Tecfidera and MRI for Brain Energy in MS

• Status: Terminated
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: Biogen
• Treatments: Dimethyl Fumarate

Criteria

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