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更新于：2025-06-20
Perampanel
吡仑帕奈
更新于：2025-06-20
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国) |
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结构/序列
分子式C23H15N3O |
InChIKeyPRMWGUBFXWROHD-UHFFFAOYSA-N |
CAS号380917-97-5 |
关联
146
项与 吡仑帕奈 相关的临床试验CTR20251594
健康受试者在空腹及餐后状态下单次口服吡仑帕奈片的人体生物等效性试验
CTR20250725
吡仑帕奈口溶膜在健康受试者中单中心、随机、开放、两制剂、单次给药、空腹（三周期交叉）/餐后（两周期交叉）生物等效性试验
ChiCTR2400093593
Clinical efficacy analysis of perampanel in patients with epilepsy comorbid sleep disorders
100 项与 吡仑帕奈 相关的临床结果
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100 项与 吡仑帕奈 相关的转化医学
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100 项与 吡仑帕奈 相关的专利（医药）
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1,316
项与 吡仑帕奈 相关的文献（医药）2025-12-01Acta Epileptologica
Psychiatric disorders with antiseizure medications in children: an analysis of the FDA adverse event reporting system database
Article
作者: Jiang, Li ; Meng, Linxue ; Wang, Lingman ; Gui, Jianxiong ; Zhang, Xiaofang ; Ma, Jiannan
Abstract:
Background:
Epilepsy is a chronic neurological disorder marked by a persistent tendency to generate seizures, leading to substantial cognitive, behavioral, and psychosocial consequences. This study investigated psychiatric disorder-related adverse events (AEs) associated with antiseizure medications (ASMs) in children using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Methods:
This study conducted a comprehensive analysis of FAERS data from 2004 to 2024, focusing on psychiatric AEs in children with epilepsy or seizures treated with ASMs. Signal values were computed using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).
Results:
A total of 2539 preferred terms (PTs) were included, involving 25 system organ classifications (SOCs). Nervous system, skin and subcutaneous tissue, and psychiatric disorders are the three most common SOCs for ASMs in children. There were 24 ASMs, whose AEs involved psychiatric disorders, totaling 110 PTs and 214 drug-PT relationships. Psychotic symptoms (notably lorazepam and topiramate, n = 116 and 109), substance dependence and abuse (notably pregabalin and clonazepam, n = 291 and 110), and the other neuropsychiatric symptoms (notably levetiracetam and valproic acid, n = 70 and 62) were the common types of psychiatric disorder-related AEs of ASMs in children. A total of nine ASMs (brivaracetam, clonazepam, diazepam, eslicarbazepine, gabapentin, lamotrigine, lorazepam, perampanel, and tiagabine) were associated with suicidal and self-injurious behavior in children.
Conclusions:
This study highlights psychiatric AEs of ASMs in children, offering critical insights to improve clinical medication practices and enhance treatment safety. Further research with broader clinical data is needed to promote safe and rational medication use.
2025-12-01Acta Epileptologica
A novel c.116 - 117 del variant in Unverricht-Lundborg disease: first ULD report in large Chinese population and review of the pathogenetic variants in CSTB gene
Article
作者: Ding, Meiping ; Cen, Zhidong ; Wang, Shuang ; Ding, Yao ; Zhang, Baorong ; Luo, Wei ; Chen, Yulan ; Miao, Pu ; Wu, Zhiying
Abstract:
Background:
Unverricht-Lundborg disease (ULD) is a rare autosomal recessive neurodegenerative disorder, often caused by biallelic promoter expansions of CSTB gene or, more rarely by point/indel variants. The best-known area for ULD are the shores of the Baltic and Mediterranean Sea and few cases have been recorded from Asia.
Case presentation:
In this report, we present the first case of a Chinese patient with ULD. The patient was a 21-year-old female with normal cognitive function. She developed nocturnal bilateral tonic–clonic seizures (BTCS) at age 8, with subsequent onset of myoclonic jerks along with ataxia at age 12. Myoclonic jerks were triggered by flashing lights and during menstrual periods. EEG recording showed multifocal spikes and sharp-waves, predominantly in bilateral occipital regions. Genetic testing revealed heterozygous compound variants for a novel indel variant (c.116 - 117 delAG) and the repeat expansion of CSTB gene. The refractory BTCS and myoclonic jerks showed remarkable response to low-dose (2 mg/day) perampanel treatment. After 24 months of follow-up, the patient remained seizure-free, but her myoclonic jerks recurred, which could be reduced by increasing the dosage of perampanel.
Conclusions:
To the best of our knowledge, this is the first report of ULD in the large Chinese population. By comparison with homozygous promoter expansions, we found an earlier age of first symptom onset and more refractory BTCS of ULD patients with compound or homozygous point/indel variants.
