更新于：2024-12-20
Brivaracetam
布立西坦
更新于：2024-12-20
概要
基本信息
原研机构 |
在研机构 |
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
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Epileptic Hippocampus in Alzheimer's Disease
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)
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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468
项与 布立西坦 相关的文献（医药）2025-02-01JOURNAL OF PHARMACY PRACTICE
The Phenytoin Ataxia Enigma Unveiled “A Case Report’’
Article
作者: Patel, Nishi ; Premal, Yatvi ; Khadela, Avinash ; Sadhwani, Devang ; Dave, Bhavarth
Background: Phenytoin (PHT) has been approved for the treatment of epilepsy. It belongs to the category of medications with a limited therapeutic window and requires therapeutic drug monitoring (TDM). PTH has been observed to induce a variety of Adverse drug reactions (ADRs) including ataxia, dystonia, nystagmus, dyskinesia, etc. Phenytoin-induced ataxia is an uncommonly observed ADR of Phenytoin whose reports are extremely limited. Case: Herein, we present a case report of a 16-year-old Asian patient with a past history of epilepsy that was admitted to a tertiary care hospital due to the development of ataxia, giddiness, and vomiting when taking Phenytoin in addition to Oxcarbazepine, Clobazam, and Levetiracetam to treat seizures. On admission, Magnetic resonance imaging (MRI) findings revealed bilateral variable cerebrospinal fluid (CSF) lesions in the parieto-occipital region of the periventricular area (periventricular leukomalacia). Additionally, serum Phenytoin levels were observed to be in the toxic range (40 μg/mL) due to which physicians confirmed the ADR to be due to Phenytoin toxicity. Thus, the Phenytoin drug was discontinued in the patient gradually and he was continued on clobazam, oxcarbazepine, and brivaracetam which led to reversal of the ADR in the patient. Conclusion: In this case, ataxia resulted from Phenytoin overdose, as confirmed by MRI and serum tests suggesting that TDM of Phenytoin is essential to prevent ADRs. Given the scarcity of ataxia cases caused by Phenytoin, awareness is lacking within the scientific community. Our aim is to provide insights to promote better monitoring and patient-centered treatment outcomes for epileptic patients.
2025-01-01INDIAN JOURNAL OF PEDIATRICS
A Study on the Emotional and Behavioral Side Effects Associated with Brivaracetam versus Levetiracetam in Pediatric Population with Epilepsy
Letter
作者: Kumar, R Uday ; Mohan, Gayathri ; Ratan, Chameli ; Anand, Vaishakh ; Lakshmi, K P ; Chandramohan, Gopika ; Singh, Apeksha ; Anil, Aswin A. ; Lakshmi, K. P. ; Anil, Aswin A ; Kumar, R. Uday
2025-01-01EPILEPSY RESEARCH
Long-term efficacy and tolerability of brivaracetam in pediatric patients with focal-onset seizures and cognitive or learning comorbidities: Post hoc analysis of an open-label trial
Article
作者: Elmoufti, Sami ; Bourikas, Dimitrios ; Dimova, Svetlana ; Moseley, Brian ; Lagae, Lieven ; Koch, Juliane ; de la Loge, Christine
OBJECTIVE:
Efficacy, tolerability, and behavioral/executive functioning during long-term adjunctive brivaracetam treatment were assessed in pediatric patients with focal-onset seizures (FOS) with/without cognitive/learning comorbidities (CLC).
METHODS:
Post hoc analysis of a phase 3 open-label follow-up trial (N01266/NCT01364597). Patients with FOS (<16 years at core trial entry; direct enrollers ≥4-<17 years) received ≤5 mg/kg/day brivaracetam (≤200 mg/day). Subgroup analyses were performed for patients with and without ongoing CLC at baseline.
RESULTS:
Patients with CLC (84/185 [45.4 %]) had longer epilepsy duration and higher number of prior antiseizure medications. Kaplan-Meier-estimated brivaracetam retention at 1, 3, and 5 years was 75.0 %/78.2 %, 61.9 %/61.9 %, and 52.2 %/53.3 % in patients with/without CLC. Efficacy assessments (patients >2 years of age) showed numerically lower median percent reduction in FOS frequency/28 days (43.8 %/74.1 % [n = 63/60]), 50 % responder rates for FOS (46.0 %/61.7 % [n = 63/60]), and ≥12-month continuous freedom from all seizures (31.7 %/55.9 % [n = 60/68 patients with ≥12 months treatment]) in patients with/without CLC. Treatment-emergent adverse events were reported in 94.0 %/95.0 % of patients with/without CLC (serious: 33.3 %/27.7 %; drug-related: 31.0 %/33.7 %). From baseline to last evaluation, most patients with/without CLC had no shift in T-score category for each Achenbach Child Behavior Checklist (CBCL) 1.5-5 syndrome (≥50.0 %/≥72.2 %), CBCL 6-18 syndrome (≥66.0 %/≥69.1 %), and Behavior Rating Inventory of Executive Function scale (≥66.7 %/≥69.0 %).
CONCLUSIONS:
These data indicate that brivaracetam could be an efficacious and well-tolerated treatment option for pediatric patients with FOS with and without CLC. Behavior and executive functioning were generally stable or slightly improved in patients with and without CLC.
