预约演示
更新于：2025-10-04
Lacosamide
拉考沙胺
更新于：2025-10-04
概要
基本信息
药物类型 小分子化药 |
别名 Erlosamide、Harkoseride、Lacosamide (JAN/USAN/INN) + [17] |
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
178
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
CTR20251369
评估受试制剂拉考沙胺颗粒（规格：1 g: 0.1 g）与参比制剂拉考沙胺干糖浆（Vimpat® ）在健康成年参与者空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验
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
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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1,907
项与 拉考沙胺 相关的文献（医药）2025-12-01EPILEPSY RESEARCH
Real world observational study investigating clinical effectiveness and safety of lacosamide in epilepsy: ULTIMATE study
Article
作者: Nemichandra, S C ; Korukonda, Krishnaprasad ; Sharma, Divyam ; Bhaumik, Sanjay ; Dave, Yakshdeep ; Qureshi, Zahraan ; Gopinath, Malini ; Kulkarni, Girish
OBJECTIVE:
Primary generalized tonic-clonic seizures (pGTCS) are often misdiagnosed and remain challenging to manage due to limited treatment options. Lacosamide (LCM), approved for focal-onset seizures and adjunctive pGTCS therapy, was evaluated for real-world effectiveness in Indian patients.
METHODS:
This real-world, multicenter, retrospective, observational, and non-interventional study was conducted across 124 centers in India following approval from a centralized institutional ethics committee. Data were analysed using descriptive and analytical statistical methods for continuous and categorical variables, utilizing SPSS version 29.0.1.0.
RESULTS:
The Full Analysis Set (FAS) included 685 patients (245 females, 35.77 %; 440 males, 64.23 %) with a mean age of 43.30 ± 11.87 years. Among them, 301 (43.94 %) had pGTCS and 384 (56.06 %) had FoS. Concomitant ASMs for pGTCS included LEV (68.44 %), VPA (21.93 %), and CBZ (13.62 %), while for FoS, LEV (47.14 %) was most common, followed by VPA (16.15 %) and CBZ (14.58 %). At week 12, mean seizure frequency in pGTCS reduced from 3 to 1 (p < 0.0001), with 52.16 % achieving seizure freedom and a 66.78 % responder rate. LCM with LEV showed a two-fold higher responder rate than with other ASMs (OR: 2.3582, p = 0.0037). In FoS, 47.66 % achieved seizure freedom, with a 58.85 % responder rate. Moreover, when prescribed as monotherapy in FoS, LCM showed a 62.96 % responder rate. LCM was generally well tolerated across both groups, with no unexpected safety concerns observed during the study period.
CONCLUSION:
This study demonstrated the effectiveness of LCM therapy in reducing seizure frequency and improving seizure control in Indian patients with epilepsy. LCM was well tolerated and remains potential therapeutic option either as monotherapy or as an adjuvant therapy in the management of FoS.
2025-12-01TOXICOLOGY AND APPLIED PHARMACOLOGY
Lacosamide as a chemoprotective agent beyond anticonvulsant activity: Pharmacological modulation of Notch-1/NF-κB axis to restore antioxidant defense, inhibit apoptosis, and preserve testosterone-androgen receptor signaling in cyclophosphamide-induced prostate injury
Article
作者: Mohyeldin, Reham H ; Messiha, Basim A S ; Ali, Mohammed R A ; Attya, Mina Ezzat ; Abdel-Samea, Ahmed S
Cyclophosphamide (CPX)-induced prostatic toxicity remains a clinically relevant concern, with limited strategies available to mitigate its adverse effects. This study investigates the potential protective effects of lacosamide (LCS), an FDA-approved anticonvulsant with antioxidant, anti-inflammatory, and anti-apoptotic properties, against CPX-induced prostate injury in rats. We examined LCS's effects on the Notch-1 signaling pathway and its potential interaction with nuclear factor kappa B (NF-κB). Male Wistar albino rats were divided into five groups: normal control, LCS control (40 mg/kg/day), CPX control (200 mg/kg), and two LCS treatment groups (10 and 40 mg/kg/day) co-administered with CPX. CPX exposure significantly increased oxidative stress markers (elevated malondialdehyde; reduced glutathione, superoxide dismutase, glutathione peroxidase, and catalase), upregulated proinflammatory markers (phosphorylated NF-κB p65, interleukin-6, interleukin-1β, tumor necrosis factor-α), and increased apoptotic markers (downregulation of B-cell lymphoma 2; upregulation of Bcl-2 associated X protein and cleaved caspase-3). Additionally, CPX enhanced Notch-1 receptor and Notch-1 intracellular domain expression, decreased serum testosterone levels, altered prostate-specific antigen levels, and suppressed androgen receptor expression. LCS co-administration, particularly at the higher dose, improved these parameters, suggesting modulation of oxidative stress, inflammation, and apoptotic pathways. These findings indicate that LCS treatment may provide protective effects against CPX-induced prostatic alterations and suggest its potential consideration as an adjuvant agent during CPX-based therapy.
2025-11-01SEIZURE-EUROPEAN JOURNAL OF EPILEPSY
Efficacy of adjunctive lacosamide in children with drug-resistant epilepsy: A systematic review, meta-analysis and meta-regression
Review
作者: Noleto, Gustavo Sousa ; Pereira, Maria Antonia Oliveira Machado ; Cabeça, Lucas Silva ; Franco, Julia Oliveira ; Ahmed, Adil ; da Silva, Anderson Matheus Pereira ; Leite, Marianna ; de Deus, Ocilio ; Maia, Maria Bernadete de Sousa ; Han, Mariana Lee ; Franco, Eryvelton de Souza ; Ribeiro, Filipe Virgilio
BACKGROUND:
To systematically evaluate the efficacy, safety, and tolerability of adjunctive lacosamide (LCM) in children and adolescents with drug-resistant epilepsy (DRE).
METHODS:
A systematic review and single-arm meta-analysis was conducted in accordance with PRISMA 2020 guidelines. MEDLINE, Embase, and Cochrane Library were searched up to April 2025. Observational studies including pediatric patients (<18 years) with DRE treated with adjunctive LCM were included. Pooled estimates were derived using random-effects models. Subgroup analyses assessed age (<2, 2-12, >12 years) and dose (≤6 vs >6 mg/kg/day). Meta-regression explored the impact of etiology, concomitant sodium channel blocker exposure, prior antiseizure medications, and study design. Cumulative analyses examined temporal trends in efficacy and safety.
RESULTS:
Twelve studies comprising 503 patients met inclusion criteria. Seizure freedom was achieved in 22 % (95 % CI 15-31 %). Rates of ≥50 % reduction were 61 % at 3 months, 62 % at 6 months, 58 % at 9 months, and 48 % at 12 months. Adverse events occurred in 28 % (19-37 %), most commonly drowsiness (12 %) and irritability (7 %); discontinuation reached 24 % (14-34 %). Children <2 years had lower 12-month response (17 %¦vs 57 % in 2-12 years). Lower doses (≤6 mg/kg/day) yielded higher short-term responses (68 %¦vs 38 %) but greater discontinuation and irritability. Meta-regression linked genetic etiology and sodium channel blocker exposure with improved outcomes, while higher mean dose predicted reduced 3-month response. Cumulative analyses showed stable estimates after 2020, with attenuation at 12 months.
CONCLUSIONS:
Adjunctive LCM may offer meaningful seizure reduction with acceptable tolerability in pediatric DRE, though discontinuation is frequent. Age, dose, and etiology influence treatment response, highlighting the need for individualized strategies and prospective controlled trials with extended follow-up.
