Status:
TERMINATED
Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS
Lead Sponsor:
Yale University
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
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 consid...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02218879
Start Date
August 1 2014
End Date
April 1 2016
Last Update
September 5 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University
New Haven, Connecticut, United States, 06519