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

This study has been completed.
Sponsor:
Collaborator:
EMD Serono
Information provided by:
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT00304291
First received: March 15, 2006
Last updated: November 27, 2006
Last verified: March 2006
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic’s Disease)

Resource links provided by NLM:

U.S. FDA Resources

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:

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

Keywords provided by State University of New York at Buffalo:
Novantrone

Additional relevant MeSH terms:
Autoimmune Diseases
Myelitis
Myelitis, Transverse
Nervous System Diseases
Neuromyelitis Optica
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Immune System Diseases
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
 Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Demyelinating Diseases
Neurodegenerative Diseases
Multiple Sclerosis
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Leukoencephalopathies
Brain Diseases
Mitoxantrone
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013