Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS
Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS
The primary objective is to directly estimate brain glutathione concentrations in vivo using
 H-MRS at 7T before and after initiation of Tecfidera in established multiple sclerosis (MS)
 patients considering switching therapy or being treatment-naive (first line).
Inclusion Criteria:

 -  Male or female adult patients

 -  18-60 years of age

 -  Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria
 (2010)

 -  Patients naive to MS therapy or patients switching from an FDA-approved MS therapy,
 including IFN-B formulations, Cop-1, Teriflunomide, and Fingolimod to BG-12

 -  Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

 Exclusion Criteria:

 -  Primary progressive multiple sclerosis patients

 -  Patients with previous exposure or known allergies to fumarates

 -  MS patients switching from natalizumab, cyclophosphamide, or mitoxantrone to BG-12

 -  Contraindications for MRI/MRS

 -  Known presence of other neurological disorders that may mimic multiple sclerosis

 -  Pregnancy or lactation

 -  Requirement for chronic treatment with systemic corticosteroids or immunosuppressants
 during the course of the study

 -  History of or currently active primary or secondary immunodeficiency

 -  Active infection, or history of or known presence of recurrent or chronic infection
 (e.g. hepatitis B or C, HIV, syphilis, tuberculosis_

 -  History of progressive multifocal leukoencephalopathy

 -  Contraindications to or intolerance of oral or intravenous (IV) corticosteroids