ReviewParkinson's disease2026
Efficacy and Safety of Safinamide as an Adjunct to Levodopa for Motor Fluctuations in Parkinson's Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Review in Parkinson's disease, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Motor fluctuations often occur with long-term levodopa treatment in Parkinson's disease (PD). Safinamide is a drug that inhibits monoamine oxidase B (MAO-B) and modulates glutamate. It is used together with levodopa. A summary of the latest evidence is needed to assess its effectiveness and safety. Objective: To assess the effectiveness and safety of safinamide as an additional therapy to levodopa for motor fluctuations in PD. Methods: A systematic review and meta-analysis followed PRISMA guidelines. A thorough literature search was done from the beginning until January 2026 across PubMed, Scopus, the Cochrane Central Register of Controlled Trials, and Google Scholar. We included randomized controlled trials (RCTs) that compared safinamide (100 mg/day) to placebo as an addition to levodopa in adults with PD and motor fluctuations. The primary effectiveness outcomes were the change in daily OFF-time (in hours) and the Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) score. The main safety outcome was the occurrence of dyskinesia. We assessed the risk of bias using the Cochrane RoB 2 tool. Data were combined using random-effects models, with results shown as mean difference (MD) or risk ratio (RR) with 95% confidence intervals (CIs). We evaluated the certainty of evidence using GRADE. The protocol was registered with PROSPERO (CRD420261298124). Results: Three RCTs ( Conclusion: Safinamide 100 mg per day appears to be a helpful addition to levodopa for reducing OFF-time and improving motor function in PD patients with motor fluctuations. However, this benefit comes with a higher risk of dyskinesia, so careful patient selection and monitoring are important. The 50-mg dose shows similar but less pronounced effects, supporting 100 mg as the preferred dose. Further research is needed to confirm these findings.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.