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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. …