Tecfidera and MRI for Brain Energy in MS

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02644083

Enrollment

Registered

2015-12-31

Start date

2016-02-29

Completion date

2018-07-31

Last updated

2018-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

DRUGDimethyl fumarate

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
Changes in fatigue	baseline and 6 months of treatment with DMF	as assessed by Fatigue Severity Scale (FSS), Modified Fatigue Impact Scale (MFIS),
Changes in cognition	baseline and 6 months of treatment with DMF	as assessed by the symbol digit modalities test (SDMT)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026