A double-blind clinical trial of mitoxantrone versus methylprednisolone in relapsing, secondary progressive multiple sclerosis.

Author(s): van de Wyngaert FA, Beguin C, D'Hooghe MB, Dooms G, Lissoir F, Carton H, Sindic CJ

Affiliation(s): Department of Neurology, Cliniques Saint-Luc, Universite Catholique de Louvain, Brussels, Belgium.

Publication date & source: 2001-12, Acta Neurol Belg., 101(4):210-6.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

A double-blind clinical trial of mitoxantrone versus methylprednisolone was performed in 49 patients with relapsing, secondary multiple sclerosis. Patients were randomized to receive 13 infusions of mitoxantrone 12 mg/m2 (n = 28), or 13 infusions of 1 g of methylprednisolone (n = 21), 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 one year of treatment (p < 0.0022). The total number of relapses, the mean number of relapses/patient/year, and the total number of gadolinium-enhanced lesions on bi-annual MRI scans were significantly decreased in the mitoxantrone group throughout the study period. Nausea, vomiting, and alopecia were more frequent in the mitoxantrone-treated patients. Mitoxantrone has a role in the treatment of MS patients with frequent exacerbations and rapid disease progression.