NCT02003144

An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder

Interventions

Type	Name	Description
BIOLOGICAL	eculizumab

Timeline

• Start date: 2015-01-12
• Primary completion: 2021-07-12
• Completion: 2021-07-12
• First posted: 2013-12-06
• Last updated: 2022-08-23
• Results posted: 2022-08-23

Locations

69 sites across 20 countries: United States, Argentina, Australia, Canada, Colombia, Croatia, Czechia, Denmark, Germany, Hong Kong, Italy, Japan, Malaysia, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom