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)

Trial Profile

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)

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Jul 2016

At a glance

  • Drugs Amifampridine (Primary)
  • Indications Lambert-Eaton myasthenic syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors BioMarin Pharmaceutical; Catalyst Pharmaceutical Partners
  • Most Recent Events

    • 18 May 2016 Results from this trial have been been published in Muscle and Nerve, according to a Catalyst Pharmaceuticals media release.
    • 18 May 2016 Results published in a Catalyst Pharmaceuticals media release.
    • 26 Apr 2016 According to Catalyst Pharmaceutical Partners media release, the FDA has stated that in addition to the results submitted by this trial the company needs to submit positive results from an additional adequate and well-controlled study in patient with LEMS.
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