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

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Drug: Tecfidera

• Registration Number: NCT02218879
• Lead Sponsor: Yale University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-18
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with relapsing MS	Tecfidera	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States