Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS)

Summary

This study evaluates the effect of withdrawing amifampridine phosphate treatment from patients with LEMS. One half of the patients will continue to receive amifampridine phosphate and the other half will receive placebo, during this double-blind study.

Timeline

Start

2016-11

Primary completion

2017-10

Completion

2017-10

Outcome

Met primary endpoint

registry analysis (superiority test); Amifampridine Phosphate vs Placebo (for Amifampridine Phosphate); p = 0.0004 NCT02970162 ↗

registry analysis (superiority test); Amifampridine Phosphate vs Placebo (for Amifampridine Phosphate); p = 0.0003; LS means 2.95 (95% CI 1.53 to 4.38) NCT02970162 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amifampridine	Small molecule	10 mg	Oral

Indications