Autoimmune Diseases of the Nervous System, Demyelinating Autoimmune Diseases, CNS, Myelitis, Transverse, Neuromyelitis Optica
Conditions
Keywords
Novantrone
Brief summary
Neuromyelitis optica (NMO) is a severe demyelinating disease that selectively involves the optic nerves and the spinal cord but usually spares the brain. NMO is considered to have a B cell induced pathogenesis. Mitoxantrone (MITO, Novantrone®), a synthetic anthracenedione approved for worsening relapsing-remitting multiple sclerosis (MS) and secondary progressive MS, has been shown to primarily suppress the humoral response. We conducted a prospective 2-year study to evaluate the benefit of MITO in five relapsing NMO patients.
Detailed description
The treatment protocol consisted of monthly 12 mg/m2 MITO intravenous infusions for 6 months followed by 3 additional treatments every 3 months. Neurological assessment including the determination of the Expanded Disability Status Scale (EDSS) score was performed every 3 months and during relapses. Orbital, brain and spinal cord MRI was performed at baseline, 3, 6, 12, 18, and 24 months. Visual evoked potentials and ophthalmologic evaluations were performed at baseline and annually.
Interventions
DRUGMitoxantrone
Sponsors
EMD Serono
State University of New York at Buffalo
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Recurrent longitudinal myelitis (\>3 segments of spinal cord involvement by MRI) with or without recurrent ON (unilateral or bilateral) but with normal brain MRI. * Patients with recurrent longitudinally extensive myelitis without optic neuritis have an underlying pathology and serology similar to NMO and it is appropriate to consider this a form of NMO10. * Cerebrospinal fluid required no intrathecal IgG synthesis or oligoclonal bands. * Age was required to be 18-55 years * Extended Disability Status Score ≤ 7.
Exclusion criteria
* Cardiac risk factors (e.g history of congestive heart failure and left ventricular ejection fraction (LVEF) \< 50% * Systemic diseases such as lupus, Sjogren's syndrome, anti-phospholipid antibody syndrome, sarcoidosis, rheumatoid arthritis, or vitamin B12 deficiency * Previous treatment with mitoxantrone or anthracyclines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
United States
Outcome results
None listed