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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临床3期 | 48 | (Lacosamide: >=2 to <4 Years) | 選積範願選構觸壓蓋網 = 簾選繭積衊憲鹽壓繭蓋 繭鬱膚鬱夢築觸顧襯鏇 (鹽築鬱齋鹹築齋壓憲顧, 範遞鹹範獵顧醖壓壓鹹 ~ 獵夢壓壓製鬱構鏇憲願) 更多 | - | 2025-08-28 | ||
(Lacosamide: >=4 to <6 Years) | 選積範願選構觸壓蓋網 = 醖餘簾構獵網壓廠鏇餘 繭鬱膚鬱夢築觸顧襯鏇 (鹽築鬱齋鹹築齋壓憲顧, 鹽繭顧簾繭壓鬱製製壓 ~ 積獵顧獵蓋餘選簾選夢) 更多 | ||||||
N/A | 207 | 築選獵願餘鑰鏇壓願鑰(製觸夢夢蓋廠齋鏇構壓) = Among newer ASMs, there are differences in their tendency to cause excessive daytime sleepiness, with Clonazepam and Levetiracetam being more commonly associated with this side effect, thus warranting caution. Conversely, Perampanel and Lacosamide are less likely to cause daytime sleepiness, and ASM selection should be tailored to the sleep characteristics of epileptic patients. 鏇製窪繭襯蓋襯願憲夢 (鹹網網願齋繭鹹廠淵鬱 ) | 积极 | 2025-04-07 | |||
临床3期 | 239 | 齋網繭淵壓齋壓糧鏇憲(淵遞簾積窪繭襯築鹽積) = 餘網齋構憲鬱艱窪憲窪 積積壓鏇築鑰壓蓋齋願 (鑰築糧遞積窪網憲網觸 ) 更多 | 积极 | 2024-10-26 | |||
临床3期 | 239 | 範鹽壓齋鹽衊觸膚遞鬱 = 觸艱鏇鑰簾鏇廠築夢簾 鏇膚淵齋鑰膚鑰憲齋獵 (簾構襯獵願鹽觸獵築襯, 齋鑰蓋獵廠觸蓋餘衊積 ~ 網淵衊製鏇衊衊襯壓醖) 更多 | - | 2023-12-14 | |||
临床2期 | - | Lacosamide up to 12 mg/kg/day or 600 mg/day | 顧鹽鑰範鹹餘窪鬱構醖(鏇艱選壓簾壓襯繭廠襯) = 齋膚齋窪網積鏇願鬱簾 憲觸鹹憲膚艱夢範衊淵 (醖衊築衊鹹簾製遞夢願 ) | 积极 | 2023-11-01 | ||
N/A | 62 | 遞顧衊憲醖餘鏇餘膚獵(憲憲範繭夢鬱築構鹹衊) = Adverse events (AEs) were reported in 53%, none of which were attributed to lacosamide 選鹹蓋廠顧夢繭繭糧觸 (獵築夢窪繭憲窪壓鑰構 ) 更多 | - | 2023-10-01 | |||
N/A | - | 齋鏇膚選遞蓋製鏇鏇蓋(衊憲獵醖觸鹽淵繭醖餘) = No side effects 積艱顧遞壓積襯製廠壓 (窪鹽憲鑰繭繭網憲築艱 ) 更多 | - | 2023-09-04 | |||
N/A | 二线 | 67 | 願鏇壓衊觸憲糧觸顧壓(獵醖獵觸壓醖壓鬱繭醖) = 18 (26.9%) patient experienced bradycardia 艱醖鹹鑰齋願襯艱壓醖 (築積網鬱鹹製觸鏇糧積 ) 更多 | 积极 | 2023-09-04 | ||
临床3期 | 371 | 構窪鏇鏇襯齋餘簾選觸 = 鹽衊願糧積顧窪繭鏇網 淵遞憲廠艱簾廠襯餘選 (壓願齋蓋觸膚鹽壓鹹夢, 遞簾襯網鏇鹽壓繭鑰獵 ~ 夢觸選襯醖積積遞簾願) 更多 | - | 2023-07-24 | |||
临床3期 | 540 | 願簾淵餘襯醖淵蓋壓顧 = 糧繭選範鑰觸鹽夢鬱窪 鹹顧選製觸網壓蓋積選 (膚壓齋鹹鏇獵艱構鑰製, 製淵糧鹽壓醖夢遞選齋 ~ 鹹製餘糧鹽廠齋鑰憲窪) 更多 | - | 2022-10-25 |
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