Evidence map›Paper›PMID 27521810›Full record

Trial reportContemporary clinical trials2016

Design, rationale, and baseline characteristics of the randomized double-blind phase II clinical trial of ibudilast in progressive multiple sclerosis.

Robert J Fox, Christopher S Coffey, Merit E Cudkowicz, Trevis Gleason, Andrew Goodman, Eric C Klawiter, Kazuko Matsuda, Michelle McGovern, Robin Conwit, Robert Naismith and 35 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 1 pooled it
4.8field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 1 synthesis or guideline pooled it, 66 citations in OpenAlex.

  1. Guideline
  2. Ibudilast reduces slowly enlarging lesions in progressive multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2024
    Trial
  3. The effect of ibudilast on thalamic volume in progressive multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2023
    Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Phase 2 Trial of Ibudilast in Progressive Multiple Sclerosis.The New England journal of medicine · 2018
    Trial
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Suppression of Plasmodium MIF-CD74 signaling protects against severe malaria.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2021
    Article
  18. Article
  19. Review
  20. Vitamin D and MRI measures in progressive multiple sclerosis.Multiple sclerosis and related disorders · 2019
    Article
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

45 authors at 20 institutions in 1 country.

Robert J FoxCleveland Clinic, Neurological Institute, Cleveland, OH, United States. Electronic address: foxr@ccf.org.
Christopher S CoffeyData Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, United States.
Merit E CudkowiczClinical Coordinating Center, NeuroNEXT, Harvard Partners, Boston, MA, United States.
Trevis GleasonPatient Advocate, Seattle, WA, United States.
Andrew GoodmanUniversity of Rochester Medical Center, Rochester, NY, United States.
Eric C KlawiterMassachusetts General Hospital, Boston, MA, United States.
Kazuko MatsudaMedicinova Inc., La Jolla, CA, United States.
Michelle McGovernClinical Coordinating Center, NeuroNEXT, Harvard Partners, Boston, MA, United States.
Robin ConwitNational Institutes of Neurological Disease and Stroke, Bethesda, MD, United States.
Robert NaismithWashington University School of Medicine, St. Louis, MO, United States.
Akshata AshokkumarData Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, United States.
Robert BermelCleveland Clinic, Neurological Institute, Cleveland, OH, United States.
Dixie EcklundData Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, United States.
Maxine KoeppData Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, United States.
Jeffrey LongData Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, United States.
Sneha NatarajanCleveland Clinic, Neurological Institute, Cleveland, OH, United States.
Srividya RamachandranCleveland Clinic, Neurological Institute, Cleveland, OH, United States.
Thomai SkaramagasCleveland Clinic, Neurological Institute, Cleveland, OH, United States.
Brenda ThornellClinical Coordinating Center, NeuroNEXT, Harvard Partners, Boston, MA, United States.
Jon YankeyData Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, United States.
Mark AgiusUniversity of California at Davis, Sacramento, CA; currently at Barrows Neurological Institute, Phoenix, AZ, United States.
Khurram BashirUniversity of Alabama at Birmingham, Birmingham, AL, United States.
Bruce CohenNorthwestern University, Chicago, IL, United States.
Patricia CoyleState University of New York, Stony Brook, NY, United States.
Silvia DelgadoUniversity of Miami School of Medicine, Miami, FL, United States.
Dana DewittUniversity of Utah, Salt Lake City, UT, United States.
Angela FloresUniversity of Texas Southwestern Medical Center, Dallas, TX, United States.
Barbara GiesserUniversity of California at Los Angeles, Los Angeles, CA, United States.
Myla GoldmanUniversity of Virginia at Charlottesville, Charlottesville, VA, United States.
Burk JubeltState University of New York Upstate Medical University, Syracuse, NY, United States.
Neil LavaEmory University, Atlanta, GA, United States.
Sharon LynchUniversity of Kansas Medical Center, Kansas City, KS, United States.
Augusto MiravalleUniversity of Colorado at Denver, Aurora, CO, United States.
Harold MosesVanderbilt University, Nashville, TN, United States.
Daniel OntanedaCleveland Clinic, Neurological Institute, Cleveland, OH, United States.
Jai PerumalWeill Cornell Medical College, New York, NY, United States.
Michael RackeThe Ohio State University, Columbus, OH, United States.
Pavle RepovicSwedish Medical Center at Seattle, Seattle, WA, United States.
Claire RileyColumbia University Medical Center, New York, NY, United States.
Christopher SeversonBrigham and Women's Hospital, Brookline, MA, United States.
Shlomo ShinnarMontefiore Medical Center, Bronx, NY, United States.
Valerie SuskiUniversity of Pittsburgh Medical Center, Pittsburgh, PA, United States.
Bianca Weinstock-GutmanState University of New York Buffalo, Buffalo, NY, United States.
Vijayshree YadavOregon Health and Science University, Portland, OR, United States.
Aram ZabetiUniversity of Cincinnati, Cincinnati, OH, United States.
Cleveland Clinic · USUniversity of Iowa · USBarrow Neurological Institute · USBuffalo State University · USCharlottesville Medical Research · USColumbia University Irving Medical Center · USCornell University · USEmory University · USMassachusetts General Hospital · USMediciNova (United States) · USMontefiore Medical Center · USNational Institute of Neurological Disorders and Stroke · USNorthwestern University · USOregon Health & Science University · USPatient Advocate Foundation · USState University of New York · USSUNY Upstate Medical University · USSwedish Medical Center · USThe Ohio State University · USThe University of Texas Southwestern Medical Center · US

