Natalizumab Treatment of Progressive Multiple Sclerosis

NCT01077466 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-02-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Natalizumab

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

Sponsors & Collaborators

  • Copenhagen University Hospital, Hvidovre

    collaborator OTHER
  • Biogen

    collaborator INDUSTRY
  • University of Copenhagen

    collaborator OTHER
  • Signifikans ApS

    collaborator OTHER
  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Finn Sellebjerg, MD PhD DMSc · Danish Multiple Sclerosis Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01077466 on ClinicalTrials.gov