Back to resultsA Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic's Disease)
Primary Purpose
Neuromyelitis Optica, Myelitis, Transverse, Demyelinating Autoimmune Diseases, CNS
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mitoxantrone
Sponsored by
About this trial
This is an interventional treatment trial for Neuromyelitis Optica focused on measuring Novantrone
Eligibility 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
Sites / Locations
- Baird Multiple Sclerosis Center
Outcomes
Primary Outcome Measures
Relapse rate
Secondary Outcome Measures
Safety
Full Information
NCT ID
NCT00304291
First Posted
March 15, 2006
Last Updated
December 23, 2020
Sponsor
State University of New York at Buffalo
Collaborators
EMD Serono
1. Study Identification
Unique Protocol Identification Number
NCT00304291
Brief Title
A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic's Disease)
Official Title
A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic's Disease)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
EMD Serono
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromyelitis Optica, Myelitis, Transverse, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System
Keywords
Novantrone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone
Primary Outcome Measure Information:
Title
Relapse rate
Secondary Outcome Measure Information:
Title
Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bianca Weinstock-Guttman, M.D.
Organizational Affiliation
Baird Multiple Sclerosis Center
Official's Role
Study Director
Facility Information:
Facility Name
Baird Multiple Sclerosis Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16831964
Citation
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. doi: 10.1001/archneur.63.7.957.
Results Reference
result
Learn more about this trial
A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic's Disease)
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