Trial reportInternal medicine (Tokyo, Japan)2025
Long-term Efficacy and Safety of Amifampridine Phosphate (Firdapse
Trial report in Internal medicine (Tokyo, Japan), 2025. 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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Authors and funding
8 authors.
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Abstract
Objective To evaluate the efficacy and safety of amifampridine (3,4-diaminopyridine) phosphate in Japanese adults with Lambert-Eaton myasthenic syndrome (LEMS). Methods The LMS-005 study was an uncontrolled, single-blind (patient blinded), multicenter, one-year phase 3 clinical study. The administration of amifampridine phosphate was started at 15 mg/day, and the dose was increased every 3 to 4 days to determine the optimal dose for each patient. After 7 days of treatment with the optimal dose, efficacy was assessed by evaluating quantitative myasthenia gravis (QMG), subject global impression (SGI), and Clinical Global Impression-Improvement scale (CGI-I) scores. Patients Adult patients with LEMS were analyzed for safety [n=12, mean age±standard deviation (SD) of 61.1±14.6 years old] and efficacy (n=10, mean age±SD of 60.7±15.9 years old). Results In the efficacy population, the mean±SD [median (interquartile range)] QMG score was 13.2±3.1 [13.5 (11.0, 15.0)] at baseline and 8.0±2.7 [8.0 (6.0, 9.0)] at the end of the treatment period, with a mean±SD [median (interquartile range)] change of -5.2±2.8 [-5.5 (-7.0, -3.0)]. All patients showed a decrease in the QMG score from baseline and experienced improvement in their LEMS symptoms. The SGI/CGI-I scores also improved. Efficacy was maintained until the end of the study. Five patients in the safety population experienced adverse drug reactions, the most common of which was dysesthesia (n=2). Conclusion This study revealed the long-term efficacy and tolerability of amifampridine phosphate in Japanese adults with LEMS.
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