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| Name | Class |
|---|---|
| Danish Research Centre for Magnetic Resonance | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erythropoietin | Experimental | Erythropoietin treated patients contra placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythropoietin | Drug | Erythropoietin 48000 IU given I.V. in 17 courses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Comparisons between the placebo-and the EPO-group regarding:difference in maximum gait distance between baseline and week 24. | 48 weeks | |
| Comparisons between the placebo-and the EPO-group regarding:difference in 9-hole peg test | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Schreiber, M.D., Ph.d. | Contact | +45 35 45 98 40 | karen.schreiber@rh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Karen Schreiber, MD., Ph.d. | Rigshospitalet, Denmark | Principal Investigator |
| Per S Soerensen, MD., Prof | Rigshospitalet, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karen Schreiber | Recruiting | Copenhagen | Oesterbro | DK-2100 | Denmark |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D047209 | Eosinophil Peroxidase |
| C103998 | epoetin beta |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Comparisons between the placebo-and the EPO-group regarding:difference in TRAIL making B | 48 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D010544 | Peroxidases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047091 | Eosinophil Granule Proteins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |