Multiple Sclerosis (Primary or Secondary Progressive Phase). Clinical Trial
Official title:
Double Blind, Placebo-controlled Study to Assess the Effects of Erythropoietin on Clinical Disability and Brain Pathology as Shown by Magnetic Resonance Imaging in Patients With Progressive Multiple Sclerosis
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment