Tecfidera and MRI for Brain Energy in MS

Stopped early

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT02644083

Run by

Oregon Health and Science University

People needed

4

Starts

2016-02-01

Expected to finish

2018-07-01

Last updated by the study team

2018-08-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of MS by 2010 McDonald criteria
• Relapsing clinical course
• Ages 18-55
• Laboratory values that allow initiation of dimethyl fumarate (Tecfidera)

You may not qualify if…

• 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

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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