ECU-NMO-301 Phase3 study:Eculizumab for Relapsing Neuromyelitis Optica
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients with Relapsing Neuromyelitis Optica (NMO)
IRAS ID
133024
Contact name
Anu Jacob
Contact email
Sponsor organisation
Alexion Pharmaceuticals, Inc.
Eudract number
2013-001150-10
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
The purpose of this study is to determine if a study drug, called eculizumab, is safe and effective for preventing relapses in patients with relapsing Neuromyelitis Optica (NMO). NMO is a rare disease of the central nervous system that mainly affects the optic nerves and spinal cord. Relapsing is when a patient’s health worsens after a period of improvement. Eculizumab is not approved for the treatment of NMO; it is considered to be experimental for use in patients with NMO.
This study will recruit a maximum of 132 patients, aged 18 years and above, globally. The total anticipated duration of the study is approximately 2 years, but the participation of an individual patient will vary depending on when he/she entered the study and whether he/she experiences a relapse. Patients will receive study drug or placebo weekly for the first 5 weeks, then every other week from Week 6 onwards. Placebo looks like the study drug but does not contain the active ingredient.
Currently there is no therapy approved for the treatment of NMO. Given the seriousness of the disease, limitations of currently available therapies, and the limited options for treatment, there remains a significant unmet medical need for an effective and safe treatment for NMO.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/0029
Date of REC Opinion
18 Feb 2014
REC opinion
Further Information Favourable Opinion