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Lacosamide

别名: ADD243037 ADD-243037ADD 243037erlosamide Vimpat 拉克酰胺;(R)-2-乙酰胺基-N-苄基-3-甲氧基丙酰胺;拉科酰胺;(R)-2-乙酰胺基-N-苄基-3-甲氧基丙酰胺拉克酰胺;拉考沙胺;拉考酰胺;拉科胺;拉克酰胺API; 拉科胺-D3;拉科胺-D6;拉科酰胺标准品;拉科酰胺杂质;拉考沙胺-D3;拉科酰胺API;拉克酰胺对映体;拉科酰胺杂质对照品
目录号: V23643 纯度: ≥98%
COA 产品数据 产品说明书 SDS
Lacosamide (ADD243037;ADD-243037;ADD 243037;erlosamide; Vimpat) 是一种市售抗惊厥药物，用于辅助治疗部分性癫痫发作和糖尿病神经性疼痛。
Lacosamide CAS号: 175481-36-4
产品类别: New12
产品仅用于科学研究，不针对患者销售
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产品描述
拉科酰胺（ADD243037；ADD-243037；ADD 243037；erlosamide；Vimpat）是一种市售抗惊厥药物，用于辅助治疗部分性癫痫发作和糖尿病神经性疼痛。它通过增强电压门控钠通道的缓慢失活来发挥作用。
生物活性&实验参考方法
药代性质 (ADME/PK)
吸收、分布和排泄
拉考沙胺口服后可完全吸收，首过效应可忽略不计。其绝对生物利用度高达约100%。食物不影响其吸收速率和程度。达峰时间（Tmax）为1至4小时。每日两次重复给药，三天后即可达到稳态血浆浓度。拉考沙胺的药代动力学在100至800毫克剂量范围内呈剂量比例关系，且不受时间影响，个体间和个体内的变异性均较低。拉考沙胺的主要O-去甲基代谢物的达峰时间（Tmax）较长，为0.5至12小时。静脉给药后，血药浓度峰值（Cmax）在输注结束时达到。30分钟和60分钟的静脉输注与口服片剂具有生物等效性。对于15分钟静脉输注，AUC0-tz符合生物等效性标准，但Cmax不符合。Cmax的点估计值比口服片剂的Cmax高20%，且Cmax的90%置信区间超过了生物等效性范围的上限。在一项比较口服片剂和含10 mg/mL拉考沙胺的口服溶液的试验中，两种制剂的生物等效性得到证实。单次200 mg的负荷剂量可达到与每日两次口服100 mg相当的稳态浓度。拉考沙胺主要通过肾脏排泄和生物转化从体循环中清除。口服和静脉注射100 mg放射性标记的拉考沙胺后，约95%的放射性物质从尿液中回收，不到0.5%从粪便中回收。主要排泄化合物为原形拉考沙胺（约占剂量的 40%）、其 O-去甲基代谢物（约占 30%）以及结构未知的极性部分（约占 20%）。
分布容积约为 0.6 L/kg，接近人体总水量。
代谢/代谢物
拉考沙胺经 CYP3A4、CYP2C9 和 CYP2C19 代谢生成 O-去甲基拉考沙胺，后者是人体内主要的、无药理活性的代谢物。拉考沙胺不存在对映体相互转化。
生物半衰期
原形药物的消除半衰期约为 13 小时，不同剂量、多次给药或静脉给药均不影响其消除半衰期。拉考沙胺的主要 O-去甲基代谢物的消除半衰期为 15 至 23 小时）。
毒性/毒理 (Toxicokinetics/TK)
肝毒性
在上市前临床试验中，935例患者中有7例（0.7%）在标准抗癫痫药物治疗的基础上加用拉考沙胺后出现ALT升高超过正常值上限3倍的情况，而356例安慰剂组患者中无一例出现这种情况。另有一例拉考沙胺治疗期间出现伴有黄疸的肝炎病例报告。自拉考沙胺获批以来，虽有少数病例报告出现与临床表现明显的肝损伤，但临床特征提示肝缺血或拉考沙胺与其他抗癫痫药物联合使用可能是致病原因。这些病例在用药后数天至数月内出现，表现为血清酶升高呈肝细胞型，其中一例无症状且症状轻微，另一例症状严重。两例均迅速康复。
可能性评分：D（可能是临床上明显的肝损伤的罕见原因）
妊娠和哺乳期影响
◉ 哺乳期用药概述
有限的信息表明，母亲每日服用 200 毫克，乳汁中的药物浓度较低。虽然一名在妊娠和哺乳期间接触过该药物的婴儿出现流涎和喂养不良，但其他几名婴儿在母乳喂养期间未出现不良反应。接触过该药物的婴儿发育正常。在获得更多数据之前，应仅在密切监测哺乳期间的嗜睡和体重增长情况的情况下使用拉考沙胺，尤其是在哺乳新生儿或早产儿时。
◉ 对母乳喂养婴儿的影响
