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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02218879
• Other study ID #: 1403013581
• Status: Terminated
• Phase: N/A
• First received: August 12, 2014
• Last updated: September 2, 2016
• Start date: August 2014
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Tecfidera
Oral Tecfidera 240 mg bid

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No