Suspended

Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With Relapsing-Remitting Multiple Sclerosis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Autoimmune Diseases+4

+ Demyelinating Diseases

+ Immune System Diseases

From 18 to 60 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: August 2014
See protocol details

Summary

Principal SponsorYale University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2014

Actual date on which the first participant was enrolled.

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).

Official TitleRestoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With Relapsing-Remitting Multiple Sclerosis
NCT02218879
Principal SponsorYale University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

7 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDemyelinating DiseasesImmune System DiseasesMultiple SclerosisNervous System DiseasesAutoimmune Diseases of the Nervous SystemDemyelinating Autoimmune Diseases, CNS

Criteria

5 inclusion criteria required to participate
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
Show More Criteria
11 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Yale University

New Haven, United StatesOpen Yale University in Google Maps
SuspendedOne Study Center