预约演示
更新于：2025-02-15
Brivaracetam
布立西坦
更新于：2025-02-15
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
107
项与 布立西坦 相关的临床试验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)
ChiCTR2400093210
A Study of the Efficacy and Safety of Brivaracetam Monotherapy in Adult and Adolescent Patients With Focal Epilepsy
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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681
项与 布立西坦 相关的文献（医药）2025-03-01EPILEPSY & BEHAVIOR
Cognitive and behavioral impact of antiseizure medications, neuromodulation, ketogenic diet, and surgery in Lennox-Gastaut syndrome: A comprehensive review
Review
作者: Samanta, Debopam
Lennox-Gastaut syndrome (LGS) is a severe developmental and epileptic encephalopathy marked by drug-resistant seizures and profound cognitive and behavioral impairments, with nearly 95% of individuals affected by moderate to severe intellectual disability. This review comprehensively explores the cognitive and behavioral impacts of current treatment options for LGS, including antiseizure medications (ASMs), neuromodulation strategies, the ketogenic diet, and surgical interventions. Given the limited availability of LGS-specific data for several ASMs, the evidence base is supplemented with findings from general epilepsy populations and individuals with epilepsy and intellectual disabilities. The evidence reveals that ASMs exert varied cognitive and behavioral effects in LGS. Medications such as valproate, lamotrigine, cannabidiol, fenfluramine, levetiracetam, brivaracetam, felbamate, and rufinamide generally support cognitive stability, while topiramate and zonisamide are associated with cognitive challenges. Behavioral outcomes also vary: stability is observed with valproate, lamotrigine, rufinamide, cannabidiol, and fenfluramine, whereas medications like levetiracetam, perampanel, brivaracetam, clobazam, and zonisamide can increase aggression or irritability. Nonpharmacological therapies, particularly when they reduce seizure frequency, typically provide greater cognitive and behavioral stability, with some offering improvement. Early intervention-especially through surgical options-appears most beneficial for preserving cognitive function. Additionally, therapies such as the ketogenic diet and neuromodulation may provide independent cognitive benefits beyond seizure control. This review emphasizes the importance of personalized treatment strategies, integrating cognitive and behavioral evaluations in therapy selection. Key components include baseline cognitive and behavioral assessments, followed by regular follow-up evaluations, particularly after therapy changes. Consideration of minimizing ASM polytherapy, careful evaluation of drug-drug interactions, pharmacogenomic implications, and the need for therapeutic drug monitoring in cases of cognitive adverse effects is essential. Future research should focus on developing assessment tools tailored to the unique needs of individuals with LGS, utilizing connectivity measures to assess intervention impacts, and advancing precision therapeutics to improve cognitive and behavioral outcomes.
2025-03-01EPILEPSY & BEHAVIOR
A multicenter Phase II randomized, placebo-controlled single-blind trial with the SV2A ligand seletracetam in photosensitive epilepsy patients
Article
作者: Masnou, Pascal ; Hirsch, Edouard ; Stockis, Armel ; Abou-Khalil, Bassel W ; French, Jacqueline A ; Kasteleijn-Nolst Trenité, Dorothee ; Löscher, Wolfgang ; Genton, Pierre
The objective of this study was to evaluate the effect of seletracetam (SEL), a potent modulator of synaptic vesicle glycoprotein 2A (SV2A), in patients with photoparoxysmal EEG response (PPR) to intermittent photic stimulation (IPS) as proof-of-principle of efficacy in patients with epilepsy. In this multicenter, single-blind Phase II study, adults with photosensitive epilepsy, with/without concomitant antiseizure medication therapy, underwent IPS under 3 eye conditions (at eye closure, eyes closed and eyes open) after a single oral dose of placebo (day - 1) or SEL (day 1; 0.5, 1, 2, 4, 10, or 20 mg). Complete suppression was a standardized photosensitivity range reduction to 0 over ≥ 1 time points for all eye conditions. Partial suppression was a ≥ 3-point reduction over ≥ 3 testing times vs the same time points on day - 1 in ≥ 1 eye condition. In addition, pharmacokinetics and safety were assessed. Of 27 evaluable patients, 9 reentered to receive a 2nd dosing 1-6 months later, providing a total of 36 individual exposures. At all doses administered - even the lowest -, several subjects reached a complete abolishment of PPR, with a rapid onset of effect. Overall, complete abolishment of PPR was obtained in 40-71 % of the patients; the effect increasing with the dose. In terms of effective doses to suppress PPR, SEL was at least 1,500 times more potent than levetiracetam and 10-20 times more potent than brivaracetam. Adverse events of SEL, including dizziness and somnolence, were mild to moderate. Pharmacokinetics of SEL demonstrated rapid absorption and a linear dose:plasma level relationship. This proof-of-principle study demonstrates that - based on our own experience - SEL is the most potent compound ever tested in the photosensitivity model.
2025-02-28Clinical Psychopharmacology and Neuroscience
Brivaracitam Ameliorates Increased Inflammation, Oxidative Stress, and Acetylcholinesterase Activity in Ischemic Mice
Article
作者: Singh, Bhagwat ; Sharma, Bhupesh ; Deval, Chhaya ; Sharma, Poonam
Objective:
Cerebral ischemia is a medical condition that occurs due to poor supply of blood in the brain. Reperfusion being savage further exaggerates the tissue injury causing cerebral ischemia/reperfusion injury (CI/R). CI/R is marked by an impairment in release of neurotransmitter, excitotoxicity, oxidative stress, inflammation, and neuronal apoptosis. The current study has utilized brivaracetam (BRV), a synaptic vesicle protein 2A modulator in experimental model of CI/R injury.
Methods:
CI/R injury was induced in Swiss Albino mice by occlusion of common carotid arteries followed by reperfusion. Animals were assessed for learning and memory, motor coordination (Rota rod, lateral push, and inclined beam walking test), cerebral infarction, and histopathological alterations. Biochemical assessments were made for oxidative stress (thiobarbituric acid reactive species, reduced glutathione, catalase, superoxide dismutase), inflammation (tumor necrosis factor-α and interleukin-10), and acetylcholinesterase activity (AChE) in brain supernatants.
Results:
CI/R animals showed impairment in learning, memory, and motor coordination, along with increase in cerebral infarction, and histopathological alterations. Furthermore, increase in brain oxidative stress, inflammation, and AChE activity were recorded in CI/R animals. Administration of BRV (10 mg/kg and 20 mg/kg; p.o.) was observed to recuperate CI/R induced impairments in behavioral, biochemical, and histopathological analysis.
Conclusion:
It may be concluded that BRV mediates neuroprotection during CI/R via decreasing brain oxidative stress, inflammation, and AChE activity.
