Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS
NCT ID: NCT02218879
Last Updated: 2016-09-05
Study Results
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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TERMINATED
7 participants
OBSERVATIONAL
2014-08-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with relapsing MS
Tecfidera
Oral Tecfidera 240 mg bid
Interventions
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Tecfidera
Oral Tecfidera 240 mg bid
Eligibility Criteria
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Inclusion Criteria
* 18-60 years of age
* Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
* Patients naive to MS therapy or patients switching from an FDA-approved MS therapy, including IFN-B formulations, Cop-1, Teriflunomide, and Fingolimod to BG-12
* Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive
Exclusion Criteria
* Patients with previous exposure or known allergies to fumarates
* MS patients switching from natalizumab, cyclophosphamide, or mitoxantrone to BG-12
* Contraindications for MRI/MRS
* Known presence of other neurological disorders that may mimic multiple sclerosis
* Pregnancy or lactation
* Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
* History of or currently active primary or secondary immunodeficiency
* Active infection, or history of or known presence of recurrent or chronic infection (e.g. hepatitis B or C, HIV, syphilis, tuberculosis\_
* History of progressive multifocal leukoencephalopathy
* Contraindications to or intolerance of oral or intravenous (IV) corticosteroids
18 Years
60 Years
ALL
No
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Daniel Pelletier, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
Countries
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References
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Juchem C, Swanberg KM, Prinsen H, Pelletier D. In vivo cortical glutathione response to oral fumarate therapy in relapsing-remitting multiple sclerosis: A single-arm open-label phase IV trial using 7-Tesla 1H MRS. Neuroimage Clin. 2023;39:103495. doi: 10.1016/j.nicl.2023.103495. Epub 2023 Aug 15.
Other Identifiers
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1403013581
Identifier Type: -
Identifier Source: org_study_id
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