A double-blind clinical trial of mitoxantrone versus methylprednisolone in relapsing, secondary progressive multiple sclerosis.
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.
van de Wyngaert
F A
FA
Department of Neurology, Cliniques Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.
Beguin
C
C
D'Hooghe
M B
MB
Dooms
G
G
Lissoir
F
F
Carton
H
H
Sindic
C J
CJ
D000328:Adult; D000505:Alopecia / Q000139:chemically induced; D003287:Contrast Media; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005682:Gadolinium; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018655:Lymphocyte Count; D008279:Magnetic Resonance Imaging; D008297:Male; D008751:Methylene Blue / Q000627:therapeutic use; D008775:Methylprednisolone / Q000009:adverse effects / Q000627:therapeutic use*; D008942:Mitoxantrone / Q000009:adverse effects / Q000627:therapeutic use*; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000473:pathology; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control; D010352:Patient Dropouts; D010689:Phlebitis / Q000139:chemically induced / Q000150:complications; D011655:Pulmonary Embolism / Q000209:etiology; D011759:Pyrrolidines / Q000627:therapeutic use; D012008:Recurrence; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control
D003287:Contrast Media; D007166:Immunosuppressive Agents; D011759:Pyrrolidines; D005682:Gadolinium; D008942:Mitoxantrone; C033968:alizapride; D008751:Methylene Blue; D008775:Methylprednisolone