A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic’s Disease)
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Bianca Weinstock-Guttman, M.D.
Baird Multiple Sclerosis Center
United States: Food and Drug Administration
|Baird Multiple Sclerosis Center||Buffalo, New York 14203|