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

Sponsor
State University of New York at Buffalo (Other)
Overall Status
Completed
CT.gov ID
NCT00304291
Collaborator
EMD Serono (Industry)
5
Enrollment
1
Location
33
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic's Disease)
Study Start Date :
Aug 1, 2001
Study Completion Date :
May 1, 2004

Outcome Measures

Primary Outcome Measures

  1. Relapse rate []

Secondary Outcome Measures

  1. Safety []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Baird Multiple Sclerosis CenterBuffaloNew YorkUnited States14203

Sponsors and Collaborators

  • State University of New York at Buffalo
  • EMD Serono

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bianca Weinstock-Guttman, Principal Investigator, State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT00304291
Other Study ID Numbers:
  • JNI-NMO-101
First Posted:
Mar 17, 2006
Last Update Posted:
Dec 28, 2020
Last Verified:
Dec 1, 2020
Keywords provided by Bianca Weinstock-Guttman, Principal Investigator, State University of New York at Buffalo
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 28, 2020