Evidence map›Paper›PMID 27385750›Full record

Trial reportNeurology2016

Quantitative strength testing in ALS clinical trials.

Jeremy M Shefner, Dawei Liu, Melanie L Leitner, David Schoenfeld, Donald R Johns, Toby Ferguson, Merit Cudkowicz

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neurology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing 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

37 citing papers in PubMed.

  1. Trial
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  16. Article
  17. Considerations for Amyotrophic Lateral Sclerosis (ALS) Clinical Trial Design.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  18. Article
  19. Article
  20. 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.

Jeremy M ShefnerFrom the Department of Neurology (J.M.S.), Barrow Neurological Institute, Phoenix, AZ; Biogen (D.L., M.L.L., D.R.J., T.F.), Cambridge; and Department of Neurology (D.S., M.C.), Massachusetts General Hospital, Boston. Jeremy.Shefner@DignityHealth.org.
Dawei LiuFrom the Department of Neurology (J.M.S.), Barrow Neurological Institute, Phoenix, AZ; Biogen (D.L., M.L.L., D.R.J., T.F.), Cambridge; and Department of Neurology (D.S., M.C.), Massachusetts General Hospital, Boston.
Melanie L LeitnerFrom the Department of Neurology (J.M.S.), Barrow Neurological Institute, Phoenix, AZ; Biogen (D.L., M.L.L., D.R.J., T.F.), Cambridge; and Department of Neurology (D.S., M.C.), Massachusetts General Hospital, Boston.
David SchoenfeldFrom the Department of Neurology (J.M.S.), Barrow Neurological Institute, Phoenix, AZ; Biogen (D.L., M.L.L., D.R.J., T.F.), Cambridge; and Department of Neurology (D.S., M.C.), Massachusetts General Hospital, Boston.
Donald R JohnsFrom the Department of Neurology (J.M.S.), Barrow Neurological Institute, Phoenix, AZ; Biogen (D.L., M.L.L., D.R.J., T.F.), Cambridge; and Department of Neurology (D.S., M.C.), Massachusetts General Hospital, Boston.
Toby FergusonFrom the Department of Neurology (J.M.S.), Barrow Neurological Institute, Phoenix, AZ; Biogen (D.L., M.L.L., D.R.J., T.F.), Cambridge; and Department of Neurology (D.S., M.C.), Massachusetts General Hospital, Boston.
Merit CudkowiczFrom the Department of Neurology (J.M.S.), Barrow Neurological Institute, Phoenix, AZ; Biogen (D.L., M.L.L., D.R.J., T.F.), Cambridge; and Department of Neurology (D.S., M.C.), Massachusetts General Hospital, Boston.

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
NINDS NIH HHS U01 NS077179
6 · The paper itself

Abstract

objectiveTo study the attributes of quantitative strength testing using hand-held dynamometry (HHD) as an efficacy measure in 2 large phase 3 amyotrophic lateral sclerosis (ALS) trials.

methodsIn the phase 3 trials of ceftriaxone and dexpramipexole, 513 and 943 patients, respectively, were enrolled in double-blind, randomized, placebo-controlled trials with planned follow-up of at least 1 year. Patients were studied every 3 months in the ceftriaxone study and every 2 months in the dexpramipexole study. Evaluators of HHD were trained and had to show evidence of adequate performance of strength testing; the testing paradigm involved testing 9 muscle groups in the upper and lower extremity bilaterally. Neither drug significantly affected any outcome measure. Strength measurements were evaluated by individual muscle and by megascores, which averaged scaled strength measures to produce an overall measure of muscle strength.

resultsA measure combining rate of decline with both within- and between-patient variabilities of measurement, the coefficient of variation for rate of change, was calculated, and showed that HHD overall performed slightly less well than Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) but better than vital capacity. Individual muscles were highly correlated to the identical muscles on the contralateral side, as well as to other muscles in the same body region. Strength decline was correlated both with ALSFRS-R and vital capacity.

conclusionQuantitative strength testing using HHD is a reliable and reproducible measure of decline in ALS.

Indexed as

Muscle Strength DynamometerAmyotrophic Lateral SclerosisBenzothiazolesCeftriaxoneFemaleHumansMaleOutcome Assessment, Health CarePramipexoleBenzothiazolesCeftriaxonePramipexole

Identifiers

PMID27385750
PMCPMC4977369

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.