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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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Dec 2018

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At a glance

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

    • 09 Dec 2018 Canada, Czech Republic, and Italy were the planned locations.
    • 28 Nov 2018 According to a U.S. Food and Drug Administration media release, US FDA approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
    • 27 Nov 2018 According to a Catalyst Pharmaceuticals media release, the company has not received any decision from the US FDA regarding the NDA application of this drug. The company states that the PDUFA data still remains the same (28 Nov 2018).
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