A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)

Lambert Eaton Myasthenic Syndrome Clinical Trial

Official title: A Phase 3, Double-blind, Placebo-controlled, Randomized Discontinuation Study Followed by Open-label Extension Evaluating Efficacy and Safety of Amifampridine Phosphate in Patients With Lambert-Eaton Myasthenic Syndrome (LEMS)

Status Completed

Clinical Trial Summary

A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients with Lambert-Eaton Myasthenic Syndrome (LEMS).

Clinical Trial Description

This multicenter, double-blind, placebo-controlled, randomized (1:1) discontinuation study is a 4-part study designed to evaluate the efficacy and safety of multiple dose administration of amifampridine phosphate in patients with LEMS. Data from parts 2 and 3 (the double-blind parts of the study) are presented in this record. ;

Related Conditions & MeSH terms

• Lambert Eaton Myasthenic Syndrome
• Lambert-Eaton Myasthenic Syndrome
• Syndrome

• NCT number: NCT01377922
• Study type: Interventional
• Source: Catalyst Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: June 2011
• Completion date: July 2016