Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II: a Randomized, Controlled, Double-blind, Parallel-group Clinical Trial.

Initially, observational studies suggested a possible effect of Lacosamide on depressive and anxious symptoms in individuals with epilepsy, and later, an open-label study demonstrated the efficacy of lacosamide in improving depressive and manic symptoms in individuals with bipolar disorder (BD). The primary objective of this study is to evaluate the efficacy of combining lacosamide as an augmentation treatment to first- or second-line medication treatments in moderate to severe major depressive episodes of treatment-resistant BD I and II (failure of at least two adequate treatments during the current episode). The main hypothesis of the study is that lacosamide produces a greater reduction in depression scores compared to a placebo treatment and that both groups will exhibit similar rates of side effects and adverse events. We will conduct a double-blind, randomized, parallel-group pilot study, comparing the enhancement of the treatment that patients had been using with lacosamide and placebo, over a duration of 12 weeks. Forty subjects aged between 18 and 65 years with a diagnosis of BD (I or II) in a moderate or severe major depressive episode, despite the use of first- or second-line treatments, will be selected. The primary outcome will be the assessment of lacosamide efficacy through the difference in scores on the Hamilton Depression Rating Scale (HAMD-17) from the initial visit to the end of week 12 of intervention between the lacosamide and placebo groups.

开始日期2026-01-09

申办/合作机构

University of Sao Paulo

[+1]

IRCT20250525065882N1

/ Recruiting临床3期IIT

Evaluating the effect of Lacosamide treatment on the severity of headache attacks and CGRP-LI levels in people with migraine: A triple-blind randomized clinical trial

开始日期2025-06-21

申办/合作机构

Tehran University of Medical Sciences

NCT06966830

/ Not yet recruitingN/AIIT

A Multicenter, Prospective, Real-World Observational Study of Lacosamide Intravenous Injection for Emergency Termination of Status Epilepticus

Status epilepticus (SE) is an acute and critical form of neurological and systemic diseases involving multiple clinical disciplines, with an annual incidence of (20-73) per 100,000 people and a clinical case fatality rate of 20%. Although there are many causes of SE, the primary goal of treatment is to terminate the seizures quickly, and timely and standardized treatment can reduce mortality and improve prognosis. The prognosis is closely related to the duration of the episode, and the longer the episode, the worse the prognosis. If seizures of convulsive status epilepticus persist for more than 10 minutes and are not provided with optimal therapeutic intervention, serious adverse outcomes and even death are likely to occur. How to effectively terminate status epilepticus and actively find effective, reliable and safe treatment options is a key research problem at present. Due to critical illness, limited treatment options, and poor prognosis, new treatments are urgently needed to terminate persistent epileptic activity.
Lacosamide (LCM) is a third-generation new antiepileptic drug, which was approved in 2008 for the additive treatment of patients aged 16 years and older with focal seizures, with or without generalized seizures. In 2017, it was extended to patients over 4 years of age. Lacosamide is an anticonvulsant drug with a new dual mechanism of action: first, lacosamide antagonizes the glycine site of N-methyl-D-aspartate (NMDA) receptor; Second, lacosamide selectively acts on the slow inactivation of sodium channels and prolongs the inactivation time of sodium channels, which can more effectively reduce sodium influx and reduce the excitability of neurons, so as to achieve the purpose of treating epilepsy. Lacosamide exhibits linear pharmacokinetics, high oral bioavailability, protein binding of < 15%, rapid and almost complete absorption in a single oral dose, and maximum plasma concentrations within 1 to 4 hours. A number of randomized controlled clinical studies and real-world studies abroad have shown that lacosamide can significantly improve the effective rate and seizure-free rate of epilepsy control, and it is well tolerated and has fewer adverse reactions. The 2022 Chinese Expert Consensus on the Diagnosis and Treatment of Post-stroke Epilepsy recommended lacosamide injection as a first-line drug for non-convulsive status epilepticus after stroke, and the Chinese Expert Consensus on the Diagnosis and Treatment of Status Epilepticus in Children (2022) recommended that lacosamide be considered as an additive treatment for refractory convulsive status epilepticus in children > 60 minutes . There is a lack of clinical research data on the efficacy and safety of intravenous bolus lacosamide for status epilepticus, including convulsive status epilepticus and non-convulsive epilepticus.

开始日期2025-06-06

申办/合作机构

广州医科大学附属第二医院

[+4]

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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1,778

项与拉考沙胺相关的文献（医药）

2026-07-01·Bioactive Materials

Collagen II hydrogel-mediated sustained delivery of lacosamide attenuates cartilage degeneration and pain in osteoarthritis

Article

作者: Moradi, Lida ; Wiznia, Daniel H ; Liu, Chuan-Ju ; Liu, Xin ; Yang, Xinyu ; Huang, Guiwu ; Cui, Xudong ; Waxman, Stephen G ; Bi, Jingwei ; Fu, Wenyu ; Varthi, Arya ; He, Chaopeng

Osteoarthritis (OA) lacks effective disease-modifying therapies. Nav1.7 has recently been identified as a regulator of both chondrocyte metabolism and pain, establishing it as a dual-acting therapeutic target in OA. This study evaluated lacosamide (LCM) as a disease-modifying candidate and developed a cartilage-targeted delivery strategy to enhance its translational potential. Sodium channel inhibitors (carbamazepine, oxcarbazepine, and LCM) were evaluated in primary human OA chondrocytes, cartilage explants, and a murine DMM model with systemic or intra-articular administration. Pain behavior was assessed by von Frey and open-field testing. A collagen II-based thermoresponsive hydrogel was developed for sustained intra-articular delivery, and outcomes were assessed by histology, immunohistochemistry, ELISA, and gene expression analyses. LCM was the most potent inhibitor in suppressing IL-1β-induced catabolism and promoting anabolism in human chondrocytes, showing greater efficacy at lower concentrations than carbamazepine or oxcarbazepine. Systemic LCM reduced cartilage degeneration and pain in murine OA and outperformed carbamazepine at equivalent doses, while intra-articular administration achieved superior protection and analgesia at one-tenth the dose. Mechanistically, LCM increased HSP70 and midkine secretion to drive anabolic and anti-catabolic responses. Sustained delivery via a collagen II-based hydrogel prolonged joint retention and enhanced therapeutic durability. Together with its clinical efficacy in Nav1.7 mutation-related neuropathy, these findings underscore LCM's translational potential as a dual-acting disease-modifying therapy for OA. LCM is a dual-acting Nav1.7 inhibitor that alleviates pain and modifies OA progression. Collagen II-based intra-articular delivery enhances efficacy and supports clinical translation as a noninvasive, non-opioid disease-modifying therapy.

2026-04-01·BIOMEDICAL CHROMATOGRAPHY

Therapeutic Drug Monitoring of Clobazam, Perampanel, and Lacosamide Using a UPLC‐MS/MS Method: Analysis of 5‐Year Experience in a Large Cohort of Pediatric Epilepsy Patients From China

Article

作者: Yu, Lu‐Hai ; Zhang, Hui‐Lan ; Zhao, Ting ; Feng, Jie ; Sun, Yan ; Li, Hong‐Jian ; Yu, Jing

ABSTRACT:

This study aims to develop an ultra high‐performance liquid chromatography–mass spectrometry (UPLC‐MS/MS) method to quantify clobazam, perampanel, and lacosamide plasma concentrations in pediatric epilepsy patients. Elution was performed using a gradient elution program, with a mobile phase composed of 0.01% formic acid in water and 0.01% formic acid in acetonitrile. The flow rate was 0.6 mL/min. The injector temperature was 10°C. The injection volume was 4 μL. Linearity, sensitivity, precision, accuracy, specificity, carryover, and extraction recovery were evaluated. Therapeutic drug monitoring data of 1132 samples were analyzed. The method was linear within 10–600 ng/mL, 100–2000 ng/mL, and 1.0–30.0 μg/mL for clobazam, perampanel, and lacosamide, respectively ( r ≥ 0.998). The results indicated that the within‐run and between‐run precision coefficient of variation (CV %) did not exceed 15.0%, and that the accuracy (bias) ranged from −8.3% to 13.6%. Recovery ranged from 90.9% to 108.1%. All plasma samples could be maintained for up to 3 h at ambient temperature, 24 h at 4°C, 30 days at −30°C, and after successive freeze–thaw cycles in the absence of significant degradation. We successfully developed a simple and rapid LC‐MS/MS method for the simultaneous measurement of three new generation ASMs, and successfully applied it to clinical practice.

