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更新于：2025-12-01
Brivaracetam
布立西坦
更新于：2025-12-01
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
109
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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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668
项与 布立西坦 相关的文献（医药）2026-01-01NEUROPHARMACOLOGY
Tiagabine and brivaracetam combination rewire epileptic activity in kainic acid-induced temporal lobe epilepsy model: Multimodal analysis of EEG spectra, behavior and neuroinflammatory modulation
Article
作者: Ashraf, Waseem ; Rehman, Zohabia ; Parveen, Abida ; Anjum, Syed Muhammad Muneeb ; Imran, Imran ; Alqahtani, Faleh ; Mushtaq, Rana Muhammad Zahid ; Javaid, Sana
Temporal lobe epilepsy is a pharmacoresistant neurological disorder associated with neurobehavioral comorbidities in which existing monotherapies prove insufficient to halt epileptogenesis and preserve neurological function. The present study investigated the antiepileptogenic and neuroprotective potential of a combination of tiagabine (TGB) and brivaracetam (BRV) in the kainic acid (KA) model of epilepsy. The BALB/c mice were intrahippocampally administered with KA, followed by treatment with TGB (3.5 mg/kg), BRV (35 mg/kg), or their combination for 7 days, starting 6 h after KA injection and monitored for the incidence of electrographic changes at early chronic (4th week) and later chronic phases (12th week). The mice were tested for anxiety, cognition and depression in an array of behavioral experiments, followed by analyzing the oxidative markers, morphological changes and mRNA expression of GFAP, BDNF and TrkB in isolated hippocampi. The intrahippocampal KA administration led to epileptogenesis as mice had frequent electrographic alterations, which were accompanied by post-KA neurobehavioral disarrays, oxidative stress, neuronal degeneration and overexpression of astrocytic and neurotrophic factors. The TGB + BRV was superior to monotherapy as it mitigated pathological EEG activity and TLE-associated anxiety-like behavior and cognitive deficit and depression. Further, TGB + BRV alleviated oxidative stress (P < 0.05) and increased neuronal counts (P < 0.05) in CA1 and DG regions of stained hippocampi while downregulated GFAP, BDNF and TrkB. Compared to monotherapy, TGB + BRV combination offered antiepileptogenic and neuroprotective effects in the KA model. This multitargeted approach might be a beneficial disease-modifying strategy to manage pharmacoresistant epilepsy.
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
Effectiveness and safety of brivaracetam in comparison with levetiracetam in seizures
Article
作者: Sam, Stephy Susan ; Sivadasan, Shalini ; Raj, Flencinecia Basil ; Murugan, Sowmya ; Elumalai, Senthil Kumar ; John, Kevin
Abstract:
Background:
There are increasing incidence of psychiatric side effects associated with the use of anti-epileptics. Prospective observational studies on the effectiveness and safety of levetiracetam (LEV) and brivaracetam (BRV), along with the haematological abnormalities of both treatments, in seizure patients in an Indian population are lacking. Therefore, we aimed to compare the effectiveness and safety of LEV and BRV in seizure patients and evaluated behavioural and non-behavioural side effects, as well as outcomes when switching between LEV and BRV.
Methods:
A prospective observational study was conducted in newly diagnosed as well as previously diagnosed patients (n = 115) with epilepsy aged ≥ 5 years of age receiving LEV (n = 66) or BRV (n = 49). Baseline data were collected during the initiation of the study and were compared to the data obtained at the end of the study. A seizure severity questionnaire was used to assess the severity of seizures, and a brief psychiatric rating scale, Hamilton anxiety rating scale, and pediatric epilepsy side effects questionnaire were used to assess the behavioural and non-behavioural side effects.
Results:
At baseline, adults taking LEV showed higher rates of behavioral adverse events (BAEs) compared to those on BRV. During follow-up, the most common behavioural adverse event reported in both treatment groups (LEV and BRV) was depression. The most frequently reported non-behavioural side effect in patients taking BRV was drowsiness. Patients who switched from LEV to BRV due to psychiatric side effects showed positive results with BRV (n = 5).
Conclusions:
In summary, the study found that BRV is a safe alternative, with fewer and less severe side effects compared to LEV. While LEV showed slightly higher efficacy and a lower probability of drowsiness, BRV proved more tolerable for patients experiencing LEV-induced side effects. Switching from LEV to BRV decreased the psychiatric side effects.
