Evidence map›Paper›PMID 37537928›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2023

Effect of ibudilast on thalamic magnetization transfer ratio and volume in progressive multiple sclerosis.

Kunio Nakamura, Yufan Zheng, Kedar R Mahajan, Jeffrey A Cohen, Robert J Fox, Daniel Ontaneda

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2023. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.5field-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.

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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Ibudilast reduces slowly enlarging lesions in progressive multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2024
    Trial
  2. Review
  3. Phosphodiesterases: Evolving Concepts and Implications for Human Therapeutics.Annual review of pharmacology and toxicology · 2025
    Review
  4. 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

6 authors at 1 institution in 1 country.

Kunio NakamuraCleveland Clinic, Cleveland, OH, USA.ORCID 0000-0002-7833-8138
Yufan ZhengCleveland Clinic, Cleveland, OH, USA.ORCID 0000-0001-9065-9674
Kedar R MahajanCleveland Clinic, Cleveland, OH, USA.ORCID 0000-0002-0339-9876
Jeffrey A CohenCleveland Clinic, Cleveland, OH, USA.ORCID 0000-0001-9245-9772
Robert J FoxCleveland Clinic, Cleveland, OH, USA.ORCID 0000-0002-4263-3717
Daniel OntanedaCleveland Clinic, Cleveland, OH, USA.ORCID 0000-0002-2838-9148
Cleveland Clinic · 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
Thalamic MRI, histopathologic, and clinical correlations in multiple sclerosisK23NS109328 · NINDS · CLEVELAND CLINIC LERNER COM-CWRU · PI MAHAJAN, KEDAR · 2018 to 2022
$919k
Molecular correlates of sub-regional thalamic degeneration in multiple sclerosisR21NS123546 · NINDS · CLEVELAND CLINIC LERNER COM-CWRU · PI DUTTA, RANJAN, MAHAJAN, KEDAR · 2022 to 2023
$443k
NINDS NIH HHS K23 NS109328NINDS NIH HHS R21 NS123546NINDS NIH HHS U01 NS077179NINDS NIH HHS U01 NS077352NINDS NIH HHS U01 NS082329
6 · The paper itself

Abstract

backgroundThalamic volume (TV) is a sensitive biomarker of disease burden of injury in multiple sclerosis (MS) and appears to reflect overall lesion loads. Ibudilast showed significant treatment effect on brain atrophy and magnetization transfer ratio (MTR) of normal-appearing brain tissue but not in new/enlarging T2 lesion in the SPRINT-MS randomized clinical trial.

objectiveTo evaluate the effect of ibudilast on thalamic tissue integrity and volume in the SPRINT-MS.

methodsA total of 255 participants with progressive MS were randomized to oral ibudilast or placebo, and thalamic MTR and normalized TV over 96 weeks were quantified. Mixed-effect modeling assessed treatment effects on the thalamic MTR and TV, separately. Similarly, the measures were compared between the participants with confirmed disability progression (CDP).

resultsIbudilast's treatment effect was observed compared to placebo for thalamic MTR (

conclusionIbudilast showed an effect on thalamic MTR, which was associated with CDP, suggesting a clinically relevant effect on thalamic tissue integrity. However, the treatment effect was not observed in TV, suggesting that thalamic atrophy is more closely associated with global inflammatory activity than local tissue integrity. CLINICALTRIALS.GOV: NCT01982942.

Indexed as

Multiple SclerosisMultiple Sclerosis, Chronic ProgressiveAtrophyBrainHumansIndolizinesMagnetic Resonance ImagingPyrazolesPyridinesibudilastIndolizinesPyrazolesPyridinesibudilastmagnetic resonance imagingProgressive multiple sclerosisrandomized clinical trialthalamic damage

Identifiers

PMID37537928
PMCPMC11130979
OpenAlexW4385564646

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.