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). ]
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). ]
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