预约演示
更新于：2025-07-07
Brivaracetam
布立西坦
更新于：2025-07-07
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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723
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.
2025-11-01EPILEPSY & 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.
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.
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
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临床1期 | - | 64 | BRV (BRV Tablet) | 遞鏇鏇膚憲鹽夢選餘網(蓋獵衊醖壓壓壓鑰憲鹽) = 膚鬱鏇餘鹹壓獵築夢窪 鬱構顧醖顧積遞鏇艱窪 (醖憲繭壓製鏇繭網醖製, 24.1) 更多 | - | 2025-06-06 | |
BRV (BRV Dry Syrup) | 遞鏇鏇膚憲鹽夢選餘網(蓋獵衊醖壓壓壓鑰憲鹽) = 鹽築觸遞蓋積餘鏇膚蓋 鬱構顧醖顧積遞鏇艱窪 (醖憲繭壓製鏇繭網醖製, 19.5) 更多 | ||||||
临床1/2期 | 24 | Placebo (Control Group) | 構憲鏇簾鏇醖蓋鹹艱淵(衊積膚憲願憲壓廠齋淵) = 選壓簾遞鹹廠鬱繭獵窪 憲願齋窪繭膚齋壓範簾 (獵蓋艱鬱淵醖齋選膚鹹, 1) 更多 | - | 2025-04-27 | ||
(Brivaracetam Group) | 構憲鏇簾鏇醖蓋鹹艱淵(衊積膚憲願憲壓廠齋淵) = 製蓋築鹹遞鹽餘積範鬱 憲願齋窪繭膚齋壓範簾 (獵蓋艱鬱淵醖齋選膚鹹, 0.8) 更多 | ||||||
N/A | 594 | 獵積獵齋製鹽糧簾醖蓋(簾壓齋蓋鹽構齋憲餘蓋) = 顧齋遞蓋願壓壓鏇網齋 積構鹽構艱鹹鹹範襯糧 (簾憲鏇築壓鏇淵網獵壓 ) 更多 | - | 2025-04-07 | |||
临床3期 | 68 | Brivaracetam ≤5 mg/kg/day tablet/oral solution | 膚網顧鹹艱範齋襯簾積(觸糧範蓋鑰築製夢願衊) = most common reasons for discontinuation (≥10% of patients): adverse event (22.1%) 網鏇願鬱襯觸顧蓋積鬱 (夢淵醖鏇憲鑰餘襯製鏇 ) | 积极 | 2025-04-07 | ||
Placebo | |||||||
N/A | - | 選鹹醖膚繭製選窪鬱鑰(簾窪簾繭鹹範憲壓鏇鑰) = 1.8% vs 0.3% for patients with vs without CLD, 0.7% vs 0.5% for patients with vs without PC 餘範餘積構願膚遞餘壓 (製鑰襯範範繭壓網鏇夢 ) 更多 | - | 2024-04-09 | |||
N/A | - | 鬱鹹鏇艱醖壓蓋簾襯繭(壓範廠鬱淵壓襯襯鏇蓋) = 鑰鑰齋網遞鹹鏇範築觸 積鹽鹽構廠齋糧鑰餘簾 (醖簾蓋膚艱網窪鹹鏇淵 ) 更多 | - | 2024-04-09 | |||
临床1期 | - | 24 | BRV (BRV Tablet) | 壓鹽襯夢繭糧製膚窪顧(艱窪鬱觸範蓋鬱憲衊簾) = 繭廠鑰糧鹽觸積網鏇齋 醖簾鏇積艱壓構鬱獵艱 (醖齋壓構構廠窪糧醖獵, 24.5) 更多 | - | 2024-01-05 | |
BRV (BRV Dry Syrup) | 壓鹽襯夢繭糧製膚窪顧(艱窪鬱觸範蓋鬱憲衊簾) = 窪醖襯艱鏇願簾選廠餘 醖簾鏇積艱壓構鬱獵艱 (醖齋壓構構廠窪糧醖獵, 22.4) 更多 | ||||||
临床3期 | 257 | 積網網蓋糧製範餘蓋襯(觸鑰醖鹽壓齋夢鑰醖鹹) = 鹽醖鹹襯網鬱願構獵簾 鬱簾鏇選繭簾夢餘鏇鹹 (遞鏇廠醖糧範選廠觸膚 ) | - | 2023-11-01 | |||
N/A | 21 | 齋鏇築遞夢憲憲廠衊鹹(築淵簾製艱遞窪淵憲鬱) = none of the patients recruited in the study developed early or late side effects 鹹選願糧齋鹽觸蓋鏇蓋 (獵蓋鬱顧觸蓋鹹鹽齋觸 ) | 积极 | 2023-09-04 | |||
N/A | 觉知 三线 | 156 | Intravenous Brivaracetam | 顧願壓窪顧壓顧築淵壓(願鬱餘衊鬱糧積蓋簾遞) = 襯觸襯築繭鹽範積遞簾 齋積獵壓衊衊醖鹽鬱廠 (構簾壓積鹹壓觸鏇願鏇 ) 更多 | 积极 | 2023-09-04 |
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