An interventional study of App randomizing dosing regimen in Multiple Sclerosis, sponsored by Hadassah Medical Organization. Completed at 1 site in Israel. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Device feasibility
A trial for evaluating the ability to improve the effect of dimethyl fumarate in patients with Multiple Sclerosis (MS) by chronobiology A controlled-randomization dosing regimen administered to patients with MS and provided by a designated app. The treatment limitations of time interval is pre-defined according to approved therapeutic windows.
Dimethyl fumarate (DMF) is an oral option for patients with relapsing forms of MS. The effectiveness of DMF on the clinical and radiological activity of multiple sclerosis were demonstrated in a real-world setting, both in naive patients and in those switching from other multiple sclerosis therapies. Sustained safety and efficacy of DMF was observed in patients continuing on treatment for up to 11 years, supporting DMF as a long-term treatment option for patients with MS. It continues to be an efficacious treatment for multiple sclerosis with a favorable safety profile demonstrated over 10 years of clinical use Patients who have partial response or non-responders in most cases require different medications associated with a less favorable safety profile. Recently fda approved Diroximel fumarate (DRF) is a noval drug which is bioequivalent to DMF regarding efficacy and safety profiles, differing only by chemical precursor structure which is hypothesized to elicit less irritation in the GI tract than DMF. Both drug active metabolites are similar in bioactivity and efficacy treating MS Many aspects of cellular physiology display circadian (approximately 12-h) rhythms. Dysfunction of the circadian clock molecular circuitry is associated with human health derangements, including neurodegeneration, increased risk of cancer, cardiovascular diseases and the metabolic syndrome. Recent evidences support a link between the circadian clock circuitry and biological cycles in multiple systems. Regular dosing of therapy may lead to compensatory mechanisms and are associated with adaptation of the immune system that may prohibit a maximal clinical effect.
This open-label study will test the implementation of controlled randomization of time of administration of Dimethyl fumarate to patients with MS. Random changes in the time of administration and dosages of Dimethyl fumarate within pre-defined approved limits which are within the approved therapeutic window will be provided to patient by a designated cellular application. Patients will be followed for 12 weeks for clinical improvement using the Expanded Disability Status Scale (EDSS) and MRI.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 8 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active malignancy or any malignancy diagnosed in the last 5 years or previous diagnosis of hepatocellular carcinoma at any time.
All of the enrolled patients will receive their dimethyl fumarate prescribed by their GP. During the 12 weeks' study period, patients in the intervention arm will receive the medication timed by the app- dose and time of administration will be determined using a designated app. The app will implement random changes in time of administration limited by a pre-defined range assigned by the therapeutic windows
Device: App randomizing dosing regimen
patients will receive their dimethyl fumarate treatment and the dose and time of administration will be determined using a designated app.
safety assessment
The primary outcome is to assess to assess the safety of incorporating controlled randomization to Dimethyl fumarate dosing regimen provided by an app in patients with MS. Safety will be assessed through clinical follow-up which will include history taking with emphasize on possible AE
Time frame: 12 weeks
assessment of AE
physical examination and assessment by EDSS score
Time frame: 12 weeks
assessment of AE
laboratory tests - detect changes in cbc for lymphopenia (below 1.03 10e9/L)
Time frame: 12 weeks
Plan to share: Undecided
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Hadassah Medical Organization