key Outcomes:

  • 245 in safinamide group and 241 in placebo group completed the study
  • Mean change in daily on time without troublesome dyskinesia: safinamide group: +1.42 (2.80) hours from baseline of 9.30 (2.41) hours; placebo group: +0.57 (2.47) hours from baseline of 9.06 (2.50) hours; least-squares mean difference: 0.96 hour; 95% CI, 0.56-1.37 hours; P < 0.001
  • Most frequently reported adverse event: dyskinesia