|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02644083 |
|
Date of registration:
|
23/12/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Tecfidera and MRI for Brain Energy in MS
|
|
Scientific title:
|
Modulation of Cerebral Grey Matter High Energy Phosphate Metabolites in Multiple Sclerosis by Dimethyl Fumarate |
|
Date of first enrolment:
|
February 2016 |
|
Target sample size:
|
4 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT02644083 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Rebecca Spain, MD, MSPH |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Oregon Health and Science University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Diagnosis of MS by 2010 McDonald criteria
- Relapsing clinical course
- Ages 18-55
- Laboratory values that allow initiation of dimethyl fumarate (Tecfidera)
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Multiple Sclerosis
|
|
Intervention(s)
|
|
Drug: Dimethyl fumarate
|
|
Primary Outcome(s)
|
|
Changes in phosphocreatine (PCr) in cerebral grey matter
[Time Frame: baseline and 6 months of treatment with Dimethyl Fumarate (DMF)]
|
|
Secondary Outcome(s)
|
|
Changes in ATP in normal appearing white matter (NAWM)
[Time Frame: baseline and 6 months of treatment with Dimethyl Fumarate]
|
|
Secondary ID(s)
|
|
IRB 11364
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|