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Natalizumab Treatment of Progressive Multiple Sclerosis

Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Progressive Multiple Sclerosis; Secondary Progressive Multiple Sclerosis

Intervention: Natalizumab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Rigshospitalet, Denmark

Official(s) and/or principal investigator(s):
Finn Sellebjerg, MD PhD DMSc, Principal Investigator, Affiliation: Danish Multiple Sclerosis Center


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.

Clinical Details

Official title: Natalizumab Treatment of Progressive Multiple Sclerosis

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Cerebrospinal fluid (CSF) osteopontin

Secondary outcome:

Expanded disability status scale (EDSS)

Timed 25-foot Walk (T25FW)

Multiple Sclerosis Impairment Score (MSIS)

Multiple Sclerosis Functional Composite

Short Form 36 Health Survey (SF36)

CSF Neurofilament Heavy Chain

CSF Myelin Basic Protein


Magnetization transfer ratio (MTR)

Diffusion transfer imaging (DTI)

CSF cell count

Change in IgG-index

CSF nitrogen oxide metabolites

CSF-serum albumine concentration quotient


Matrix metalloproteinase-9 (MMP-9)

New Gadolinium-enhancing lesions (GdEL)

Volume of lesions on T2-weighted MRI images

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

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.


Minimum age: 19 Years. Maximum age: 55 Years. Gender(s): Both.


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)


- 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.

Locations and Contacts

Danish Multiple Sclerosis Center, Section 2082, Rigshospitalet, Copenhagen 2100, Denmark
Additional Information

Starting date: March 2010
Last updated: February 15, 2012

Page last updated: August 23, 2015

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