Evidence map›Paper›PMID 33635141›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2021

Neurofilament light chain in a phase 2 clinical trial of ibudilast in progressive multiple sclerosis.

Robert J Fox, Paola Raska, Christian Barro, Matthew Karafa, Victoria Konig, Robert A Bermel, Marianne Chase, Christopher S Coffey, Andrew D Goodman, Eric C Klawiter and 2 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01982942 (A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
5.8field-weighted citation impact, top 3% 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.

NCT01982942 phase2completednot on this map

A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects With Progressive Multiple Sclerosis

TypeinterventionalSponsorMediciNovaRan2013 to 2017Enrolled255ConditionsMultiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary ProgressiveArmsibudilast, Placebo oral capsule
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Neurofilament heavy chain in secondary progressive multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2025
    Article
  10. Review
  11. Imaging Outcomes for Phase 2 Trials Targeting Compartmentalized Inflammation.Multiple sclerosis (Houndmills, Basingstoke, England) · 2024
    Review
  12. Towards Treating Multiple Sclerosis Progression.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Review of potential medical treatments for middle ear cholesteatoma.Cell communication and signaling : CCS · 2022
    Review
  19. Review
  20. 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

12 authors at 6 institutions in 2 countries.

Robert J FoxMellen Center for Multiple Sclerosis, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0002-4263-3717
Paola RaskaQuantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA.
Christian BarroNeurologic Clinic and Policlinic, Departments of Medicine, Biomedicine, and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Matthew KarafaQuantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA.
Victoria KonigQuantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA.
Robert A BermelMellen Center for Multiple Sclerosis, Cleveland Clinic, Cleveland, OH, USA.
Marianne ChaseMassachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Christopher S CoffeyUniversity of Iowa, Iowa City, IA, USA.
Andrew D GoodmanDepartment of Neurology, University of Rochester, Rochester, NY, USA.
Eric C KlawiterMassachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Robert T NaismithDepartment of Neurology, Washington University, St Louis, MO, USA.
Jens KuhleNeurologic Clinic and Policlinic, Departments of Medicine, Biomedicine, and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Cleveland Clinic · USHarvard University · USUniversity of Basel · CHUniversity of Iowa · USUniversity of Rochester · USWashington University in St. Louis · US

Funding

Clinical Coordinating Center Network of Excellence in Neuroscience Clinical TrialU01NS077179 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI Merit E CUDKOWICZ, Aleksandar Videnovic · 2011 to 2026
$43.4M
Network of Excellence in Neuroscience Clinical Trials (NEXT)-DCCU01NS077352 · NINDS · UNIVERSITY OF IOWA · PI CHRISTOPHER S. COFFEY · 2011 to 2026
$28.1M
Ibudilast Phase II trial in progressive MSU01NS082329 · NINDS · CLEVELAND CLINIC LERNER COM-CWRU · PI FOX, ROBERT J. · 2013 to 2017
$12.5M
NINDS NIH HHS U01 NS077179NINDS NIH HHS U01 NS077352NINDS NIH HHS U01 NS082329
6 · The paper itself

Abstract

backgroundSensitive and specific biomarkers for use in progressive multiple sclerosis (MS) have not been established. We investigate neurofilament light (NfL) as a treatment response biomarker in progressive MS.

objectiveTo evaluate whether ibudilast 100 mg/day alters serum and cerebrospinal fluid (CSF) levels of NfL in progressive MS.

methodsIn a protocol-defined exploratory analysis from a 2-year, phase 2 clinical trial of ibudilast in progressive MS (NCT01982942), serum samples were collected from 239 subjects and a subset contributed CSF and assayed using single-molecule assay (SIMOA) immunoassay. A mixed model for repeated measurements yielded log(NfL) as the response variable.

resultsThe geometric mean baseline serum NfL was 31.9 and 28.8 pg/mL in placebo and ibudilast groups, respectively. The geometric mean baseline CSF NfL was 1150.8 and 1290.3 pg/mL in placebo and ibudilast groups, respectively. Serum and CSF NfL correlations were

conclusionIbudilast treatment was not associated with a change in either serum or CSF NfL.

Indexed as

Multiple SclerosisMultiple Sclerosis, Chronic ProgressiveBiomarkersHumansIndolizinesIntermediate FilamentsNeurofilament ProteinsPyrazolesPyridinesBiomarkersibudilastIndolizinesNeurofilament ProteinsPyrazolesPyridinesbiomarkerMultiple sclerosisneurofilament

Identifiers

PMID33635141
PMCPMC8387506
OpenAlexW3132472946

What OpenQuestion holds

Textmetadata
LicenceTDM
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.