2026-04-01·Legal Medicine

Two fatal cases of lacosamide poisoning with contrasting postmortem findings: implications for forensic toxicology

Article

作者: Minamiyama, Takumi ; Kondou, Hiroki ; Yamaki, Taeka ; Shintani-Ishida, Kaori ; Hirata, Mayu ; Kawamoto, Masataka ; Ikegaya, Hiroshi

Lacosamide is a third-generation antiepileptic drug with expanding clinical use worldwide. Although generally considered safe, it has occasionally resulted in fatal intoxications; however, detailed postmortem data remain limited. Here, we describe two fatal cases of acute lacosamide poisoning with contrasting postmortem findings. In case 1, the cardiac blood concentration was extremely high (200 µg/mL). The gastric contents contained no visible solid residue at autopsy, although computed tomography images revealed hyperdense material in the stomach, extending toward the pyloric region. The cardiac blood included soft clots. The direct cause of death was presumed to be acute lacosamide poisoning. The cardiac/peripheral blood concentration ratio was 1.67, which exceeded previously reported values. In case 2, the cardiac blood concentration (74 µg/mL) was within the range reported in fatal cases. The gastric contents showed visible white powder, which was limited to the stomach cavity. The cardiac blood was a dark-reddish liquid. The urinary concentration was higher compared with that in case 1, which was consistent with rapid renal excretion. Alcohol intake and underlying sick sinus syndrome likely contributed to the fatal outcome. The cardiac/peripheral blood concentration ratio was 1.12, which was a comparable value to those previously reported. These cases demonstrate variability in the postmortem findings of fatal lacosamide poisoning, which highlights the importance of interpreting gastric, urinary, and coagulation findings along with blood levels. Given the increasing use of lacosamide, it is necessary to incorporate this substance into forensic toxicology screening protocols to aid in the precise diagnosis of drug-related fatalities.

368

项与拉考沙胺相关的新闻（医药）

2026-03-24

·米内网

【重磅】青峰医药1类新药来袭，抢攻1000亿市场

精彩内容近日，青峰医药申报的化药1类新药KR23248胶囊获得临床试验默示许可，拟用于精神分裂症的治疗。米内网数据显示，2025年中国三大终端六大市场（统计范围详见本文末）神经系统药物（化药+生物药）销售额超过1000亿元。 KR23248胶囊是青峰医药开发的一款化药1类创新药，其临床申请于今年2月获得CDE承办受理（受理号CXHL2600180），3月就顺利获批临床，拟用于精神分裂症的治疗。米内网数据显示，近年来中国三大终端六大市场神经系统药物（化药+生物药）销售额均超过1000亿元。从治疗亚类看，以其它神经系统药物为主，此外，麻醉剂、止痛药、精神兴奋药、精神安定药占比均超过10%。近年来中国三大终端六大市场神经系统药物（化药+生物药）销售情况（单位：万元）来源：米内网格局数据库 2025年中国三大终端六大市场神经系统药物（化药+生物药）通用名TOP5合计市场份额接近19%，其中丁苯酞、瑞芬太尼、舒芬太尼稳居前三；依达拉奉右莰醇排位第四，较2024年提升5个位次。 2025年中国三大终端六大市场神经系统药物（化药+生物药）通用名TOP5 来源：米内网格局数据库在神经系统领域，青峰医药拥有10余个产品的生产批文，包括吡仑帕奈口服混悬液、利多布比卡因注射液、布立西坦片、拉考沙胺片、拉考沙胺注射液等多个首仿品种（含剂型首仿），分布在抗癫痫、精神兴奋、止痛、麻醉等细分领域。青峰医药已获批上市的神经系统药物来源：米内网中国上市药品（MID）数据库在研神经系统新药中，3款化药1类新药处于获批临床及以上阶段，其中KR23343片、KR23335片均处于I期临床试验，且均用于癫痫发作的治疗。米内网数据显示，2025年中国三大终端六大市场抗癫痫化药销售额超过76亿元。青峰医药在研的神经系统1类新药来源：米内网综合数据库仿制药方面，布立西坦口服溶液、布立西坦注射液、拉米地坦片3个品种以新注册分类申报在审，目前国内均暂无企业拥有生产批文。青峰医药猛攻布立西坦制剂产品，早前已拿下布立西坦片国内首仿，2025年在中国三大终端六大市场的销售额突破3000万元。青峰医药以新注册分类申报在审的神经系统药物来源：米内网中国申报进度（MED）数据库注：米内网《中国三大终端六大市场药品竞争格局》，统计范围：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至3月24日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 ●温馨提示● 因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下：【分享、点赞、在看】点一点不失联哦

2026-03-21

·验证硬科技

癫痫行业研究报告

摘要癫痫（Epilepsy）作为一种常见的慢性神经系统疾病，全球约有5000-7000万患者（不同来源数据存在差异，WHO官方数据为约5000万），中国约有900万患者，市场规模达数百亿元。本报告基于全面的文献调研和数据分析，系统梳理了癫痫的定义与发病机制、流行病学特征、诊断方式、患者人群、临床痛点、已上市及在研药物、市场规模与发展趋势。癫痫的核心发病机制涉及神经元异常放电，其分类体系依据国际抗癫痫联盟（ILAE）2021年标准分为局灶性发作、全面性发作、未知起始发作等类型。在诊断方面，脑电图（EEG）和磁共振成像（MRI）是核心手段，新型高密度EEG和7T MRI进一步提升了诊断准确率。约30%的癫痫患者最终发展为药物难治性癫痫，存在巨大的未满足临床需求。已上市药物涵盖传统、新型和第三代抗癫痫药物，新靶点药物如KCNQ钾通道开放剂、AMPA受体拮抗剂等正在研发中。全球抗癫痫药物市场预计到2030年将达到117亿美元，中国市场增长迅速。第一章：行业概述1.1 癫痫的定义与发病机制癫痫（Epilepsy）是一种由脑部神经元异常放电导致的慢性神经系统疾病，其特征为反复发作性、短暂性的大脑功能障碍。根据国际抗癫痫联盟（ILAE）的定义，癫痫是一种以具有持久性的致痫倾向为特征的脑部疾病，有着不同病因基础、临床表现各异但以反复癫痫发作为共同特征的慢性脑部疾病状态。1.2 癫痫的流行病学分析癫痫影响所有年龄、种族、社会阶层和地区的人群，在全球范围内造成重大经济负担。关于全球患者数量，不同来源数据存在差异：WHO官方数据显示约5000万人患有癫痫；多个学术文献引用约7000万数据；这一差异可能源于统计口径不同（活动性癫痫 vs 历史累计确诊患者）。1.3 癫痫分类体系（ILAE 2021标准）根据2017年ILAE癫痫分类框架，诊断分为三个层级：发作类型（Seizure Type）、癫痫类型（Epilepsy Type）和癫痫综合征（Epilepsy Syndrome）。2025年ILAE对癫痫发作分类进行了更新，维持四个主要发作类别：局灶性、全面性、未知、无法分类。图1：癫痫分类体系图第二章：癫痫诊断方式2.1 临床诊断流程癫痫的诊断原则为：首先明确发作性症状是否为癫痫发作，其次确定是哪一种类型的癫痫或癫痫综合征，最后明确发病的病因是什么。病史采集是诊断的关键环节，主要内容包括：发作的频率、持续时间、诱因；发作时的具体表现；发作先兆；发作后状态；既往史；家族史；用药史。2.2 脑电图（EEG）检查脑电图是诊断癫痫最常用的方法，可识别脑部异常的电活动，有助于判断癫痫类型和病灶位置。包括常规脑电图、长程脑电图（LTM）、视频脑电图（VEEG）、高密度脑电图（HD-EEG）和颅内脑电图。2.3 神经影像学检查 MRI可以清晰地显示大脑结构，帮助医生识别癫痫病灶。7T超高清MRI作为2025版推荐检查手段，可显示微小结构异常。PET-CT可显示脑代谢异常区域，在MRI阴性患者中尤为重要。2.4 新型诊断技术基于AI的用药预测模型被纳入指南，通过患者代谢基因组数据推荐最优抗癫痫药物，减少30%的试药周期。FDA认证的智能手环（如Embrace2）可实时监测心率变异性和肌电信号，预测发作前预警。第三章：患者人群分析3.1 局灶性癫痫患者人群局灶性癫痫是最常见的癫痫类型，约占所有癫痫患者的60%，可发生于任何年龄。病因分布包括：结构性病因（40-50%）、海马硬化（常见原因）、皮质发育不良（儿童多见）、脑血管病（成人多见）、未知病因（30-40%）。3.2 全面性癫痫患者人群全面性癫痫约占癫痫患者的30-40%，儿童和青少年多见，常有遗传倾向。主要亚型包括儿童失神癫痫（CAE）、青少年失神癫痫（JAE）和青少年肌阵挛癫痫（JME）。图2：全球癫痫患者人群分布3.3 难治性癫痫患者人群难治性癫痫约占癫痫病人的30%。