Natalizumab Treatment of Progressive Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Primary Progressive Multiple Sclerosis Secondary Progressive Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Natalizumab

24 patients: 12 with secondary progressive multiple sclerosis 12 with primary progressive multiple sclerosis

Group Type EXPERIMENTAL

Natalizumab

Intervention Type DRUG

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

Interventions

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Natalizumab

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

Intervention Type DRUG

Other Intervention Names

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Tysabri

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No