Natalizumab Treatment of Progressive Multiple Sclerosis

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study safety and efficacy of natalizumab treatment of primary and secondary progressive multiple sclerosis.

This will be done by measuring the effect of treatment on inflammation in the CNS by means of osteopontin levels in the cerebrospinal fluid (CSF). Safety measures further includes physical and neurological examination,blood samples and MRI measures of disease activity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborators: Biogen; Copenhagen University Hospital, Hvidovre; Signifikans ApS; University of Copenhagen
• Treatments: Natalizumab

Criteria

Inclusion Criteria:

• Age between 19 and 55 years

• Progressive disease course of multiple sclerosis (primary or secondary)

• Duration of progressive phase of at least 1 year

• Progression of > 1 EDSS point during the last 2 years (>½ EDSS point if EDSS > 5,5)

• EDSS
• Written and informed consent

Exclusion Criteria:

• Pregnancy, breast-feeding or lack of anti.conception for fertile women.

• Attack during the last month before inclusion.

• Treatment with methylprednisolone during 3 months before inclusion.

• Treatment with interferon-beta, glatirameracetate, immunoglobulin G or other immune-modulating treatment 3 months prior to inclusion.

• Treatment with mitoxantrone, cyclophosphamide, azathioprine or other strong immunosuppressive drug 6 months prior to inclusion.

• Prior experimental treatment with strong immunosuppressive drug which the treating physician means will influence the results of the trial.

• Diseases associated with immunodeficiency.

• Treatment with other anticoagulant than aspirin.

• Current malign disease.

• Diabetes Mellitus or other autoimmune disease.

• Renal insufficiency or creatinine > 150 μmol/l.

• Travel in tropical areas 3 months prior to inclusion.

• Acute or chronic infectious diseases, which the treating physician finds relevant (e.g.hepatitis B virus, hepatitis C virus, HIV).

• Psychiatric disease or other circumstances that may limit the patients participation in the trial.

• Contraindication for MRI scan or gadolinium contrast .

• Known hypersensitivity to natalizumab.