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Clinical Trials/NCT00752778
NCT00752778
Terminated
Phase 4

MRI Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri

University Hospital, Strasbourg, France3 sites in 1 country8 target enrollmentDecember 2008
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ConditionsMultiple Sclerosis

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University Hospital, Strasbourg, France
Enrollment
8
Locations
3
Primary Endpoint
Number of enhanced lesions on MRI before and after treatment. PET scan modification in brain (in enhanced lesions and in the whole brain).
Status
Terminated
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

To evaluate the diagnosis value of MRI and positon emission tomography (PET) scan for studying macrophagic infiltration and other brain modification in multiple sclerosis (MS) patients treated with Natalizumab (Tysabri).

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
March 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Patients diagnosed with MS
  • •Treatment with Tysabri planned

Exclusion Criteria

  • •Allergy to Tysabri or MRI contrast products
  • •Pregnancy

Outcomes

Primary Outcomes

Number of enhanced lesions on MRI before and after treatment. PET scan modification in brain (in enhanced lesions and in the whole brain).

Time Frame: At baseline and after 3 months of treatment.

Secondary Outcomes

  • Correlation with relapses.(During the 3 months of treatment and the 3 following months.)

Study Sites (3)

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