dc.contributor.author
Albert, Christian
dc.contributor.author
Mikolajczak, Janine
dc.contributor.author
Liekfeld, Anja
dc.contributor.author
Piper, Sophie K.
dc.contributor.author
Scheel, Michael
dc.contributor.author
Zimmermann, Hanna G.
dc.contributor.author
Nowak, Claus
dc.contributor.author
Dörr, Jan
dc.contributor.author
Bellmann-Strobl, Judith
dc.contributor.author
Chien, Claudia
dc.contributor.author
Brandt, Alexander U.
dc.contributor.author
Paul, Friedemann
dc.contributor.author
Hoffmann, Olaf
dc.date.accessioned
2020-08-19T11:31:41Z
dc.date.available
2020-08-19T11:31:41Z
dc.identifier.uri
https://refubium.fu-berlin.de/handle/fub188/28088
dc.identifier.uri
http://dx.doi.org/10.17169/refubium-27838
dc.description.abstract
Background: Neuroprotection and promotion of remyelination represent important therapeutic gaps in multiple sclerosis (MS). Acute optic neuritis (ON) is a frequent MS manifestation. Based on the presence and properties of sphingosine-1-phosphate receptors (S1PR) on astrocytes and oligodendrocytes, we hypothesized that remyelination can be enhanced by treatment with fingolimod, a S1PR modulator currently licensed for relapsing-remitting MS.
Methods: MOVING was an investigator-driven, rater-blind, randomized clinical trial. Patients with acute unilateral ON, occurring as a clinically isolated syndrome or MS relapse, were randomized to 6 months of treatment with 0.5 mg oral fingolimod or subcutaneous IFN-β 1b 250 μg every other day. The change in multifocal visual evoked potential (mfVEP) latency of the qualifying eye was examined as the primary (month 6 vs. baseline) and secondary (months 3, 6 and 12 vs. baseline) outcome. In addition, full field visual evoked potentials, visual acuity, optical coherence tomography as well as clinical relapses and measures of disability, cerebral MRI, and self-reported visual quality of life were obtained for follow-up. The study was halted due to insufficient recruitment (n = 15), and available results are reported.
Results: Per protocol analysis of the primary endpoint revealed a significantly larger reduction of mfVEP latency at 6 months compared to baseline with fingolimod treatment (n = 5; median decrease, 15.7 ms) than with IFN-β 1b treatment (n = 4; median increase, 8.15 ms) (p < 0.001 for interaction). Statistical significance was maintained in the secondary endpoint analysis. Descriptive results are reported for other endpoints.
Conclusion: Preliminary results of the MOVING trial argue in support of a beneficial effect of fingolimod on optic nerve remyelination when compared to IFN-β treatment. Interpretation is limited by the small number of complete observations, an unexpected deterioration of the control group and a difference in baseline mfVEP latencies. The findings need to be confirmed in larger studies.
Trial registration: The trial was registered as EUDRA-CT 2011-004787-30 on October 26, 2012 and as NCT01647880 on July 24, 2012.
en
dc.rights.uri
https://creativecommons.org/licenses/by/4.0/
dc.subject
Optic neuritis
en
dc.subject
Interferon Beta-1b
en
dc.subject
Remyelination
en
dc.subject
Multifocal VEP
en
dc.subject.ddc
600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit
dc.title
Fingolimod after a first unilateral episode of acute optic neuritis (MOVING) - preliminary results from a randomized, rater-blind, active-controlled, phase 2 trial
dc.type
Wissenschaftlicher Artikel
dcterms.bibliographicCitation.articlenumber
75
dcterms.bibliographicCitation.doi
10.1186/s12883-020-01645-z
dcterms.bibliographicCitation.journaltitle
BMC Neurology
dcterms.bibliographicCitation.originalpublishername
BMC
dcterms.bibliographicCitation.volume
20
refubium.affiliation
Charité - Universitätsmedizin Berlin
refubium.resourceType.isindependentpub
no
dcterms.accessRights.openaire
open access
dcterms.bibliographicCitation.pmid
32126977
dcterms.isPartOf.eissn
1471-2377