NCT00752778

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_4 multiple-sclerosis

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

November 12, 2012

Status Verified

November 1, 2012

Enrollment Period

2.2 years

First QC Date

September 11, 2008

Last Update Submit

November 9, 2012

Conditions

Multiple Sclerosis

Keywords

MRI, PET scan

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Correlation with relapses.

    During the 3 months of treatment and the 3 following months.

Interventions

pet-scan FDG-F18OTHER

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with MS
  • Treatment with Tysabri planned

You may not qualify if:

  • Allergy to Tysabri or MRI contrast products
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Service de Neurologie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, 37091, France

Location

Service de Médecine Nucléaire, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67098, France

Location

Service de Radiologie 2, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jérôme DE SEZE, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2008

First Posted

September 15, 2008

Study Start

December 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

November 12, 2012

Record last verified: 2012-11

Locations

FR(3)