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]

CTR20251369

/ CompletedN/A

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

主要试验目的：研究空腹状态下单次口服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® ，规格：10%；UCB日本株式会社生产）在健康参与者体内的药代动力学特征，评价空腹状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂拉考沙胺颗粒（规格：1 g: 0.1 g）和参比制剂拉考沙胺干糖浆（Vimpat® ）在健康参与者中的安全性。

开始日期2025-05-20

申办/合作机构

海南卫康制药（潜山）有限公司

CTRI/2025/04/084766

/ Not yet recruitingN/A

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

开始日期2025-04-23

申办/合作机构

Eris Lifesciences Ltd.

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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1,868

项与拉考沙胺相关的文献（医药）

2025-12-01·BRAIN & DEVELOPMENT

A patient presenting with chapeau de gendarme and three phase-ictal EEG pattern: Suggesting a focus in the interhemispheric fissure

Article

作者: Sasaki, Michiru ; Okanishi, Tohru ; Kumazaki, Kensuke ; Ohta, Kento ; Maegaki, Yoshihiro ; Kanai, Sotaro

INTRODUCTION:

We report a pediatric case of frontal lobe epilepsy with seizures characterized by the "chapeau de gendarme (CdG)" sign and a three phase-ictal scalp EEG (3Ph-EEG) pattern, suggesting a seizure focus in the interhemispheric fissure (IHF) cortex.

CASE REPORT:

An 8-year-old boy with autism spectrum disorder (ASD) presented with daily episodes of impaired consciousness, staring, and bilateral tonic posturing of the upper limbs, accompanied by stiffening and drooping of both corners of the mouth. These episodes were initially misdiagnosed as behavioral disturbances in patients with ASD. Video-scalp EEG at age 11 revealed a 3Ph-EEG pattern: 1) brief β bursts in the left frontal region; 2) diffuse attenuation; and 3) rhythmic activity evolving from β to δ frequencies over the left fronto-centro-parietal regions. Seizure semiology and EEG findings were consistent with a seizure focus in the anterior IHF cortex, including the cingulate gyrus. Although valproate and levetiracetam were ineffective, lacosamide (LCM) effectively controlled the seizures, and its efficacy was sustained over a 3-year follow-up period.

DISCUSSION:

The combination of CdG and 3Ph-EEG patterns may serve as clinical and electrophysiological markers for seizures originating in the frontal IHF cortex. Therefore, LCM may be an effective treatment option for such cases. This case underscores the importance of detailed seizure semiology and EEG interpretation for accurate localization.

2025-12-01·EPILEPSY 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.

2025-12-01·Journal of Mass Spectrometry and Advances in the Clinical Lab

A simple, rapid and cost-effective UHPLC–MS/MS method for simultaneous quantitation of seven antiepileptic drugs/metabolites in human serum

Article

作者: Li, Xiangtang ; He, Hui ; Fu, Xiaowei

Background:

Epilepsy affects approximately 50 million people worldwide. Antiepileptic drugs (AEDs) are the mainstream treatment. Therapeutic drug monitoring (TDM) of AEDs is necessary to maximize efficacy and minimize toxicity. We report a simple, rapid, and cost-effective ultra-performance liquid chromatography-mass spectrometry method that can simultaneously measure seven AEDs/metabolites, including levetiracetam (LEV), lacosamide (LCM), zonisamide (ZON), lamotrigine (LMT), 10-hydroxycarbazepine (OXC-M1), clobazam (CLO), and N-desmethyl clobazam (N-CLB) in serum.

Method:

Only 20 µl of serum was used with simple protein precipitation and dilution. Analysis was performed on a SCIEX 6500 UHPLC-MS/MS in positive ion mode. Separation was performed on a C18 reversed-phase column using a gradient. The seven AEDs/metabolites were eluted in 4.5 min.

