A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic's Disease)
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2001
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 15, 2006
CompletedFirst Posted
Study publicly available on registry
March 17, 2006
CompletedDecember 28, 2020
December 1, 2020
March 15, 2006
December 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relapse rate
Secondary Outcomes (1)
Safety
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- State University of New York at Buffalolead
- EMD Seronocollaborator
Study Sites (1)
Baird Multiple Sclerosis Center
Buffalo, New York, 14203, United States
Related Publications (1)
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.
PMID: 16831964RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bianca Weinstock-Guttman, M.D.
Baird Multiple Sclerosis Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 15, 2006
First Posted
March 17, 2006
Study Start
August 1, 2001
Study Completion
May 1, 2004
Last Updated
December 28, 2020
Record last verified: 2020-12