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

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ClinicalTrials.gov Identifier: NCT02218879
Recruitment Status : Terminated
First Posted : August 18, 2014
Last Update Posted : September 5, 2016
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
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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).

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Tecfidera

Study Design
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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With Relapsing-Remitting Multiple Sclerosis
Study Start Date : August 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with relapsing MS Drug: Tecfidera
Oral Tecfidera 240 mg bid


Outcome Measures
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Primary Outcome Measures :
  1. Change in Glutathione Concentrations In Normal Appearing Gray Matter in Brain Measured by 7T Magnetic Resonance Imaging Scan [ Time Frame: Before and 12 months after Tecfidera Initiation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a relapsing form of MS
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218879


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Daniel Pelletier, MD Yale University
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02218879    
Other Study ID Numbers: 1403013581
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs