Multiple Sclerosis
Conditions
Brief summary
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).
Interventions
DRUGTecfidera
Oral Tecfidera 240 mg bid
Sponsors
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Glutathione Concentrations In Normal Appearing Gray Matter in Brain Measured by 7T Magnetic Resonance Imaging Scan | Before and 12 months after Tecfidera Initiation |
Countries
United States
Outcome results
None listed