A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic’s Disease) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Neuromyelitis Optica Myelitis, Transverse Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System	Drug: Mitoxantrone	Phase IV

MedlinePlus related topics:

Autoimmune Diseases Multiple Sclerosis Neurologic Diseases

ChemIDplus related topics:

Mitoxantrone hydrochloride Mitoxantrone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:

Relapse rate

Secondary Outcome Measures:

Safety

Estimated Enrollment:	5
Study Start Date:	August 2001
Estimated Study Completion Date:	May 2004

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304291

Locations


United States, New York
	Baird Multiple Sclerosis Center
	Buffalo, New York, United States, 14203

Sponsors and Collaborators

State University of New York at Buffalo

EMD Serono

Investigators


Study Director:	Bianca Weinstock-Guttman, M.D.	Baird Multiple Sclerosis Center

More Information

Publications of Results:

Weinstock-Guttman B, Ramanathan M, Lincoff N, Napoli SQ, Sharma J, Feichter J, Bakshi R. Study of mitoxantrone for the treatment of recurrent neuromyelitis optica (Devic disease). Arch Neurol. 2006 Jul;63(7):957-63.

Study ID Numbers:	JNI-NMO-101
First Received:	March 15, 2006
Last Updated:	November 27, 2006
ClinicalTrials.gov Identifier:	NCT00304291
Health Authority:	United States: Food and Drug Administration

Keywords provided by State University of New York at Buffalo:

Novantrone

Study placed in the following topic categories:

Papillitis

Spinal Cord Diseases

Neuromyelitis Optica

Demyelinating diseases

Neurodegenerative Diseases

Neuritis

Multiple Sclerosis

Myelitis, Transverse

Nervous System Neoplasms

Autoimmune Diseases of the Nervous System

Optic Neuritis

Autoimmune Diseases

Devic disease

Demyelinating Diseases

Eye Diseases

Central Nervous System Diseases

Sclerosis

Optic nerve disorder

Recurrence

Virus Diseases

Paraneoplastic Syndromes

Central Nervous System Infections

Demyelinating Autoimmune Diseases, CNS

Myelitis

Optic Nerve Diseases

Mitoxantrone

Additional relevant MeSH terms:

Immune System Diseases

Antineoplastic Agents

Physiological Effects of Drugs

Nervous System Diseases

Central Nervous System Viral Diseases

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Sensory System Agents

Therapeutic Uses

Cranial Nerve Diseases

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

Paraneoplastic Syndromes, Nervous System

ClinicalTrials.gov processed this record on August 29, 2008

Sponsors and Collaborators:	State University of New York at Buffalo EMD Serono
Information provided by:	State University of New York at Buffalo
ClinicalTrials.gov Identifier:	NCT00304291