Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS
Stopped early
Conditions studied: Multiple Sclerosis
In brief
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).
Key facts
- Study ID
- NCT02218879
- Run by
- Yale University
- People needed
- 7
- Starts
- 2014-08-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2016-09-05
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female adult patients
- 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
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
Where it is running
- Yale University — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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