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 - EPO-ProgMS

Phase 1

• Conditions: Multiple Sclerosis, with primary and secondary progressive courses.; MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis

• Registration Number: EUCTR2009-011516-37-DK
• Lead Sponsor: Danish Multiple Sclerosis Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-15
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age between 19 and 55 years inclusive. Multiple Sclerosis (MS) according to the revised McDonald criteria: either primary progressive MS or secondary progressive MS without relapses during the last one year. MS disease duration of at least two years from onset of disease. Progression of more than 1 point on the EDSS scale during the last 2 years. EDSS (Expanded Disability Status Score) of more than or equal to 4 and less than or equal to 6.5.
MRI scan of the brain that fulfills the Barkhof criteria for MS.
Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy or period of breastfeeding; missing adequate contraceptive protection for female patients with childbearing potential. Acceptable methods of birth control in this study include: sexually inactive, surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, longacting injectable contraceptive or a double-barrier method (condom or diaphragm with spermicide).
Treatment with steroids in the last 30 days
Previous treatment with EPO
Treatment with interferons, glatiramer acetate or IVIG in the 3 months 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 MRI (e.g. pace maker, aortic clip or any metal implant)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified