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Mitoxantrone slowed progression of disability and reduced relapses in multiple sclerosis

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 QUESTION: In patients with worsening relapsing remitting or secondary progressive multiple sclerosis (MS), is mitoxantrone effective for slowing progression of disability and reducing relapses?


Randomised (allocation concealed*), blinded (patients and outcome assessors),* placebo controlled trial with 24 months of follow up.


17 centres in Belgium, Germany, Hungary, and Poland.


194 patients 18–55 years of age who had worsening relapsing-remitting or secondary progressive MS. Additional inclusion criteria included Kurtzke Expanded Disability Status Scale (EDSS) score 3.0–6.0 and worsening by ≥1 EDSS point during the 18 months before enrolment. 188 patients (97%) (mean age 40 y, 52% women) completed follow up.


Patients were allocated to mitoxantrone, 12 mg/m2 (n=63), 5 mg/m2 (n=66), or placebo (n=65) administered intravenously every 3 months for 24 months. …

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  • Source of funding: Wyeth-Lederle.

  • For correspondence: Professor HP Hartung, Heinrich-Heine-Universität, Düsseldorf, Germany. hans-peter.hartung{at}

  • Abstract and commentary also appear in ACP Journal Club.

  • * See glossary.