Evidence map›Paper›PMID 41194593›Full record

ArticleMuscle & nerve2026

Participation in U.S.-Based ALS Clinical Trials by Sex and Race.

Mark P Levine, Sun Young Chung, Kellen H Quigg, Judith Carey, Suma Babu, Sabrina Paganoni, James D Berry

Abstract read
In one paragraph

Article in Muscle & nerve, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. 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

7 authors.

Mark P LevineDepartment of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA.
Sun Young ChungDepartment of Neurology, New York-Presbyterian Weill Cornell Medical Center, New York, New York, USA.
Kellen H QuiggDepartment of Neurology, University of Michigan, Ann Arbor, Michigan, USA.
Judith CareySean M. Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, Massachusetts, USA.
Suma BabuSean M. Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, Massachusetts, USA.
Sabrina PaganoniSean M. Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, Massachusetts, USA.
James D BerrySean M. Healey & AMG Center for ALS, Massachusetts General Hospital, Boston, Massachusetts, USA.

Funding

Access for All in ALS (ALL ALS) West Clinical Coordinating Center OT2NS136939 · NINDS · ST. JOSEPH'S HOSPITAL AND MEDICAL CENTER · PI ROBERT P BOWSER, BRENT T HARRIS · 2023 to 2026
$76.5M
Access for All in ALS (ALL ALS) East Clinical Coordinating Center OT2NS136938 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI Jinsy Andrews, Suma Babu · 2023 to 2026
$71.5M
NIH HHSNINDS NIH HHS 1OT2NS136938-01NINDS NIH HHS 1OT2NS136939-01NINDS NIH HHS OT2 NS136938NINDS NIH HHS OT2 NS136939
6 · The paper itself

Abstract

INTRODUCTION/

aimsIn global amyotrophic lateral sclerosis (ALS) trials, women and men appear to be proportionately enrolled, but quantification of enrollment by sex and race in U.S.-based ALS trials is limited. The objective of this study was to evaluate the sex and race of participants enrolled in U.S.-based ALS clinical trials.

methodsParticipant demographics were extracted from recent U.S.-based Phase 2 and 3 ALS trials identified in literature and on ClinicalTrials.gov. The Centers for Disease Control and Prevention (CDC) National ALS Registry and a 2014 State Surveillance Project were used as proxies for prevalence. Participation-to-prevalence (PPR) ratios were calculated for sex and race. A modified time-trend analysis was performed for race for participants enrolled before and after 2020.

resultsA total of 11 trials met criteria for inclusion with a total of 1153 patients enrolled. Compared to the CDC Registry, the PPR was 0.76 (95% CI: 0.63-0.90) for women, 1.26 (95% CI: 1.23-1.29) for White participants, 0.34 (95% CI: 0.17-0.51) for Black participants, and 0.35 (95% CI: 0.14-0.56) for all other races/multiracial. The modified time trend analysis showed no significant difference in the PPRs before and after 2020 (White: t = 1.44, p = 0.22; Black: t = -0.99, p = 0.37; Other races/multiracial: t = -1.50, p = 0.21). The comparison to the 2014 State Surveillance Project yielded similar findings. DISCUSSION: U.S.-based ALS trials significantly under-enroll non-White participants, and there are trends toward slight underrepresentation of women. Efforts to broaden trial enrollment amongst people with ALS will help with the generalizability of trial results and hasten trial completion.

Indexed as

Amyotrophic Lateral SclerosisClinical Trials as TopicPatient ParticipationRacial GroupsSex DistributionAdultAgedFemaleHumansMaleMiddle AgedPatient SelectionRegistriesUnited Statesamyotrophic lateral sclerosisclinical trials as topichealth equityracial disparitiessex distribution

Identifiers

PMID41194593
PMCPMC12689998

What OpenQuestion holds

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Registered trials

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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.