Clinical Trial: An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: A Phase III, Open-label, Extension Trial of ECU-NMO-301 to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)

Brief Summary: The purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing NMO.

Detailed Summary: This study is an open label extension study to confirm the long term safety and efficacy of eculizumab in subjects with relapsing NMO who have completed the initial double-blind, randomized, placebo-controlled trial ECU-NMO-301.
Sponsor: Alexion Pharmaceuticals

Current Primary Outcome: Evaluate the long-term safety of eculizumab in patients with relapsing NMO. [ Time Frame: From first dose to study completion (maximum of 4 years). ]

Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), change from baseline in vital signs, clinical laboratory tests, and suicide risk as assessed with Columbia-Suicide Rating Scale (C-SSRS)


Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluate the long-term efficacy of eculizumab in patients with relapsing NMO [ Time Frame: From first dose to study completion (maximum of 4 years). ]

Change from baseline in Annualized Relapsing Rate, disability, quality of life and neurologic function.


Original Secondary Outcome: Same as current

Information By: Alexion Pharmaceuticals

Dates:
Date Received: November 18, 2013
Date Started: January 2015
Date Completion: December 2018
Last Updated: February 1, 2017
Last Verified: February 2017