Clinical Trial for ALS Treatment: Evaluating Safety and Efficacy of Masitinib and Riluzole Combination Therapy
Efficacy and Safety of Masitinib Versus Placebo in the Treatment
Summary
This study is a clinical trial designed to compare the safety and efficacy of combining masitinib with riluzole versus a matched placebo in patients suffering from Amyotrophic Lateral Sclerosis (ALS). The goal is to evaluate the potential of this tyrosine kinase inhibitor for neuroprotection.
Details
This Phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study (NCT03127267) aims to compare the efficacy and safety of masitinib combined with riluzole against a matched placebo in patients with ALS. Masitinib is described as a selective oral tyrosine kinase inhibitor demonstrating neuroprotective capabilities based on preclinical studies. Its primary targets are mast cells and microglia, which play critical roles in neuroinflammatory processes. The study hypothesizes that by modulating the activity of these cells—thereby reducing neuroinflammation and regulating the neuronal microenvironment—masitinib can slow disease progression in ALS. The data is registered on ClinicalTrials.gov and includes a FHIR Transform (NCT03127267_FHIR_Transform). The inclusion of standardized identifiers, status updates (e.g., recruiting, overall study), and structured metadata highlights the importance of using interoperability standards like FHIR for sharing complex clinical trial information across global healthcare systems.
Technology Note
FHIR（Fast Healthcare Interoperability Resources）は医療データ交換の国際標準。このエントリの関連技術: HL7
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