Evidence map›Paper›PMID 32126977›Full record

Trial reportBMC neurology2020

Fingolimod after a first unilateral episode of acute optic neuritis (MOVING) - preliminary results from a randomized, rater-blind, active-controlled, phase 2 trial.

Christian Albert, Janine Mikolajczak, Anja Liekfeld, Sophie K Piper, Michael Scheel, Hanna G Zimmermann, Claus Nowak, Jan Dörr, Judith Bellmann-Strobl, Claudia Chien and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC neurology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01647880 (Phase II/III Study to Investigate the Effects of Fingolimod Versus Interferon Beta-1b on Visual Recovery After Optic Neuritis), which is not on this map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
1.6field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01647880 phase2 / phase3terminatednot on this map

Phase II/III Study to Investigate the Effects of Fingolimod Versus Interferon Beta-1b on Visual Recovery After Optic Neuritis

TypeinterventionalSponsorCharite University, Berlin, GermanyRan2013 to 2016Enrolled15ConditionsMultiple SclerosisArmsVerum arm receiving Gilenya®, Active Comparator receiving Extavia®
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. Treatment and Relapse Prevention of Typical and Atypical Optic Neuritis.International journal of molecular sciences · 2022
    Review
  10. Review
  11. Article
  12. Review
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  15. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 3 countries.

Christian AlbertDepartment of Neurology, Alexianer St. Josefs-Krankenhaus Potsdam, Allee nach Sanssouci 7, 14471, Potsdam, Germany.
Janine MikolajczakNeurocure Clinical Research Center, Charite-Universitätsmedizin Berlin, Berlin, Germany.
Anja LiekfeldDepartment of Ophthalmology, Klinikum Ernst von Bergmann, Potsdam, Germany.
Sophie K PiperInstitute of Biometry and Clinical Epidemiology, Charité-Universitätmedizin Berlin, Berlin, Germany.
Michael ScheelNeurocure Clinical Research Center, Charite-Universitätsmedizin Berlin, Berlin, Germany.
Hanna G ZimmermannNeurocure Clinical Research Center, Charite-Universitätsmedizin Berlin, Berlin, Germany.
Claus NowakBerlin Institute of Health, Berlin, Germany.
Jan DörrNeurocure Clinical Research Center, Charite-Universitätsmedizin Berlin, Berlin, Germany.
Judith Bellmann-StroblNeurocure Clinical Research Center, Charite-Universitätsmedizin Berlin, Berlin, Germany.
Claudia ChienNeurocure Clinical Research Center, Charite-Universitätsmedizin Berlin, Berlin, Germany.
Alexander U BrandtNeurocure Clinical Research Center, Charite-Universitätsmedizin Berlin, Berlin, Germany.
Friedemann PaulNeurocure Clinical Research Center, Charite-Universitätsmedizin Berlin, Berlin, Germany.
Olaf HoffmannDepartment of Neurology, Alexianer St. Josefs-Krankenhaus Potsdam, Allee nach Sanssouci 7, 14471, Potsdam, Germany. o.hoffmann@alexianer.de.ORCID http://orcid.org/0000-0001-6399-1911
Charité - Universitätsmedizin Berlin · DEAlexion Pharma (Switzerland) · CHBerlin Institute of Health at Charité - Universitätsmedizin Berlin · DECleopa (Germany) · DEHumboldt-Universität zu Berlin · DEKlinikum Ernst von Bergmann · DESt. Josef Krankenhaus · DEUniversity of California, Irvine · USZimmer Biomet (Germany) · DE

Funding

Novartis Pharma n.a.
6 · The paper itself

Abstract

backgroundNeuroprotection 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.

methodsMOVING 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.

resultsPer 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.

conclusionPreliminary 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 registrationThe trial was registered as EUDRA-CT 2011-004787-30 on October 26, 2012 and as NCT01647880 on July 24, 2012.

Indexed as

AdultEvoked Potentials, VisualFemaleFingolimod HydrochlorideHumansImmunosuppressive AgentsInterferon beta-1bMaleMiddle AgedOptic NeuritisFingolimod HydrochlorideImmunosuppressive AgentsInterferon beta-1bFingolimodInterferon Beta-1bMultifocal VEPOptic neuritisRemyelination

Identifiers

PMID32126977
PMCPMC7052969
OpenAlexW3009693047

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.