Natalizumab Treatment of Progressive Multiple Sclerosis (NAPMS)

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Rigshospitalet

Status and phase

Completed
Phase 2

Conditions

Primary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis

Treatments

Drug: Natalizumab

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01077466
NAPMS version 3.4

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

19 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Natalizumab
Experimental group
Description:
24 patients: 12 with secondary progressive multiple sclerosis 12 with primary progressive multiple sclerosis
Treatment:
Drug: Natalizumab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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