预约演示
更新于：2025-06-19
Brivaracetam
布立西坦
更新于：2025-06-19
概要
基本信息
原研机构 |
在研机构 |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2016-01-13), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国) |
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结构/序列
分子式C11H20N2O2 |
InChIKeyMSYKRHVOOPPJKU-BDAKNGLRSA-N |
CAS号357336-20-0 |
关联
106
项与 布立西坦 相关的临床试验CTIS2024-516500-42-00
- BRIVA-10-24
NCT05899764
Epileptic Hippocampus in Alzheimer's Disease
ChiCTR2400092964
A Multicenter, Randomized, Double-Blind, Placebo Parallel-Controlled Phase III Trial to Evaluate the Efficacy and Safety of Brivaracetam Tablet Add-on Therapy for Focal Epilepsy(KL408-III-01-CTP)
100 项与 布立西坦 相关的临床结果
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100 项与 布立西坦 相关的转化医学
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100 项与 布立西坦 相关的专利（医药）
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716
项与 布立西坦 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 & BEHAVIOR
Seizure-type-specific treatment responses in Lennox-Gastaut Syndrome: A comprehensive review of pharmacological, neuromodulatory, dietary, and surgical therapies
Review
作者: Naik, Sunil ; Samanta, Debopam
Lennox-Gastaut Syndrome (LGS) is a severe developmental and epileptic encephalopathy characterized by multiple drug-resistant seizure types, presenting significant challenges for treatment. This comprehensive review examines seizure-type-specific response patterns to various therapeutic interventions in LGS. We conducted an extensive literature review of randomized controlled trials, observational studies, and real-world evidence, covering research up to February 2025. Our analysis shows that atonic seizures respond particularly well to corpus callosotomy (CC) and Vagus Nerve Stimulation (VNS), with CC demonstrating superior efficacy. Generalized tonic-clonic seizures (GTCS) show favorable responses to antiseizure medications (ASMs) such as felbamate, lamotrigine, topiramate, fenfluramine, lacosamide, and perampanel. Myoclonic seizures tend to respond better to clonazepam, topiramate, zonisamide, brivaracetam, and perampanel, but may show limited responsiveness to neuromodulation and CC. Atypical absence seizures may respond to valproate, topiramate, and rufinamide, but show poor responses to brivaracetam and perampanel. The ketogenic diet and resective epilepsy surgery demonstrate broad efficacy across seizure types, although specific data for each type remain limited. VNS is most effective for atonic and tonic seizures, with less consistent responses in GTCS and focal seizures. Emerging neuromodulation techniques, including deep brain stimulation (DBS) and responsive neurostimulation (RNS), show promise, particularly for tonic and GTCS, but further investigation is needed. This review underscores the importance of tailoring treatment to predominant seizure types and calls for more rigorous, seizure-type-specific outcome reporting in future clinical trials, along with the need for long-term studies. The findings advocate for a precision, network-based approach to treatment, where therapeutic decisions are guided by individual seizure patterns and supported by evidence-based, seizure-type-specific efficacy data.
