The Effects of Erythropoietin on Clinical Disability and Brain Pathology in Patients With Progressive Multiple Sclerosis
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
  • Phase

    Phase 2
  • Study Type

  • Status

    Unknown status
  • Intervention/Treatment

    epoetin ...
  • Study Participants

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 Started
Nov 30
Primary Completion
Dec 31
Study Completion
Apr 30
Last Update
Aug 08

Drug Erythropoietin

Erythropoietin 48000 IU given I.V. in 17 courses

  • Other names: Epo, NeoRecormon

Erythropoietin Experimental

Erythropoietin treated patients contra placebo.


Inclusion Criteria:

age between 19 and 60 years
primary progressive MS or secondary progressive MS without relapses during the last one year
duration of the disease of at least 2 years Clinical disability progression should have been observed in the 2 years prior to screening as per clinical judgment of the investigator. In addition, progression must be documented by an increase in the EDSS score of at least 0.5 points at any time during the 2 years prior to Screening; or progression of 1 point in the pyramidal, cerebellar, brain stem , visual or sensory functional system during the last 2 years. Should documented EDSS scores not be available, a written summary of the clinical evidence of disability progression in the previous 2 years must be submitted (for example walking distance or hand function).
EDSS (Expanded Disability Status Scale) 4.0-6.5
MRI fulfilling the Barkhof criteria for MS
written informed consent

Exclusion Criteria:

pregnancy or period of breastfeeding or missing adequate contraceptive protection
treatment with steroids in the last 30 days
treatment with interferons, glatiramer acetate or IVIG in the last1 month prior to enrolment
treatment with azathioprin, mitoxantrone or any other immuno-suppressive in the 6 months prior to enrolment
cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (CCS III or IV), malignant hypertension (systolic > 180, diastolic > 110)
history of any haematological disorder
history of renal insufficiency
any medical psychiatric or other circumstances which impede or restrict the subjects participation in the study in the manner intended
contraindication for contrast enhanced MRI (e.g. pace maker, aortic clip or any metal implant)
No Results Posted