Neuromyelitis Optica Clinical Trial
Official title:
An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica
The purpose of this study is to determine if the drug eculizumab reduces the attack rate and improves outcome in patients with neuromyelitis optica.
It has been shown in some scientific studies that the the antibody marker specific for
neuromyelitis optica (NMO), known as NMO-Immunoglobulin G (IgG), causes inflammation in
brain tissues by activating a substance called complement. Complement can greatly increase
the immune attack in the optic nerves (causing optic neuritis (ON)), spinal cords (causing
transverse myelitis (TM)) and brains of patients with NMO. Eculizumab has already been shown
to be effective in a rare blood disorder known as paroxysmal nocturnal hemoglobinuria (PNH).
Attacks of PNH are also mediated through complement. Therefore, the investigators of this
study are investigating whether by 'turning off' complement in NMO, further attacks of NMO
can be prevented.
The primary (most important) objectives of this study are to determine:
Whether Eculizumab reduces relapse frequency in patients with relapsing NMO. The number of
attacks during the one year treatment period will be compared to the number of attacks that
occurred prior to initiation of eculizumab treatment. For patients with more than 2 year
disease duration, the average number of attacks in the preceding 2 years will be calculated.
For patients with less than 2 years disease duration the number of attacks in the preceding
year will be used.
The safety profile of eculizumab in patients with NMO.
The secondary objectives are to determine:
Whether eculizumab maintains or improves walking, visual function and quality of life as
measured by a variety of established disability scales. We will also assess the severity of
an individual attack and the degree of recovery.
How the drug behaves in the patient's blood (called pharmacodynamics and pharmacokinetics).
Depending on our preliminary investigations we may evaluate patient cerebrospinal fluid in
the laboratory to see how effective eculizumab is at getting into the cerebrospinal fluid
from the blood stream, and to see if the drug reverses the biological effects of the NMO-IgG
antibody.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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