Evidence map›Paper›PMID 33054533›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2021

Optical coherence tomography outcomes from SPRINT-MS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis.

Robert A Bermel, Janel K Fedler, Peter Kaiser, Cindy Novalis, Jeff Schneebaum, Elizabeth A Klingner, Dawn Williams, Jon W Yankey, Dixie J Ecklund, Marianne Chase and 5 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
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 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.9field-weighted citation impact, top 13% 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

13 citing papers in PubMed, 25 citations in OpenAlex.

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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

15 authors at 6 institutions in 1 country.

Robert A BermelMellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.
Janel K FedlerData Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA.
Peter KaiserCole Eye Institute, Cleveland Clinic, Cleveland, OH, USA.
Cindy NovalisDigital Angiography Reading Center, Great Neck, NY, USA.
Jeff SchneebaumDigital Angiography Reading Center, Great Neck, NY, USA.
Elizabeth A KlingnerData Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA.
Dawn WilliamsDigital Angiography Reading Center, Great Neck, NY, USA.
Jon W YankeyData Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA.
Dixie J EcklundData Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA.
Marianne ChaseClinical Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Robert T NaismithDepartment of Neurology, Washington University, St. Louis, MI, USA.
Eric C KlawiterDepartment of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Andrew D GoodmanDepartment of Neurology, University of Rochester Medical Center, Rochester, NY, USA.
Christopher S CoffeyData Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA.
Robert J FoxMellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0002-4263-3717
University of Iowa · USCleveland Clinic · USSociety for Cardiovascular Angiography and Interventions · USHarvard University · USUniversity of Rochester Medical Center · 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
The Utah Regional Network for Excellence in Neuroscience Clinical Trials (UR-NEXT)U24NS107156 · NINDS · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI Joshua Leitch Bonkowsky, John Robinson Singleton · 2018 to 2026
$3.2M
Network for Excellence in Neuroscience Clinical Trials Center at The Ohio State UniversityU24NS107205 · NINDS · OHIO STATE UNIVERSITY · PI KOLB, STEPHEN J. · 2018 to 2022
$1.6M
NINDS NIH HHS U01 NS077179NINDS NIH HHS U01 NS077352NINDS NIH HHS U01 NS082329NINDS NIH HHS U24 NS107156NINDS NIH HHS U24 NS107205
6 · The paper itself

Abstract

backgroundThe SPRINT-MS trial demonstrated benefit of ibudilast on brain atrophy over 96 weeks in progressive multiple sclerosis (MS). Optical coherence tomography (OCT) was performed in all trial participants.

objectiveReport the OCT results of the SPRINT-MS trial.

methodsOCT was obtained at baseline and every 6 months using spectral domain OCT and analyzed by an OCT reading center. Change in each OCT outcome measure by treatment group was estimated using linear mixed models.

resultsChange in pRNFL thickness was +0.0424 uM/year (95% confidence interval (CI): -0.3091 to 0.3939) for ibudilast versus -0.2630 uM (95% CI: -0.5973 to 0.0714) for placebo (

conclusionRetinal thinning in MS may be attenuated by ibudilast. Sample size estimates suggest OCT can be a viable outcome measure in progressive MS trials if a therapy has a large treatment effect.

trial registrationNN102/SPRINT-MS ClinicalTrials.gov number, NCT01982942.

Indexed as

Multiple Sclerosis, Chronic ProgressiveHumansIndolizinesPyrazolesPyridinesTomography, Optical CoherenceibudilastIndolizinesPyrazolesPyridinesibudilastmultiple sclerosisneuroprotectionOptical coherence tomography

Identifiers

PMID33054533
PMCPMC8046841
OpenAlexW3093261605

What OpenQuestion holds

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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.