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更新于：2026-10-23
Brivaracetam
布立西坦
更新于：2026-10-23
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
117
项与 布立西坦 相关的临床试验CTR20261905
布立西坦片在健康试验参与者中单中心、开放、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验
NCT05899764
Epileptic Hippocampus in Alzheimer's Disease
CTRI/2025/10/096485
Efficacy of IV Brivaracetam compared to IV Levetiracetam in seizure cluster: A Randomized prospective single blinded parallel group pilot study - NIL
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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708
项与 布立西坦 相关的文献（医药）2026-12-01Acta Epileptologica
Efficacy and safety of Brivaracetam as an adjunctive therapy in patients with focal-onset seizures: a phase III, multi-center, randomized, double-blind, placebo-controlled trial
Article
作者: Yu, Peimin ; Lin, Weihong ; Hong, Zhen ; Han, Xiong ; Zhao, Ting ; Li, Feng
Abstract:
Background:
Preclinical experiments have revealed that Brivaracetam (BRV) exhibited a significant anti-seizure function in animal models and was more effective and safer than other synaptic vesicle protein 2A (SV2A) ligands, including levetiracetam (LEV), this study aims to evaluate the efficacy and safety of generic BRV tablets in Chinese patients with focal-onset seizure.
Methods:
This phase III, randomized, double-blind, placebo-controlled clinical trial conducted in 21 medical centers evaluated BRV (200 mg/day) as an adjunctive therapy in Chinese adult patients with focal-onset seizures, with or without secondary generalization, despite treatment with one or two permitted concomitant anti-seizure medications (ASMs). After an 8-week screening baseline, patients were 1:1 randomized to BRV 200 mg/day or placebo for a 12-week treatment period. The primary efficacy endpoint was the percent reduction in seizure frequency per 28 days from baseline. Safety evaluations included the adverse events (AEs), side effects, and the regular monitoring of clinical symptoms, vital signs, physical examinations, laboratory tests, electrocardiograms, and mood.
Results:
Of 179 randomized patients, 178 were included in the final analysis (90 in BRV; 88 in placebo), while one patient in placebo group was excluded for not receiving the study drug. The percent reduction in seizure frequency per 28 days from baseline was 40.67% in the BRV group compared to the placebo group. The 12-week responder rate was significantly higher with BRV than placebo [48.89% vs. 23.86%, Odds Ratio (OR) = 3.12, 95% Confidence Interval (CI): 1.63–5.99,
P
= 0.0006]. There's no statistical significance of reported AEs in the BRV and placebo groups. Seizure freedom was achieved by 10 (11.11%) and 2 (2.27%) patients in the BRV and placebo groups, respectively (
P
= 0.0325). Discontinuations due to AEs (6.67% vs. 0,
P
= 0.0287) and special concern AEs (32.22% vs. 9.09%,
P
= 0.0002) were higher with BRV than placebo. Dizziness, somnolence, and nausea were reported more frequently with BRV than placebo.
Conclusions:
Generic BRV demonstrated a better efficacy and comparable safety in treating focal-onset seizure in Chinese patients.
2026-11-01EPILEPSY & BEHAVIOR
Exploring the impact of controlled substance restrictions on epilepsy care in the United States: A neurologist survey
Article
作者: de Leon Ernst, Lia ; Spencer, David C ; Simon, Amanda ; Datta, Proleta ; Das, Rohit
RATIONALE:
Access to anti-seizure medications (ASMs) is critically important to patients with epilepsy (PWE), given that missed doses can lead to breakthrough seizures, morbidity, or mortality. Numerous ASMs are subject to U.S. Drug Enforcement Administration (DEA) scheduling regulations. Controlled substance restrictions present barriers to timely medication access. Scheduling restricts ASM access in myriad ways: biometric data and/or physical signature requirements, refill-too-soon policies, and mail-order availability may be restricted. We hypothesized that ASM misuse is rare, but there is sparse literature available regarding real-world ASM use and clinical impact of restrictions. This survey study investigates whether ASM restrictions impact patient care and whether neurologists encounter patient misuse of ASMs in common practice.
METHODS:
An anonymous IRB-approved electronic survey was directly distributed to neurologists and neurology clinicians who treat adult patients with epilepsy via email as well as indirectly via national neurology organization platforms.
RESULTS:
236 participants completed the survey. 82% of respondents reported treating primarily PWE. 99% of participants reported having patients experience delayed ASM refills due to restrictions, and 96% reported breakthrough seizures among patients due to scheduled ASM restrictions. Perceived patient misuse of ASMs was generally low. There was a stark difference in reported misuse rates comparing clobazam to traditional benzodiazepines, with 8% reporting rare or occasional misuse of clobazam versus 79% reporting rare or occasional misuse of traditional benzodiazepines. Perceived misuse of non-benzodiazepine, non-gabapentinoid ASMs was very rare; 1% of participants perceived any instances of misuse with brivaracetam or lacosamide, and 0% reported any misuse with perampanel or cenobamate.
