Tecfidera and MRI for Brain Energy in MS
Modulation of Cerebral Grey Matter High Energy Phosphate Metabolites in Multiple Sclerosis by Dimethyl Fumarate
1 other identifier
observational
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2015
CompletedFirst Posted
Study publicly available on registry
December 31, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedAugust 29, 2018
August 1, 2018
2.4 years
December 23, 2015
August 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in phosphocreatine (PCr) in cerebral grey matter
PCr levels evaluated by magnetic resonance spectroscopy
baseline and 6 months of treatment with Dimethyl Fumarate (DMF)
Secondary Outcomes (1)
Changes in ATP in normal appearing white matter (NAWM)
baseline and 6 months of treatment with Dimethyl Fumarate
Other Outcomes (3)
Changes in fatigue
baseline and 6 months of treatment with DMF
Changes in fatigue
baseline and 6 months of treatment with DMF
Changes in cognition
baseline and 6 months of treatment with DMF
Interventions
Eligibility Criteria
21 patients with a diagnosis of relapsing-remitting multiple sclerosis
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- Biogencollaborator
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Spain, MD, MSPH
Oregon Health and Science University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Rebecca Spain, MD, MSPH
Study Record Dates
First Submitted
December 23, 2015
First Posted
December 31, 2015
Study Start
February 1, 2016
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
August 29, 2018
Record last verified: 2018-08