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

Neuromyelitis Optica Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Autoimmune Diseases
• Autoimmune Diseases of the Nervous System
• Demyelinating Autoimmune Diseases, CNS
• Myelitis
• Myelitis, Transverse
• Nervous System Diseases
• Neuromyelitis Optica

• NCT number: NCT00304291
• Study type: Interventional
• Source: State University of New York at Buffalo
• Status: Completed
• Phase: Phase 4
• Start date: August 2001
• Completion date: May 2004