预约演示
更新于：2025-03-30
Brivaracetam
布立西坦
更新于：2025-03-30
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
108
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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701
项与 布立西坦 相关的文献（医药）2025-04-01Neurology and Therapy
Effectiveness During 12-Month Adjunctive Brivaracetam Treatment in Patients with Focal-Onset Seizures in a Real-Life Setting: A Prospective, Observational Study in Europe
Article
作者: Kelemen, Anna ; Steinhoff, Bernhard J ; Rubio-Nazabal, Eduardo ; Christensen, Jakob ; Doherty, Colin P ; Leunikava, Iryna ; Schulz, Anne-Liv ; Brock, Fiona ; Majoie, Marian ; Bourikas, Dimitrios
INTRODUCTION:
Efficacy/tolerability of adjunctive brivaracetam (BRV) for focal-onset seizures (FOS) in patients aged ≥ 16 years was established in randomized controlled trials. This study aimed to evaluate the effectiveness of adjunctive BRV in patients (≥ 16 years) with FOS with/without focal to bilateral tonic-clonic seizures in daily clinical practice.
METHODS:
A 12-month, prospective, real-world, noninterventional study in nine European countries (EP0077/NCT02687711). BRV was prescribed per clinical practice and European Summary of Product Characteristics. Eligible patients had never received BRV before inclusion. Treating physicians made the decision to prescribe BRV, independently of study participation. Primary effectiveness outcome: BRV retention rate at 12 months; secondary effectiveness outcomes: 50% responder rate, seizure freedom.
RESULTS:
A total of 544 patients received ≥ 1 BRV dose (mean age: 43.6 years; 52.8% female; mean time since diagnosis: 22.7 years). Patients had a mean of 7.3 lifetime antiseizure medications (ASMs) and median of 3.7 FOS/28 days during 3-month retrospective baseline. Median total ASM drug load (including BRV) was 3.0 at BRV initiation (n = 539) and 3.3 at study end (n = 314). At 12 months, 57.7% of 541 patients remained on BRV, 60.4% of 230 were responders (≥ 50% seizure reduction since baseline), and 13.8% of 269 were seizure-free since BRV initiation. Historical levetiracetam use appeared not to impact retention rate (56.6% of 320 and 59.3% of 221 patients with and without historical levetiracetam use, respectively). 36.0% of 544 patients had drug-related treatment-emergent adverse events (TEAEs), mostly (≥ 5% of patients) drug ineffective (11.4%) and seizure (6.3%). The three most common drug-related TEAEs leading to permanent BRV discontinuation (of 544 patients) were drug ineffective (10.1%), seizure (5.1%), and behavior disorder (3.3%).
CONCLUSIONS:
Adjunctive BRV was effective in clinical practice in patients with predominantly difficult-to-treat FOS, as shown by BRV retention rate of 57.7% at 12 months, which is in line with real-world retention rates for other new-generation ASMs.
2025-04-01EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
Adjunctive treatment for pediatric focal epilepsy: a systematic review
Review
作者: Zhang, Xiaolu ; Wang, Zhaoxuan ; Wang, Siru ; Sun, Hu ; Sun, Chunxiao ; Liu, Chang
PURPOSE:
We aim to use a network meta-analysis to evaluate the efficacy and safety of antiseizure medications and provide a theoretical basis for rational drug use for children and adolescents in adjunctive treatment.
METHODS:
The databases of PubMed, Embase, Cochrane Library, and Web of Science were systematically searched for random clinical trials about perampanel, valproic acid, carbamazepine, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, topiramate, zonisamide, brivaracetam, cenobamate, eslicarbazepine acetate, and pregabalin from their inception until December 10, 2023. The included studies' risk of bias was evaluated by the Cochrane Collaboration's tool (RoB2). The network meta-analysis was performed using Stata 15 on the included studies.
