Multiple Sclerosis (Primary or Secondary Progressive Phase).
Conditions
Keywords
Progressive Multiple Sclerosis
Brief summary
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.
Detailed description
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.
Interventions
DRUGErythropoietin
Erythropoietin 48000 IU given I.V. in 17 courses
Sponsors
Danish Research Centre for Magnetic Resonance
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| Comparisons between the placebo-and the EPO-group regarding:difference in TRAIL making B | 48 weeks |
Countries
Denmark
Contacts
Primary ContactKaren Schreiber, M.D., Ph.d.
Outcome results
None listed