Tecfidera and MRI for Brain Energy in MS

August 28, 2018 updated by: Rebecca Spain, Oregon Health and Science University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

21 patients with a diagnosis of relapsing-remitting multiple sclerosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in phosphocreatine (PCr) in cerebral grey matter
Time Frame: baseline and 6 months of treatment with Dimethyl Fumarate (DMF)
PCr levels evaluated by magnetic resonance spectroscopy
baseline and 6 months of treatment with Dimethyl Fumarate (DMF)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in ATP in normal appearing white matter (NAWM)
Time Frame: baseline and 6 months of treatment with Dimethyl Fumarate
ATP levels evaluated by magnetic resonance spectroscopy
baseline and 6 months of treatment with Dimethyl Fumarate

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Biogen

Investigators

  • Principal Investigator: Rebecca Spain, MD, MSPH, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria

December 29, 2015

First Posted (Estimate)

December 31, 2015

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 11364

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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