A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic's Disease)

Completed · Phase 4

Conditions studied: Neuromyelitis Optica, Myelitis, Transverse, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System

In brief

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.

Key facts

Study ID

NCT00304291

Run by

State University of New York at Buffalo

People needed

5

Starts

2001-08-01

Expected to finish

2004-05-01

Last updated by the study team

2020-12-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Baird Multiple Sclerosis Center — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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