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更新于：2025-06-18
Lacosamide
拉考沙胺
更新于：2025-06-18
概要
基本信息
药物类型 小分子化药 |
别名 Erlosamide、Harkoseride、Lacosamide (JAN/USAN/INN) + [16] |
作用方式 阻滞剂 |
作用机制 钠通道阻滞剂 |
非在研适应症 |
原研机构 |
权益机构 |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2008-08-29), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C13H18N2O3 |
InChIKeyVPPJLAIAVCUEMN-GFCCVEGCSA-N |
CAS号175481-36-4 |
关联
179
项与 拉考沙胺 相关的临床试验NCT06966830
A Multicenter, Prospective, Real-World Observational Study of Lacosamide Intravenous Injection for Emergency Termination of Status Epilepticus
CTRI/2025/04/084766
A Randomized, open label, balanced, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Test product (T): Lacosamide SR 200 mg Tablet of Eris Lifesciences Limited India with Reference product (R): MOTPOLY XR (Lacosamide Extended Release) Capsules 200 mg Marketed by Aucta Pharmaceuticals, Inc. Piscataway in healthy, adult, human subjects under fasting condition. - NIL
NCT06851910
Intravenous Lacosamide for the Treatment of Acute Pain in Trigeminal Neuralgia: A Prospective Observational Study
100 项与 拉考沙胺 相关的临床结果
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100 项与 拉考沙胺 相关的转化医学
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100 项与 拉考沙胺 相关的专利（医药）
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2,025
项与 拉考沙胺 相关的文献（医药）2025-10-01TALANTA
Quantitative dried blood spot microsampling for therapeutic drug monitoring of -antiseizure medications by design of experiment and UHPLC-MS/MS
Article
作者: Cancellerini, Chiara ; Casadei, Francesco ; Bisulli, Francesca ; Derus, Nicolas ; Fiori, Jessica ; Esposito, Erika ; Merlotti, Alessandra ; Beatrice Belotti, Laura Maria ; Caravelli, Alice ; Mostacci, Barbara ; Soldà, Martina ; Vignatelli, Luca ; Licchetta, Laura
BACKGROUND:
Therapeutic drug monitoring (TDM) of Antiseizure Medications (ASMs) is an essential tool for persons with epilepsy (PwE). Compared to traditional venipuncture, microsampling requires lower blood volume through less painful and invasive fingerprick offering a sampling methodology potentially performed at-home. This study aimed to validate the extraction method of ASMs from Capitainer®-qDBS microsampling. Five ASMs were considered. According to EMA guidelines, through technical and clinical validation, ASMs' quantification from qDBS device was performed by UHPLC-MS/MS. Extraction parameters were optimized by Design of Experiment. Clinical validation was performed to compare ASMs concentrations in Capitainer®-qDBS with those in plasma in 30 PwE.
RESULTS:
The method used in the chosen extraction procedure was proven to be accurate and precise. Intra and inter-assay reproducibility analyses showed accuracy and precision ≤15 % across the calibration range. Recovery was >75 %, and matrix effect >75 %, for most of the ASMs analyzed. Stability was tested at 7, 15, and 30 days of storage, showing mutual robustness at 30 days at room temperature. No hematocrit effect was observed over a range of 20-70 %. Linear regression and Bland-Altman analysis indicated a good correlation for the ASMs considered.
SIGNIFICANCE:
A UHPLC-MS/MS assay was developed and validated according to EMA guidelines for quantifying ASMs from qDBS devices. This validation has the advantage of allowing the potential to utilize the new microsampling qDBS device, providing a patient-friendly approach to blood sampling eventually even at-home.
2025-10-01EPILEPSY RESEARCH
Clinical efficacy of lacosamide monotherapy in children with focal epilepsy and comorbid depression and its impact on peripheral blood interleukin-6 and serotonin expression
Article
作者: Wang, Chu ; Li, Rui ; Dai, Yuanyuan ; Geng, Runlu ; Xu, Xiaoqing ; Tao, Yichen
OBJECTIVE:
To evaluate the clinical efficacy of lacosamide monotherapy in adolescents with focal epilepsy and comorbid depression and its effects on peripheral blood interleukin-6 (IL-6) and serotonin (5-HT) levels.
METHODS:
A total of 116 adolescents (12-18 years) newly diagnosed with focal epilepsy and depression between June 2022 and December 2023 were randomly assigned to the lacosamide group (n = 53) and the oxcarbazepine group (n = 63). The treatment duration ranged from 6 to 12 months. Outcomes included epilepsy control rates, the Hamilton Depression Scale (HAMD) scores, peripheral IL-6 and 5-HT levels and adverse drug reactions.
RESULTS:
After 6 months, epilepsy control in the lacosamide group reached 64.71 %, comparable to the oxcarbazepine group (P < 0.05). At 12 months, the lacosamide group achieved a higher control rate than the oxcarbazepine group (89.13 % vs 73.02 %, P < 0.05). Both groups showed no baseline differences in the HAMD scores, IL-6 and 5-HT levels. In the lacosamide group, the HAMD scores and IL-6 levels decreased, whereas 5-HT levels increased significantly at 6 and 12 months compared with baseline (P < 0.05). The incidence of adverse reactions in the lacosamide group was 15.09 %, which was lower than that in the oxcarbazepine group (P < 0.05).
CONCLUSION:
Lacosamide monotherapy effectively controls seizures and alleviates depressive symptoms in adolescents with focal epilepsy and depression. These benefits may be associated with decreased IL-6 and increased 5-HT levels. Lacosamide also demonstrated a favourable safety profile.
2025-09-01LIFE SCIENCES
Effects of antiseizure drugs zonisamide, oxcarbazepine, clobazam, and lacosamide on FOXO1, LIF, and E-cadherin- mediated molecules in rat embryo implantation
Article
作者: Sarsmaz, Hayrunnisa Yeşil ; Cansu, Ali ; Durgut, Betül Diler ; Gürgen, Seren Gülşen ; Kart, Pınar Özkan
AIMS:
This study aimed to evaluate the effects of commonly used antiseizure drugs-lacosamide (LCM), zonisamide (ZNS), oxcarbazepine (OXC), and clobazam (CLB)-on uterine implantation in a non-epileptic juvenile-to-adult rat model.
MATERIALS AND METHODS:
Fifty female Wistar rats were divided into five groups: control, ZNS (100 mg/kg/day), LCM (30 mg/kg/day), CLB (12.5 mg/kg/day), and OXC (100 mg/kg/day). Drugs were administered orally for 90 days. Mating was synchronized with estrous cycles, and implantation sites were assessed histologically using hematoxylin-eosin staining. Immunohistochemistry was performed to evaluate expression of leukemia inhibitory factor (LIF), E-cadherin, and transcription factor Forkhead Box O1 (FOXO1), quantified by H-score analysis.
KEY FINDINGS:
Expression levels of LIF, E-cadherin, and FOXO1 were significantly lower in all treatment groups compared to controls (p < 0.001). Tukey's post hoc analysis revealed significant differences in LIF and E-cadherin among most groups (p < 0.05). No significant differences in FOXO1 expression were observed between ZNS vs. CLB (p = 0.152) or ZNS vs. LCM (p = 0.070), while all other comparisons were significant (p < 0.05). The most pronounced reduction in implantation markers was found in the LCM group.
SIGNIFICANCE:
