Last updated on November 2017

ECU-NMO-301: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)


Brief description of study

ECU-NMO-301: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)

Detailed Study Description

Neuromyelitis Optica (NMO) or NMO Spectrum Disorders (NMOSD), also known as Devic’s Disease, is a rare, severe disabling autoimmune inflammatory disorder of the central nervous system (CNS) that predominately affects the optic nerves and spinal cord, and is often characterized by a relapsing course. Throughout this protocol the term NMO refers to both NMO and NMOSD. Women are much more commonly affected than men, with a female to male ratio of at least 3:1. Currently there are no approved therapies for the treatment of NMO. Acute attacks are usually treated with high dose corticosteroids or plasma exchange (PE) or both. Supportive treatments for relapse prevention using immunosuppressive therapies (ISTs) are based on clinical experience and consensus; there have been no controlled trials. Complement activation is a key element in the development of CNS lesions in NMO. Eculizumab (h5G1.1-mAb) is a terminal complement inhibitor that blocks conversion of C5 to C5a and C5b thus blocking terminal complement activation. The mechanism of action of eculizumab as a terminal complement inhibitor suggests that it may provide therapeutic benefit in the management of NMO by reducing NMO relapses and thus reducing disability. In a recently reported investigator initiated trial, eculizumab reduced the annualized relapse rate (ARR) in a highly relapsing NMO patient population from a median of 3 relapses per year to zero relapses per year (p < 0.0001). This phase 3 registrational trial is intended to confirm the safety and efficacy of eculizumab in the treatment of relapsing NMO.

Clinical Study Identifier: TX11950

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Keri Turner

Baptist Health Clinical Research Center & Lexington Cardiac Research Foundation
Lexington, KY USA
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