In a double-blind, placebo-controlled, parallel group trial, recombinant human erythropoietin (rhEPO) (48000 IU) treatment or placebo will be administered weekly i.v. for 24 weeks: weekly for 12 weeks and bi-weekly for 12 weeks. Methylprednisolone (MP) 1 g i.v. will be administered before the first and second EPO/placebo administration. The 24-week treatment period will be followed by a 24-week observation period.
Patients with primary progressive MS or secondary progressive MS without relapses during the last 1 year will be suitable for the trial. In all 56 patients will be enrolled into the study. The primary outcome measure is the change from baseline to 24 weeks in a composite of maximum gait distance, 9-hole peg test, TRAIL making B comparing the placebo-treatment group with the EPO-treatment group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
Erythropoietin 48000 IU given I.V. in 17 courses
Karen Schreiber
Copenhagen, Oesterbro, Denmark
RECRUITINGThe primary outcome measure is the change from baseline to 24 weeks in a composite of maximum gait distance, 9-hole peg test, TRAIL making B comparing the placebo-treatment group with the EPO-treatment group.
Time frame: 48 weeks
Comparisons between the placebo-and the EPO-group regarding:difference in maximum gait distance between baseline and week 24.
Time frame: 48 weeks
Comparisons between the placebo-and the EPO-group regarding:difference in 9-hole peg test
Time frame: 48 weeks
Comparisons between the placebo-and the EPO-group regarding:difference in TRAIL making B
Time frame: 48 weeks
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