Tecfidera and MRI for Brain Energy in MS



Status:Terminated
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 55
Updated:8/31/2018
Start Date:February 2016
End Date:July 2018

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Trial Summary
Trial Overview
Inclusion Criteria

Modulation of Cerebral Grey Matter High Energy Phosphate Metabolites in Multiple Sclerosis by Dimethyl Fumarate

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.


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
We found this trial at
1
site
Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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mi
from
Portland, OR
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