Results:

The assay was linear over the concentration ranges 0.4-100 µg/mL for LEV, 0.12-30 µg/mL for LMT, 0.12-30 µg/mL for LCM, 0.32-80 µg/mL for ZON, 0.28-70 µg/mL for OXC-M1, and 7.82-2000 ng/mL for CLO, 78.2-20000 ng/mL for N-CLB, respectively, with correlation coefficient greater than 0.99. Recovery was from 88 to 108 %. Intra and inter assay precision for three levels of quality controls were from 2.1 to 6.8 % and 4.2 to 10.9 %, respectively. The accuracy was evaluated by comparing with the College of American Pathologists survey results, and a correlation coefficient greater than 0.96 was observed. The absence of matrix effects was also confirmed.

Conclusion:

We have developed and validated a simple, rapid, and cost-effective UHPLC-MS/MS method for the simultaneous quantitation of seven AEDs/metabolites in serum within a 4.5-min analysis time. It has been implemented in our children's hospital with same-day turnaround time.

300

项与拉考沙胺相关的新闻（医药）

2025-10-21

·分迪科技

药物设计 | 钠离子通道抑制剂 | 甲状腺髓质癌

2025年4月美国亚拉巴马大学利用SeeSAR13.0和FlexX 6.0工业技术平台，设计、合成了17个钠离子通道抑制剂，并评估了其在甲状腺髓质癌的抗侵袭活性。结果表明，其中最具潜力的分子IIB7在浓度在100 μM时对MZ-CRC-1细胞没有表现出细胞毒性，在15 μM时，对VGSC介导的细胞侵入抑制率可达71%。本研究亮点在于将药物化学家日常的设计工作流程和计算机辅助设计方法巧妙地融合，将基于经验的药物设计工作和分子对接技术结合在一起，辅助药物化学家更快的进行构效关系（SAR）和ADMET性质的研究。文献研究的药物设计起点是化学物SV188，其活性如下图一所示：图一：SV188的结构式和活性本次设计的目的是“减少SV188的细胞毒性、增强钠电流阻断作用”，在MZ-CRC-1细胞内更强的细胞侵袭抑制活性（基于这个目的），设计了一系列SV188的类似物。图二：SV188类似物的结构简要的介绍一下作者思路：首先在“尾端苯环加取代基来调节疏水性”。头部的哌啶环被替换成吗啉环来增加亲水性和形成额外氢键的能力。（文献里是这样描述“设计的考虑”：因为在大部分的电压门控钠通道（VGSC）的抑制剂中观察到亲水的胺头部和芳香疏水尾部，中间通过酯键和酰胺键连接。分子长度也有要求，在10-15Å之间，这可能与结合口袋大小有关系。分子头部的带正电的N原子对于SV188的抑制活性非常重要，引入吗啉基团时为了保证这个N原子位置不变的同时，引入氧原子期望获得额外的氢键作用。）同样的，中间的正电N原子其亲水性对于活性同样重要，在生理条件下，SV188中三级胺和二级胺的pKa值分别是7.9和10.5。SV188 的极性特征表明，它可能在通道处于开放构象（open conformation）时通过通道的中央腔（central cavity）进入细胞。）为了验证SV188的尾部基团的疏水性的重要性，作者首先移除了一个尾端苯环。并通过在单苯环上引入吸电子基团（F，Cl）和给电子基团（OMe和OH）来调节其疏水性。在双苯环的尾端部分上引入F和Cl以及非极性的甲基。自此，设计了一系列SV188的类似物（如图二）。图三：NAV1.7的结构域补充一下VGSC信息，这对后续的构效关系研究很有作用。VGSC由一个α亚基和一到两个β亚基组成，其中α亚基由四个同源结构域(DI−DIV）。值得注意的是，VGSC α 亚基的第 IV 结构域中的阻断剂结合位点在不同亚型之间高度保守，由异亮氨酸（I）、苯丙氨酸（F）、亮氨酸（L）和缬氨酸（V）等疏水性残基组成。F1748对于NaV1.7的结合非常重要。增加分子尾端的疏水性很可能会增加效力和持续性（图三）。遗憾的是，SV188并没有晶体复合物结构，这也是我们常会遇到的问题，作者选用了临床上的抗癫痫药物拉科酰胺与NAV1.7的复合物结构（8S9B）-为什么会选择这个PDB？此前报道在转移性 MTC 细胞系 MZ-CRC-1 和原发性 MTC 细胞系 TT 中鉴定出了 NaV1.5、NaV1.6 和NaV1.7亚型的存在，并且在 MTC 患者样本中检测到了 NaV1.7 的表达。图四：拉科酰胺-结合位点更加关键问题在于SV188会结合在NaV1.7的哪个位置？ “结合位点的选择“对于接下来的分子对接来说十分重要。根据实验结果表明，SV188 能够根据使用情况对通道产生依赖性抑制作用，其效果类似于能阻断电压门控钠通道的局部麻醉剂以及抗癫痫药物。另外，SV188不影响Na离子通道的失活曲线，基于以上现象，作者推测SV188的结合位点与拉科酰胺类似，在NaV1.7的S6-DIV区域（图四）所示。当确定药物作用的靶点和靶点上具体的结合位点之后，我们就可以开始对设计出的类似物进行对接验证工作。本次我使用的是3D可视化基于结构药物设计工具SeeSAR14.2.1-Docking Mode(FlexX工具集合在此模块内，CADD也可以单独试用命令行FlexX工具），对接结果如图五所示：图五：SV188对接结果通过本次对接，可以明确两个方面：第一，SV188的头端的带正电的N原子和中间带正电的N原子对于结合确实很重要，分别和苏氨酸1696和谷氨酰胺360形成氢键相互作用，同样之前提到的F1748和SV188的芳香环形成Pi-Pi相互作用，对于结合也很关键。第二，SV188和拉科酰胺的结合模式非常类似。图六：SV188类似物对接结果接下来我对SV188及其类似物进行构效关系研究，移除尾端的一个苯环并没有打乱SV188的结合模式，也没有如预期那样减少通道结合力（如图六）。图七：苯环上羟基类似物在苯环上加一个羟基，可以与异亮氨酸1744形成新的氢键，获得亲和力提升图七所示。图八：吗啉环类似物将哌啶环替换成吗啉环，O原子和酪氨酸形成新的氢键，活性得到进一步提升图八所示。视频1：SeeSAR-ADMET性质预测药物结合位点位于钠通道孔内，使得亲脂性和pKa成为通道阻断的重要决定因素。LogP值通常用来表示药物分子的亲脂性，Lipinski五规则通常要求小分子药物的LogP小于5，因此SeeSAR被用来分析SV188类似物的LogP值。结果表明，三个类似物的LogP值小于0，表明是亲水性的分子。总的来说，双苯环的分子更加疏水，吗啉基团比哌啶更加亲水。图九：SeeSAR-ADMET列表参数当然除了LogP值，SeeSAR还提供了多维度的ADMET性质的预测(图九)，以“秒”的速度辅助药物化学家在药物分子优化阶段提供“所想即所见、所见即所得”的可视化辅助支持。以上案例内容展示了药物化学家与计算机辅助手段结合的实践方法的可行性（构效关系），欢迎更多的药物化学家们来体验工业药物设计解决方案“See、SAR”，加速推进成药性更优的药物分子验证速度。(作者：YU编) 参考文献： https://doi.org/10.1021/acsmedchemlett.4c00576 关于我们关于分迪成都分迪科技有限公司（简称“分迪科技”），“分子设计，启迪未来”-（分迪科技）专注于新药设计与药物发现15年（德国BioSolveIT公司工业药物设计技术在中国独家合作公司-SeeSAR、infiniSee），分迪一直在路上为工业制药企业、科研机构提供最前沿的药物设计解决方案与工具应用、以及药物设计项目合作等。 “分迪科技”是“分迪药业”的前身，现为分迪药业的全资子公司。分迪药业是一家致力于开发靶向蛋白降解创新药研发企业，目前“分子胶”新药已经进入临床实验。关于BioSolveIT We are BioSolveIT and we visualize drug discovery. Our fast and easy-to-use software enables every chemist to advance their research. Our trusted platforms SeeSAR and infiniSee support you in structure-based and ligand-based drug discovery to inspire you with new, vivid ideas. Perceptive visualization helps you to understand computational results at a glance.We at BioSolveIT believe in full transparency, and all the science behind our software is published. We are passionate about the needs of our customers and live this through the discovery services we offer. Working together with users in this way helps us stay at the forefront of current research, addressing the questions that chemists are interested in right now.We develop software that is indispensable to drug discovery and, more importantly, software that is a pleasure to use every day.etc：Chemical Space Docking、Covalent Docking、FlexX、FlexS、FTrees、HYDE、Recore、Fastgrow、DoGSiteScorer、POSEVIEW、MONA、LEADIT。(Clients: 100+ pharma and universities, 80% of fortune top 10, for ex.: Pfizer, AstraZeneca, Johnson&Johnson, Roche, Bayer, Merck, AbbVie, Novartis, Boehringer Ingelheim, Syngenta, BASF, …