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 | - | 壓艱憲壓繭窪範選顧鏇(蓋壓艱夢蓋遞遞窪壓鹽) = 憲觸蓋構廠衊淵衊蓋網 繭顧壓遞鑰壓糧鹹窪鏇 (襯膚襯膚艱壓壓夢艱艱 ) 更多 | - | 2024-04-09 | |||
N/A | - | 鹽範鹹遞膚遞醖簾鬱鹽(鑰鏇遞製繭選廠廠顧蓋) = 1.8% vs 0.3% for patients with vs without CLD, 0.7% vs 0.5% for patients with vs without PC 構窪範顧憲網觸襯繭製 (選衊選鬱壓積願顧製夢 ) 更多 | - | 2024-04-09 | |||
临床1期 | - | 24 | BRV (BRV Tablet) | 網選窪獵簾顧襯衊壓願(觸鹹網鏇製範憲鬱觸網) = 鏇齋壓範製繭簾衊鹽壓 襯淵膚範夢構築範廠蓋 (鑰鹹鏇襯顧淵齋鹹糧鬱, 蓋鹹醖鏇繭製淵築蓋鹹 ~ 衊網鹹鏇鹽選齋鹹艱觸) 更多 | - | 2024-01-05 | |
BRV (BRV Dry Syrup) | 網選窪獵簾顧襯衊壓願(觸鹹網鏇製範憲鬱觸網) = 糧網憲繭獵廠鑰夢膚壓 襯淵膚範夢構築範廠蓋 (鑰鹹鏇襯顧淵齋鹹糧鬱, 淵繭鬱淵觸顧構淵壓簾 ~ 糧鹹鹽衊夢網糧鹽選糧) 更多 | ||||||
临床3期 | 449 | Placebo (Placebo) | 齋顧糧鏇醖鬱壓壓窪鹽(選衊網齋廠築夢膚選艱) = 醖築憲鑰憲襯鹽壓積獵 餘襯襯憲艱鬱夢憲遞齋 (齋鹹築憲淵齋繭鹽構蓋, 網鬱醖壓齋廠襯糧繭範 ~ 廠構簾鬱窪餘範餘範觸) 更多 | - | 2023-11-09 | ||
Placebo+Brivaracetam (BRV 50 mg/Day) | 齋顧糧鏇醖鬱壓壓窪鹽(選衊網齋廠築夢膚選艱) = 淵網憲範鑰膚蓋壓網鏇 餘襯襯憲艱鬱夢憲遞齋 (齋鹹築憲淵齋繭鹽構蓋, 衊願蓋鬱襯鹽蓋淵餘壓 ~ 窪鹹選鹽願願窪鑰衊衊) 更多 | ||||||
临床3期 | 257 | Adjunctive brivaracetam | 廠艱糧鹽積鏇範獵醖齋(鹽壓憲鑰夢廠夢簾選艱) = 鑰艱簾願廠窪鹹糧遞觸 範獵築願繭鹹壓鑰鬱廠 (獵獵獵糧築顧鬱襯醖願 ) | - | 2023-11-01 | ||
N/A | - | Brivaracetam from Levetiracetam | 鹹積衊襯膚壓淵範鏇選(鹹遞繭繭窪範獵窪積願) = 0.8%/0.3% 顧壓衊築顧願憲鑰鬱廠 (廠醖窪齋鹹壓範膚齋觸 ) 更多 | 积极 | 2023-09-04 | ||
Brivaracetam from other ASMs | |||||||
N/A | 觉知 三线 | 156 | Intravenous Brivaracetam | 餘網選壓襯範鏇鏇範選(壓製築築艱廠襯獵夢製) = 糧艱範觸壓衊網築襯獵 齋願觸憲顧鑰艱鑰淵膚 (憲鏇鑰繭構網淵鑰糧繭 ) 更多 | 积极 | 2023-09-04 | |
N/A | 21 | 夢襯觸夢廠範憲願淵鬱(廠簾壓觸製顧膚蓋窪積) = none of the patients recruited in the study developed early or late side effects 淵膚積積餘齋繭齋廠鏇 (觸製餘艱壓襯顧構廠醖 ) | 积极 | 2023-09-04 | |||
N/A | - | 242 | 遞鬱構構獵衊鹹淵餘糧(獵鏇憲鹹願築廠獵鹽積) = There were no factors significantly affecting the likelihood of AE occurrence. 糧範選構網蓋蓋膚選艱 (餘鏇艱齋壓繭醖願衊膚 ) 更多 | 积极 | 2023-09-04 | ||
N/A | 1,448 | (Patients with/without BTRE) | 膚憲夢齋製餘積夢廠廠(壓蓋蓋築壓憲鑰艱膚繭) = 鏇夢憲選衊觸憲餘選積 選蓋選壓夢製鬱繭艱網 (觸齋網鑰觸蓋積網獵窪 ) 更多 | 积极 | 2023-09-04 | ||
(Patients with/without PSE) | 膚憲夢齋製餘積夢廠廠(壓蓋蓋築壓憲鑰艱膚繭) = 願觸範鏇夢繭壓醖淵醖 選蓋選壓夢製鬱繭艱網 (觸齋網鑰觸蓋積網獵窪 ) 更多 |
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