Multiple SclerosisNCT02218879
Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS
An observational study of Multiple Sclerosis, run by Yale University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Tecfidera
- Type of treatment
- Pill or oral medicine
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with a relapsing form of MS
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Multiple Sclerosis
- Being tested
- Tecfidera
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TecfideraDrug
Oral Tecfidera 240 mg bid
| Study group | Role | What they receive |
|---|---|---|
| Patients with relapsing MS | Not described Receives: Drug: Tecfidera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glutathione Concentrations In Normal Appearing Gray Matter in Brain Measured by 7T Magnetic Resonance Imaging Scan
Measured: Before and 12 months after Tecfidera Initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Pelletier, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218879
- Sponsor's protocol ID
- 1403013581
- Status last verified
- Sep 2016
- First submitted
- 12 Aug 2014
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Juchem C, Swanberg KM, Prinsen H, Pelletier D. In vivo cortical glutathione response to oral fumarate therapy in relapsing-remitting multiple sclerosis: A single-arm open-label phase IV trial using 7-Tesla 1H MRS. Neuroimage Clin. 2023;39:103495. doi: 10.1016/j.nicl.2023.103495. Epub 2023 Aug 15.
PubMed 37651844
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02218879
- Acronym / sponsor ID
- 1403013581
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with relapsing MS | – | Drug: Tecfidera |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with a relapsing form of MS
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TecfideraOral Tecfidera 240 mg bid | Drug | Patients with relapsing MS |
Primary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
- Derived from this study: PubMed 37651844Juchem C, Swanberg KM, Prinsen H, Pelletier D. In vivo cortical glutathione response to oral fumarate therapy in relapsing-remitting multiple sclerosis: A single-arm open-label phase IV trial using 7-Tesla 1H MRS. Neuroimage Clin. 2023;39:103495. doi: 10.1016/j.nicl.2023.103495. Epub 2023 Aug 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Pelletier, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02218879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016.