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Lambert-Eaton myasthenic syndrome (LEMS) is an autoimmune disease in which antibodies against voltage-gated calcium channels inhibit cholinergic neurotransmission. This syndrome is characterized clinically by muscle weakness and autonomic dysfunction. 3,4-diaminopyridine (3,4-DAP; amifampridine) blocks potassium channels in nerve terminals, producing an increase in acetyl choline release.
In this manufacturer-supported, phase 3, randomized, double blind study, investigators evaluated the efficacy and safety of amifampridine phosphate. Patients enrolled were initially treated with amifampridine phosphate for 7 to 91 days, followed by randomization to continue the drug for 14 days or taper off with placebo replacement (7-day taper followed by …