诊断标准为：频繁的癫痫发作至少每月4次以上；适当的AEDs正规治疗且药物在有效范围以内；至少观察两年，仍不能控制发作；影响日常生活；除外进行性中枢神经系统疾病或颅内占位性病变。图3：难治性癫痫形成机制3.4 患者人群特征对比类型比例主要病因药物控制率治疗难度局灶性癫痫 60% 结构性（40-50%）约60% 中等全面性癫痫 30-40% 遗传性约74% 相对较低难治性癫痫约30% 多种 <10% 高表1：癫痫患者人群特征对比第四章：临床痛点分析4.1 诊断延迟问题诊断延迟的主要原因包括：医疗资源分布不均（基层医疗机构诊断能力有限，癫痫专科医生数量不足）；诊断复杂性（癫痫发作表现形式多样，需要与其他疾病鉴别）；患者认知不足（对癫痫症状认识不足，首次发作后就医率低）。4.2 药物控制困境约30%的癫痫患者最终发展为药物难治性癫痫。尽管近40年来新药不断研发上市，但药物难治性癫痫的比例在1982年至2018年间基本保持不变。难治性原因包括：病因复杂性、药物选择和剂量问题、药物相互作用等。4.3 药物安全性问题大约一半的癫痫患者面临药物不良反应的问题。常见不良反应包括：困倦、疲劳、记忆减退、步态不稳、头晕、头痛、恶心、呕吐、情绪异常。长期用药还可能导致骨骼问题、糖代谢异常、肝功能损害等。4.4 疾病经济负担中国癫痫患者的年平均治疗费用为4316.4元，药物费用是主要支出，难治性癫痫患者费用显著更高。第五章：已上市药物5.1 传统抗癫痫药物传统抗癫痫药物（1990年前上市）包括：苯巴比妥（Phenobarbital）、苯妥英（Phenytoin）、卡马西平（Carbamazepine）、丙戊酸（Valproate）、乙琥胺（Ethosuximide）、氯硝西泮（Clonazepam）等。这些药物具有较好的抗癫痫效果，但存在较多不良反应。5.2 新型抗癫痫药物新型抗癫痫药物（1990年后上市）具有较好的治疗效果以及较小的不良反应。包括托吡酯（Topiramate）、拉莫三嗪（Lamotrigine）、左乙拉西坦（Levetiracetam）、奥卡西平（Oxcarbazepine）、加巴喷丁（Gabapentin）、唑尼沙胺（Zonisamide）等。5.3 第三代抗癫痫药物近年来第三代抗癫痫药物如拉考沙胺（Lacosamide）、布瓦西坦（Brivaracetam）、吡仑帕奈（Perampanel）等具有更高靶向性，可减少传统药物导致的认知功能损害等副作用。图4：抗癫痫药物发展历程第六章：在研药物6.1 临床III期在研药物 Fenfluramine（芬氟拉明）：适应症为Dravet综合征、Lennox-Gastaut综合征，机制为5-HT受体激动，已完成III期临床试验。XEN1101：靶点为KCNQ2/3钾通道，适应症为癫痫部分性发作，机制为钾通道开放剂。6.2 临床II期在研药物大麻二酚（CBD）：适应症为Dravet综合征、LGS，机制为多靶点作用，已获FDA批准为难治性癫痫提供新选择。苯巴那酯（Cenobamate）：靶点为GABAA通道与钠离子通道，适应症为部分性发作，已在日本上市。6.3 新靶点药物 KCNQ2/3钾通道开放剂（如XEN1101）正在临床试验中，通过开放钾通道稳定神经元膜电位。新型作用机制包括5-HT2C受体激动（Fenfluramine已上市）、SV2A蛋白调节（布瓦西坦已上市）、mTOR通路（依维莫司等研究中）。6.4 基因与细胞治疗前沿基因疗法正在成为难治性癫痫治疗的新策略。主要研究方向包括：反义寡核苷酸（ASO）治疗靶向特定基因突变；基因递送载体如AAV向量递送神经营养因子基因；基因编辑技术CRISPR/Cas9精准修正致病突变。第七章：市场规模7.1 全球抗癫痫药物市场规模根据Grand View Research数据，2023年全球抗癫痫药物市场约87亿美元，预计到2030年将达到117亿美元。不同市场研究机构的数据存在差异，药智咨询2019年数据显示约180-200亿美元，这一差异可能源于统计口径不同。 7.2 中国抗癫痫药物市场规模 2023年中国抗癫痫药物市场约220亿元，预计2025年将达到约450亿元。中国市场增长迅速，主要驱动因素包括：患者数量增加（癫痫患者约900万）、治疗率提升（从55%提升至65%）、新药研发和医保覆盖扩大。 7.3 市场竞争格局全球市场主要厂商包括：UCB（优时比）占据领先地位（左乙拉西坦、布瓦西坦）；Eisai（卫材）是重要参与者（吡仑帕奈）；Pfizer是主要仿制药商；GSK也是重要参与者（拉莫三嗪）。中国市场竞争以仿制药为主，国内企业占据主导地位。第八章：临床用药指南8.1 ILAE指南 ILAE发布了多项关于癫痫发作分类和癫痫综合征定义的重要文件，包括2017年ILAE癫痫发作类型分类、2021年新生儿癫痫发作分类、2022年特发性全身性癫痫综合征定义、2022年不同发病年龄癫痫综合征分类、2025年更新版癫痫发作分类。8.2 中国指南中国《临床诊疗指南-癫痫病分册》于2007年首次出版，2015年重大更新，2023年发布最新版本。全书共13章，包括癫痫的定义、分类、诊断、预后、药物治疗、外科治疗、癫痫持续状态的诊断与处理等内容。8.3 用药推荐一线药物选择：全面性强直-阵挛发作推荐丙戊酸、拉莫三嗪；失神发作推荐乙琥胺、丙戊酸、拉莫三嗪；局灶性发作推荐卡马西平、拉莫三嗪、左乙拉西坦、吡仑帕奈。 8.4 特殊人群用药儿童用药需根据年龄调整剂量、关注对认知发育的影响。老年用药需注意药物相互作用，关注认知和情绪影响。第三代药物如拉考沙胺、吡仑帕奈、布瓦西坦已被FDA和EMA批准用于老年患者。孕妇用药需特别关注抗癫痫药物的致畸风险，丙戊酸有较高致畸风险。第九章：未来发展趋势9.1 新靶点与新机制 KCNQ2/3钾通道开放剂（如XEN1101）正在临床试验中。钠通道亚型选择性药物正在开发中，以减少传统药物的副作用。AMPA受体拮抗剂（如吡仑帕奈）已上市为难治性癫痫提供新选择。GABA能系统方面，加奈索酮用于CDKL5缺陷障碍相关癫痫发作。9.2 精准医疗基因检测技术可识别患者药物代谢相关基因多态性，通过CYP2C9等基因分型实现给药剂量个体化。基于AI的用药预测模型通过患者代谢基因组数据推荐最优抗癫痫药物，可减少30%的试药周期。9.3 神经调控技术迷走神经刺激术（VNS）：1997年FDA批准用于临床，约30-60%患者可获得明显效果。脑深部电刺激术（DBS）：SANTE试验等研究证实有效，丘脑前核（ANT）是常用靶点。反应性神经刺激术（RNS）：可感知并响应发作前兆脑电活动，闭环给药/刺激。9.4 市场展望全球市场预计到2030年将达到117亿美元。中国市场持续快速增长，2025年预计约450亿元。发展方向包括：创新药物（第三代药物扩大应用、新型靶点药物研发）、精准治疗（基因检测普及、个体化用药）、神经调控（VNS技术迭代、DBS/RNS发展）、数字健康（可穿戴设备普及、远程管理平台）。结论癫痫作为一种常见的慢性神经系统疾病，全球约有5000-7000万患者，中国约有900万患者，行业规模庞大且持续增长。本报告通过对癫痫的定义与发病机制、流行病学、诊断方式、患者人群、临床痛点、已上市及在研药物、市场规模和未来趋势的系统分析，得出以下主要结论：市场潜力巨大全球抗癫痫药物市场预计到2030年将达到117亿美元，中国市场增长迅速，具有显著的投资价值。存在未满足临床需求约30%的癫痫患者最终发展为药物难治性，传统治疗手段面临瓶颈，新型靶点药物和基因治疗为突破方向。诊断技术持续进步高密度脑电图、7T MRI、AI辅助诊断等新技术提升了诊断准确率，为精准治疗奠定基础。精准医疗是发展方向基因检测指导用药、AI预测模型等新技术正在改变癫痫治疗模式，推动个体化治疗发展。神经调控技术前景广阔 VNS、DBS、RNS等神经调控技术为难治性癫痫提供了新的治疗选择，中国本土企业也开始在这一领域取得突破。