2025-10-15

·思齐俱乐部

171个非集采品种过评

药智数据显示，9月有276个药品通过/视同通过一致性评价，其中105个药品已纳入集采，占38%，非集采品种有171个，占62%。新增23个独家过评品种 1.一致性过评整体情况 9月，共有276个药品通过/视同通过一致性评价，新增23个独家过评品种。以新注册分类仿制药上市视同通过一致性评价的药品242个，以一致性评价补充申请过评的药品共42个。图1 2024年9月-2025年9月一致性过评趋势注：以药品名称除重后统计过评品种数在通过或视同通过一致性评价的276个药品中，以新注册分类仿制药上市的药品共有242个，其中19个为国内首家过评，在这19个药品中，有14个属于首仿上市（详见下表1）。以一致性评价补充申请过评的药品有42个，有4个为首家过评品种。表1 2025年9月首家通过一致性评价详情表 2.企业过评品种数 9月通过/视同通过一致性评价的276个药品，共涉及270家集团企业，其中60家企业为多品种过评，11家企业超过3个品种过评；单个企业过评药品数方面，石家庄四药位居榜首。图2 2025年9月企业过评品种数注：以药品名称+持有人对应的集团企业进行除重后统计 3.品种过评企业数从品种过评企业数而言，9月过评的276个药品中，72个药品为多企业过评，其中盐酸甲氧氯普胺注射液、碳酸氢钠注射液和法莫替丁注射液以过评企业6家位居第一，其次为二羟丙茶碱注射液和恩格列净片，各有5家企业过评。图3 2025年9月品种过评企业数注：以药品名称+持有人对应的集团企业进行除重后统计 4.171个非集采品种过评 9月过评的276个药品中，105个药品已纳入集采，占38%，非集采品种有171个，占62%。集采品种中，消化道及代谢方面最多，有22个，占21%；其次为系统用抗感染药，有20个，占19%。非集采药品中，心血管系统用药批准的最多，有32个，占19%；其次为消化道及代谢用药，有30个，占18%。图4 2025年9月通过集采品种情况备注：以药品名称进行除重后统计图5 2025年9月纳入集采品种ATC分类情况注：以药品名称除重后统计图6 2025年9月未纳入集采品种ATC分类情况注：以药品名称除重后统计消化道及代谢用药申报品种数最多 1.一致性申报整体情况在一致性评价补充申请品种数量方面，整体持续呈下降趋势。9月申报一致性评价补充申请受理号24个，共17个药品，涉及企业16家。在新注册分类仿制药上市方面，共涉及225个药品，242家企业，其中按4类注册申报上市的药品146个；按3类注册申报上市的药品78个，其中，海南卫康制药的拉考沙胺颗粒首次在国内申请上市；按5.2类注册申报上市的药品1个。图7 2024年9月至2025年9月申报详情注：数据按药品名称除重后进行统计 2.申请品种ATC分类情况 9月新增仿制药上市申请和一致性评价补充申请药品，在ATC分类方面，消化道及代谢方面最多，有35个，占15%；其次为系统用抗感染药和心血管系统，有34个，各占14.6%。图8 2025年9月申请品种ATC分类情况注：以药品名称除重后统计数据来源：药智数据企业版——仿制药一致性评价分析系统来源：药智网作者：勤轩思齐圈公开课报名中！点击阅读原文了解更多