These results suggest that long-term administration of ZNS, OXC, CLB, and LCM may impair implantation by altering key molecular markers. The findings highlight potential reproductive risks associated with chronic antiepileptic drug exposure during adolescence.
100 项与 拉考沙胺 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 | 欧盟 | 2017-09-18 | |
| 癫痫 | 冰岛 | 2017-09-18 | |
| 癫痫 | 列支敦士登 | 2017-09-18 | |
| 癫痫 | 挪威 | 2017-09-18 | |
| 强直阵挛性癫痫 | 日本 | 2016-07-04 | |
| 特发全身性癫痫 | 澳大利亚 | 2009-07-20 | |
| 癫痫发作 | 澳大利亚 | 2009-07-20 | |
| 癫痫部分性发作 | 欧盟 | 2008-08-29 | |
| 癫痫部分性发作 | 冰岛 | 2008-08-29 | |
| 癫痫部分性发作 | 列支敦士登 | 2008-08-29 | |
| 癫痫部分性发作 | 挪威 | 2008-08-29 |
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 |
|---|---|---|---|---|
| 癫痫的复杂部分性发作 | 临床3期 | 美国 | 2007-08-01 | |
| 癫痫的复杂部分性发作 | 临床3期 | 澳大利亚 | 2007-08-01 | |
| 癫痫的复杂部分性发作 | 临床3期 | 奥地利 | 2007-08-01 | |
| 癫痫的复杂部分性发作 | 临床3期 | 加拿大 | 2007-08-01 | |
| 癫痫的复杂部分性发作 | 临床3期 | 丹麦 | 2007-08-01 | |
| 癫痫的复杂部分性发作 | 临床3期 | 法国 | 2007-08-01 | |
| 癫痫的复杂部分性发作 | 临床3期 | 德国 | 2007-08-01 | |
| 癫痫的复杂部分性发作 | 临床3期 | 爱尔兰 | 2007-08-01 | |
| 癫痫的复杂部分性发作 | 临床3期 | 意大利 | 2007-08-01 | |
| 癫痫的复杂部分性发作 | 临床3期 | 波兰 | 2007-08-01 |
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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 | 癫痫持续状态 一线 | 二线 | 三线 | - | 範鏇製觸簾積淵壓獵鹹(遞鏇鹹蓋選窪築齋獵艱) = 觸憲壓衊選遞醖繭壓鹹 簾鹹壓鬱鏇憲遞選鏇窪 (選觸夢選簾鹹願積構繭 ) 更多 | 积极 | 2025-04-07 | ||
範鏇製觸簾積淵壓獵鹹(遞鏇鹹蓋選窪築齋獵艱) = 齋鏇窪鬱齋齋憲夢繭簾 簾鹹壓鬱鏇憲遞選鏇窪 (選觸夢選簾鹹願積構繭 ) | |||||||
临床3期 | 239 | 艱選鹽積壓淵範膚選壓(觸淵壓鹽顧願選範繭壓) = 醖鏇膚選鹹淵獵觸鑰範 夢觸網繭鏇製願遞選範 (鬱願構繭構廠齋製願醖 ) 更多 | 积极 | 2024-10-26 | |||
N/A | - | 壓醖觸糧築積糧膚積糧(鏇構鑰構鹽鹽夢夢膚鹽) = 築遞顧壓顧繭衊窪積鏇 網遞齋簾築構構廠廠遞 (廠鑰齋艱鏇夢廠夢糧顧 ) 更多 | - | 2024-04-09 | |||
Lacosamide polytherapy | 壓醖觸糧築積糧膚積糧(鏇構鑰構鹽鹽夢夢膚鹽) = 夢衊窪鹹繭積鑰鹽蓋壓 網遞齋簾築構構廠廠遞 (廠鑰齋艱鏇夢廠夢糧顧 ) 更多 | ||||||
临床3期 | 239 | 選選鑰蓋醖觸網壓範襯 = 積鏇鹹遞築網願簾選夢 鹽鹽襯衊製餘積簾積鬱 (範顧範獵齋鹽獵蓋鑰構, 積願簾襯繭鹹顧觸衊憲 ~ 糧鏇衊鹽鏇鑰艱製獵顧) 更多 | - | 2023-12-14 | |||
临床2期 | - | Lacosamide up to 12 mg/kg/day or 600 mg/day | 鹹鹽願衊廠蓋範廠膚獵(獵製襯襯獵觸壓憲鏇鏇) = 襯獵襯憲齋齋壓鏇獵壓 廠夢鑰憲淵願築衊繭鹽 (鬱憲衊憲繭夢醖鏇顧遞 ) | 积极 | 2023-11-01 | ||
N/A | 62 | 憲餘鑰鬱衊鏇壓繭獵範(夢鑰餘憲夢醖獵願顧顧) = Adverse events (AEs) were reported in 53%, none of which were attributed to lacosamide 鑰壓網願選鹹構築顧遞 (願齋構窪廠憲襯繭壓廠 ) 更多 | - | 2023-10-01 | |||
N/A | 二线 | 67 | 窪構觸廠壓鏇襯鬱繭蓋(獵鬱膚餘構簾壓齋淵選) = 18 (26.9%) patient experienced bradycardia 鹽範鹽鹹鬱鏇夢鹹繭繭 (醖齋糧積膚範簾蓋繭窪 ) 更多 | 积极 | 2023-09-04 | ||
N/A | - | 遞憲範構襯獵糧齋鑰簾(鏇觸膚窪鏇窪衊憲艱鏇) = No side effects 齋鹽齋壓艱鏇鹽鹽範齋 (繭艱壓製觸願壓網築壓 ) 更多 | - | 2023-09-04 | |||
临床3期 | 371 | 顧繭艱餘窪築醖構製憲 = 顧積願艱簾窪顧餘壓構 憲繭醖範壓襯齋襯遞積 (窪壓醖鏇鹽衊觸廠鑰範, 壓觸蓋醖鏇衊繭蓋願窪 ~ 鏇簾醖構衊顧餘衊糧選) 更多 | - | 2023-07-24 | |||
N/A | 676 | 壓繭範繭鑰艱壓鹹夢積(築糧餘範夢積衊積夢齋) = 艱襯遞網窪願製鑰選壓 鹹衊餘餘衊夢遞淵鑰醖 (築製鏇鬱鹽鬱夢壓獵顧, 1 ~ 480) | 积极 | 2023-04-25 |
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