2026-03-19

·drugs

Prenatal Valproate Exposure Tied to Offspring Neurodevelopmental Risks

THURSDAY, March 19, 2026 -- Prenatal valproate exposure is associated with increased neurodevelopmental risks among offspring, according to a study published online March 11 in The BMJ . In a study using health care use data from 2000 to 2021, Loreen Straub, M.D., from Brigham and Women's Hospital and Harvard Medical School in Boston, and colleagues examined whether prenatal exposure to specific antiseizure drugs increases the risk for neurodevelopmental disorders in children. A total of 8,887 children who were unexposed prenatally were included in the cohort; exposed pregnancies ranged from 219 to 5,261 for lacosamide and levetiracetam, respectively. The researchers observed associations with several outcomes for valproate and zonisamide (adjusted hazard ratio range, 1.26 to 4.50), while no associations with an increased risk for any outcome were seen for levetiracetam and phenytoin. A twofold to fourfold increase in risk for intellectual disability was seen in association with several drugs; due to the small number of children with this disorder, the estimates were imprecise. Across most outcomes, no meaningful associations were seen for topiramate and lamotrigine, but a potential signal was seen for intellectual disability (both drugs) and learning difficulty (topiramate only; hazard ratio, 1.23 based on small numbers). A modest increase in risk for attention-deficit/hyperactivity disorder and behavioral disorders was seen in association with carbamazepine and oxcarbazepine (hazard ratio range, 1.23 to 1.40). "Our findings raise potential concerns for zonisamide, which was associated with several neurodevelopmental disorders in the main analysis," the authors write. "However, these estimates are based on small numbers and should be interpreted with caution." Several authors disclosed ties to the pharmaceutical industry. Abstract/Full Text

临床结果

100 项与拉考沙胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D07299	拉考沙胺	N03AX18	DB06218

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
癫痫	欧盟	Accord Healthcare SLU	2017-09-18
癫痫	冰岛	Accord Healthcare SLU	2017-09-18
癫痫	列支敦士登	Accord Healthcare SLU	2017-09-18
癫痫	挪威	Accord Healthcare SLU	2017-09-18
强直阵挛性癫痫	日本	UCB Japan Co. Ltd.	2016-07-04
特发全身性癫痫	澳大利亚	UCB Australia Pty Ltd.	2009-07-20
癫痫发作	澳大利亚	UCB Australia Pty Ltd.	2009-07-20
癫痫部分性发作	欧盟	UCB Pharma SA	2008-08-29
癫痫部分性发作	冰岛	UCB Pharma SA	2008-08-29
癫痫部分性发作	列支敦士登	UCB Pharma SA	2008-08-29
癫痫部分性发作	挪威	UCB Pharma SA	2008-08-29