一名孕妇在妊娠 8 周时出现鼻窦血栓和 2 次小的颅内出血，随后出现癫痫持续状态。她在孕期剩余时间和产后接受了左乙拉西坦1000毫克和拉考沙胺100毫克每日两次的治疗，同时还服用依诺肝素和拉贝洛尔。她的婴儿在妊娠36周时分娩，出生后的最初几天母乳喂养率约为50%。婴儿嗜睡且喂养困难，但暂停母乳喂养并未改善婴儿的状况。产后15天停止母乳喂养后，婴儿的情况逐渐好转。婴儿在7个月大时发育正常。拉考沙胺和左乙拉西坦可能是导致婴儿嗜睡和喂养困难的原因。
一家医疗中心报告了3名患有癫痫的母亲在母乳喂养期间服用拉考沙胺。母乳喂养的程度没有明确说明，但其中一名母亲只对婴儿进行了部分母乳喂养。第一位母亲每日服用左乙拉西坦 2000 毫克，并每日两次服用拉考沙胺 200 毫克，母乳喂养婴儿 7 个月，婴儿 24 个月大时未出现任何不良反应。第二位母亲每日服用拉考沙胺 300 毫克，部分母乳喂养婴儿 8 个月，婴儿在 6、12 和 18 个月大时发育里程碑均正常。第三位母亲每日服用拉考沙胺 400 毫克，母乳喂养 9 个月，婴儿 36 个月大时未出现任何喂养或警觉性问题，也未出现认知改变或发育迟缓。
一位女性在整个孕期和纯母乳喂养期间均服用拉考沙胺和左乙拉西坦。尽管母乳中药物剂量相对较高，但据报道，该婴儿在产后6个月时发育里程碑均已达到，且无任何健康问题。
一位母亲服用布瓦西坦、拉考沙胺和吡仑帕奈后，纯母乳喂养婴儿6周，之后改为部分母乳喂养。该婴儿未出现觉醒减少或喂养困难的情况。婴儿一岁时，母亲报告其发育正常。
一位母亲在孕期和产后每日服用200毫克拉考沙胺。在9个月的随访期内，她纯母乳喂养的婴儿未出现任何与药物相关的不良事件。
某中心报告了三名在孕期和哺乳期服用拉考沙胺的女性。其中一名女性每日两次服用200毫克拉考沙胺，并母乳喂养12个月。该婴儿12个月大时，未发现任何健康问题或发育迟缓。另一名女性每日两次服用150毫克拉考沙胺，并母乳喂养6个月。该患儿在12个月大时发育里程碑均正常，未发现任何健康问题。第三位女性在服用200毫克/天、每日两次的药物期间，母乳喂养了7个月。该患儿四岁时未发现任何健康问题或发育迟缓。
◉ 对哺乳和母乳的影响
截至修订日期，未找到相关的已发表信息。
蛋白结合
拉考沙胺与血浆蛋白的结合率低于15%。
其他信息
药效学
拉考沙胺是一种口服效力高、立体选择性强且具有抗惊厥作用的抗癫痫药物。拉考沙胺通过阻断介导神经性疼痛反应的感觉神经元电压门控钠通道，展现出镇痛活性。拉考沙胺是一种手性功能化氨基酸。其S-立体异构体不具有抗癫痫活性。
*注: 文献方法仅供参考, InvivoChem并未独立验证这些方法的准确性
化学信息 & 存储运输条件
分子式
C13H18N2O3
分子量
250.2
精确质量
250.131
CAS号
175481-36-4
PubChem CID
219078
外观&性状
Typically exists as solid at room temperature
密度
1.1±0.1 g/cm3
沸点
536.4±50.0 °C at 760 mmHg
熔点
141-143?C
闪点
278.2±30.1 °C
蒸汽压
0.0±1.4 mmHg at 25°C
折射率
1.520
LogP
0.9
tPSA
67.43
氢键供体(HBD)数目
2
氢键受体(HBA)数目
3
可旋转键数目(RBC)
6
重原子数目
18
分子复杂度/Complexity
275
定义原子立体中心数目
1
SMILES
O(C([H])([H])[H])C([H])([H])[C@]([H])(C(N([H])C([H])([H])C1C([H])=C([H])C([H])=C([H])C=1[H])=O)N([H])C(C([H])([H])[H])=O
InChi Key
VPPJLAIAVCUEMN-GFCCVEGCSA-N
InChi Code
InChI=1S/C13H18N2O3/c1-10(16)15-12(9-18-2)13(17)14-8-11-6-4-3-5-7-11/h3-7,12H,8-9H2,1-2H3,(H,14,17)(H,15,16)/t12-/m1/s1
化学名
(2R)-2-acetamido-N-benzyl-3-methoxypropanamide
别名
ADD243037 ADD-243037ADD 243037erlosamide Vimpat
HS Tariff Code
2934.99.9001
存储方式

