Tecfidera and MRI for Brain Energy in MS
Terminated
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT02644083
- Lead Sponsor
- Oregon Health and Science University
- Brief Summary
The primary objective of this study is to test the hypothesis that DMF can improve mitochondrial function in the brain of people with MS. The investigators will assess mitochondrial function in the cerebral grey matter by measuring PCr and ATP by 31P magnetic resonance spectroscopy (MRS) and NAA in NAWM by 1H MRS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria
- Diagnosis of MS by 2010 McDonald criteria
- Relapsing clinical course
- Ages 18-55
- Laboratory values that allow initiation of dimethyl fumarate (Tecfidera)
Exclusion Criteria
- Systemic disease associated with cerebrovascular disease (e.g. diabetes mellitus, hypertension, hyperlipidemia, coronary heart disease)
- Treatment with corticosteroids or disease-modifying therapies (interferon beta, glatiramer acetate, natalizumab, fingolimod, teriflunomide) within 30 days of the first baseline MRI scan.
- Treatment at any time with mitoxantrone, cyclophosphamide, or any other long acting immunosuppressant
- Prior treatment of greater than 1 month at any time with DMF
- Inability to tolerate MRI procedures
- Pregnant/breastfeeding
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in phosphocreatine (PCr) in cerebral grey matter baseline and 6 months of treatment with Dimethyl Fumarate (DMF) PCr levels evaluated by magnetic resonance spectroscopy
- Secondary Outcome Measures
Name Time Method Changes in ATP in normal appearing white matter (NAWM) baseline and 6 months of treatment with Dimethyl Fumarate ATP levels evaluated by magnetic resonance spectroscopy
Trial Locations
- Locations (1)
Oregon Health & Science University
🇺🇸Portland, Oregon, United States