Tecfidera and MRI for Brain Energy in MS

NCT ID: NCT02644083

Last Updated: 2018-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Dimethyl fumarate

Intervention Type DRUG

Other Intervention Names

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Tecfidera

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Spain

Dr Rebecca Spain, MD, MSPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca Spain, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 11364

Identifier Type: -

Identifier Source: org_study_id

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