Danish Multiple Sclerosis Center, Section 2082, Rigshospitalet
Copenhagen, 2100, Denmark
NCT Number: NCT01077466
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.
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Notify Me19 year–55 year
All sexes
Interventional
Phase 2
Copenhagen, 2100, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
300 mg Natalizumab IV for every 4 week for 56 weeks (15 doses for every patient)
Other names: Tysabri
Time frame: Change from baseline to week 60
The primary endpoint is change in CSF osteopontin from baseline to week 60.
Time frame: Baseline to week 60
Change in expanded disability status scale (EDSS)from baseline to week 60
Time frame: Baseline to week 60
Time frame: Baseline to week 60
Time frame: Baseline to week 60
Time frame: Baseline to week 60
Time frame: Baseline to week 60
Change in neurofilament heavy chain in the cerebrospinal fluid
Time frame: Baseline to week 60
Change in myelin basic protein in CSF from baseline to week 60
Time frame: Week 12 to week 60
Change in normalised brain volume (NBV), grey matter volume (GMV) og white matter volume (WMV) from week 12 to week 60
Time frame: Baseline to week 60
Change in MTR in whole brain, lesions, normal-appearing grey matter (NAGM) og normal-appearing white matter (NAWM) from baseline to week 60
Time frame: Baseline to week 60
Change in FA and ADC in lesions, GM and NAWM between baseline and week 60.
Time frame: Baseline to week 60
Change in CSF cell count from baseline to week 60
Time frame: Baseline to week 60
Time frame: Baseline to week 60
Time frame: Baseline to week 60
Time frame: Baseline to week 60
Time frame: Baseline to week 60
Time frame: Baseline to week 60
Time frame: Baseline to week 60
Time frame: Baseline to week 60
Rigshospitalet, Denmark
Other
Acronym: NAPMS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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