An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
The purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing NMO.
Neuromyelitis Optica Spectrum Disorder
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Evaluate the long-term safety of eculizumab in patients with relapsing NMO. [ Time Frame: From first dose to study completion (maximum of 4 years). ] [ Designated as safety issue: Yes ]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)
- Evaluate the long-term efficacy of eculizumab in patients with relapsing NMO [ Time Frame: From first dose to study completion (maximum of 4 years). ] [ Designated as safety issue: No ]Change from baseline in Annualized Relapsing Rate, disability, quality of life and neurologic function.
- Describe the pharmacokinetics (PK) and pharmacodynamics (PD) of eculizumab in patients with relapsing NMO [ Time Frame: From first dose to study completion (maximum of 4 years). ] [ Designated as safety issue: No ]Change in plasma PK of eculizumab and in free C5 activity (PD marker) before and after treatment with the study drug.
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Eculizumab intravenous infusion every two weeks.
Other Name: Soliris
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02003144
|Hospital Universitario Clinico San Carlos|
|Madrid, Spain, 28040|