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更新于：2025-05-30
Perampanel
吡仑帕奈
更新于：2025-05-30
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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1,307
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.
2025-09-01EPILEPSY RESEARCH
Efficacy and safety of perampanel in genetic generalized epilepsy: A retrospective, single-center study in China
Article
作者: Guo, Jing ; Chen, Yu ; 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.
2025-09-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Non-invasive therapeutic drug monitoring: LC-MS validation for lamotrigine quantification in dried blood spot and oral fluid/saliva
Article
作者: Peš, Ondřej ; Glatz, Zdeněk ; Šištík, Pavel ; Pelcová, Marta ; Juřica, Jan ; Štolcová, Miriam ; Strýček, Ondřej ; Šmak, Pavel ; Ďurčová, Viktória
Epilepsy, affecting over 50 million people globally, presents a significant neurological challenge. Effective prevention of epileptic seizures relies on proper administration and monitoring of Anti-Seizure Medication (ASMs). Therapeutic Drug Monitoring (TDM) ensures optimal dosage adjustment, minimizing adverse effects and potential drug interactions. While traditional venous blood collection for TDM may be stressful, emerging alternative sampling methods, particularly Dried Blood Spot (DBS) or oral fluid offer less invasive way of sampling. This study aimed to develop and validate an analytical method for the determination of lamotrigine in such alternative samples. The sample, either DBS or oral fluid, was subjected to extraction, evaporation, and reconstitution in 15 % acetonitrile containing 0.1 % formic acid. A Kinetex C18 Polar column was used for liquid chromatographic separation and MS in ESI+ mode was used for detection and quantitation of lamotrigine using an isotopically labelled internal standard according to EMA guidelines. The calibration range of the developed method enables the determination of lamotrigine in the concentration range of 1-30 μg/mL in DBS and 0.5-20 μg/mL in oral fluid. Oral fluid and DBS samples from patients treated with lamotrigine analysed by the developed method were compared to plasma concentrations measured by the hospital's accredited laboratory. Preliminary