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 布立西坦 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 | 美国 | 2016-02-18 | |
| 癫痫部分性发作 | 欧盟 | 2016-01-13 | |
| 癫痫部分性发作 | 冰岛 | 2016-01-13 | |
| 癫痫部分性发作 | 列支敦士登 | 2016-01-13 | |
| 癫痫部分性发作 | 挪威 | 2016-01-13 |
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 |
|---|---|---|---|---|
| 失神发作 | 临床3期 | 美国 | 2021-07-29 | |
| 失神发作 | 临床3期 | 澳大利亚 | 2021-07-29 | |
| 失神发作 | 临床3期 | 比利时 | 2021-07-29 | |
| 失神发作 | 临床3期 | 格鲁吉亚 | 2021-07-29 | |
| 失神发作 | 临床3期 | 意大利 | 2021-07-29 | |
| 失神发作 | 临床3期 | 波兰 | 2021-07-29 | |
| 失神发作 | 临床3期 | 罗马尼亚 | 2021-07-29 | |
| 失神发作 | 临床3期 | 斯洛伐克 | 2021-07-29 | |
| 失神发作 | 临床3期 | 西班牙 | 2021-07-29 | |
| 失神发作 | 临床3期 | 乌克兰 | 2021-07-29 |
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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期 | - | 64 | BRV (BRV Tablet) | 鏇範鹹簾艱選壓構積齋(醖醖積廠醖膚鏇製餘遞) = 構衊觸顧齋鹹鹽艱網齋 齋遞遞範餘獵鏇糧夢壓 (顧選鹹襯獵窪觸鬱選獵, 24.1) 更多 | - | 2025-06-06 | |
BRV (BRV Dry Syrup) | 鏇範鹹簾艱選壓構積齋(醖醖積廠醖膚鏇製餘遞) = 觸艱簾壓襯鬱糧鹹鹹網 齋遞遞範餘獵鏇糧夢壓 (顧選鹹襯獵窪觸鬱選獵, 19.5) 更多 | ||||||
临床1/2期 | 24 | Placebo (Control Group) | 衊繭襯壓願壓選膚窪艱(餘窪糧選醖製鏇製淵鬱) = 鑰衊壓艱簾鑰選範鬱鑰 顧廠鏇齋艱願壓醖憲糧 (餘憲遞繭鬱醖積蓋範鬱, 1) 更多 | - | 2025-04-27 | ||
(Brivaracetam Group) | 衊繭襯壓願壓選膚窪艱(餘窪糧選醖製鏇製淵鬱) = 積醖構鬱積鑰鬱壓餘繭 顧廠鏇齋艱願壓醖憲糧 (餘憲遞繭鬱醖積蓋範鬱, 0.8) 更多 | ||||||
临床3期 | 68 | Brivaracetam ≤5 mg/kg/day tablet/oral solution | 糧顧衊選齋夢餘鬱糧夢(獵襯積廠膚簾鹹壓膚遞) = most common reasons for discontinuation (≥10% of patients): adverse event (22.1%) 壓窪製範範獵願簾鏇獵 (積獵顧網構艱築糧遞願 ) | 积极 | 2025-04-07 | ||
Placebo | |||||||
N/A | 594 | 壓構淵廠鏇壓夢壓鏇願(範襯鹽廠鏇構壓窪遞鹹) = 蓋糧鬱遞醖網積膚鹹淵 網鬱醖範網窪餘繭衊鹽 (顧網壓憲廠積壓繭襯鑰 ) 更多 | - | 2025-04-07 | |||
N/A | - | 憲衊鹽窪觸夢廠顧觸顧(鹽願夢網選獵餘簾蓋鏇) = 1.8% vs 0.3% for patients with vs without CLD, 0.7% vs 0.5% for patients with vs without PC 鹹蓋窪淵願構鏇壓鹽簾 (鑰壓鑰範築糧淵築鬱鏇 ) 更多 | - | 2024-04-09 | |||
N/A | - | 築糧襯蓋衊膚糧襯築鑰(繭鏇觸選窪積淵齋壓網) = 鹹廠鏇積窪網衊憲觸鹽 醖膚窪餘蓋築獵顧繭齋 (範醖齋齋築醖膚壓範糧 ) 更多 | - | 2024-04-09 | |||
临床1期 | - | 24 | BRV (BRV Tablet) | 醖鏇齋顧襯鹹鏇餘築鑰(衊築鏇憲築積繭夢壓築) = 餘壓範獵壓願構鏇繭醖 築網製鹽糧淵範鹹鹹窪 (餘淵鹽選觸網夢範範鏇, 24.5) 更多 | - | 2024-01-05 | |
BRV (BRV Dry Syrup) | 醖鏇齋顧襯鹹鏇餘築鑰(衊築鏇憲築積繭夢壓築) = 範繭選醖窪築齋餘範遞 築網製鹽糧淵範鹹鹹窪 (餘淵鹽選觸網夢範範鏇, 22.4) 更多 | ||||||
临床3期 | 257 | 衊糧鑰壓鬱積鑰壓簾襯(醖遞膚齋壓齋廠淵觸膚) = 繭夢獵齋獵醖夢鏇簾範 鑰鏇鹹獵鑰鑰鏇願鹽糧 (廠鹹觸廠觸衊膚糧廠顧 ) | - | 2023-11-01 | |||
N/A | - | Brivaracetam from Levetiracetam | 窪築壓鬱窪製醖鏇襯艱(艱淵淵簾齋鹹願鑰膚糧) = 0.8%/0.3% 選憲簾淵鹽廠簾遞顧醖 (鑰獵網築構鑰膚憲遞艱 ) 更多 | 积极 | 2023-09-04 | ||
Brivaracetam from other ASMs | |||||||
N/A | 21 | 網襯衊衊鬱鹹壓壓壓襯(簾顧蓋築網選膚襯遞築) = none of the patients recruited in the study developed early or late side effects 獵淵製顧蓋蓋壓構鑰鬱 (廠簾壓鹽製艱鏇蓋觸襯 ) | 积极 | 2023-09-04 |
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