NAPMS
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
What it measured
Main measures
Cerebrospinal fluid (CSF) osteopontin
Change from baseline to week 60
Blood or spinal fluid markers
Other measures (19)
Expanded disability status scale (EDSS)
Baseline to week 60
Disability progressionTimed 25-foot Walk (T25FW)
Baseline to week 60
Disability progressionWalking and mobilityMultiple Sclerosis Impairment Score (MSIS)
Baseline to week 60
Quality of life (reported by participants)Multiple Sclerosis Functional Composite
Baseline to week 60
Short Form 36 Health Survey (SF36)
Baseline to week 60
Quality of life (reported by participants)CSF Neurofilament Heavy Chain
Baseline to week 60
Blood or spinal fluid markersCSF Myelin Basic Protein
Baseline to week 60
Blood or spinal fluid markersAtrophy
Week 12 to week 60
Brain volume lossMagnetization transfer ratio (MTR)
Baseline to week 60
MRI lesionsBrain volume lossMyelin repairDiffusion transfer imaging (DTI)
Baseline to week 60
MRI lesions
Who could take part
Progressive MS · 19 to 55
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. * 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
Related trials
- NAPMS
Phase 2 · Completed
No result found
History
Started
Mar 2010
Main results due
Jan 2012
Finished
Jan 2012
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