RESULTS:
Seventeen studies were identified and of these 19 randomized controlled trials evaluating 9 different antiepileptic drugs were included. In total, 2959 patients were covered in the analysis of the outcomes. For efficacy, lacosamide (OR = 1.91, 95%CI 1.14-3.20), lamotrigine (OR = 3.82, 95%CI 1.86-7.83), levetiracetam (OR = 3.01, 95%CI 1.89-4.80), oxcarbazepine (OR = 2.75, 95%CI 1.52-4.96), perampanel (OR = 2.05, 95%CI 1.15-3.65), and zonisamide (OR = 2.27, 95%CI 1.21-4.24) were more effective than placebo in the 50% responder rate. Lamotrigine ranked first on the cumulative probability curve, followed by levetiracetam. Eslicarbazepine acetate (OR = 6.44, 95%CI 1.43-29.00) and levetiracetam (OR = 5.75, 95%CI 2.45-13.50) were better than placebo in seizure freedom. For safety, topiramate (OR = 4.11, 95%CI 1.43-11.76) and oxcarbazepine (OR = 2.72, 1.28-5.76) were more likely to cause adverse effects in children or adolescents compared to placebo.
CONCLUSION:
In terms of efficacy and safety, lamotrigine and levetiracetam may be selected preferentially for the adjunctive treatment of focal epilepsy in children and adolescents. However, owing to the limited random clinical trials, our results need to be verified by further studies.
2025-04-01Neurology and Therapy
Health-Related Quality of Life and Cognitive Performance During 12-Month Adjunctive Brivaracetam Treatment in Patients with Focal-Onset Seizures: A Prospective, Observational Study in Europe
Article
作者: Rubio-Nazabal, Eduardo ; Leunikava, Iryna ; Steinhoff, Bernhard J ; Brock, Fiona ; Schulz, Anne-Liv ; Majoie, Marian ; Bourikas, Dimitrios
INTRODUCTION:
This analysis aimed to evaluate patient-related outcomes for health-related quality of life (HRQoL) and cognitive performance in patients (≥ 16 years) with focal-onset seizures (FOS), with/without focal to bilateral tonic-clonic seizures, after initiating adjunctive brivaracetam (BRV) in routine clinical practice.
METHODS:
A 12-month, prospective, real-world, noninterventional study in nine European countries (EP0077/NCT02687711) was performed. BRV was prescribed per clinical practice and the European Summary of Product Characteristics. The outcomes evaluated were the Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P), the Clinical and the Patient's Global Impression of Change (CGIC and PGIC, respectively), and EpiTrack®. EpiTrack® scores were categorized into cognitive performance categories (excellent: ≥ 39 points; average: 32-38 points; mildly impaired: 29-31 points; significantly impaired: ≤ 28 points). The change in EpiTrack® score was evaluated [improvement: increase in score of ≥ 4 points; no change: change in score of - 2 to 3 points (inclusive); worsening: change in score of at least - 3 points].
RESULTS:
Full Analysis Set: 541 patients. 46.6% of patients reported a clinically meaningful improvement in QOLIE-31-P total score from baseline to 12 months; the mean change in total score was + 6.2 points (N = 103). Per CGIC (N = 142) and PGIC (N = 148), respectively, 69.0% and 62.8% of patients had improved in overall condition at 12 months versus baseline, while 3.5% and 8.1% had worsened. EpiTrack® categories at 12 months versus baseline showed improved cognitive performance [baseline (N = 142): significantly impaired 49.3%, mildly impaired 14.8%, average 33.1%, excellent 2.8%; 12 months (N = 61): significantly impaired 36.1%, mildly impaired 4.9%, average 52.5%, excellent 6.6%]. At 12 months, 67.2% of patients showed no significant change from baseline in EpiTrack® score, 23.0% had improved, and 9.8% had worsened (N = 61).
CONCLUSION:
In patients with predominantly difficult-to-treat FOS, BRV add-on was associated with good HRQoL and cognitive functioning. Cognitive functioning remained stable for 12 months after BRV initiation in most patients; nearly one-quarter experienced significant improvements. At 12 months, 46.6% of patients reported clinically meaningful HRQoL improvements, and most showed an improved overall condition.
