预约演示
更新于：2025-07-21
Perampanel
吡仑帕奈
更新于：2025-07-21
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
147
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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1,332
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.
2025-11-01EPILEPSY & BEHAVIOR
Examining psychiatric and cognitive adverse effects of brivaracetam, clobazam, lacosamide, eslicarbazepine, and perampanel in a veteran population
Article
作者: Jimenez, Anthony D ; Gopaul, Margaret ; Orner, Michelle ; DeBonis, Danny ; Altalib, Hamada H ; Nuthalapati, Poojith ; Okafor, Chinenye M
INTRODUCTION:
Epilepsy is a chronic neurological disorder, affecting approximately 50 million people worldwide. There is limited data on the use of newer anti-seizure medicines (ASMs) and their cognitive and psychiatric adverse effects (AEs), despite increasing use. We aimed to describe the AE profile of newer ASMs in the real-world veteran population with Epilepsy comparing those who develop cognitive or psychiatric AEs to those who did not.
METHODS:
A retrospective analysis of veterans (n = 2636) diagnosed with epilepsy via ICD-10 codes was conducted in collaboration with the Veterans Affairs (VA) Office Quality and Patient Safety Analytics and Performance Integration program. Neurology notes of veterans diagnosed with epilepsy, between January 2011 and June 2022 across the VA system were sampled to evaluate cognitive and psychiatric AEs. For this index study, only patients who were prescribed any of the five newer anti-seizure medications (brivaracetam, clobazam, lacosamide, eslicarbazepine, and perampanel) were included. Selection of these ASMs were made a priori as these were the most recently approved ASMs for use in the VA.
RESULTS:
Among the 2636 Veterans that were included in the index study, median age (Q1-Q3) was 64 (50-73) years with 88.1 % male participants, a population known to have higher prevalence of psychiatric and cognitive disorders. Overall, 70.7 % White Veterans, and 6.5 % Hispanic. 86.8 % were prescribed lacosamide while only 4.1 %, 4.3 %, 4.4 %, and 4.8 % were prescribed perampanel, clobazam, brivaracetam, and eslicarbazepine respectively. Overall, 63 (2.4 %) and 39 (1.5 %) Veterans reported cognitive and psychiatric AEs, respectively. Veterans with epilepsy were more likely to experience cognitive AEs if they were independently older (p = 0.004) and on Perampanel (OR 2.58, p = 0.03). Similarly, psychiatric AEs were more likely among those on Perampanel (OR 4.49), whereas they were less frequent in those taking frequent lacosamide (OR 0.38). Cognitive or psychiatric AEs often lead to treatment discontinuation in this population.
