A double blind clinical trial of mitoxantrone versus methylprednisolone was performed in 49 Belgian patients with relapsing, secondary MS. Patients were randomized to receive 13 infusions of mitoxantrone 12 mg/m2 ( 2 8 patients) or 13 infusions of 1g of methylprednisolone (21 patients), over 32 months. Twenty-four patients completed the trial.

There were no statistical differences between the two groups of patients at study entry. A significant improvement in the Expanded Disability Scale Score (EDSS) was observed in the mitoxantrone group after 1 year of treatment (p < 0.0022). The total number of relapses, the mean number of relapses per patient per year, and the total number of gadolinium-enhanced lesions on biannual MRI scans were significantly decreased in the mitoxantrone group throughout the study period. Nausea, vomiting, and alopecia (loss of hair) were more frequent in the mitoxantrone-treated patients. Mitoxantrone has a role in the treatment of patients with MS with frequent exacerbations and rapid disease progression. www.ncbi.nlm.nih.gov

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