Tecfidera and MRI for Brain Energy in MS

Terminated

• Conditions: Multiple Sclerosis

• Registration Number: NCT02644083
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-31
• Study Start: 2016-02
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States