一致性评价

2025-10-14

·普利制药

【招商】普利制药拉考沙胺注射液国内获批上市！

【招商】普利制药拉考沙胺注射液国内获批上市！海南普利制药股份有限公司于近日收到国家药品监督管理局（以下简称“NMPA”）所签发的拉考沙胺注射液的药品注册批件，视为通过一致性评价批准上市。诚邀合作，欢迎垂询，国内招商： GNXS@hnpoly.com 0571-89385059 1 普利制药拉考沙胺注射液拉考沙胺为第三代新型AEDs，是一系列功能性氨基酸中的一种，在不同的临床前模型和临床研究中显示出具有抗癫痫作用；最早由UCB制药研发，2008年8月UCB开发的原研药拉考沙胺注射液Vimpat首先在欧盟批准上市，2008年10月获准在美国上市。普利制药的拉考沙胺注射液成功研发后，分别提交了中国、美国、欧洲、英国、加拿大和泰国等多个国家和地区的仿制药注册申请，并且已于2024年2月获得了美国食品药品监督管理局（FDA）的批准，于2025年7月获得了英国药品和健康产品管理局（MHRA）的批准；本次国内获批，与美国、英国市场共用同一产线，同质量标准，将为国内患者提供出口品质的药品。诚邀合作，欢迎垂询，国内招商： GNXS@hnpoly.com 0571-89385059 2 拉考沙胺注射剂市场容量根据米内网数据显示，拉考沙胺注射剂2024年国内市场容量为3.08亿元，其中城市公立为2.96亿元，渠道占比为96.21%，销售额呈高速上升趋势。诚邀合作，欢迎垂询，国内招商： GNXS@hnpoly.com 0571-89385059 3 普利制药普利制药 1992 年成立于海口，是中国医药制剂国际化先导企业和国家工信部智能制造示范企业，已被国家工信部纳入工业转型升级中国制造 2025 年儿童药重点项目企业，2023年海南普利通过海关“AEO”高级认证。此前，海南普利及其子公司浙江普利、安徽普利也曾多次顺利通过美国FDA、欧盟EMA现场审计。作为中国医药制剂国际化先导企业，普利制药多年来一直恪守全球较高质量标准，是国内为数不多的原料药和注射剂研发和生产平台，也是为数不多的同时获得美国、中国、欧盟等药监部门批准的原料药、关键辅料、药物药剂和GMP中间体CMO/CDMO的优质供应商。诚邀合作，欢迎垂询，国内招商： GNXS@hnpoly.com 0571-89385059

上市批准一致性评价

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

10 条进展最快的记录,

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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	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
癫痫的复杂部分性发作	临床3期	爱尔兰	UCB Biosciences, Inc.	2007-08-01
癫痫的复杂部分性发作	临床3期	意大利	UCB Biosciences, Inc.	2007-08-01
癫痫的复杂部分性发作	临床3期	波兰	UCB Biosciences, Inc.	2007-08-01

