Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS
1 other identifier
observational
7
1 country
1
Brief Summary
The primary objective is to directly estimate brain glutathione concentrations in vivo using H-MRS at 7T before and after initiation of Tecfidera in established multiple sclerosis (MS) patients considering switching therapy or being treatment-naive (first line).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 12, 2014
CompletedFirst Posted
Study publicly available on registry
August 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedSeptember 5, 2016
September 1, 2016
1.7 years
August 12, 2014
September 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Glutathione Concentrations In Normal Appearing Gray Matter in Brain Measured by 7T Magnetic Resonance Imaging Scan
Before and 12 months after Tecfidera Initiation
Study Arms (1)
Patients with relapsing MS
Interventions
Eligibility Criteria
Patients with a relapsing form of MS
You may qualify if:
- Male or female adult patients
- 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
You may not qualify if:
- Primary progressive multiple sclerosis patients
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale University
New Haven, Connecticut, 06519, United States
Related Publications (1)
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.
PMID: 37651844DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Pelletier, MD
Yale University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2014
First Posted
August 18, 2014
Study Start
August 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
September 5, 2016
Record last verified: 2016-09