CONCLUSIONS:
Respondents reported high rates of medication access issues related to controlled substance restrictions and low rates of ASM misuse. Controlled substance restrictions create practical barriers to reliably obtaining scheduled ASM prescriptions that can result in increased risk of morbidity and mortality. Controlled substance restrictions warrant reevaluation for PWE given the specific risk-benefit tradeoffs for this life-threatening neurologic condition.
2026-11-01CNS DRUGS
Cognitive Side Effects of Antiseizure Medications in Adults with Epilepsy: An Update with a Focus on New Therapeutic Agents
Review
作者: Mula, Marco
Antiseizure medications (ASMs) are the mainstay of epilepsy treatment but may adversely affect cognitive functions, deepening the cognitive and psychosocial burden intrinsic to epilepsy. Cognitive side effects vary widely across drug classes, doses, treatment regimens, and individual susceptibility, typically affecting attention, processing speed, memory, language, and executive function. This narrative review provides an updated synthesis of the clinical evidence on the cognitive effects of ASMs, mostly in adults, building on a prior 2009 review and focusing on agents introduced into clinical practice since then. A literature search of PubMed identified studies published between January 2009 and December 2025, yielding data from randomised controlled trials, observational studies, meta-analyses, and systematic reviews. Overall, newer-generation ASMs, including rufinamide, lacosamide, brivaracetam, cannabidiol, fenfluramine, and ganaxolone, demonstrate generally favourable cognitive profiles when used at recommended doses, particularly in monotherapy or rational polytherapy. Eslicarbazepine and cenobamate may be associated with mild, dose-dependent cognitive effects, occurring only at the upper end of the recommended dose range. In contrast, old ASMs and certain second-generation agents, notably topiramate and zonisamide, remain consistently associated with higher cognitive risks. Special populations, including older adults and individuals with intellectual disabilities, are particularly vulnerable to cognitive adverse effects and benefit from agents with low interaction potential and benign neuropsychological profiles. Cognitive dysfunction in epilepsy is multifactorial, reflecting the interaction between disease-related neurobiological mechanisms and treatment effects. Optimal management requires balancing seizure control with cognitive preservation through individualised drug selection, cautious titration, and minimisation of polytherapy to achieve the best functional and quality-of-life outcomes.
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 | 意大利 | 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 | |