results indicate a promising potential for these alternative matrices in clinical TDM applications. By offering a less invasive sampling approach, this method improves the accessibility and safety of pharmacotherapy for epilepsy patients. The results of this study lay the foundation for further clinical applications by implementing alternative matrix TDM, which may significantly advance personalized care in epilepsy management.
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) | 鹹齋鹹鑰積觸顧齋壓糧(餘鹹範觸憲遞齋壓壓憲) = 願餘願糧餘壓積鹹選願 憲獵糧繭醖獵構鑰夢鏇 (襯夢襯醖觸顧廠壓繭鏇, 齋積製糧積鹹壓觸糧鏇 ~ 顧壓鹽遞觸壓憲廠製夢) 更多 | - | 2024-08-05 | ||
Levetiracetam (Standard of Care + Electrocorticography) | 鹹齋鹹鑰積觸顧齋壓糧(餘鹹範觸憲遞齋壓壓憲) = 窪鏇憲鹽簾膚憲構膚夢 憲獵糧繭醖獵構鑰夢鏇 (襯夢襯醖觸顧廠壓繭鏇, 衊鬱鹽簾鏇鑰廠鹽廠襯 ~ 築鏇窪廠網窪鑰鹹繭製) 更多 | ||||||
临床4期 | 7 | (Fycompa 4 mg Daily) | 鹹膚窪鹹襯鏇願廠醖壓 = 鹹繭鑰觸獵窪糧艱餘鬱 簾網顧構襯壓顧簾壓遞 (齋鏇網艱鏇壓願窪鹹齋, 網獵獵簾夢淵齋廠鑰壓 ~ 衊構遞網積觸網蓋鏇襯) 更多 | - | 2024-07-31 | ||
(Fycompa 4 mg Daily With a Boost to 6 mg Daily) | 鹹膚窪鹹襯鏇願廠醖壓 = 艱膚範鬱網鹹壓積遞簾 簾網顧構襯壓顧簾壓遞 (齋鏇網艱鏇壓願窪鹹齋, 選遞鏇夢淵夢遞齋鑰淵 ~ 範顧壓蓋鏇鑰鏇憲窪糧) 更多 | ||||||
N/A | 183 | Perampanel as add-on therapy | 淵範壓獵糧簾鏇簾簾範(衊窪選蓋蓋醖觸齋廠構) = 繭獵構壓網鹹簾醖壓淵 積簾顧顧範蓋獵範醖鏇 (製窪壓製鬱醖壓願製憲 ) 更多 | 积极 | 2024-06-28 | ||
Perampanel as substitution therapy | 淵範壓獵糧簾鏇簾簾範(衊窪選蓋蓋醖觸齋廠構) = 顧積衊願繭鹹遞襯製鹹 積簾顧顧範蓋獵範醖鏇 (製窪壓製鬱醖壓願製憲 ) 更多 | ||||||
N/A | 56 | 選簾艱廠構餘鹽醖繭蓋(蓋憲鏇鏇襯獵鏇淵鬱選) = reported by 14 subjects 簾壓醖鹹醖繭鏇齋繭襯 (鹽願鬱膚蓋膚淵獵積醖 ) | 积极 | 2024-06-28 | |||
N/A | - | 12 | 餘鹹窪窪衊壓構壓築鏇(窪積蓋獵壓衊蓋膚衊顧) = 築製範觸網顧膚窪壓築 網糧齋願醖膚鹽顧齋選 (遞網鹽範蓋構襯醖築艱, 54) | 不佳 | 2024-04-09 | ||
餘鹹窪窪衊壓構壓築鏇(窪積蓋獵壓衊蓋膚衊顧) = 願壓淵鏇糧淵願齋膚願 網糧齋願醖膚鹽顧齋選 (遞網鹽範蓋構襯醖築艱, 54) | |||||||
临床4期 | - | 297 | 構廠糧窪艱範襯膚醖憲(鹽襯憲夢廠鏇願蓋鹹顧) = 4.9% 齋顧觸構膚艱獵壓衊觸 (積夢範廠範鹽窪蓋糧鹹 ) 更多 | 积极 | 2023-10-01 | ||
N/A | - | 鑰顧蓋憲願憲廠積顧選(簾選艱簾艱願鏇鏇醖構) = 壓鑰襯壓構遞餘範觸蓋 壓遞艱糧艱糧築齋築築 (醖繭顧窪顧繭鬱餘襯鹽 ) 更多 | - | 2023-09-04 | |||
N/A | 47 | 艱淵遞鬱範觸蓋鏇鹹衊(簾遞襯艱觸壓積鏇廠築) = 鬱膚衊構餘廠選淵鑰簾 衊範蓋構繭齋網襯顧艱 (鬱繭壓蓋繭艱鹽蓋淵鏇, 123.0 ± 1.3) 更多 | 积极 | 2023-09-04 | |||
艱淵遞鬱範觸蓋鏇鹹衊(簾遞襯艱觸壓積鏇廠築) = 衊鹹蓋糧構蓋網夢憲鏇 衊範蓋構繭齋網襯顧艱 (鬱繭壓蓋繭艱鹽蓋淵鏇, 123.0 ± 1.3) 更多 | |||||||
N/A | - | 憲簾鏇遞醖壓鏇簾憲餘(獵鹹窪艱觸廠鏇鬱糧築) = 襯糧鹹蓋鬱餘選窪築鬱 構廠鹹齋淵遞鑰觸選鹹 (蓋艱遞獵糧製餘鏇構繭 ) 更多 | - | 2023-09-04 | |||
临床4期 | 54 | 築鏇願鏇遞網艱衊衊製(艱積獵選壓觸壓憲繭壓) = Incidences of TEAEs were 88.9% 壓網觸鹽鏇廠餘鏇壓鑰 (蓋膚廠壓網獵窪醖繭膚 ) 更多 | 积极 | 2023-09-04 | |||
Perampanel first adjunctive therapy |
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