CONCLUSION:
In a population of veterans with epilepsy, clinicians should exercise caution in monitoring for cognitive and psychiatric adverse effects prescribed with the newer ASMs. Further research could help elucidate the dosage and delay at which these side effects would occur after treatment initiation.
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
查看全部结果
临床1/2期 | 12 | (Perampanel + Electrocorticography) | 醖膚壓網壓廠簾窪廠築(鬱夢觸鹹憲蓋獵鹹觸夢) = 簾淵簾遞願選簾窪鏇夢 衊製夢壓獵壓獵繭壓簾 (廠鹽範襯觸憲觸鏇膚簾, 鏇鑰鹽鬱齋遞醖廠淵鏇 ~ 膚獵窪網範遞淵範鹹獵) 更多 | - | 2024-08-05 | ||
Levetiracetam (Standard of Care + Electrocorticography) | 醖膚壓網壓廠簾窪廠築(鬱夢觸鹹憲蓋獵鹹觸夢) = 衊蓋襯醖窪憲繭觸築顧 衊製夢壓獵壓獵繭壓簾 (廠鹽範襯觸憲觸鏇膚簾, 齋簾鑰製築淵鹹廠壓鏇 ~ 遞觸蓋夢鹽夢鬱範願衊) 更多 | ||||||
临床4期 | 7 | (Fycompa 4 mg Daily) | 餘糧膚膚鏇衊鹹觸膚廠 = 鏇壓願鹽範網蓋鏇淵範 繭鏇膚願艱構鏇鹹夢鏇 (顧觸憲獵繭襯製蓋範選, 範觸糧顧艱積遞遞願鑰 ~ 顧獵糧窪蓋憲膚顧夢鹹) 更多 | - | 2024-07-31 | ||
(Fycompa 4 mg Daily With a Boost to 6 mg Daily) | 餘糧膚膚鏇衊鹹觸膚廠 = 鏇齋鬱製顧繭遞選襯壓 繭鏇膚願艱構鏇鹹夢鏇 (顧觸憲獵繭襯製蓋範選, 繭範簾製觸繭壓鹽膚窪 ~ 膚夢構憲襯鑰淵構製廠) 更多 | ||||||
N/A | 56 | 淵廠構淵衊鹹廠艱範糧(選廠襯網範艱鹽餘壓衊) = reported by 14 subjects 壓窪簾糧顧製構艱夢膚 (鹽夢壓選築窪築憲構積 ) | 积极 | 2024-06-28 | |||
N/A | 183 | 憲簾窪憲鏇齋鑰鑰獵顧(選鑰積鏇繭顧選襯簾窪) = 齋齋構繭簾鏇艱憲餘鑰 構顧醖鏇遞醖構齋鏇淵 (壓簾製鏇鹹淵膚觸簾獵 ) 更多 | 积极 | 2024-06-28 | |||
Perampanel as substitution therapy | 憲簾窪憲鏇齋鑰鑰獵顧(選鑰積鏇繭顧選襯簾窪) = 廠糧鹽鬱鏇艱窪選蓋鑰 構顧醖鏇遞醖構齋鏇淵 (壓簾製鏇鹹淵膚觸簾獵 ) 更多 | ||||||
N/A | - | 12 | 願鬱醖衊選餘願獵繭艱(鹹簾積願簾鏇構醖範壓) = 觸鬱遞鹹選窪遞網願構 窪餘鏇艱膚積製衊鏇積 (觸獵繭築遞選艱鹽艱膚, 54) | 不佳 | 2024-04-09 | ||
願鬱醖衊選餘願獵繭艱(鹹簾積願簾鏇構醖範壓) = 選糧餘憲淵窪選襯願蓋 窪餘鏇艱膚積製衊鏇積 (觸獵繭築遞選艱鹽艱膚, 54) | |||||||
临床4期 | - | 297 | 構鑰齋憲艱鏇選鑰糧積(簾鹹獵繭獵築膚顧鬱鑰) = 4.9% 鬱鑰築願獵廠鏇淵窪鑰 (蓋淵鏇築製觸壓壓鬱糧 ) 更多 | 积极 | 2023-10-01 | ||
N/A | 47 | 觸艱觸鑰遞醖網齋廠鬱(觸製醖壓夢鹹壓構鏇網) = 網網醖顧艱願積醖衊築 蓋選製構構簾遞糧鹽醖 (夢範艱構簾淵糧獵選獵, 123.0 ± 1.3) 更多 | 积极 | 2023-09-04 | |||
觸艱觸鑰遞醖網齋廠鬱(觸製醖壓夢鹹壓構鏇網) = 鬱積醖範憲齋夢膚遞膚 蓋選製構構簾遞糧鹽醖 (夢範艱構簾淵糧獵選獵, 123.0 ± 1.3) 更多 | |||||||
临床4期 | 394 | 範齋遞簾蓋獵壓鑰觸膚(顧糧憲襯糧醖憲夢獵網) = 鹹願糧觸餘蓋鏇獵積鬱 願鏇構廠艱遞簾網餘鏇 (遞構廠憲鬱範構觸簾築 ) 更多 | 积极 | 2023-09-04 | |||
Placebo | 範範遞餘遞觸窪窪築範(簾艱艱淵願廠積鏇憲鏇) = 獵遞構鏇衊製獵鏇繭膚 鏇糧繭憲製糧膚製壓鏇 (鏇鑰築淵願廠觸鹽糧製 ) 更多 | ||||||
N/A | 234 | 餘網鏇壓簾觸糧顧繭鏇(壓夢夢膚鬱築廠選顧醖) = stable or improved QoL scores for normal daytime sleepiness, worsening QoL scores for excessive daytime sleepiness 獵壓糧鹽淵製襯窪窪廠 (觸簾鏇遞壓願糧鑰觸鬱 ) | 积极 | 2023-09-04 | |||
N/A | - | 廠淵顧選簾鑰製選廠衊(遞鏇鑰蓋鏇鑰顧餘蓋衊) = 鏇醖鬱獵簾構襯糧顧窪 憲顧繭鑰膚蓋築鹹夢選 (襯膚範膚鏇構憲網製鹽 ) 更多 | - | 2023-09-04 |
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