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临床结果

适应症

分期

评价

查看全部结果

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)	築壓糧憲壓鬱簾衊餘積 = 積糧膚襯範鹽襯膚構鹽獵鏇襯廠構鏇範窪選鬱 (獵積鑰網遞鹽鹹構鏇餘, 鹹繭遞夢觸製艱觸壓繭 ~ 網範餘艱鹽製餘遞繭顧) 更多	-	2025-08-28
NCT04627285 (CTgov)	临床3期	癫痫	48	Lacosamide (Lacosamide: >=4 to <6 Years)	築壓糧憲壓鬱簾衊餘積 = 鏇網膚繭願網醖簾憲顧獵鏇襯廠構鏇範窪選鬱 (獵積鑰網遞鹽鹹構鏇餘, 鏇膚艱窪鑰壓顧繭襯獵 ~ 積鏇願艱觸觸積鹹糧獵) 更多	-	2025-08-28
P9-9.015 (AAN2025)	N/A	白天过度嗜睡	207	Clonazepam	顧網繭觸願餘襯鑰襯選(衊壓簾壓觸範膚憲顧網) = 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. 夢繭夢鹹製廠窪鬱鹽顧 (選獵製夢夢窪膚壓願醖 )	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	淵艱鹽餘獵構糧齋淵艱(製鹽艱廠鏇範淵製遞窪) = 憲鹽憲壓網鹹鹹積淵廠鹽繭壓齋鹽淵壓蓋網願 (選鏇築醖觸獵鑰觸壓鑰 ) 更多	积极	2024-10-26
NCT02408549 (EP0012 \| VALUE, CTgov)	临床3期	特发全身性癫痫 \| 强直阵挛性癫痫	239	Lacosamide	齋選餘鏇築鏇鏇鬱衊廠 = 艱範鬱醖獵憲窪鬱鹹廠鹹選壓構餘願蓋簾鏇廠 (醖築鑰鹽糧鏇獵顧鏇憲, 範鹹鹹積積簾齋構醖廠 ~ 糧顧範艱夢餘構網網襯) 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	構網鏇獵積遞鏇醖襯觸(構鑰獵獵夢範鬱襯鹽遞) = 襯製鑰鹹壓鬱艱遞夢糧窪窪範鹹醖醖窪淵憲鹽 (窪顧願淵鏇築膚鹽襯壓 )	积极	2023-11-01
CNS2023	N/A	新生儿癫痫	62	Lacosamide	鏇構獵窪艱網願窪糧製(壓窪願鬱艱襯壓壓選範) = Adverse events (AEs) were reported in 53%, none of which were attributed to lacosamide 窪鹹壓願鹹淵蓋鬱憲顧 (夢網襯餘願積鬱淵鬱糧 ) 更多	-	2023-10-01
IEC2023	N/A	二线	67	Intravenous Lacosamide	選願憲鏇齋範憲窪遞鹹(鹽衊構糧鹽廠獵築鏇壓) = 18 (26.9%) patient experienced bradycardia 顧齋鹹廠繭積餘淵鬱醖 (窪鑰壓廠願窪選衊壓壓 ) 更多	积极	2023-09-04
IEC2023	N/A	癫痫发作	-	Lacosamide	願襯範齋艱構獵憲膚蓋(襯顧願簾獵窪顧鑰遞築) = No side effects 糧繭築遞蓋蓋鹹積壓醖 (築製廠齋蓋鹽構願鑰鹹 ) 更多	-	2023-09-04
NCT00220337 (CTgov)	临床3期	糖尿病性神经病变	371	Lacosamide	醖齋鹽齋觸窪鹽餘遞鑰 = 糧願窪遞艱餘醖鏇築夢製窪製淵糧憲顧製鹹蓋 (夢夢遞襯獵淵製顧艱鹹, 獵鹽壓繭鏇餘餘鏇糧構 ~ 積獵憲獵構餘構窪獵衊) 更多	-	2023-07-24
NCT01964560 (EP0034, CTgov)	临床3期	癫痫部分性发作	540	Lacosamide	糧願襯齋簾鬱夢艱繭選 = 選憲窪繭鏇齋廠糧壓壓衊簾簾餘艱遞鬱衊襯壓 (艱衊鏇網壓襯壓襯築窪, 餘壓鹹蓋醖糧廠選齋齋 ~ 鏇獵鹹範襯衊淵齋壓遞) 更多	-	2022-10-25