Evidence map›Paper›PMID 41342004›Full record

ArticleNeurology open access2025

Effect of Ibudilast vs Placebo on GFAP and Contactin levels in a phase 2 clinical trial in progressive multiple sclerosis.

Alexis Novak, Tucker Harvey, Anna Wojdala, Charlotte Teunissen, Robert Fox

Registry-linked trialAbstract read
In one paragraph

Article in Neurology open access, 2025. 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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

5 authors.

Alexis NovakMellen Center for Multiple Sclerosis, Neurological Institute, Cleveland, OH, USA.
Tucker HarveyCenter for Populations Health Research, Department of Quantitative Health Sciences, Cleveland Clinic.
Anna WojdalaNeurochemistry Laboratory, Department of Laboratory Medicine, Amsterdam University Medical Center, Amsterdam, Netherlands.
Charlotte TeunissenNeurochemistry Laboratory, Department of Laboratory Medicine, Amsterdam University Medical Center, Amsterdam, Netherlands.
Robert FoxMellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.

Funding

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 NS082329
6 · The paper itself

Abstract

Objective: To evaluate GFAP and contactin as potential treatment response biomarkers in progressive MS. Methods: The SPRINT-MS trial utilized the NeuroNEXT network to enroll people with progressive MS, age 18-65 years, with evidence of progression in the past two years. Participants were randomized 1:1 and followed over two years. Serum and CSF were analyzed for GFAP and contactin. Mixed-effects models examined the longitudinal changes in biomarker and the effect of ibudilast treatment. Results: 246 participants (mean age 56 yrs; 53% female) were included. There was no effect of ibudilast treatment on the rate of change of either GFAP or contactin in either serum or CSF (p>0.3 for all comparisons). Serum GFAP increased over time (14.4 pg/ml over 96 weeks; p=0.008), while CSF GFAP levels remained stable. Contactin didn't change significantly over the course of follow-up in either serum or CSF. Both age and sex affected GFAP and contactin levels. Discussion: We found that although ibudilast treatment previously was associated with positive effects on MRI measures of MS disease, it didn't affect GFAP or contactin. The generalizability of these findings regarding the utility of GFAP or contactin as a treatment response biomarker in progressive MS requires further study.Registered on ClinicalTrials.gov: NCT01982942.

Identifiers

PMID41342004
PMCPMC12671437

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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 Socratic graph.