Evidence map›Paper›PMID 40915921›Full record

Trial reportNeurologia medico-chirurgica2025

Preliminary Safety Study of a Single-dose Perampanel Drip Infusion in Brain Tumor Patients to Prevent Early Postoperative Seizures: The poSTOP Seizure-1 SF Study.

Narushi Sugii, Kota Araki, Eiichi Ishikawa

Abstract readClinical Trial
In one paragraph

Trial report in Neurologia medico-chirurgica, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

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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

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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

3 authors.

Narushi SugiiDepartment of Neurosurgery, Institute of Medicine, University of Tsukuba.
Kota ArakiDepartment of Neurosurgery, Institute of Medicine, University of Tsukuba.
Eiichi IshikawaDepartment of Neurosurgery, Institute of Medicine, University of Tsukuba.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Early postoperative seizures, defined as occurring within 7 days after surgery, are a significant complication that occurs following neurosurgical procedures involving cerebral manipulation. As a result, short-term antiseizure medication is typically administered in Japan despite the lack of consensus regarding its prophylactic use. Perampanel hydrate, an α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor antagonist, was recently introduced in an intravenous formulation in Japan, providing new potential for early postoperative seizures prevention during the perioperative period. This study aimed to evaluate the safety and feasibility of a single-dose intravenous infusion of perampanel hydrate during brain tumor surgery. We conducted a single-arm, open-label, exploratory safety trial involving 10 adult patients undergoing brain tumor resection. Each participant received a 6 mg intravenous dose of perampanel hydrate during surgery, with no additional antiseizure medication administered postoperatively unless clinically indicated. The primary endpoint was the incidence of grade 3 or higher adverse events related to the study drug. Secondary endpoints included hematological toxicity, the incidence of early postoperative seizures, anesthetic recovery time, and perampanel hydrate blood concentration profiles. No grade 3 or higher adverse events were observed. Minor adverse events included transient grade 2 liver enzyme elevations and postoperative restlessness, both of which resolved within a week. Notably, no cases of early postoperative seizures occurred, and perampanel hydrate blood levels remained high even 7 days after a single administration. Intravenous perampanel hydrate appears safe and well tolerated in the perioperative setting and may effectively prevent early postoperative seizures. Further studies are planned to evaluate its efficacy in larger patient cohorts.

Indexed as

AnticonvulsantsBrain NeoplasmsPostoperative ComplicationsPyridonesSeizuresAdultAgedFemaleHumansInfusions, IntravenousMaleMiddle AgedNitrilesAnticonvulsantsNitrilesperampanelPyridonesearly postoperative seizureintravenous drip infusionperampanel hydratesafety studysingle-dose

Identifiers

PMID40915921
PMCPMC12605754

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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.