Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/2/2016 |
| Start Date: | August 2014 |
| End Date: | June 2016 |
| Contact: | Aracely Delgadillo |
| Email: | aracely.delgadillo@yale.edu |
| Phone: | 203-737-2033 |
Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With Relapsing-Remitting Multiple Sclerosis
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).
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).
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
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