This clinical trial aims to study the effectiveness of safinamide in reducing pain in people with Parkinson’s disease who experience motor fluctuations. Motor fluctuations are periods when medication becomes less effective, causing symptoms to return before the next dose. The study will compare safinamide (marketed as Xadago) against placebo in patients who are already taking levodopa or other medications for Parkinson’s disease.
The medication being tested comes in two strengths – 50 mg and 100 mg film-coated tablets that are taken by mouth. During the study, some participants will receive safinamide while others will receive placebo tablets that look identical but contain no active medication. Neither the participants nor the doctors conducting the study will know who is receiving which treatment until the study is complete.
The study will last for 12 weeks, during which participants will take their assigned medication daily while continuing their regular Parkinson’s disease treatments. Throughout the study, doctors will measure changes in pain levels using a rating scale that helps track if the pain is getting better or worse. They will also monitor other aspects of Parkinson’s disease symptoms and how they affect daily life.



Italy