Status:
COMPLETED
A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic's Disease)
Lead Sponsor:
State University of New York at Buffalo
Collaborating Sponsors:
EMD Serono
Conditions:
Neuromyelitis Optica
Myelitis, Transverse
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
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 pat...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00304291
Start Date
August 1 2001
End Date
May 1 2004
Last Update
December 28 2020
Active Locations (1)
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1
Baird Multiple Sclerosis Center
Buffalo, New York, United States, 14203