Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis Patients
What it found
The trial ended early for another reason (see below).
Reason given: Funding ended prematurely
This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Ozanimod
Sphingosine 1-phosphate receptor 5 modulator
What it measured
Main measures
Three-months change in Modified Fatigue Impact Scale (MFIS) score
3 months
Fatigue
Other measures (5)
Three-months change in Chalder Fatigue Scale (CFS) score
3 months
FatigueThree-months change in Fatigue Severity Scale (FSS) score
3 months
FatigueThree-months change in NeuroQOL-fatigue questionnaire score
3 months
FatigueVisual Analog Scale (VAS) for fatigue score
3 months
FatigueThree-months change in NeuroQOL-cognitive function questionnaire score
3 months
Thinking and memory
Who could take part
MS (type not specified) · 18 and over
Inclusion Criteria: 1. age≥18 2. diagnosis of MS (according to the 2010 McDonald criteria) Exclusion Criteria: 1. neurodegenerative disorders other than MS 2. terminal medical condition 3. currently treated for active malignancy 4. alcohol or substance abuse in the past year, except marijuana 5. non-English speakers (the mobile application is not available in other languages) 6. inability to undergo MRI scan Patients undergoing COVID-19 vaccination will be allowed to participate in the study if at least 2 weeks have elapsed from their last dose of vaccine.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Multi-center observational study to assess the short-term response of multiple sclerosis (MS) patients initiated on Ozanimod with respect to fatigue. Patterns of brain changes on brain magnetic resonance imaging (MRI) that might modulate the effect of Ozanimod treatment on fatigue will also be assessed.
Papers
Background
Palotai M, Wallack M, Kujbus G, Dalnoki A, Guttmann C. Usability of a Mobile App for Real-Time Assessment of Fatigue and Related Symptoms in Patients With Multiple Sclerosis: Observational Study. JMIR Mhealth Uhealth. 2021 Apr 16;9(4):e19564. doi: 10.2196/19564.Background
Cella M, Chalder T. Measuring fatigue in clinical and community settings. J Psychosom Res. 2010 Jul;69(1):17-22. doi: 10.1016/j.jpsychores.2009.10.007. Epub 2009 Dec 11.Background
Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.Background
Cella D, Lai JS, Nowinski CJ, Victorson D, Peterman A, Miller D, Bethoux F, Heinemann A, Rubin S, Cavazos JE, Reder AT, Sufit R, Simuni T, Holmes GL, Siderowf A, Wojna V, Bode R, McKinney N, Podrabsky T, Wortman K, Choi S, Gershon R, Rothrock N, Moy C. Neuro-QOL: brief measures of health-related quality of life for clinical research in neurology. Neurology. 2012 Jun 5;78(23):1860-7. doi: 10.1212/WBackground
Palotai M, Guttmann CR. Brain anatomical correlates of fatigue in multiple sclerosis. Mult Scler. 2020 Jun;26(7):751-764. doi: 10.1177/1352458519876032. Epub 2019 Sep 19.Background
Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.Background
Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.Background
Billiard M, Broughton R. Modafinil: its discovery, the early European and North American experience in the treatment of narcolepsy and idiopathic hypersomnia, and its subsequent use in other medical conditions. Sleep Med. 2018 Sep;49:69-72. doi: 10.1016/j.sleep.2018.05.027. Epub 2018 Jun 6.Background
Miller P, Soundy A. The pharmacological and non-pharmacological interventions for the management of fatigue related multiple sclerosis. J Neurol Sci. 2017 Oct 15;381:41-54. doi: 10.1016/j.jns.2017.08.012. Epub 2017 Aug 12.Background
Yang TT, Wang L, Deng XY, Yu G. Pharmacological treatments for fatigue in patients with multiple sclerosis: A systematic review and meta-analysis. J Neurol Sci. 2017 Sep 15;380:256-261. doi: 10.1016/j.jns.2017.07.042. Epub 2017 Jul 28.
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History
Started
Apr 2022
Main results due
Jul 2024
Finished
Jul 2024
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