未上市

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适应症	最高研发状态	国家/地区	公司	日期
躁郁症	临床3期	巴西	Libbs Farmacêutica Ltda.	2026-01-09
躁郁症1型	临床3期	巴西	Libbs Farmacêutica Ltda.	2026-01-09
重度抑郁症	临床3期	巴西	Libbs Farmacêutica Ltda.	2026-01-09
癫痫的复杂部分性发作	临床3期	美国	UCB Biosciences, Inc.	2007-08-01
癫痫的复杂部分性发作	临床3期	澳大利亚	UCB Biosciences, Inc.	2007-08-01
癫痫的复杂部分性发作	临床3期	奥地利	UCB Biosciences, Inc.	2007-08-01
癫痫的复杂部分性发作	临床3期	加拿大	UCB Biosciences, Inc.	2007-08-01
癫痫的复杂部分性发作	临床3期	丹麦	UCB Biosciences, Inc.	2007-08-01
癫痫的复杂部分性发作	临床3期	法国	UCB Biosciences, Inc.	2007-08-01
癫痫的复杂部分性发作	临床3期	德国	UCB Biosciences, Inc.	2007-08-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04627285 (CTgov)	临床3期	癫痫	48	Lacosamide (Lacosamide: >=2 to <4 Years)	蓋夢遞窪艱觸衊鏇鏇繭 = 鑰壓襯鹽積製築鹽鏇鹹鹽鑰夢積衊糧齋憲鏇願 (蓋製構鏇鹽鏇積觸觸衊, 網蓋鹹壓鬱網夢繭蓋觸 ~ 構築簾觸窪夢齋夢獵夢) 更多	-	2025-08-28
NCT04627285 (CTgov)	临床3期	癫痫	48	Lacosamide (Lacosamide: >=4 to <6 Years)	蓋夢遞窪艱觸衊鏇鏇繭 = 顧遞鹹醖築衊餘鏇廠遞鹽鑰夢積衊糧齋憲鏇願 (蓋製構鏇鹽鏇積觸觸衊, 夢壓夢壓膚製壓醖繭鹹 ~ 鑰夢製餘網鏇艱遞餘夢) 更多	-	2025-08-28
P9-9.015 (AAN2025)	N/A	白天过度嗜睡	207	Clonazepam	範構醖夢餘壓繭獵築窪(醖艱糧積築鑰廠憲廠夢) = 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. 範艱願夢鏇憲網艱遞觸 (築顧鏇齋觸獵廠淵艱鬱 )	积极	2025-04-07
P9-9.015 (AAN2025)	N/A	白天过度嗜睡	207	Levetiracetam		积极	2025-04-07
NCT02408549 (EP0012, Pubmed \| Epilepsia) 人工标引	临床3期	癫痫发作	239	Lacosamide	襯築遞繭廠鏇餘繭繭鬱(觸選蓋構衊觸壓築鏇範) = 顧糧鑰鏇築鑰積鑰獵壓遞蓋夢夢鬱願積憲鹽繭 (夢積製願醖衊壓憲繭鏇 ) 更多	积极	2024-12-01
NCT00350103 (CTgov)	临床3期	糖尿病周围神经性疼痛	551	Placebo	簾繭築壓選蓋鹹獵膚窪(憲齋憲觸顧鏇齋鏇鑰壓) = 衊衊獵糧構艱願遞繭廠顧蓋淵遞憲糧製鹽鑰築 (廠壓襯遞窪簾範鏇壓窪, 2.20) 更多	-	2024-03-22
NCT02408549 (EP0012 \| VALUE, CTgov)	临床3期	特发全身性癫痫 \| 强直阵挛性癫痫	239	Lacosamide	鬱範壓遞鹽鑰膚廠積積 = 製範積築鑰遞醖積遞願鹹蓋鏇觸構壓繭艱觸窪 (醖壓齋範壓鬱鬱願觸鬱, 築蓋襯製獵選繭醖鹹齋 ~ 醖艱獵製選襯窪餘膚憲) 更多	-	2023-12-14
NCT01969851 (SP0966, Pubmed \| Epilepsia)	临床2期	癫痫发作 \| 癫痫综合征	-	Lacosamide up to 12 mg/kg/day or 600 mg/day	襯膚鹹膚築齋糧鹹獵襯(壓艱選鬱遞壓築顧顧鹽) = 淵網遞膚蓋繭齋齋築齋範鬱構齋鹹遞憲齋鬱鬱 (鏇鏇築觸鏇遞獵淵製範 )	积极	2023-11-01
CNS2023	N/A	新生儿癫痫	62	Lacosamide	餘蓋築衊淵獵壓築簾艱(遞遞廠衊壓夢齋願範鬱) = Adverse events (AEs) were reported in 53%, none of which were attributed to lacosamide 艱製餘襯齋簾鑰願蓋鏇 (餘範範憲構鹽願選鏇艱 ) 更多	-	2023-10-01
IEC2023	N/A	二线	67	Intravenous Lacosamide	齋構艱鏇鹽顧醖繭鬱齋(夢築顧簾蓋餘範網夢窪) = 18 (26.9%) patient experienced bradycardia 壓淵鏇鑰糧膚選簾醖淵 (簾築淵積鬱壓艱簾衊網 ) 更多	积极	2023-09-04
IEC2023	N/A	癫痫发作	-	Lacosamide	齋艱鏇襯構鏇鹹廠糧製(衊鹽遞鏇獵衊繭築範範) = No side effects 廠鏇築醖積窪構壓蓋艱 (蓋鏇膚鑰糧製鏇醖鑰觸 ) 更多	-	2023-09-04
NCT00220337 (CTgov)	临床3期	糖尿病性神经病变	371	Lacosamide	簾選築網製網醖選鬱願 = 鬱鑰鬱憲願構淵製餘獵簾淵積顧簾齋醖築積廠 (範鏇遞繭築醖夢淵窪願, 艱築範糧繭遞簾獵鑰獵 ~ 選鹽餘廠網蓋選遞範獵) 更多	-	2023-07-24