Multiple SclerosisNCT02644083
Tecfidera and MRI for Brain Energy in MS
An observational study of Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The primary objective of this study is to test the hypothesis that DMF can improve mitochondrial function in the brain of people with MS. The investigators will assess mitochondrial function in the cerebral grey matter by measuring PCr and ATP by 31P magnetic resonance spectroscopy (MRS) and NAA in NAWM by 1H MRS. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Dimethyl fumarate
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jul 2018
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: 21 patients with a diagnosis of relapsing-remitting multiple sclerosis
Who may be able to join
- Diagnosis of MS by 2010 McDonald criteria
- Relapsing clinical course
- Ages 18-55
- Laboratory values that allow initiation of dimethyl fumarate (Tecfidera)
Who cannot join
- Systemic disease associated with cerebrovascular disease (e.g. diabetes mellitus, hypertension, hyperlipidemia, coronary heart disease)
- Treatment with corticosteroids or disease-modifying therapies (interferon beta, glatiramer acetate, natalizumab, fingolimod, teriflunomide) within 30 days of the first baseline MRI scan.
- Treatment at any time with mitoxantrone, cyclophosphamide, or any other long acting immunosuppressant
- Prior treatment of greater than 1 month at any time with DMF
- Inability to tolerate MRI procedures
- Pregnant/breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Modulation of Cerebral Grey Matter High Energy Phosphate Metabolites in Multiple Sclerosis by Dimethyl Fumarate
The primary objective of this study is to test the hypothesis that DMF can improve mitochondrial function in the brain of people with MS. The investigators will assess mitochondrial function in the cerebral grey matter by measuring PCr and ATP by 31P magnetic resonance spectroscopy (MRS) and NAA in NAWM by 1H MRS.
- Conditions
- Multiple Sclerosis
- Being tested
- Dimethyl fumarate
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimethyl fumarateDrug
Also called Tecfidera
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in phosphocreatine (PCr) in cerebral grey matter
PCr levels evaluated by magnetic resonance spectroscopy
Measured: baseline and 6 months of treatment with Dimethyl Fumarate (DMF)
Secondary outcomes (1)
Changes in ATP in normal appearing white matter (NAWM)
ATP levels evaluated by magnetic resonance spectroscopy
Measured: baseline and 6 months of treatment with Dimethyl Fumarate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Responsible party
- Principal investigator, Rebecca Spain, Oregon Health and Science University
- Investigators
- Rebecca Spain, MD, MSPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644083
- Sponsor's protocol ID
- IRB 11364
- Status last verified
- Aug 2018
- First submitted
- 23 Dec 2015
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Cerebral Grey Matter High Energy Phosphate Metabolites in Multiple Sclerosis by Dimethyl Fumarate
- ClinicalTrials.gov ID
- NCT02644083
- Acronym / sponsor ID
- IRB 11364
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Feb 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 31 Dec 2015 (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 of this study is to test the hypothesis that DMF can improve mitochondrial function in the brain of people with MS. The investigators will assess mitochondrial function in the cerebral grey matter by measuring PCr and ATP by 31P magnetic resonance spectroscopy (MRS) and NAA in NAWM by 1H MRS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 21 patients with a diagnosis of relapsing-remitting multiple sclerosis
Key inclusion criteria (4 listed)
- Diagnosis of MS by 2010 McDonald criteria
- Relapsing clinical course
- Ages 18-55
- Laboratory values that allow initiation of dimethyl fumarate (Tecfidera)
Key exclusion criteria (6 listed)
- Systemic disease associated with cerebrovascular disease (e.g. diabetes mellitus, hypertension, hyperlipidemia, coronary heart disease)
- Treatment with corticosteroids or disease-modifying therapies (interferon beta, glatiramer acetate, natalizumab, fingolimod, teriflunomide) within 30 days of the first baseline MRI scan.
- Treatment at any time with mitoxantrone, cyclophosphamide, or any other long acting immunosuppressant
- Prior treatment of greater than 1 month at any time with DMF
- Inability to tolerate MRI procedures
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 |
|---|---|---|
| Dimethyl fumarateAlso: Tecfidera | Drug | – |
Primary outcome
Changes in phosphocreatine (PCr) in cerebral grey matter
Time frame: baseline and 6 months of treatment with Dimethyl Fumarate (DMF)
PCr levels evaluated by magnetic resonance spectroscopy
1 secondary outcome
Changes in ATP in normal appearing white matter (NAWM)
Time frame: baseline and 6 months of treatment with Dimethyl Fumarate
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 29 Aug 2018.
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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.
Rebecca Spain, MD, MSPH principal investigator
Oregon Health and Science 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 Oregon Health and Science 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 4 inclusion and 6 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 29 Aug 2018. 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?
Changes in phosphocreatine (PCr) in cerebral grey matter (time frame: baseline and 6 months of treatment with Dimethyl Fumarate (DMF)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2018; AzTrials last refreshed its copy on 1 Nov 2026.