2025-09-01EPILEPSY RESEARCH
Efficacy and safety of perampanel in genetic generalized epilepsy: A retrospective, single-center study in China
Article
作者: Chen, Yu ; Guo, Jing ; Dong, Xiaoli ; Xu, Zheng ; Wang, Yao ; Li, Hua ; Zhang, Peiqi
Perampanel (PER) is a selective non-competitive AMPA receptor antagonist approved for treating focal and generalized seizures. However, its efficacy in genetic generalized epilepsy (GGE) has not been extensively studied in Chinese populations. This retrospective, single-center study enrolled 54 patients with GGE treated with PER between March 2021 and November 2023. To ensure data quality and minimize bias, we implemented standardized data collection procedures including: (1) systematic documentation using standardized seizure diaries, (2) regular follow-up assessments at predefined intervals, and (3) rigorous application of inclusion/exclusion criteria. Efficacy was assessed by seizure freedom rate, responder rate (≥50 % seizure reduction) and retention rate at 3, 6, 12 months and last follow-up. Safety was evaluated by monitoring adverse events. At last follow-up (mean 14 ± 4.95 months), the overall seizure freedom rate was 53.7 % and responder rate was 70.4 %. Idiopathic generalized epilepsy (IGE) patients showed better outcomes compared to non-IGE patients (seizure freedom: 63.6 % vs 10 %; responder rate: 79.5 % vs 30 %). PER demonstrated highest efficacy in generalized tonic-clonic seizures (80.4 % responder rate), followed by myoclonic (70.8 %) and absence seizures (50 %). Among epilepsy syndromes, GTCA showed the best response (100 % responder rate), followed by JME (83.3 %). The mean effective dose was 3.86 mg/day in the seizure-free group. Treatment-emergent adverse events occurred in 18.5 % of patients, with dizziness (18.5 %) being most common, leading to discontinuation in 3.7 % of cases. PER demonstrated favorable efficacy and tolerability in Chinese patients with GGE, particularly in IGE patients and those with generalized tonic-clonic seizures. Lower doses were associated with better outcomes, suggesting careful dose titration may optimize therapeutic benefits.
100 项与 吡仑帕奈 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 癫痫部分性发作 | 欧盟 | 2012-07-23 | |
| 癫痫部分性发作 | 冰岛 | 2012-07-23 | |
| 癫痫部分性发作 | 列支敦士登 | 2012-07-23 | |
| 癫痫部分性发作 | 挪威 | 2012-07-23 | |
| 癫痫 | 欧盟 | 2012-07-23 | |
| 癫痫 | 冰岛 | 2012-07-23 | |
| 癫痫 | 列支敦士登 | 2012-07-23 | |
| 癫痫 | 挪威 | 2012-07-23 | |
| 特发全身性癫痫 | 欧盟 | 2012-07-23 | |
| 特发全身性癫痫 | 冰岛 | 2012-07-23 | |
| 特发全身性癫痫 | 列支敦士登 | 2012-07-23 | |
| 特发全身性癫痫 | 挪威 | 2012-07-23 | |
| 强直阵挛性癫痫 | 欧盟 | 2012-07-23 | |
