Evidence map›Paper›PMID 40829828›Full record

ArticleBMJ open2025

Perampanel for alleviation of secondary injury in traumatic brain injury (PEACE-TBI): a protocol for a phase-II multicentre randomised clinical trial.

Ryo Yamamoto, Ryota Tamura, Yukina Morimoto, Masato Nakaya, Satoshi Terao, Takahiro Shoji, Tokunori Kanazawa, Ryota Sasao, Makoto Inaba, Masayuki Shimizu and 14 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

24 authors.

Ryo YamamotoDepartment of Emergency and Critical Care Medicine, Keio University School of Medicine, Tokyo, Japan ryo.yamamoto@gmail.com.ORCID http://orcid.org/0000-0001-8772-9600
Ryota TamuraDepartment of Neurosurgery, Keio University School of Medicine, Tokyo, Japan.
Yukina MorimotoDepartment of Neurosurgery, Tokyo Saiseikai Central Hospital, Tokyo, Japan.
Masato NakayaDepartment of Neurosurgery, Tokyo Saiseikai Central Hospital, Tokyo, Japan.
Satoshi TeraoDepartment of Neurosurgery, Tokyo Saiseikai Central Hospital, Tokyo, Japan.
Takahiro ShojiDepartment of Emergency and Critical Care Medicine, Tokyo Saiseikai Central Hospital, Tokyo, Japan.ORCID http://orcid.org/0000-0003-2945-8421
Tokunori KanazawaDepartment of Neurosurgery, Saiseikai Yokohamashi Tobu Hospital, Kanagawa, Japan.
Ryota SasaoDepartment of Neurosurgery, Saiseikai Yokohamashi Tobu Hospital, Kanagawa, Japan.
Makoto InabaDepartment of Neurosurgery, Saiseikai Yokohamashi Tobu Hospital, Kanagawa, Japan.
Masayuki ShimizuDepartment of Trauma and Emergency Surgery, Saiseikai Yokohamashi Tobu Hospital, Kanagawa, Japan.
Yuki KuranariDepartment of Neurosurgery, Kawasaki Municipal Hospital, Kanagawa, Japan.
Makoto KatayamaDepartment of Neurosurgery, Kawasaki Municipal Hospital, Kanagawa, Japan.
Koichi UenoEmergency Department, Kawasaki Municipal Hospital, Kanagawa, Japan.
Yumiko OishiDepartment of Neurosurgery, Hiratsuka City Hospital, Kanagawa, Japan.
Akiyoshi NakamuraDepartment of Neurosurgery, Hiratsuka City Hospital, Kanagawa, Japan.
Yo KikuoDepartment of Emergency and Critical Care Medicine, Hiratsuka City Hospital, Kanagawa, Japan.
Ryosuke MurakamiDepartment of Emergency and Critical Care Medicine, Keio University School of Medicine, Tokyo, Japan.
Koichiro HommaDepartment of Emergency and Critical Care Medicine, Keio University School of Medicine, Tokyo, Japan.
Sota WakaharaDepartment of Neurosurgery, Keio University School of Medicine, Tokyo, Japan.
Konosuke IshikawaDepartment of Neurosurgery, Keio University School of Medicine, Tokyo, Japan.
Kenzo KosugiDepartment of Neurosurgery, Keio University School of Medicine, Tokyo, Japan.
Masahiro TodaDepartment of Neurosurgery, Keio University School of Medicine, Tokyo, Japan.
Tatsuro OzakiBiostatistics Unit, Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.
Junichi SasakiDepartment of Emergency and Critical Care Medicine, Keio University School of Medicine, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTraumatic brain injury (TBI) often causes permanent neurological dysfunction. Although no medication has been validated yet to prevent secondary injury of brain tissue, recent animal studies have reported that perampanel, a glutamine receptor antagonist, could improve the neurological functions of animals with TBI by mitigating the abnormal calcium influx and cell death around the site of primary injury. The present study aims to elucidate the efficacy of perampanel administration in improving the neurological function of patients with TBI. METHODS AND ANALYSIS: The perampanel for alleviation of secondary injury in TBI trial is a multicentre, phase-II, open-label randomised controlled trial targeting patients with mild-to-moderate TBI. This trial will include adult TBI patients with a Glasgow Coma Scale score of 9-14 from five tertiary centres. Patients with epilepsy as a comorbidity, delayed presentation of symptoms (>24 hours after injury) or Injury Severity Score of ≥25 will be excluded. The study participants will be randomly assigned to either the perampanel group (2 mg/day) or the control group (fosphenytoin administered at a dose of 15-18 mg/kg/day, followed by 5-7.5 mg/kg/day of fosphenytoin). In both groups, the medication will be initiated within 12 hours of the TBI diagnosis and continued for 7 days. The antiepileptic drugs can be increased, changed or added as necessary if early post-traumatic seizures are observed. The primary outcome is favourable neurological outcome, defined as a Glasgow Outcome Scale Extended score of ≥5 at 90 days after the TBI diagnosis, which will then be compared between the groups through an intention-to-treat analysis. ETHICS AND DISSEMINATION: The present study has been approved by the Certified Review Board of Keio at the principal institution (approval number: N20240004). Written informed consent will be obtained from all participants or their legal representatives. The results will be disseminated via publications and presentations. TRIAL REGISTRATION NUMBER: Japan Registry of Clinical Trials (jRCTs031250067).

Indexed as

AnticonvulsantsBrain Injuries, TraumaticPyridonesAdultClinical Trials, Phase II as TopicFemaleGlasgow Coma ScaleHumansMaleMulticenter Studies as TopicNitrilesPhenytoinRandomized Controlled Trials as TopicAnticonvulsantsNitrilesperampanelPhenytoinPyridonesBrain InjuriesPatientsTreatment Outcome

Identifiers

PMID40829828
PMCPMC12366614

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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.