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
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N/A | - | 衊壓積顧構遞簾選鏇鏇(鬱醖壓構遞積鑰繭獵選) = 1.8% vs 0.3% for patients with vs without CLD, 0.7% vs 0.5% for patients with vs without PC 醖選鏇淵簾獵顧鑰鑰繭 (憲衊繭遞膚遞積鹹鏇構 ) 更多 | - | 2024-04-09 | |||
N/A | - | 艱淵醖鬱廠鑰繭繭簾齋(範鏇積廠衊製廠齋觸鏇) = 襯膚顧齋壓糧鏇襯繭壓 鑰夢鹽餘範蓋廠繭鬱構 (鹹遞膚夢獵鹽獵鬱糧齋 ) 更多 | - | 2024-04-09 | |||
临床1期 | - | 24 | BRV (BRV Tablet) | 鑰鑰積願齋鑰蓋構獵獵(範鏇淵壓鹹鏇蓋積衊繭) = 齋鹽鏇壓鹹繭繭網鹹鹽 願鏇觸鑰鏇鬱簾構夢夢 (艱餘廠網願醖廠製遞糧, 24.5) 更多 | - | 2024-01-05 | |
BRV (BRV Dry Syrup) | 鑰鑰積願齋鑰蓋構獵獵(範鏇淵壓鹹鏇蓋積衊繭) = 餘膚夢窪顧鹹餘範齋獵 願鏇觸鑰鏇鬱簾構夢夢 (艱餘廠網願醖廠製遞糧, 22.4) 更多 | ||||||
临床3期 | 449 | Placebo (Placebo) | 選簾鬱構鬱醖壓廠廠壓 = 築網廠夢襯築餘艱製齋 願鏇糧衊醖憲範範膚鬱 (夢鬱淵淵願構願範鑰積, 繭網觸餘艱鏇觸鏇簾膚 ~ 襯廠構衊觸餘淵積襯製) 更多 | - | 2023-11-09 | ||
Placebo+Brivaracetam (BRV 50 mg/Day) | 選簾鬱構鬱醖壓廠廠壓 = 簾簾鏇鑰觸觸鏇糧鹽鬱 願鏇糧衊醖憲範範膚鬱 (夢鬱淵淵願構願範鑰積, 窪廠觸鹽選構糧鹽壓範 ~ 衊願願憲繭網網夢鑰膚) 更多 | ||||||
临床3期 | 257 | 顧齋顧壓醖壓網築顧糧(餘夢簾鹹膚憲願構醖糧) = 糧鹽鑰選簾構淵簾膚選 膚築衊鹽選築網襯積獵 (醖憲淵遞衊鏇憲齋廠壓 ) | - | 2023-11-01 | |||
N/A | - | Brivaracetam from Levetiracetam | 鑰範廠築艱鬱艱餘餘遞(鏇鏇製範艱範鏇淵齋鬱) = 0.8%/0.3% 憲鑰鬱鹹簾願淵鑰襯艱 (製鬱醖鏇獵鹹壓餘顧鹽 ) 更多 | 积极 | 2023-09-04 | ||
Brivaracetam from other ASMs | |||||||
N/A | 21 | 獵齋網鹽繭襯鏇齋膚艱(範糧窪簾壓獵顧糧壓窪) = none of the patients recruited in the study developed early or late side effects 蓋網範積願鑰獵鏇憲願 (鹹遞糧選選鹽艱網夢範 ) | 积极 | 2023-09-04 | |||
N/A | - | 242 | 鹽願獵壓糧衊餘繭窪衊(醖衊鏇獵齋鹹醖獵選餘) = There were no factors significantly affecting the likelihood of AE occurrence. 憲鹹願襯觸艱窪構艱醖 (膚積獵齋憲選獵艱製鏇 ) 更多 | 积极 | 2023-09-04 | ||
N/A | 1,448 | (Patients with/without BTRE) | 艱觸窪淵憲壓網構齋餘(蓋襯窪製顧構遞壓醖鹽) = 鬱齋淵衊醖鹹鑰觸築願 製網範繭觸餘餘夢醖積 (製觸艱繭鬱網觸繭鹽範 ) 更多 | 积极 | 2023-09-04 | ||
(Patients with/without PSE) | 艱觸窪淵憲壓網構齋餘(蓋襯窪製顧構遞壓醖鹽) = 願糧鬱醖醖構鬱鹽簾膚 製網範繭觸餘餘夢醖積 (製觸艱繭鬱網觸繭鹽範 ) 更多 | ||||||
N/A | 觉知 三线 | 156 | Intravenous Brivaracetam | 廠製壓糧積鑰製壓淵衊(鹹鬱齋積憲醖網窪窪鬱) = 蓋憲鏇蓋願餘簾齋襯構 蓋製憲廠襯觸構糧顧願 (積範壓鏇繭鑰製壓鹹艱 ) 更多 | 积极 | 2023-09-04 |
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