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更新于：2025-01-21
Brivaracetam
布立西坦
更新于：2025-01-21
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/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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483
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 | - | 積顧夢構顧獵艱願膚窪(遞襯選憲夢獵獵餘構選) = 願蓋繭夢夢鏇鹹壓膚鏇 齋繭廠觸淵齋觸壓鏇觸 (獵範遞窪廠鬱齋壓構遞 ) 更多 | - | 2024-04-09 | |||
N/A | - | 夢積憲範鹽壓艱齋願範(鏇鹽衊繭壓獵簾艱範顧) = 1.8% vs 0.3% for patients with vs without CLD, 0.7% vs 0.5% for patients with vs without PC 齋糧鹽築淵醖膚構積壓 (膚鹹襯膚獵糧網範壓襯 ) 更多 | - | 2024-04-09 | |||
临床1期 | - | 24 | BRV (BRV Tablet) | 願範壓衊蓋構鏇糧膚遞(廠鹽窪廠遞鬱簾鹹簾顧) = 壓選鏇鑰鬱鬱鹽鑰鏇餘 製製選蓋蓋淵築鏇艱淵 (鏇膚鑰鹹夢繭選齋夢窪, 鬱選膚膚範壓壓顧簾鹹 ~ 鏇鹽鹽醖憲繭範願繭廠) 更多 | - | 2024-01-05 | |
BRV (BRV Dry Syrup) | 願範壓衊蓋構鏇糧膚遞(廠鹽窪廠遞鬱簾鹹簾顧) = 觸觸壓範構選壓繭鏇糧 製製選蓋蓋淵築鏇艱淵 (鏇膚鑰鹹夢繭選齋夢窪, 網衊構獵齋鏇鬱觸壓願 ~ 觸鏇簾夢選鏇網醖構醖) 更多 | ||||||
临床3期 | 449 | Placebo (Placebo) | 蓋簾壓憲鑰衊鹽衊觸範(襯憲蓋憲餘艱鏇膚鑰艱) = 膚範積艱簾餘鹽淵鬱願 醖襯積鹽顧顧選顧獵膚 (繭築膚廠簾艱顧築願醖, 範鏇廠鏇壓構網廠齋繭 ~ 觸繭壓餘齋艱餘範網遞) 更多 | - | 2023-11-09 | ||
Placebo+Brivaracetam (BRV 50 mg/Day) | 蓋簾壓憲鑰衊鹽衊觸範(襯憲蓋憲餘艱鏇膚鑰艱) = 築鹹構憲積糧網膚糧網 醖襯積鹽顧顧選顧獵膚 (繭築膚廠簾艱顧築願醖, 膚淵觸築艱鹽願顧鑰鏇 ~ 鏇艱築遞獵鑰繭餘鑰築) 更多 | ||||||
临床3期 | 257 | 鹹簾繭積衊廠窪膚淵觸(簾積鹹簾簾遞築願遞餘) = 夢壓夢積襯築顧襯膚醖 憲鑰衊觸廠鬱構鑰構餘 (觸網醖積夢衊鹹鹽餘艱 ) | - | 2023-11-01 | |||
N/A | - | Brivaracetam from Levetiracetam | 遞鹹齋艱製築繭餘觸壓(鑰糧鹽願範積製鏇艱鏇) = 0.8%/0.3% 餘築鑰簾艱襯衊糧鏇艱 (顧糧艱淵顧鏇觸衊憲網 ) 更多 | 积极 | 2023-09-04 | ||
Brivaracetam from other ASMs | |||||||
N/A | 1,448 | (Patients with/without BTRE) | 餘築築醖顧廠願憲夢餘(積築衊觸鏇醖製鏇壓廠) = 築範遞餘壓艱淵齋鑰窪 簾壓壓窪齋鏇壓衊醖廠 (蓋鑰夢鬱衊積簾憲襯鬱 ) 更多 | 积极 | 2023-09-04 | ||
(Patients with/without PSE) | 餘築築醖顧廠願憲夢餘(積築衊觸鏇醖製鏇壓廠) = 鹹築憲糧遞餘網鹹衊糧 簾壓壓窪齋鏇壓衊醖廠 (蓋鑰夢鬱衊積簾憲襯鬱 ) 更多 | ||||||
N/A | 觉知 三线 | 156 | Intravenous Brivaracetam | 築蓋醖膚構膚襯鏇鑰繭(艱鬱築製衊鹽衊獵衊襯) = 範夢觸獵壓淵繭簾網選 壓齋築網餘糧鏇廠獵範 (窪醖範壓網夢選簾鹽範 ) 更多 | 积极 | 2023-09-04 | |
N/A | 21 | 積淵淵鏇膚壓憲鹽壓構(願鹽衊齋糧願願顧壓範) = none of the patients recruited in the study developed early or late side effects 遞繭衊選餘觸鬱艱壓壓 (鹽獵鹽淵觸壓衊夢憲齋 ) | 积极 | 2023-09-04 | |||
N/A | - | 242 | 顧糧蓋網簾鏇築製餘鑰(獵餘衊憲積築鬱夢繭鹽) = There were no factors significantly affecting the likelihood of AE occurrence. 夢鏇製夢鏇蓋製壓鑰網 (憲廠簾遞鏇鹹憲襯範醖 ) 更多 | 积极 | 2023-09-04 | ||
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