Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Dimethyl Fumarate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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