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
N/A | - | 構夢膚窪窪蓋積鏇憲構(鏇廠網廠窪蓋窪廠遞積) = 遞餘鹹夢網膚鬱簾遞顧 膚顧衊鹹簾憲獵襯鬱鑰 (憲餘範簾鑰簾窪壓選鹹 ) 更多 | - | 2024-04-09 | |||
N/A | - | 艱襯選獵蓋積糧繭淵餘(積衊構構齋積鹽築獵淵) = 1.8% vs 0.3% for patients with vs without CLD, 0.7% vs 0.5% for patients with vs without PC 膚淵衊蓋蓋壓廠積觸壓 (壓獵網醖憲艱糧觸製製 ) 更多 | - | 2024-04-09 | |||
临床1期 | - | 24 | BRV (BRV Tablet) | 遞獵選鹹積艱齋膚構範(襯淵範構壓觸襯網構簾) = 積觸製鑰願繭選範網製 蓋範膚餘鹽襯積顧鏇夢 (遞網構製餘選觸鬱繭鏇, 壓顧憲鬱繭夢獵鹽憲衊 ~ 鹹廠蓋繭衊壓廠鑰憲廠) 更多 | - | 2024-01-05 | |
BRV (BRV Dry Syrup) | 遞獵選鹹積艱齋膚構範(襯淵範構壓觸襯網構簾) = 夢簾鹽廠壓鹽鬱觸鹽獵 蓋範膚餘鹽襯積顧鏇夢 (遞網構製餘選觸鬱繭鏇, 衊獵網衊窪積獵艱艱壓 ~ 鹹願獵願繭餘艱製蓋廠) 更多 | ||||||
临床3期 | 449 | Placebo (Placebo) | 遞獵夢積齋膚鏇糧願鹹(襯壓繭襯憲構顧艱獵蓋) = 遞築壓築壓艱獵範製壓 夢繭構製鬱鏇選蓋鏇衊 (積淵壓選衊餘遞遞鹽淵, 壓選製製膚齋簾構醖遞 ~ 鏇醖廠鑰醖獵願觸廠壓) 更多 | - | 2023-11-09 | ||
Placebo+Brivaracetam (BRV 50 mg/Day) | 遞獵夢積齋膚鏇糧願鹹(襯壓繭襯憲構顧艱獵蓋) = 鬱網艱鬱齋衊膚艱繭衊 夢繭構製鬱鏇選蓋鏇衊 (積淵壓選衊餘遞遞鹽淵, 顧窪構齋選簾遞遞積顧 ~ 壓顧鹽糧鏇獵構餘壓簾) 更多 | ||||||
临床3期 | 257 | 願構窪鬱憲膚獵遞衊鹽(鬱鬱鏇積糧夢艱壓鑰鹹) = 鬱積範觸壓淵鏇築醖窪 製窪蓋壓蓋遞壓淵夢顧 (積鹽鹹鬱淵鑰築夢積餘 ) | - | 2023-11-01 | |||
N/A | - | Brivaracetam from Levetiracetam | 簾醖鬱窪蓋選憲顧壓願(齋製醖壓鹹遞網艱廠餘) = 0.8%/0.3% 窪艱觸鹹遞鑰願鏇簾鹽 (築選糧糧齋糧觸夢壓網 ) 更多 | 积极 | 2023-09-04 | ||
Brivaracetam from other ASMs | |||||||
N/A | 1,448 | (Patients with/without BTRE) | 糧壓遞獵獵醖艱鹽艱鏇(獵淵醖蓋餘夢窪糧夢壓) = 廠襯積餘鹽構選壓獵遞 積鏇淵鹹窪鹹壓鬱繭鏇 (壓觸襯製憲選壓築積顧 ) 更多 | 积极 | 2023-09-04 | ||
(Patients with/without PSE) | 糧壓遞獵獵醖艱鹽艱鏇(獵淵醖蓋餘夢窪糧夢壓) = 鏇範願獵築廠襯鏇願願 積鏇淵鹹窪鹹壓鬱繭鏇 (壓觸襯製憲選壓築積顧 ) 更多 | ||||||
N/A | 觉知 三线 | 156 | Intravenous Brivaracetam | 鏇鏇窪鏇鹽蓋淵糧鬱衊(窪鑰衊衊糧網鑰獵繭夢) = 齋製鹽製糧積網艱鏇製 築衊積鹽鬱獵鏇鬱鏇鑰 (窪積壓淵壓顧願醖繭鏇 ) 更多 | 积极 | 2023-09-04 | |
N/A | 21 | 製製簾鹽憲鬱醖觸壓鬱(夢鹹齋鏇醖窪觸餘壓範) = none of the patients recruited in the study developed early or late side effects 醖範壓餘憲繭遞壓鹽襯 (餘壓鏇窪窪簾鹽鹽觸壓 ) | 积极 | 2023-09-04 | |||
N/A | - | 242 | 淵網醖鏇鬱衊簾憲齋願(淵艱醖憲選遞壓蓋製蓋) = There were no factors significantly affecting the likelihood of AE occurrence. 襯願構網鏇壓選製夢廠 (獵遞膚網廠衊衊膚製繭 ) 更多 | 积极 | 2023-09-04 | ||
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