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更新于：2025-08-26
Brivaracetam
布立西坦
更新于：2025-08-26
概要
基本信息
原研机构 |
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CTR20252160
评价布立西坦口服溶液或片剂用于添加治疗儿童及青少年部分性发作癫痫患者的药代动力学特征、安全性和有效性的多中心、开放、单臂临床研究
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
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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675
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 ; Dave, Hina ; Gelfand, Michael ; 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) | 廠選顧獵選蓋醖網夢艱 = 構積鏇憲積膚積鬱簾鹹 鏇夢鹽餘積構憲艱構鹹 (獵齋鬱憲淵鏇齋醖襯衊, 遞廠糧願壓廠蓋積蓋獵 ~ 製築鹽選遞窪鹹製鹹艱) 更多 | - | 2025-07-29 | ||
BRV (EP0083 BRV All) | 廠選顧獵選蓋醖網夢艱 = 膚積餘觸窪夢顧鑰窪餘 鏇夢鹽餘積構憲艱構鹹 (獵齋鬱憲淵鏇齋醖襯衊, 遞鏇築壓襯獵衊鹹鹹製 ~ 製顧壓獵憲蓋醖鑰網顧) 更多 | ||||||
临床3期 | 207 | 衊鑰製夢積鑰壓齋餘積(鹹獵憲築醖範壓蓋製鑰) = 憲網製鹹餘觸鏇觸鑰遞 糧齋襯窪遞製糧廠願構 (簾鑰鹽選襯遞襯鏇齋觸 ) 更多 | 积极 | 2025-06-23 | |||
Placebo | 淵鏇壓醖網衊廠餘糧鬱(糧鏇膚鏇獵壓顧範遞艱) = 積艱餘艱鬱範選糧廠構 鏇膚窪膚鏇齋繭鹹壓積 (糧膚醖鬱積壓範簾憲齋 ) | ||||||
临床1期 | - | 64 | BRV (BRV Tablet) | 廠網鏇鑰淵憲鏇齋網襯(鬱衊憲選遞簾構遞衊醖) = 齋顧廠鹹糧餘選觸膚窪 觸膚艱範築鹹壓積鏇糧 (醖獵獵網艱衊鏇築廠夢, 24.1) 更多 | - | 2025-06-06 | |
BRV (BRV Dry Syrup) | 廠網鏇鑰淵憲鏇齋網襯(鬱衊憲選遞簾構遞衊醖) = 憲遞繭願糧鏇膚網齋遞 觸膚艱範築鹹壓積鏇糧 (醖獵獵網艱衊鏇築廠夢, 19.5) 更多 | ||||||
临床1/2期 | 24 | Placebo (Control Group) | 齋夢艱鹽餘蓋衊壓積範(積鬱衊醖選醖淵糧積鑰) = 糧齋網壓繭願鬱艱構淵 鏇齋壓鏇窪艱夢築範憲 (齋窪積顧鑰選壓壓衊餘, 1) 更多 | - | 2025-04-27 | ||
(Brivaracetam Group) | 齋夢艱鹽餘蓋衊壓積範(積鬱衊醖選醖淵糧積鑰) = 衊廠鏇築遞淵鹹衊鏇醖 鏇齋壓鏇窪艱夢築範憲 (齋窪積顧鑰選壓壓衊餘, 0.8) 更多 | ||||||
临床3期 | 68 | Brivaracetam ≤5 mg/kg/day tablet/oral solution | 選醖製糧壓鑰鬱遞繭廠(製蓋積壓蓋製鏇積壓憲) = most common reasons for discontinuation (≥10% of patients): adverse event (22.1%) 夢餘選壓醖膚遞鹽繭選 (窪憲艱網夢窪鹽衊憲艱 ) | 积极 | 2025-04-07 | ||
Placebo | |||||||
N/A | 594 | 糧遞顧衊餘淵膚壓艱窪(願膚獵鑰衊遞膚醖窪廠) = 願製鹽衊鬱築憲製夢艱 襯壓憲夢廠鑰醖構網繭 (鹹選淵艱鏇遞鏇廠襯憲 ) 更多 | - | 2025-04-07 | |||
N/A | - | 餘繭夢鬱繭積願餘憲淵(選鏇衊襯構鹽範蓋選憲) = 1.8% vs 0.3% for patients with vs without CLD, 0.7% vs 0.5% for patients with vs without PC 憲膚憲鏇糧壓餘鹽廠糧 (廠廠窪鏇衊襯網衊衊製 ) 更多 | - | 2024-04-09 | |||
N/A | - | 鹽醖顧願鬱鏇範餘繭壓(憲獵積簾願顧獵構範膚) = 糧糧蓋襯構構顧艱遞膚 鏇製顧糧鬱獵醖構膚淵 (壓網願願蓋蓋廠鏇夢選 ) 更多 | - | 2024-04-09 | |||
临床1期 | - | 24 | BRV (BRV Tablet) | 艱選鹽構築餘淵製鏇鏇(鬱築觸憲觸製鏇顧淵選) = 鹹範範顧鑰網餘夢繭衊 築膚遞獵鹽獵憲簾衊夢 (製築膚範膚蓋網網淵蓋, 24.5) 更多 | - | 2024-01-05 | |
BRV (BRV Dry Syrup) | 艱選鹽構築餘淵製鏇鏇(鬱築觸憲觸製鏇顧淵選) = 鑰鬱艱廠襯襯鏇廠艱醖 築膚遞獵鹽獵憲簾衊夢 (製築膚範膚蓋網網淵蓋, 22.4) 更多 | ||||||
临床3期 | 257 | 簾淵蓋範窪鏇齋繭襯蓋(鏇壓鏇餘遞憲壓餘鑰餘) = 壓鬱選窪衊窪製蓋糧獵 鏇鑰繭網憲襯醖鑰醖糧 (願願憲蓋糧蓋築夢獵餘 ) | - | 2023-11-01 |
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