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Completed

NCT Number: NCT01077466

Natalizumab Treatment of Progressive Multiple Sclerosis

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Natalizumab

Drug

300 mg Natalizumab IV for every 4 week for 56 weeks (15 doses for every patient)

Other names: Tysabri

Primary outcomes

  1. 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

  1. Expanded disability status scale (EDSS)

    Time frame: Baseline to week 60

    Change in expanded disability status scale (EDSS)from baseline to week 60

  2. Timed 25-foot Walk (T25FW)

    Time frame: Baseline to week 60

  3. Multiple Sclerosis Impairment Score (MSIS)

    Time frame: Baseline to week 60

  4. Multiple Sclerosis Functional Composite

    Time frame: Baseline to week 60

  5. Short Form 36 Health Survey (SF36)

    Time frame: Baseline to week 60

  6. CSF Neurofilament Heavy Chain

    Time frame: Baseline to week 60

    Change in neurofilament heavy chain in the cerebrospinal fluid

  7. CSF Myelin Basic Protein

    Time frame: Baseline to week 60

    Change in myelin basic protein in CSF from baseline to week 60

  8. Atrophy

    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

  9. Magnetization transfer ratio (MTR)

    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

  10. Diffusion transfer imaging (DTI)

    Time frame: Baseline to week 60

    Change in FA and ADC in lesions, GM and NAWM between baseline and week 60.

  11. CSF cell count

    Time frame: Baseline to week 60

    Change in CSF cell count from baseline to week 60

  12. Change in IgG-index

    Time frame: Baseline to week 60

  13. CSF nitrogen oxide metabolites

    Time frame: Baseline to week 60

  14. CSF-serum albumine concentration quotient

    Time frame: Baseline to week 60

  15. CSF CXCL13

    Time frame: Baseline to week 60

  16. Matrix metalloproteinase-9 (MMP-9)

    Time frame: Baseline to week 60

  17. New Gadolinium-enhancing lesions (GdEL)

    Time frame: Baseline to week 60

  18. Volume of lesions on T2-weighted MRI images

    Time frame: Baseline to week 60

  19. Number of new or enlarging lesions on T2-weighted MRI images

    Time frame: Baseline to week 60

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Biogen
  • Copenhagen University Hospital, Hvidovre
  • Signifikans ApS
  • University of Copenhagen

Registry information

Acronym: NAPMS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 1, 2010
Registry last updated
Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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