Evidence map›Paper›PMID 20200338›Full record

Trial reportNeurology2010

Ibudilast in relapsing-remitting multiple sclerosis: a neuroprotectant?

F Barkhof, H E Hulst, J Drulovic, B M J Uitdehaag, K Matsuda, R Landin, MN166-001 Investigators

2 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Neurology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 64 papers.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed
8.4field-weighted citation impact, top 2% 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.

NCT02714036 phase1 / phase2completednot on this mapstarted 2016, after this paper: background citation

A Multi-Center, Open-Label Biomarker Study to Evaluate MN-166 in Subjects With Amyotrophic Literal Sclerosis (ALS)

TypeinterventionalSponsorMediciNovaRan2016 to 2020Enrolled35ConditionsAmyotrophic Lateral SclerosisArmsibudilast, Ibudilast
NCT04631471 phase3recruitingnot on this mapstarted 2021, after this paper: background citation

Regeneration in Cervical Degenerative Myelopathy - a Multi-centre, Double-blind, Randomised, Placebo Controlled Trial Assessing the Efficacy of Ibudilast as an Adjuvant Treatment to Decompressive Surgery for Degenerative Cervical Myelopathy

TypeinterventionalSponsorCambridge University Hospitals NHS Foundation TrustRan2021 to 2026Enrolled400ConditionsMyelopathy, Spinal Cord DiseasesArmsIbudilast, Cervical decompressive surgery, Matching placebo
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 154 citations in OpenAlex.

  1. The effect of ibudilast on thalamic volume in progressive multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2023
    Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Randomized, Placebo-Controlled Trial of Targeting Neuroinflammation with Ibudilast to Treat Methamphetamine Use Disorder.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2020
    Trial
  8. Trial
  9. Phase 2 Trial of Ibudilast in Progressive Multiple Sclerosis.The New England journal of medicine · 2018
    Trial
  10. Trial
  11. Trial
  12. Trial
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Review
  20. Review

4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

F BarkhofDepartment of Radiology, VU University Medical Center, MB, Amsterdam, The Netherlands. f.barkhof@vumc.nl
H E Hulst
J Drulovic
B M J Uitdehaag
K Matsuda
R Landin
MN166-001 Investigators
Cancer Research And Biostatistics · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIbudilast is a phosphodiesterase inhibitor influencing inflammation and neurodegeneration in multiple sclerosis (MS). This study evaluated the safety, tolerability, and effects on MRI parameters of 2 different doses of ibudilast in relapsing forms of MS.

methodsIn this multicenter, double-blind, phase 2 trial, patients with relapsing MS and gadolinium-enhancing lesions were randomly assigned 1:1:1 to receive 30 or 60 mg ibudilast or placebo every day for 12 months. The primary endpoint was the cumulative number of newly active lesions on bimonthly brain MRI over 12 months. Secondary endpoints included relapse rate, change in Expanded Disability Status Scale (EDSS) score, T2-hyperintense and T1-hypointense lesion volumes, and percent brain volume change (PBVC).

resultsA total of 297 patients were randomized in 19 centers. During the first 12 months, the mean number of active lesions and relapse rate did not differ between treatment arms. A reduction in PBVC (p = 0.04) was found in the 60-mg group (0.8%) compared with placebo (1.2%). Post hoc analysis showed a reduction in the proportion active lesions that evolved into persistent black holes for the 60-mg (0.14; p = 0.004) and 30-mg (0.17; p = 0.036) groups compared with the placebo group (0.24). Over 2 years, there were fewer patients (p = 0.026) with confirmed progression on the EDSS. Treatment with ibudilast was generally safe and well tolerated.

conclusionIbudilast showed no beneficial effect on the rate of newly active lesions and relapses. However, preliminary evidence suggests that ibudilast seems to act in a neuroprotective fashion as measured by 2 independent MRI outcomes, with a possible beneficial clinical effect on disability progression. CLASSIFICATION OF EVIDENCE: This interventional study provides Class III evidence on the effect of ibudilast on disease activity.

Indexed as

AdultBrainDisability EvaluationDisease ProgressionDouble-Blind MethodFemaleHumansIndolizinesMagnetic Resonance ImagingMaleMultiple Sclerosis, Chronic ProgressiveMultiple Sclerosis, Relapsing-RemittingNeuroprotective AgentsOrgan SizePyrazolesPyridinesibudilastIndolizinesNeuroprotective AgentsPyrazolesPyridines

Identifiers

PMID20200338
OpenAlexW2096967123

What OpenQuestion holds

Textmetadata
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.