Improving the Effect of Multiple Sclerosis Drugs by Chronobiology
Improving the Effect of Dimethyl Fumarate and Diroximel Fumarate (DRF) for Patients With Multiple Sclerosis by Chronobiology
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- App randomizing dosing regimen
What it measured
Main measures
safety assessment
12 weeks
Safetyassessment of AE
12 weeks
Disability progression
Who could take part
MS (type not specified) · 18 to 60
Show the full criteria
Inclusion criteria
1. Age between 18-60 at the time of enrollment 2. A diagnosis of MS and treatment with dimethyl fumarateDimethyl fumarate or Diroximel fumarate for at least 6 months 3. Females of childbearing potential must be non-pregnant (as determined by a serum pregnancy test at enrollment) and agree to use adequate contraceptive means throughout the study. 4. Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study. 5. Patients must satisfy a medical examiner about their fitness to participate in the study. 6. Patients must provide written informed consent to participate in the study.
Exclusion criteria
* 1. Active malignancy or any malignancy diagnosed in the last 5 years or previous diagnosis of hepatocellular carcinoma at any time. 2. Known human deficiency virus (HIV) or Hepatitis virus infections. 3. The use of steroids, or other immunosuppression. 4. Participation in another clinical trial within 30 days prior to intervention. 5. Patients with an inability to communicate well with the PI and staff (i.e., language problem, poor mental development or impaired cerebral function). 6. Patients who will be unavailable for the duration of the trial, are likely to be noncompliant with the protocol, or who are felt to be unsuitable by the PI for any other reason. 7. Any underlying medical condition that in the opinion of the study investigator impair the ability of the patient to complete the follow-up or to receive the planned treatment regimen
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Lehmann H, Hershkowitz Y, Hurvitz N, Agus S, Berg M, Ilan Y, Vaknin-Dembinsky A. A novel therapeutic regimen based on the constrained-disorder principles may improve the response to dimethyl fumarate in multiple sclerosis: Findings from an exploratory feasibility open-label clinical trial. IBRO Neurosci Rep. 2026 Sep 2;21:774-779. doi: 10.1016/j.ibneur.2026.08.020. eCollection 2026 Dec.Background
Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020.Background
Chinea A, Amezcua L, Vargas W, Okai A, Williams MJ, Su R, Parks B, Mendoza JP, Lewin JB, Jones CC. Real-World Safety and Effectiveness of Dimethyl Fumarate in Hispanic or Latino Patients with Multiple Sclerosis: 3-Year Results from ESTEEM. Neurol Ther. 2020 Dec;9(2):495-504. doi: 10.1007/s40120-020-00192-6. Epub 2020 May 29.Background
Barros A, Sequeira J, de Sousa A, Parra J, Brum M, Pedrosa R, Capela C. Real-Word Effectiveness and Safety of Dimethyl Fumarate in a Multiple Sclerosis Portuguese Population. Clin Neuropharmacol. 2020 May/Jun;43(3):55-60. doi: 10.1097/WNF.0000000000000391.Background
Lanzillo R, Moccia M, Palladino R, Signoriello E, Carotenuto A, Maniscalco GT, Sacca F, Bonavita S, Russo CV, Iodice R, Petruzzo M, Sinisi L, De Angelis M, Lavorgna L, De Rosa A, Romano F, Orlando V, Ronga B, Florio C, Lus G, Brescia Morra V. Clinical predictors of Dimethyl Fumarate response in multiple sclerosis: a real life multicentre study. Mult Scler Relat Disord. 2020 Feb;38:101871. doi: 10.Background
Miclea A, Leussink VI, Hartung HP, Gold R, Hoepner R. Safety and efficacy of dimethyl fumarate in multiple sclerosis: a multi-center observational study. J Neurol. 2016 Aug;263(8):1626-32. doi: 10.1007/s00415-016-8175-3. Epub 2016 Jun 3.Background
Goldberger AL; New Collective Author. Non-linear dynamics for clinicians: chaos theory, fractals, and complexity at the bedside. Lancet. 1996 May 11;347(9011):1312-4. doi: 10.1016/s0140-6736(96)90948-4. No abstract available.Background
Singh N, Moneghetti KJ, Christle JW, Hadley D, Plews D, Froelicher V. Heart Rate Variability: An Old Metric with New Meaning in the Era of using mHealth Technologies for Health and Exercise Training Guidance. Part One: Physiology and Methods. Arrhythm Electrophysiol Rev. 2018 Aug;7(3):193-198. doi: 10.15420/aer.2018.27.2.Background
Shields RW Jr. Heart rate variability with deep breathing as a clinical test of cardiovagal function. Cleve Clin J Med. 2009 Apr;76 Suppl 2:S37-40. doi: 10.3949/ccjm.76.s2.08.Background
Konig N, Singh NB, Baumann CR, Taylor WR. Can Gait Signatures Provide Quantitative Measures for Aiding Clinical Decision-Making? A Systematic Meta-Analysis of Gait Variability Behavior in Patients with Parkinson's Disease. Front Hum Neurosci. 2016 Jun 30;10:319. doi: 10.3389/fnhum.2016.00319. eCollection 2016.
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History
Started
May 2022
Main results due
Jun 2023
Finished
Jun 2023