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Natalizumab Treatment of Progressive Multiple Sclerosis (NAPMS)

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ClinicalTrials.gov Identifier: NCT01077466
Recruitment Status : Completed
First Posted : March 1, 2010
Last Update Posted : February 17, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Primary Progressive Multiple Sclerosis Secondary Progressive Multiple Sclerosis Drug: Natalizumab Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Natalizumab Treatment of Progressive Multiple Sclerosis
Study Start Date : March 2010
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Natalizumab
24 patients: 12 with secondary progressive multiple sclerosis 12 with primary progressive multiple sclerosis
Drug: Natalizumab
300 mg Natalizumab IV for every 4 week for 56 weeks (15 doses for every patient)
Other Name: Tysabri

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077466

Danish Multiple Sclerosis Center, Section 2082, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Copenhagen University Hospital, Hvidovre
University of Copenhagen
Signifikans ApS
Principal Investigator: Finn Sellebjerg, MD PhD DMSc Danish Multiple Sclerosis Center
More Information

Responsible Party: Finn Sellebjerg, Assoc. professor, MD, PhD, DMSci, Finn Sellebjerg, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01077466     History of Changes
Other Study ID Numbers: NAPMS version 3.4
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012

Keywords provided by Finn Sellebjerg, Rigshospitalet, Denmark:
Primary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Cerebrospinal fluid

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs