Evidence map›Paper›PMID 34191081›Full record

Trial reportJournal of neurology2022

Randomized phase 2 study of perampanel for sporadic amyotrophic lateral sclerosis.

Hitoshi Aizawa, Haruhisa Kato, Koji Oba, Takuya Kawahara, Yoshihiko Okubo, Tomoko Saito, Makiko Naito, Makoto Urushitani, Akira Tamaoka, Kiyotaka Nakamagoe and 21 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 10% 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

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Perampanel for 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 · 2022
    Pooled it
  2. Pooled it
  3. Review
  4. Network Dysfunction Precedes Neurodegeneration in a dox-Regulatable TDP-43 Mouse Model of ALS-FTD.The Journal of neuroscience : the official journal of the Society for Neuroscience · 2025
    Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Kainate Receptor Antagonists: Recent Advances and Therapeutic Perspective.International journal of molecular sciences · 2023
    Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Evidence-Based Research Strategy of Traditional Chinese Medicine for Amyotrophic Lateral Sclerosis.Evidence-based complementary and alternative medicine : eCAM · 2021
    Review
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

31 authors at 13 institutions in 1 country.

Hitoshi AizawaDepartment of Neurology, Tokyo Medical University, Tokyo, Japan. haizawa@tokyo-med.ac.jp.ORCID http://orcid.org/0000-0002-5395-695X
Haruhisa KatoDepartment of Neurology, Tokyo Medical University, Tokyo, Japan.
Koji ObaDepartment of Biostatics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Takuya KawaharaCentral Coordinating Unit, Clinical Research Support Center, The University of Tokyo Hospital, Tokyo, Japan.
Yoshihiko OkuboDepartment of Neurology, Tokyo Medical University, Tokyo, Japan.
Tomoko SaitoDepartment of Neurology, Tokyo Medical University, Tokyo, Japan.
Makiko NaitoDepartment of Neurology, Tokyo Medical University, Tokyo, Japan.
Makoto UrushitaniDepartment of Neurology, Shiga University of Medical Science, Otsu, Japan.
Akira TamaokaDivision of Clinical Medicine, Department of Neurology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Kiyotaka NakamagoeDivision of Clinical Medicine, Department of Neurology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Kazuhiro IshiiDivision of Clinical Medicine, Department of Neurology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Takashi KandaDepartment of Neurology and Clinical Neuroscience, Yamaguchi University Graduate School of Medicine, Ube, Japan.
Masahisa KatsunoDepartment of Neurology, Nagoya University, Nagoya, Japan.
Naoki AtsutaDepartment of Neurology, Nagoya University, Nagoya, Japan.
Yasushi MaedaDepartment of Neurology, National Hospital Organization Kumamoto Saishun Medical Center, Kumamoto, Japan.
Makiko NagaiDepartment of Neurology, Kitasato University School of Medicine, Sagamihara, Japan.
Kazutoshi NishiyamaDepartment of Neurology, Kitasato University School of Medicine, Sagamihara, Japan.
Hiroyuki IshiuraDepartment of Neurology, University of Tokyo, Tokyo, Japan.
Tatsushi TodaDepartment of Neurology, University of Tokyo, Tokyo, Japan.
Akihiro KawataDepartment of Neurology, Tokyo Metropolitan Neurological Hospital, Tokyo, Japan.
Koji AbeDepartment of Neurology, University of Okayama, Okayama, Japan.
Ichiro YabeDepartment of Neurology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Ikuko Takahashi-IwataDepartment of Neurology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Hidenao SasakiDepartment of Neurology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Hitoshi WaritaDepartment of Neurology, Tohoku University Hospital, Sendai, Japan.
Masashi AokiDepartment of Neurology, Tohoku University Hospital, Sendai, Japan.
Gen SobueDepartment of Neurology, Nagoya University, Nagoya, Japan.
Hidehiro MizusawaNational Center of Neurology and Psychiatry, Tokyo, Japan.
Yutaka MatsuyamaDepartment of Biostatics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Tomohiro HagaCentral Coordinating Unit, Clinical Research Support Center, The University of Tokyo Hospital, Tokyo, Japan.
Shin KwakDepartment of Neurology, Tokyo Medical University, Tokyo, Japan.
Tokyo Medical University · JPThe University of Tokyo · JPHokkaido University · JPNagoya University · JPUniversity of Tsukuba · JPKitasato University · JPTohoku University Hospital · JPUniversity of Tokyo Hospital · JPKumamoto Medical Center · JPNational Center of Neurology and Psychiatry · JPShiga University of Medical Science · JPTokyo Metropolitan Neurological Hospital · JPYamaguchi University · JP

Funding

Japan Agency for Medical Research and Development CCT-B-2804
6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of perampanel in patients with sporadic amyotrophic lateral sclerosis (SALS).

methodsThis randomized, double-blind, placebo-controlled, multicenter, phase 2 clinical study was conducted at 12 sites. Patients with probable or definite ALS as defined by revised El Escorial criteria were enrolled. Sixty-six patients were randomly assigned (1:1:1) to receive placebo, 4 mg perampanel, or 8 mg perampanel daily for 48 weeks. Adverse events (AEs) were recorded throughout the trial period. The primary efficacy outcome was the change in Amyotrophic Lateral Sclerosis Rating Scale-Revised (ALSFRS-R) score after 48 weeks of treatment.

resultsOne patient withdrew before starting the treatment. Of 65 patients included, 18 of 22 patients randomized to placebo (82%), 14 of 22 patients randomized to 4 mg perampanel (64%), and 7 of 21 patients randomized to 8 mg perampanel (33%) completed the trial. There was a significant difference in the change of ALSFRS-R scores [- 8.4 (95% CI - 13.9 to - 2.9); p = 0.015] between the placebo and the perampanel 8 mg group, primarily due to worsening of the bulbar subscore in the perampanel 8 mg group. Serious AEs were more frequent in the perampanel 8 mg group than in the placebo group (p = 0.0483).

conclusionsPerampanel was associated with a significant decline in ALSFRS-R score and was linked to worsening of the bulbar subscore in the 8 mg group.

Indexed as

Amyotrophic Lateral SclerosisDouble-Blind MethodHumansNitrilesPyridonesTreatment OutcomeNitrilesperampanelPyridonesAMPA receptorEfficacyPerampanelSafetySporadic amyotrophic lateral sclerosis

Identifiers

PMID34191081
PMCPMC8782807
OpenAlexW3174305744

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.