Multiple Sclerosis MedDRA version: 9.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive
Conditions
Interventions
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must have a confirmed diagnosis of multiple sclerosis or clinically isolated syndrome Age 18-65 Able to give written informed consent Subjects fulfil NICE criteria for use of natalizumab (NICE, 2007) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Unable to give informed consent Primary progressive MS Patient unable to tolerate MRI scan or PET scan Those that have experienced a relapse or have been treated with steroids (both i.v. and oral) within 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the [(11)C](R)-PK11195 identified inflammatory response to natalizumab therapy (Tysabri) in active relapsing remitting MS.;Secondary Objective: ;Primary end point(s): The identification of 11C-PK11195 binding potential in cortical areas correspondent to B-cell follicles and the changes in the extent of 11C-PK11195 binding potential in the grey matter over one year in the presence of Tysabri therapy. | — |
Countries
United Kingdom
Outcome results
None listed