Natalizumab Treatment of Progressive Multiple Sclerosis
Overview
- Phase
- Phase 2
- Intervention
- Natalizumab
- Conditions
- Primary Progressive Multiple Sclerosis
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Cerebrospinal fluid (CSF) osteopontin
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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.
Detailed Description
The study will include 12 secondary progressive multiple sclerosis patients and 12 primary progressive multiple sclerosis patients to treatment with IV natalizumab for 60 weeks. At baseline and week 60 a lumbar puncture will be performed. MRI scans will be performed at baseline week 12 and week 60.Safety blood samples will be collected every 12 week.
Investigators
Finn Sellebjerg
Assoc. professor, MD, PhD, DMSci, Finn Sellebjerg
Rigshospitalet, Denmark
Eligibility 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 \</= 6.5
- •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.
Arms & Interventions
Natalizumab
24 patients: 12 with secondary progressive multiple sclerosis 12 with primary progressive multiple sclerosis
Intervention: Natalizumab
Outcomes
Primary Outcomes
Cerebrospinal fluid (CSF) osteopontin
Time Frame: Change from baseline to week 60
The primary endpoint is change in CSF osteopontin from baseline to week 60.
Secondary Outcomes
- Expanded disability status scale (EDSS)(Baseline to week 60)
- Timed 25-foot Walk (T25FW)(Baseline to week 60)
- Multiple Sclerosis Impairment Score (MSIS)(Baseline to week 60)
- Multiple Sclerosis Functional Composite(Baseline to week 60)
- Short Form 36 Health Survey (SF36)(Baseline to week 60)
- CSF Neurofilament Heavy Chain(Baseline to week 60)
- CSF Myelin Basic Protein(Baseline to week 60)
- Atrophy(Week 12 to week 60)
- Magnetization transfer ratio (MTR)(Baseline to week 60)
- Diffusion transfer imaging (DTI)(Baseline to week 60)
- CSF cell count(Baseline to week 60)
- Change in IgG-index(Baseline to week 60)
- CSF nitrogen oxide metabolites(Baseline to week 60)
- CSF-serum albumine concentration quotient(Baseline to week 60)
- CSF CXCL13(Baseline to week 60)
- Matrix metalloproteinase-9 (MMP-9)(Baseline to week 60)
- New Gadolinium-enhancing lesions (GdEL)(Baseline to week 60)
- Volume of lesions on T2-weighted MRI images(Baseline to week 60)
- Number of new or enlarging lesions on T2-weighted MRI images(Baseline to week 60)