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Natalizumab Treatment of Progressive Multiple Sclerosis (NAPMS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01077466
First Posted: March 1, 2010
Last Update Posted: February 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Copenhagen University Hospital, Hvidovre
Biogen
University of Copenhagen
Signifikans ApS
Information provided by (Responsible Party):
Finn Sellebjerg, Rigshospitalet, Denmark
February 26, 2010
March 1, 2010
February 17, 2012
March 2010
January 2012   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01077466 on ClinicalTrials.gov Archive Site
  • Expanded disability status scale (EDSS) [ Time Frame: Baseline to week 60 ]
    Change in expanded disability status scale (EDSS)from baseline to week 60
  • Timed 25-foot Walk (T25FW) [ Time Frame: Baseline to week 60 ]
  • Multiple Sclerosis Impairment Score (MSIS) [ Time Frame: Baseline to week 60 ]
  • Multiple Sclerosis Functional Composite [ Time Frame: Baseline to week 60 ]
  • Short Form 36 Health Survey (SF36) [ Time Frame: Baseline to week 60 ]
  • CSF Neurofilament Heavy Chain [ Time Frame: Baseline to week 60 ]
    Change in neurofilament heavy chain in the cerebrospinal fluid
  • CSF Myelin Basic Protein [ Time Frame: Baseline to week 60 ]
    Change in myelin basic protein in CSF from baseline to week 60
  • 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
  • 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
  • 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.
  • CSF cell count [ Time Frame: Baseline to week 60 ]
    Change in CSF cell count from baseline to week 60
  • Change in IgG-index [ Time Frame: Baseline to week 60 ]
  • CSF nitrogen oxide metabolites [ Time Frame: Baseline to week 60 ]
  • CSF-serum albumine concentration quotient [ Time Frame: Baseline to week 60 ]
  • CSF CXCL13 [ Time Frame: Baseline to week 60 ]
  • Matrix metalloproteinase-9 (MMP-9) [ Time Frame: Baseline to week 60 ]
  • New Gadolinium-enhancing lesions (GdEL) [ Time Frame: Baseline to week 60 ]
  • Volume of lesions on T2-weighted MRI images [ Time Frame: Baseline to week 60 ]
  • Number of new or enlarging lesions on T2-weighted MRI images [ Time Frame: Baseline to week 60 ]
Same as current
Not Provided
Not Provided
 
Natalizumab Treatment of Progressive Multiple Sclerosis
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.

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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Primary Progressive Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis
Drug: Natalizumab
300 mg Natalizumab IV for every 4 week for 56 weeks (15 doses for every patient)
Other Name: Tysabri
Experimental: Natalizumab
24 patients: 12 with secondary progressive multiple sclerosis 12 with primary progressive multiple sclerosis
Intervention: Drug: Natalizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
January 2012
January 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
19 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01077466
NAPMS version 3.4
Yes
Not Provided
Not Provided
Finn Sellebjerg, Rigshospitalet, Denmark
Rigshospitalet, Denmark
  • Copenhagen University Hospital, Hvidovre
  • Biogen
  • University of Copenhagen
  • Signifikans ApS
Principal Investigator: Finn Sellebjerg, MD PhD DMSc Danish Multiple Sclerosis Center
Rigshospitalet, Denmark
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP