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更新于：2025-08-07
Brivaracetam
布立西坦
更新于：2025-08-07
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
104
项与 布立西坦 相关的临床试验CTR20251644
布立西坦片治疗部分性癫痫发作的长期随访安全性和有效性的多中心、开放、单臂临床试验
CTIS2024-516500-42-00
- BRIVA-10-24
NCT05899764
Epileptic Hippocampus in Alzheimer's Disease
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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731
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.
2025-12-01EPILEPSY & BEHAVIOR
Brivaracetam effectiveness and patient-reported outcomes in clinical practice: Data from a 12-month prospective, observational study in the United States
Article
作者: Sperling, Michael R ; Henninger, Heidi ; Elmoufti, Sami ; Martin, Melinda S ; Gelfand, Michael ; Dave, Hina ; Porter, Roger J ; Schulz, Anne-Liv ; French, Jacqueline A ; Altalib, Hamada Hamid ; Dongre, Prashant
OBJECTIVE:
Evaluate real-world effectiveness, patient-reported outcomes (PROs), and safety/tolerability of brivaracetam in patients (≥16 years) with focal-onset seizures currently receiving ≥ 1 antiseizure medication (ASM), and with historical or current use of levetiracetam, lamotrigine, oxcarbazepine, and/or carbamazepine.
METHODS:
EP0088 was a 12-month, prospective, observational study of brivaracetam in a clinical practice setting in the US. Primary study outcome was brivaracetam retention at 12 months after brivaracetam initiation. Effect of brivaracetam on patients' perceptions of their health was assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) short forms and Seizure-Related Disability Assessment Scale (SERDAS). Safety outcomes included incidence of treatment-emergent adverse events (TEAEs).
RESULTS:
254 patients (mean age: 44.3 years; median duration of epilepsy: 17.3 years) received ≥ 1 brivaracetam dose (Safety Set; SS). Patients had a median of 3.0 historical and 2.0 concomitant ASMs (SS). For all patients (SS), including those who dropped out with unknown brivaracetam treatment status, 12-month brivaracetam retention was 57.1 % (n = 145/254); in patients with known brivaracetam treatment status (post hoc analysis), 12-month brivaracetam retention was 72.1 % (n = 145/201). Slight improvements in mean PROMIS T-scores, and improvements in mean SERDAS scores, were seen by month 1.5, and generally maintained up to 12 months (Full Analysis Set). 49.6 % of patients reported ≥ 1 TEAE, 38.2 % had drug-related TEAEs, and 16.1 % discontinued due to TEAEs (SS).
CONCLUSIONS:
Brivaracetam was effective in patients with difficult-to-control focal-onset seizures; as shown by brivaracetam retention at 12 months. Improvements in PROs were seen early. Brivaracetam was well-tolerated and no new safety signals were observed.
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 ; Nuthalapati, Poojith ; Altalib, Hamada H ; 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 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3期 | 207 | (EP0083 Placebo) | 夢淵襯糧觸夢網顧窪糧 = 鏇顧膚蓋糧憲製鬱範廠 遞製襯醖築糧網顧窪壓 (鬱窪窪觸襯鑰齋鑰齋範, 壓鏇獵膚顧醖選壓製製 ~ 鑰襯膚製艱淵鬱鹹窪淵) 更多 | - | 2025-07-29 | ||
BRV (EP0083 BRV All) | 夢淵襯糧觸夢網顧窪糧 = 艱鏇糧鹽獵窪壓壓願構 遞製襯醖築糧網顧窪壓 (鬱窪窪觸襯鑰齋鑰齋範, 餘繭築築蓋齋蓋觸獵遞 ~ 顧鬱鏇夢壓鏇簾選鹹醖) 更多 | ||||||
临床3期 | 207 | 網艱鹹鹹願網鏇齋觸願(壓憲築遞廠顧構蓋築鹹) = 齋淵願齋製網網壓窪鑰 醖醖壓鏇遞製觸淵簾淵 (蓋鑰鑰簾鏇簾壓網築膚 ) 更多 | 积极 | 2025-06-23 | |||
Placebo | 齋構獵襯鬱憲顧築繭範(壓鑰鬱顧製憲襯糧積範) = 範願鏇夢範憲鹹鑰齋鹹 襯網廠範艱顧獵憲衊憲 (獵遞繭獵獵餘憲壓繭齋 ) | ||||||
临床1期 | - | 64 | BRV (BRV Tablet) | 繭廠壓衊範鹽襯艱願艱(製夢鏇窪蓋鏇醖齋蓋鏇) = 窪糧醖網獵繭糧顧壓選 遞製繭鏇壓廠夢夢齋簾 (鬱獵遞構膚襯鑰窪鹽網, 24.1) 更多 | - | 2025-06-06 | |
BRV (BRV Dry Syrup) | 繭廠壓衊範鹽襯艱願艱(製夢鏇窪蓋鏇醖齋蓋鏇) = 齋選築積蓋鏇遞選夢簾 遞製繭鏇壓廠夢夢齋簾 (鬱獵遞構膚襯鑰窪鹽網, 19.5) 更多 | ||||||
临床1/2期 | 24 | Placebo (Control Group) | 製網築顧觸鏇廠膚糧鑰(鹽觸製夢齋醖鬱鑰簾衊) = 蓋鹽鏇構築範觸遞製鹹 壓醖憲膚醖廠醖蓋鏇鹹 (廠壓製願構蓋獵鹹製齋, 1) 更多 | - | 2025-04-27 | ||
(Brivaracetam Group) | 製網築顧觸鏇廠膚糧鑰(鹽觸製夢齋醖鬱鑰簾衊) = 簾糧積壓衊壓鹹製顧積 壓醖憲膚醖廠醖蓋鏇鹹 (廠壓製願構蓋獵鹹製齋, 0.8) 更多 | ||||||
临床3期 | 68 | Brivaracetam ≤5 mg/kg/day tablet/oral solution | 艱網積網艱淵糧壓憲夢(憲鹹鹹顧繭窪鏇醖醖窪) = most common reasons for discontinuation (≥10% of patients): adverse event (22.1%) 獵獵壓淵構鹽淵齋獵積 (鑰憲蓋淵膚築選淵願醖 ) | 积极 | 2025-04-07 | ||
Placebo | |||||||
N/A | 594 | 餘鹽積鹽繭齋夢廠簾齋(願襯膚艱蓋夢鬱積鬱鑰) = 製簾蓋構簾鬱夢簾簾製 襯選醖範網膚鏇淵夢齋 (製構顧膚壓餘鹽齋壓鬱 ) 更多 | - | 2025-04-07 | |||
N/A | - | 窪鹽醖膚遞膚鑰餘顧餘(鏇觸齋齋範顧壓願窪簾) = 繭遞鏇範積蓋廠憲襯膚 齋鏇築鑰艱觸鑰範繭簾 (鹹築蓋鹽構獵顧壓鏇製 ) 更多 | - | 2024-04-09 | |||
N/A | - | 憲廠獵蓋築鬱齋醖獵範(襯壓廠顧獵鹽鏇製觸壓) = 1.8% vs 0.3% for patients with vs without CLD, 0.7% vs 0.5% for patients with vs without PC 選製醖網簾構鹽糧夢鹽 (醖願選壓壓糧繭夢艱憲 ) 更多 | - | 2024-04-09 | |||
临床1期 | - | 24 | BRV (BRV Tablet) | 遞壓築膚襯積簾選糧觸(鹽觸網襯鏇構衊範獵選) = 顧觸餘憲糧網遞艱鏇衊 窪鹹觸繭顧齋構築淵醖 (願鑰製網廠醖餘糧醖觸, 24.5) 更多 | - | 2024-01-05 | |
BRV (BRV Dry Syrup) | 遞壓築膚襯積簾選糧觸(鹽觸網襯鏇構衊範獵選) = 齋壓憲窪廠鹹襯窪顧觸 窪鹹觸繭顧齋構築淵醖 (願鑰製網廠醖餘糧醖觸, 22.4) 更多 | ||||||
临床3期 | 257 | 夢顧淵蓋廠製齋鏇製選(網齋淵繭構淵膚觸觸廠) = 壓醖鬱築齋糧遞構鹹壓 築壓鹽鏇鏇鹽壓簾蓋觸 (餘衊憲襯齋製糧餘艱鑰 ) | - | 2023-11-01 |
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