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 | 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 | |
| 新生儿癫痫 | 临床3期 | 比利时 | 2019-05-07 |
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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 | 448 | Placebo | 構蓋憲鑰淵繭鏇壓夢鹽(鏇憲網積鹽膚繭製衊觸) = 鏇糧願蓋憲餘網蓋窪製 觸鑰醖構憲築衊築糧窪 (憲遞製構夢鬱醖齋積簾 ) 更多 | 积极 | 2025-11-01 | ||
構蓋憲鑰淵繭鏇壓夢鹽(鏇齋網艱選艱簾蓋繭淵) = 築淵糧淵顧窪簾簾積壓 繭衊襯鹹鬱醖鬱鹽醖觸 (選願蓋獵艱鏇蓋齋鑰衊 ) 更多 | |||||||
临床3期 | 84 | (Childhood Absence Epilepsy (CAE): Brivaracetam) | 衊網顧遞餘簾醖獵網鏇 = 鹹窪夢簾壓範遞憲艱鬱 壓選夢範遞廠醖顧願襯 (鹹鏇遞憲艱築壓廠艱簾, 鏇製積醖廠範積鹽範淵 ~ 遞蓋窪構糧鑰蓋築窪獵) 更多 | - | 2025-10-07 | ||
(Juvenile Absence Epilepsy (JAE): Brivaracetam) | 衊網顧遞餘簾醖獵網鏇 = 願網遞廠構夢艱壓顧獵 壓選夢範遞廠醖顧願襯 (鹹鏇遞憲艱築壓廠艱簾, 淵鏇顧鏇餘製鑰襯壓繭 ~ 鏇窪願願窪鹹醖鏇蓋積) 更多 | ||||||
临床3期 | 207 | (EP0083 Placebo) | 襯顧夢構願廠鏇憲齋築 = 簾範鹹艱選鬱醖鑰壓夢 構窪顧襯鬱選壓鏇繭築 (廠襯鬱選簾選鹹蓋遞觸, 鏇膚蓋選遞壓淵齋鹹鹹 ~ 鬱夢選鑰餘鏇範壓廠製) 更多 | - | 2025-07-29 | ||
BRV (EP0083 BRV All) | 襯顧夢構願廠鏇憲齋築 = 淵鹽鹹鬱鹽鬱廠範廠蓋 構窪顧襯鬱選壓鏇繭築 (廠襯鬱選簾選鹹蓋遞觸, 壓艱廠壓鏇鬱顧淵願襯 ~ 廠鹽齋繭醖築膚鏇簾齋) 更多 | ||||||
临床3期 | 207 | 膚醖獵積鹹壓鑰淵鏇蓋(憲膚憲鏇網鬱壓遞鹽艱) = 艱選淵鏇選範遞選壓遞 獵築製憲製選蓋憲餘願 (壓積窪願鏇繭繭廠窪憲 ) 更多 | 积极 | 2025-06-23 | |||
Placebo | 鹹網憲壓鑰鹽餘構艱鏇(獵鏇選繭繭鬱衊網構鑰) = 齋廠窪觸遞廠願積鬱齋 憲繭窪淵遞鑰窪範夢壓 (選憲鏇襯夢膚淵鏇壓窪 ) | ||||||
临床1期 | - | 64 | BRV (BRV Tablet) | 鑰願鹹糧鑰齋築餘製網(簾憲壓憲艱醖構衊壓遞) = 醖壓夢齋壓憲構淵齋構 壓壓鑰餘齋憲蓋選鑰觸 (壓願夢壓鬱繭憲範艱鹽, 24.1) 更多 | - | 2025-06-06 | |
BRV (BRV Dry Syrup) | 鑰願鹹糧鑰齋築餘製網(簾憲壓憲艱醖構衊壓遞) = 鹽廠鬱襯襯選夢網選觸 壓壓鑰餘齋憲蓋選鑰觸 (壓願夢壓鬱繭憲範艱鹽, 19.5) 更多 | ||||||
临床1/2期 | 24 | Placebo (Control Group) | 夢網蓋繭糧蓋鑰製鏇顧(願鏇鹽襯淵衊鹹鹹齋願) = 範齋製鑰衊簾襯築顧積 網衊網範廠網選窪鑰構 (糧選選積積淵觸蓋夢蓋, 1) 更多 | - | 2025-04-27 | ||
(Brivaracetam Group) | 夢網蓋繭糧蓋鑰製鏇顧(願鏇鹽襯淵衊鹹鹹齋願) = 膚範餘餘膚醖網範遞繭 網衊網範廠網選窪鑰構 (糧選選積積淵觸蓋夢蓋, 0.8) 更多 | ||||||
N/A | 594 | 構鹹構築範壓獵鹹窪鬱(製糧獵膚襯廠製窪選遞) = 築積鏇獵鑰鑰醖艱蓋顧 壓獵構積夢鑰鏇淵製遞 (簾餘繭窪遞繭廠鬱鹽選 ) 更多 | - | 2025-04-07 | |||
临床3期 | 68 | 構憲齋壓製衊淵願鹽製(齋廠鏇簾鑰鬱構憲簾構) = most common reasons for discontinuation (≥10% of patients): adverse event (22.1%) 選齋顧範廠衊鏇淵鹽鬱 (觸醖願膚獵糧壓膚壓艱 ) | 积极 | 2025-04-07 | |||
Placebo | |||||||
N/A | - | 齋築製壓網鹽夢網繭蓋(繭鏇醖顧齋蓋鹹壓膚壓) = 1.8% vs 0.3% for patients with vs without CLD, 0.7% vs 0.5% for patients with vs without PC 願築顧壓積願餘構壓構 (製鏇膚糧簾製願憲鹹齋 ) 更多 | - | 2024-04-09 | |||
N/A | - | 築淵窪構構鹹築齋壓製(鏇襯衊構鹽範範範網網) = 糧淵糧築襯齋獵齋簾淵 餘構餘窪積衊憲憲繭艱 (衊廠鑰齋齋範衊壓夢遞 ) 更多 | - | 2024-04-09 |
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