Evidence map›Paper›PMID 37712083›Full record

ArticleFrontiers in neurology2023

Efficacy and safety of perampanel as early add-on therapy in Chinese patients with focal-onset seizures: a multicenter, open-label, single-arm study.

Lehong Gao, Qiang Lu, Zan Wang, Wei Yue, Guoping Wang, Xiaoqiu Shao, Yi Guo, Yonghong Yi, Zhen Hong, Yuwu Jiang and 7 more

Abstract read
In one paragraph

Article in Frontiers in neurology, 2023. 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. Observational
  2. 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

17 authors.

Lehong GaoDepartment of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
Qiang LuDepartment of Neurology, Peking Union Medical College Hospital, Beijing, China.
Zan WangDepartment of Neurology, The First Hospital of Jilin University, Changchun, China.
Wei YueDepartment of Neurology, Tianjin Huanhu Hospital, Tianjin, China.
Guoping WangDivision of Life Sciences and Medicine, Department of Neurology, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China.
Xiaoqiu ShaoDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Yi GuoDepartment of Neurology, Shenzhen People's Hospital, The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology, Shenzhen, China.
Yonghong YiKey Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Department of Neurology, Institute of Neuroscience, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Zhen HongDepartment of Neurology, Huashan Hospital, Fudan University, Shanghai, China.
Yuwu JiangDepartment of Pediatrics and Pediatric Epilepsy Center, Peking University First Hospital, Beijing, China.
Bo XiaoDepartment of Neurology, Xiangya Hospital, Central South University, Changsha, China.
Guiyun CuiDepartment of Neurology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Feng GaoDepartment of Neurology, Children's Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Jiasheng HuDepartment of Neurology, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Jianmin LiangDepartment of Pediatric Neurology, The First Hospital of Jilin University, Changchun, China.
Meiyun ZhangDepartment of Neurology, Tianjin Union Medical Center, Tianjin, China.
Yuping WangDepartment of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: No interventional study has been conducted in China to assess efficacy and safety of perampanel in treating Chinese patients with epilepsy, nor has there been any study on perampanel early add-on therapy in China. This interventional study aimed to assess efficacy and safety of perampanel as an early add-on treatment of focal-onset seizures (FOS) with or without focal-to-bilateral tonic-clonic seizures (FBTCS) in Chinese patients. Methods: In this multicenter, open-label, single-arm, phase 4 interventional study, Chinese patients ≥ 12 years old with FOS with or without FBTCS who failed anti-seizure medication (ASM) monotherapy from 15 hospitals in China were enrolled and treated with perampanel add-on therapy (8-week titration followed by 24-week maintenance). The primary endpoint was 50% responder rate. Secondary endpoints included seizure-freedom rate and changes in seizure frequency from baseline. Treatment-emergent adverse events (TEAEs) and drug-related TEAEs were recorded. Results: The full analysis set included 150 patients. The mean maintenance perampanel dose was 5.9 ± 1.5 mg/day and the 8-month retention rate was 72%. The 50% responder rate and seizure-freedom rate for all patients during maintenance were 67.9 and 30.5%, respectively. Patients with FBTCS had higher 50% responder rate (96.0%) and seizure-freedom rate (76.0%) during maintenance. Patients on concomitant sodium valproate had a significantly higher seizure-freedom rate than those on concomitant oxcarbazepine. Eight-six (55.1%) patients experienced treatment-related TEAEs, and the most common TEAEs were dizziness (36.5%), hypersomnia (11.5%), headache (3.9%), somnolence (3.2%), and irritability (3.2%). Withdrawal due to TEAEs occurred to 14.7% of the patients. Conclusion: Perampanel early add-on was effective and safe in treating Chinese patients≥12 years old with FOS with or without FBTCS.

Indexed as

50% responder rateChinese patientsfocal-onset seizuresperampanelperampanel early add-onseizure-freedom rateseizure-freedom rate perampanel

Identifiers

PMID37712083
PMCPMC10499319

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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.