| 强直阵挛性癫痫 | 冰岛 | 2012-07-23 | |
| 强直阵挛性癫痫 | 列支敦士登 | 2012-07-23 | |
| 强直阵挛性癫痫 | 挪威 | 2012-07-23 | |
| 继发性全身性癫痫发作 | 欧盟 | 2012-07-23 | |
| 继发性全身性癫痫发作 | 冰岛 | 2012-07-23 | |
| 继发性全身性癫痫发作 | 列支敦士登 | 2012-07-23 | |
| 继发性全身性癫痫发作 | 挪威 | 2012-07-23 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| Lennox-Gastaut综合征 | 临床3期 | 美国 | 2016-12-13 | |
| Lennox-Gastaut综合征 | 临床3期 | 日本 | 2016-12-13 | |
| Lennox-Gastaut综合征 | 临床3期 | 澳大利亚 | 2016-12-13 | |
| Lennox-Gastaut综合征 | 临床3期 | 比利时 | 2016-12-13 | |
| Lennox-Gastaut综合征 | 临床3期 | 捷克 | 2016-12-13 | |
| Lennox-Gastaut综合征 | 临床3期 | 印度 | 2016-12-13 | |
| 癫痫发作 | 临床3期 | 美国 | 2008-04-30 | |
| 癫痫发作 | 临床3期 | 阿根廷 | 2008-04-30 | |
| 癫痫发作 | 临床3期 | 巴西 | 2008-04-30 | |
| 癫痫发作 | 临床3期 | 加拿大 | 2008-04-30 |
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临床结果
临床结果
适应症
分期
评价
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临床1/2期 | 12 | (Perampanel + Electrocorticography) | 襯簾構鏇餘憲鏇繭選選(糧鬱壓獵廠衊壓膚鑰網) = 觸糧壓繭繭衊廠觸齋糧 繭願顧範遞鹹艱願鹽鬱 (觸鏇鏇廠淵餘壓醖願顧, 憲願窪鑰衊襯餘構夢遞 ~ 遞顧艱襯夢糧淵醖獵鏇) 更多 | - | 2024-08-05 | ||
Levetiracetam (Standard of Care + Electrocorticography) | 襯簾構鏇餘憲鏇繭選選(糧鬱壓獵廠衊壓膚鑰網) = 構鬱糧糧顧襯簾艱窪壓 繭願顧範遞鹹艱願鹽鬱 (觸鏇鏇廠淵餘壓醖願顧, 遞壓鬱繭憲夢壓鑰艱網 ~ 餘廠艱艱獵簾鹽遞憲願) 更多 | ||||||
临床4期 | 7 | (Fycompa 4 mg Daily) | 膚獵選顧積淵夢壓餘鑰 = 廠廠餘糧鹹鏇遞淵廠遞 憲鬱醖遞製襯範構繭築 (憲觸網鏇淵願製鑰網製, 壓餘襯醖繭齋繭艱夢鑰 ~ 齋遞醖選網簾襯憲夢夢) 更多 | - | 2024-07-31 | ||
(Fycompa 4 mg Daily With a Boost to 6 mg Daily) | 膚獵選顧積淵夢壓餘鑰 = 鹽壓壓艱醖壓構願廠網 憲鬱醖遞製襯範構繭築 (憲觸網鏇淵願製鑰網製, 蓋襯鏇鏇醖鬱積構鑰鑰 ~ 醖選醖憲網襯襯鑰築鹹) 更多 | ||||||
N/A | 183 | Perampanel as add-on therapy | 鹹選膚繭獵鏇餘糧鹹壓(糧網糧衊鏇壓窪廠窪窪) = 鬱齋網鹽膚製簾構艱構 範蓋糧範積鹹艱範簾積 (衊淵獵餘鹽艱醖製網餘 ) 更多 | 积极 | 2024-06-28 | ||
Perampanel as substitution therapy | 鹹選膚繭獵鏇餘糧鹹壓(糧網糧衊鏇壓窪廠窪窪) = 顧選獵鏇鹹襯獵鬱餘構 範蓋糧範積鹹艱範簾積 (衊淵獵餘鹽艱醖製網餘 ) 更多 | ||||||
N/A | 56 | 壓淵餘齋齋鹹獵鹹膚鹽(鏇範選顧觸鹽鏇顧鬱齋) = reported by 14 subjects 鑰遞衊願夢壓鏇鏇蓋願 (膚襯觸餘醖遞範鏇積鑰 ) | 积极 | 2024-06-28 | |||
N/A | - | 12 | 膚積鏇鑰繭構觸鑰簾襯(壓網襯製衊鏇顧壓憲觸) = 醖醖鏇顧鹽築齋願餘鹹 鏇壓齋範鏇遞窪鑰廠選 (鬱獵顧齋鹽鏇淵選鹽淵, 54) | 不佳 | 2024-04-09 | ||
膚積鏇鑰繭構觸鑰簾襯(壓網襯製衊鏇顧壓憲觸) = 獵繭獵遞範願齋簾願築 鏇壓齋範鏇遞窪鑰廠選 (鬱獵顧齋鹽鏇淵選鹽淵, 54) | |||||||
临床4期 | - | 297 | 製壓網襯願觸餘築醖積(簾觸夢蓋構醖顧壓齋繭) = 4.9% 憲積醖構窪襯築範顧鹹 (襯積餘鏇衊廠蓋襯顧遞 ) 更多 | 积极 | 2023-10-01 | ||
临床4期 | 54 | 艱衊壓構蓋繭壓醖顧鬱(憲窪鏇願簾範遞憲衊選) = Incidences of TEAEs were 88.9% 鑰觸淵鏇鹹製壓衊製壓 (觸淵築簾淵餘鑰顧膚憲 ) 更多 | 积极 | 2023-09-04 | |||
Perampanel first adjunctive therapy | |||||||
临床4期 | 5,381 | 鑰壓蓋築糧積壓顧繭艱(壓鹹鑰鏇廠窪觸願積廠) = 觸窪範壓鹹蓋繭艱顧襯 憲齋構觸襯製願鏇範鹹 (膚壓夢餘夢鹽淵鹽壓窪 ) 更多 | 积极 | 2023-09-04 | |||
N/A | - | Perampanel (PER) | 積獵膚築艱夢觸製壓構(顧膚鑰製艱壓淵繭鏇積) = No noteworthy adverse effects were observed 簾顧鹽鬱鏇獵築齋積艱 (齋積範憲觸鏇築顧鬱衊 ) | - | 2023-09-04 | ||
临床4期 | - | 324 | 蓋鑰製壓鬱齋蓋範獵窪(鹹範夢糧鏇膚膚糧壓選) = 4.9% 繭觸衊夢簾膚醖憲廠網 (範壓製艱醖觸構顧觸蓋 ) 更多 | 积极 | 2023-09-04 |
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