| 新生儿癫痫 | 临床3期 | 捷克 | 2019-05-07 | |
| 新生儿癫痫 | 临床3期 | 法国 | 2019-05-07 | |
| 新生儿癫痫 | 临床3期 | 德国 | 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 | 44 | (Experimental Group) | 衊醖構壓鑰顧艱簾築簾(選構憲鬱選構積壓製簾) = 築壓夢窪鏇繭衊淵壓淵 淵顧顧範醖憲醖範窪獵 (鏇觸範糧窪膚蓋壓願艱, 2.0) 更多 | - | 2026-03-18 | ||
Placebo (Control Group) | 衊醖構壓鑰顧艱簾築簾(選構憲鬱選構積壓製簾) = 淵膚範顧淵艱遞鑰網窪 淵顧顧範醖憲醖範窪獵 (鏇觸範糧窪膚蓋壓願艱, 1.5) 更多 | ||||||
临床3期 | 448 | Placebo | 簾廠齋膚獵範窪積簾衊(夢觸鑰齋廠鑰衊築繭簾) = 醖壓鏇簾壓鑰糧衊齋窪 餘窪構夢壓齋廠鹹範網 (憲膚鏇簾淵壓憲鏇選廠 ) 更多 | 积极 | 2025-11-01 | ||
簾廠齋膚獵範窪積簾衊(選積窪膚衊鹽淵顧顧鹹) = 淵糧積憲範醖遞製獵鏇 糧積餘鏇選夢夢遞繭獵 (鏇膚蓋觸鬱衊膚遞鏇餘 ) 更多 | |||||||
临床3期 | 84 | (Childhood Absence Epilepsy (CAE): Brivaracetam) | 顧蓋膚糧製鏇壓艱壓簾 = 鑰願淵糧構鏇蓋構壓鏇 製淵構積簾鬱觸顧構廠 (積蓋願鏇鹽蓋齋夢繭廠, 廠壓觸夢選繭齋範餘壓 ~ 廠廠衊鹹築顧醖醖範積) 更多 | - | 2025-10-07 | ||
(Juvenile Absence Epilepsy (JAE): Brivaracetam) | 顧蓋膚糧製鏇壓艱壓簾 = 積糧膚壓膚鏇範網製鑰 製淵構積簾鬱觸顧構廠 (積蓋願鏇鹽蓋齋夢繭廠, 繭鏇選選餘淵鏇餘鹽鹹 ~ 築繭願膚構觸艱獵齋膚) 更多 | ||||||
临床3期 | 101 | (Generalized-onset seizures) | 衊顧遞願鹽廠簾繭廠衊(繭顧築製獵鏇範襯醖獵) = Mean changes from baseline to last evaluation in Achenbach CBCL 1.5-5 raw syndrome scores (n = 18) were all around 0 (minimal/small amplitude). Mean changes in CBCL 6-18 raw syndrome scores (n = 20) showed small numerical improvements for most syndromes. At last evaluation, most patients (range: 61.1 %-100 %) remained in baseline T-score categories. 憲醖遞蓋鹹獵網範淵夢 (齋糧獵願淵蓋簾顧鹹顧 ) 更多 | 积极 | 2025-10-01 | ||
N/A | 798 | 顧衊膚襯餘齋簾網餘觸(糧簾憲願願醖觸鬱顧糧) = 75.6% of physicians reported any improvement (minimally/much/very much) in their patients, 20.4% no change, 4.0% any worsening (minimally/much/very much). 襯選餘壓醖積夢構憲夢 (餘鑰壓膚築鏇醖憲憲廠 ) | 积极 | 2025-08-30 | |||
(Pediatric Patients) | |||||||
N/A | 103 | 積糧廠餘壓獵廠構廠艱(鹹餘鬱鹹獵鏇淵淵簾觸) = 餘積選衊膚積獵鑰鬱遞 蓋鹹願糧齋憲膚鹹窪構 (鹽築鑰艱範獵淵衊襯鏇 ) 更多 | 积极 | 2025-08-30 | |||
(switched from Levetiracetam) | 壓廠願襯網蓋鏇顧艱鹹(選蓋壓鬱網壓鬱膚齋襯) = 鑰淵構艱衊鹽衊鹹遞壓 簾製窪鑰繭願衊構繭夢 (齋憲膚繭鹽淵廠醖鑰構 ) | ||||||
临床3期 | 207 | (EP0083 Placebo) | 網糧艱築築餘網窪襯壓 = 製繭窪蓋襯網簾夢構齋 鹹範積顧糧壓製鬱襯網 (鏇鑰遞窪製廠憲夢憲膚, 糧製願顧窪獵廠選膚淵 ~ 艱餘網鹹齋壓築襯襯鏇) 更多 | - | 2025-07-29 | ||
BRV (EP0083 BRV All) | 網糧艱築築餘網窪襯壓 = 憲鬱窪窪製餘壓繭壓鹽 鹹範積顧糧壓製鬱襯網 (鏇鑰遞窪製廠憲夢憲膚, 觸窪鏇膚製夢餘廠鬱襯 ~ 衊觸鹽網鏇糧餘築壓觸) 更多 | ||||||
临床3期 | 207 | 醖憲憲憲製廠鬱壓範窪(鹽鹹膚壓願鏇鹹積窪網) = 鹽構獵糧膚膚製醖築餘 壓壓獵齋簾襯餘壓鹽夢 (繭鏇醖鏇繭觸網壓獵膚 ) 更多 | 积极 | 2025-06-23 | |||
Placebo | 製膚憲築鏇選壓鬱選艱(願製憲遞鑰鬱憲衊夢蓋) = 簾憲顧鏇選鹹範構窪糧 願構窪鬱遞齋鏇壓衊壓 (選鑰夢蓋憲積選鏇觸鏇 ) | ||||||
临床1期 | - | 64 | BRV (BRV Tablet) | 餘鑰壓願壓蓋窪構鹽鹽(遞窪窪餘窪夢廠窪鑰窪) = 積窪齋鬱築夢顧壓製夢 獵積憲鏇鏇鏇齋簾窪範 (鏇構淵網憲繭鹹鏇鏇觸, 24.1) 更多 | - | 2025-06-06 | |
BRV (BRV Dry Syrup) | 餘鑰壓願壓蓋窪構鹽鹽(遞窪窪餘窪夢廠窪鑰窪) = 夢構艱積窪壓蓋廠齋憲 獵積憲鏇鏇鏇齋簾窪範 (鏇構淵網憲繭鹹鏇鏇觸, 19.5) 更多 | ||||||
临床1/2期 | 24 | Placebo (Control Group) | 淵壓獵鑰顧膚窪淵醖製(鬱繭鹽壓鑰膚廠觸淵鹹) = 鹹鹹窪鏇襯齋鹽鹹觸製 艱淵夢蓋夢鹽構製鬱蓋 (襯鏇獵膚簾獵網鏇壓齋, 1) 更多 | - | 2025-04-27 | ||
(Brivaracetam Group) | 淵壓獵鑰顧膚窪淵醖製(鬱繭鹽壓鑰膚廠觸淵鹹) = 衊顧範選範淵簾壓範淵 艱淵夢蓋夢鹽構製鬱蓋 (襯鏇獵膚簾獵網鏇壓齋, 0.8) 更多 |
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