Evidence map›Paper›PMID 25286015›Full record

Trial reportAmyotrophic lateral sclerosis & frontotemporal degeneration2014

Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients.

Koji Abe, Yasuto Itoyama, Gen Sobue, Shoji Tsuji, Masashi Aoki, Manabu Doyu, Chikuma Hamada, Kazuoki Kondo, Takatomo Yoneoka, Makoto Akimoto and 2 more

3 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Amyotrophic lateral sclerosis & frontotemporal degeneration, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 167 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
167citing papers in PubMed, 8 pooled it
13.3field-weighted citation impact, top 1% 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.

NCT00330681 phase3completednot on this map

A Confirmatory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-blind, Parallel-group, Placebo-controlled Manner.

TypeinterventionalSponsorShionogiRan2006 to 2008Enrolled206ConditionsAmyotrophic Lateral Sclerosis (ALS)ArmsMCI-186, Placebo of MCI-186
NCT03272802 phase2 / phase3unknown statusnot on this mapstarted 2017, after this paper: background citation

Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) in a Representative Iranian Population

TypeinterventionalSponsorIsfahan University of Medical SciencesRan2017 to 2019Enrolled20ConditionsNeuromuscular DiseasesArmsEdaravone, Riluzole
NCT03580616 phase2terminatednot on this mapstarted 2018, after this paper: background citation

Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis: A Phase IIa Study

TypeinterventionalSponsorElijah W. StommelRan2018 to 2022Enrolled43ConditionsAmyotrophic Lateral Sclerosis (ALS)ArmsL-Serine
3 · Its place in the literature

Who cites it

167 citing papers in PubMed, 8 syntheses or guidelines pooled it, 351 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Safety and efficacy of edaravone in patients with amyotrophic lateral sclerosis: a systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2023
    Pooled it
  4. Pooled it
  5. Canadian best practice recommendations for the management of amyotrophic lateral sclerosis.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2020
    Guideline
  6. Cell-based therapies for amyotrophic lateral sclerosis/motor neuron disease.The Cochrane database of systematic reviews · 2019
    Pooled it
  7. Efficacy and safety of edaravone in treatment of amyotrophic lateral sclerosis-a systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2019
    Pooled it
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107 more citing papers are in PubMed but not listed here.

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

12 authors at 8 institutions in 1 country.

Koji AbeDepartment of Neurology, Okayama University Hospital , Okayama.
Yasuto Itoyama
Gen Sobue
Shoji Tsuji
Masashi Aoki
Manabu Doyu
Chikuma Hamada
Kazuoki Kondo
Takatomo Yoneoka
Makoto Akimoto
Hiide Yoshino
Edaravone ALS Study Group
International University of Health and Welfare · JPMitsubishi Group (Japan) · JPAichi Medical University Hospital · JPMitsubishi Tanabe Pharma CorporationNagoya University · JPOkayama University · JPThe University of Tokyo · JPTokyo University of Science · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Our objective was to confirm the efficacy and safety of edaravone in amyotrophic lateral sclerosis (ALS) patients. We conducted a 36-week confirmatory study, consisting of 12-week pre-observation period followed by 24-week treatment period. Patients received placebo or edaravone i.v. infusion over 60 min for the first 14 days in cycle 1, and for 10 of the first 14 days during cycles 2 to 6. The efficacy primary endpoint was changed in the revised ALS functional rating scale (ALSFRS-R) scores during the 24-week treatment. Patients were treated with placebo (n = 104) and edaravone (n = 102). Changes in ALSFRS-R during the 24-week treatment were -6.35 ± 0.84 in the placebo group (n = 99) and -5.70 ± 0.85 in the edaravone group (n = 100), with a difference of 0.65 ± 0.78 (p = 0.411). Adverse events amounted to 88.5% (92/104) in the placebo group and 89.2% (91/102) in the edaravone group. In conclusion, the reduction of ALSFRS-R was smaller in the edaravone group than in the placebo group, but efficacy of edaravone for treatment of ALS was not demonstrated. Levels and frequencies of reported adverse events were similar in the two groups.

Indexed as

AdultAgedAmyotrophic Lateral SclerosisAnalysis of VarianceAntipyrineDouble-Blind MethodEdaravoneFemaleFollow-Up StudiesFree Radical ScavengersHumansMaleMiddle AgedRetrospective StudiesSeverity of Illness IndexTime FactorsAntipyrineEdaravoneFree Radical ScavengersALSFRS-RAmyotrophic lateral sclerosisedaravoneplaceborandomized trial

Identifiers

PMID25286015
PMCPMC4266079
OpenAlexW2128167427

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.