Funding

Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
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
Einstein Center for Excellence for Clinical Trials in NeuroscienceU10NS077308 · NINDS · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI LIPTON, RICHARD B., SHINNAR, SHLOMO · 2011 to 2017
$2.2M
Network of Excellence in Neuroscience Clinical Trials (NEXT)U10NS077420 · NINDS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI BASHIR, KHURRAM, NABORS, LOUIS B · 2011 to 2017
$2.0M
Network of Excellence in Neuroscience Clinical Trials (NEXT)U24NS107155 · NINDS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI BASHIR, KHURRAM, NABORS, LOUIS B · 2018 to 2022
$1.5M
NCATS NIH HHS UL1 TR002384NINDS NIH HHS U01 NS077179NINDS NIH HHS U01 NS077352NINDS NIH HHS U01 NS082329NINDS NIH HHS U10 NS077308NINDS NIH HHS U10 NS077420NINDS NIH HHS U24 NS107155
6 · The paper itself

Abstract

backgroundPrimary and secondary progressive multiple sclerosis (MS), collectively called progressive multiple sclerosis (PMS), is characterized by gradual progression of disability. The current anti-inflammatory treatments for MS have little or no efficacy in PMS in the absence of obvious active inflammation. Optimal biomarkers for phase II PMS trials is unknown. Ibudilast is an inhibitor of macrophage migration inhibitor factor and phosphodiesterases-4 and -10 and exhibits possible neuroprotective properties. The goals of SPRINT-MS study are to evaluate the safety and efficacy of ibudilast in PMS and to directly compare several imaging metrics for utility in PMS trials.

methodsSPRINT-MS is a randomized, placebo-controlled, phase II trial of ibudilast in patients with PMS. Eligible subjects were randomized 1:1 to receive either ibudilast (100mg/day) or placebo for 96weeks. Imaging is conducted every 24weeks for whole brain atrophy, magnetization transfer ratio, diffusion tensor imaging, cortical brain atrophy, and retinal nerve fiber layer thickness. Clinical outcomes include neurologic disability and patient reported quality of life. Safety assessments include laboratory testing, electrocardiography, and suicidality screening.

resultsA total of 331 subjects were enrolled, of which 255 were randomized onto active study treatment. Randomized subjects were 53.7% female and mean age 55.7 (SD 7.3) years. The last subject is projected to complete the study in May 2017.

conclusionSPRINT-MS is designed to evaluate the safety and efficacy of ibudilast as a treatment for PMS while simultaneously validating five different imaging biomarkers as outcome metrics for use in future phase II proof-of-concept PMS trials.

Indexed as

AdultBrainDiffusion Tensor ImagingDisease ProgressionDouble-Blind MethodHumansIndolizinesMiddle AgedMultiple Sclerosis, Chronic ProgressivePhosphodiesterase InhibitorsPyrazolesPyridinesQuality of LifeResearch DesignibudilastIndolizinesPhosphodiesterase InhibitorsPyrazolesPyridinesClinical trialIbudilastMagnetic resonance imagingProgressive multiple sclerosis

Identifiers

PMID27521810
PMCPMC5035622
OpenAlexW2513018262

What OpenQuestion holds

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Registered trials

None linked

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.