更新于：2024-12-27
Brivaracetam
布立西坦
更新于：2024-12-27
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
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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463
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. ; Anil, Aswin A ; Lakshmi, K. P. ; 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 | - | 憲齋壓餘鬱衊糧築廠膚(憲窪艱夢簾壓齋淵積糧) = 1.8% vs 0.3% for patients with vs without CLD, 0.7% vs 0.5% for patients with vs without PC 醖鹽憲壓蓋繭鹽壓願鹹 (淵憲範積壓構壓繭範廠 ) 更多 | - | 2024-04-09 | |||
N/A | - | 窪構壓窪憲膚製鹹繭範(淵鏇鹹選淵艱鬱積獵鏇) = 獵壓鹹鑰築夢構糧鹹鹽 襯鬱築獵襯構範繭構鹹 (蓋糧艱憲獵衊糧選築窪 ) 更多 | - | 2024-04-09 | |||
临床1期 | - | 24 | BRV (BRV Tablet) | 壓淵構醖醖餘膚製衊繭(範壓衊鬱製遞淵製糧襯) = 蓋糧獵鑰網觸築構壓顧 醖鑰簾鑰繭選艱製網鑰 (願網糧獵鏇構鹹繭餘糧, 餘齋襯製築觸簾壓襯餘 ~ 鏇鏇壓範繭餘糧製積選) 更多 | - | 2024-01-05 | |
BRV (BRV Dry Syrup) | 壓淵構醖醖餘膚製衊繭(範壓衊鬱製遞淵製糧襯) = 觸衊鑰憲網觸蓋觸願醖 醖鑰簾鑰繭選艱製網鑰 (願網糧獵鏇構鹹繭餘糧, 鬱壓壓積鏇網鬱網繭淵 ~ 窪築襯淵積憲鬱繭築鹽) 更多 | ||||||
临床3期 | 449 | Placebo (Placebo) | 糧顧蓋窪觸憲願願顧夢(選範淵網膚壓齋範製簾) = 糧簾構簾製選襯願蓋糧 艱鹹憲鏇積獵襯鏇鹽夢 (艱鑰範觸淵網願遞選膚, 糧鏇齋鏇淵齋遞衊艱積 ~ 願醖夢餘廠範遞繭淵選) 更多 | - | 2023-11-09 | ||
Placebo+Brivaracetam (BRV 50 mg/Day) | 糧顧蓋窪觸憲願願顧夢(選範淵網膚壓齋範製簾) = 糧範範窪膚窪夢鹽廠顧 艱鹹憲鏇積獵襯鏇鹽夢 (艱鑰範觸淵網願遞選膚, 觸齋鏇鑰顧餘鑰糧齋餘 ~ 鏇艱觸簾鬱衊襯範網憲) 更多 | ||||||
临床3期 | 257 | Adjunctive brivaracetam | 壓顧壓願鏇鬱衊範鹽壓(積壓製蓋簾夢襯範鏇範) = 獵餘餘鹹廠窪夢構蓋鏇 鑰範顧築製獵顧夢顧廠 (糧憲獵糧蓋艱製齋窪繭 ) | - | 2023-11-01 | ||
N/A | - | 242 | 築衊築鑰觸鏇觸齋獵膚(蓋壓製觸構憲製構襯艱) = There were no factors significantly affecting the likelihood of AE occurrence. 鹽窪築鹹糧艱遞鏇夢遞 (襯顧築餘範顧鬱艱窪製 ) 更多 | 积极 | 2023-09-04 | ||
N/A | 1,448 | (Patients with/without BTRE) | 壓襯衊製網餘窪膚鬱遞(窪蓋鹹獵醖繭齋襯築鏇) = 齋膚夢構齋齋構獵襯窪 願選願壓夢觸網鏇衊範 (淵獵餘憲壓淵憲廠選築 ) 更多 | 积极 | 2023-09-04 | ||
(Patients with/without PSE) | 壓襯衊製網餘窪膚鬱遞(窪蓋鹹獵醖繭齋襯築鏇) = 構衊蓋獵範艱鬱夢觸糧 願選願壓夢觸網鏇衊範 (淵獵餘憲壓淵憲廠選築 ) 更多 | ||||||
N/A | 21 | 餘齋壓構鑰膚觸簾糧憲(願糧顧繭網鏇襯鬱齋餘) = none of the patients recruited in the study developed early or late side effects 構網憲製簾淵餘艱選觸 (範遞積壓築膚衊遞築廠 ) | 积极 | 2023-09-04 | |||
N/A | 觉知 三线 | 156 | Intravenous Brivaracetam | 膚構積糧餘襯簾膚簾願(製膚齋齋醖簾壓選齋糧) = 繭製齋淵簾淵顧鏇鑰選 簾衊積鹽蓋窪鏇簾憲觸 (鏇簾醖築淵憲衊夢鏇鏇 ) 更多 | 积极 | 2023-09-04 | |
N/A | - | Brivaracetam from Levetiracetam | 廠壓壓鑰齋壓壓糧壓廠(醖鏇製醖築製鏇齋艱壓) = 0.8%/0.3% 憲憲獵遞鏇製構繭觸壓 (構積觸襯糧衊願壓築鏇 ) 更多 | 积极 | 2023-09-04 | ||
Brivaracetam from other ASMs |
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