Mechanisms of Action of Dimethyl Fumarate (Tecfidera) in Relapsing MS
Mechanisms of Action of Dimethyl Fumarate in Relapsing MS
What it found
The trial ended early for another reason (see below).
Reason given: Principal Investigator decided to withdraw.
What was tested
Treatment tested
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
What it measured
Main measures
Mean differences in Indicators of Oxidative stress (Nitrate, nitrite (um/L), Glutathione (uM), and F2-isoprostanes (pg/ml)) in blood and CSF at baseline and 12 months
24 months
Blood or spinal fluid markersMean differences in markers of axonal damage to assess whether DMF protects against neurodegeneration at baseline and 12 months
24 months
Blood or spinal fluid markersMean differences in MS-relevant cytokines, chemokines and osteopontin to examine the immunologic consequences of DMF therapy during autoimmune CNS inflammation.
24 months
Immune responseMean differences in the phenotype and activation status of adaptive and innate immune cells in the CSF and peripheral circulation at baseline and 12 months.
24 months
Blood or spinal fluid markersImmune response
Other measures (1)
Correlation of Biomarkers with Imaging and Clinical Outcome Measures
24 months
MRI lesionsBlood or spinal fluid markers
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion criteria
* Diagnosis of Relapsing MS (2010 McDonald Criteria) * Age greater than or equal to 18. * Starting treatment with dimethyl fumarate (DMF). Enrolled patients will be either naive to disease modifying therapy (DMT) or will be enrolled after a greater than or equal to 30 days from last dose of prior DMT. If enrolled patients cannot tolerate DMF, the will be replaced by another subject. All subjects will serve as their own control.
Exclusion criteria
* Women of Childbearing Potential who are pregnant, breastfeeding, or planning to become pregnant or breastfeed for the duration of the study. * Chronic diseases that will have effects on the laboratory, clinical and imaging parameters we will study: Insulin-dependent diabetes mellitus, stroke, Alzheimer's disease, auto-immune disorders such as rheumatoid arthritis, lupus, neuromyelitis optica, mixed connective disease, or sjogren's disease. * Any prior treatment with mitoxantrone or alemtuzumab. * Those undergoing DMT within the past 12 months with rituximab or daclizumab. * Patients treated with chronic (monthly) systemic steroids. * Patients treated with steroids (intravenous, intramuscular, oral or ACTH) with the intent to treat MS within 30 days of the baseline visit.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a prospective study that will explore the mechanisms of efficacy of dimethyl fumarate (DMF) treatment in multiple sclerosis (MS). Investigators will enroll relapsing MS patients who are beginning therapy with DMF into a one-year longitudinal study in which blood and spinal fluid analyses, imaging and clinical studies will be performed to identify and measure changes associated with DMF therapy.
Papers
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History
Started
Apr 2016
Main results due
Apr 2016
Finished
Apr 2016