Magnetic Resonance Imaging (MRI) Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri

Phase 4

Terminated

• Conditions: Multiple Sclerosis

• Registration Number: NCT00752778
• Lead Sponsor: University Hospital, Strasbourg, France

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-12
• Study First Posted: 2008-09-15
• Study Start: 2008-12
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-09
• Last Update Posted: 2012-11-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Patients diagnosed with MS
• Treatment with Tysabri planned

Exclusion Criteria

• Allergy to Tysabri or MRI contrast products
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of enhanced lesions on MRI before and after treatment. PET scan modification in brain (in enhanced lesions and in the whole brain).	At baseline and after 3 months of treatment.

Secondary Outcome Measures

Name	Time	Method
Correlation with relapses.	During the 3 months of treatment and the 3 following months.

Trial Locations

Locations (3)

Service de Neurologie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Service de Médecine Nucléaire, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Service de Radiologie 2, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France