Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304291
Status:
COMPLETED
Last Update Posted:
2020-12-28
First Post:
2006-03-15
Brief Title:
A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica Devics Disease
Sponsor:
State University of New York at Buffalo
Organization:
State University of New York at Buffalo
Study Overview
Official Title:
A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica Devics Disease
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgm2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None