Long-term safety and efficacy of safinamide as add-on therapy in levodopa-treated Japanese patients with Parkinson's disease with wearing-off: Results of an open-label study

Safinamide add-on therapy was evaluated as a long-term treatment for Japanese people with Parkinson's disease who experience wearing-off while taking levodopa. In a 52-week, open-label Phase III study, the main outcome was change in mean daily ON-time without troublesome dyskinesias. Secondary outcomes included changes in mean daily OFF-time and UPDRS measures, along with PDQ-39. Among 203 enrolled patients, ON-time without troublesome dyskinesias increased by about 1.42 hours at week 52, while OFF-time decreased by about 1.40 hours and UPDRS Part III ON-phase improved. Adverse events occurred in 78.3% of patients, serious adverse events occurred in 17.2%, and the overall conclusion was that safinamide was safe, well tolerated, and effective over 52 weeks when used with levodopa.