Trial reportAdvances in therapy2024
The Effects of Safinamide in Chinese and Non-Chinese Patients with Parkinson's Disease.
Trial report in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.
What it found
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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.
The trial behind it
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.
A Phase III, Double-blind, Placebo-controlled, Randomised Trial to Determine the Efficacy and Safety of a Dose Range of 50 to 100 mg/Day of Safinamide, as add-on Therapy, in Subjects With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, an Anticholinergic and/or Amantadine
A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa
Who cites it
3 citing papers in PubMed, 5 citations in OpenAlex.
- Expert perspectives on the use of safinamide for Parkinson's disease in Portugal: insights from a Portuguese Delphi Consensus.Journal of comparative effectiveness research · 2025Article
- Optimized use of safinamide as an add-on therapy in Asian patients with Parkinson's disease: a narrative review and expert opinion.Therapeutic advances in neurological disorders · 2025Review
- Safinamide as an adjunct to levodopa monotherapy in Asian patients with Parkinson's disease experiencing early wearing-off: a pooled analysis of the J-SILVER and KEEP studies.Frontiers in neurology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionEthnicity differences are an important determinant in the clinical manifestation of Parkinson's disease (PD), but they are not yet widely recognized, particularly regarding the response to dopaminergic medications. The aim of this paper is to analyze the efficacy and safety of safinamide in Chinese patients with PD in the pivotal studies SETTLE and XINDI compared to the non-Chinese population of the SETTLE trial.
methodsSETTLE (NCT00627640) and XINDI (NCT03881371) were phase III, randomized, double-blind, placebo-controlled, multicenter trials. Patients received safinamide or placebo as add-on to levodopa. The primary efficacy endpoint was the change in the mean total daily OFF time. Secondary efficacy endpoints included total daily ON time, ON time with no/non-troublesome dyskinesia, Unified Parkinson's Disease Rating Scale, and Parkinson's Disease Questionnaire-39 items. Safety was evaluated through the frequency of adverse events. Data from 440 non-Chinese and 109 Chinese patients in the SETTLE study, and 305 Chinese patients in the XINDI trial were considered for this post hoc analysis.
resultsSignificant positive results were seen in favor of safinamide in all populations for the primary and secondary endpoints, with no differences in terms of magnitude. No "treatment by ethnicity" interaction was detected for any parameters, confirming the homogeneity of treatment effects between different populations. The safety and tolerability of safinamide in Chinese patients were similar to those in the other ethnic groups, without unexpected adverse reactions.
conclusionsSafinamide was shown to improve PD symptoms and quality of life in different ethnic populations, without any treatment by race interaction. Further studies are warranted to investigate potential differences in a real-life situation. TRIAL REGISTRATION NUMBER: SETTLE (NCT00627640) and XINDI (NCT03881371).
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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.