Powder      -20°C    3 years

                     4°C     2 years

In solvent   -80°C    6 months

                  -20°C    1 month
运输条件
Room temperature (This product is stable at ambient temperature for a few days during ordinary shipping and time spent in Customs)
溶解度数据
溶解度 (体外实验)
May dissolve in DMSO (in most cases), if not, try other solvents such as H2O, Ethanol, or DMF with a minute amount of products to avoid loss of samples
溶解度 (体内实验)
注意: 如下所列的是一些常用的体内动物实验溶解配方，主要用于溶解难溶或不溶于水的产品（水溶度<1 mg/mL）。 建议您先取少量样品进行尝试，如该配方可行，再根据实验需求增加样品量。
注射用配方
(IP/IV/IM/SC等)
注射用配方1: DMSO : Tween 80： Saline = 10 : 5 : 85 (如： 100 μL DMSO → 50 μL Tween 80 → 850 μL Saline)
*生理盐水/Saline的制备：将0.9g氯化钠/NaCl溶解在100 mL ddH ₂ O中，得到澄清溶液。
注射用配方 2: DMSO : PEG300 ：Tween 80 : Saline = 10 : 40 : 5 : 45 (如： 100 μL DMSO → 400 μL PEG300 → 50 μL Tween 80 → 450 μL Saline)
注射用配方 3: DMSO : Corn oil = 10 : 90 (如： 100 μL DMSO → 900 μL Corn oil)
示例: 以注射用配方 3 (DMSO : Corn oil = 10 : 90) 为例说明, 如果要配制 1 mL 2.5 mg/mL的工作液, 您可以取 100 μL 25 mg/mL 澄清的 DMSO 储备液，加到 900 μL Corn oil/玉米油中, 混合均匀。
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注射用配方 4: DMSO : 20% SBE-β-CD in Saline = 10 : 90 [如：100 μL DMSO → 900 μL (20% SBE-β-CD in Saline)]
*20% SBE-β-CD in Saline的制备（4°C，储存1周）：将2g SBE-β-CD (磺丁基-β-环糊精) 溶解于10mL生理盐水中，得到澄清溶液。
注射用配方 5: 2-Hydroxypropyl-β-cyclodextrin : Saline = 50 : 50 (如： 500 μL 2-Hydroxypropyl-β-cyclodextrin (羟丙基环胡精)→ 500 μL Saline)
注射用配方 6: DMSO : PEG300 : Castor oil : Saline = 5 : 10 : 20 : 65 (如： 50 μL DMSO → 100 μL PEG300 → 200 μL Castor oil → 650 μL Saline)
注射用配方 7: Ethanol : Cremophor : Saline = 10： 10 : 80 (如： 100 μL Ethanol → 100 μL Cremophor → 800 μL Saline)
注射用配方 8: 溶解于Cremophor/Ethanol (50 : 50), 然后用生理盐水稀释。
注射用配方 9: EtOH : Corn oil = 10 : 90 (如： 100 μL EtOH → 900 μL Corn oil)
注射用配方 10: EtOH : PEG300：Tween 80 : Saline = 10 : 40 : 5 : 45 (如： 100 μL EtOH → 400 μL PEG300 → 50 μL Tween 80 → 450 μL Saline)

口服配方
口服配方 1: 悬浮于0.5% CMC Na (羧甲基纤维素钠)
口服配方 2: 悬浮于0.5% Carboxymethyl cellulose (羧甲基纤维素)
示例: 以口服配方 1 (悬浮于 0.5% CMC Na)为例说明, 如果要配制 100 mL 2.5 mg/mL 的工作液, 您可以先取0.5g CMC Na并将其溶解于100mL ddH2O中，得到0.5%CMC-Na澄清溶液；然后将250 mg待测化合物加到100 mL前述 0.5%CMC Na溶液中，得到悬浮液。
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口服配方 3: 溶解于 PEG400 (聚乙二醇400)
口服配方 4: 悬浮于0.2% Carboxymethyl cellulose (羧甲基纤维素)
口服配方 5: 溶解于0.25% Tween 80 and 0.5% Carboxymethyl cellulose (羧甲基纤维素)
口服配方 6: 做成粉末与食物混合

注意: 以上为较为常见方法，仅供参考， InvivoChem并未独立验证这些配方的准确性。具体溶剂的选择首先应参照文献已报道溶解方法、配方或剂型，对于某些尚未有文献报道溶解方法的化合物，需通过前期实验来确定（建议先取少量样品进行尝试），包括产品的溶解情况、梯度设置、动物的耐受性等。
请根据您的实验动物和给药方式选择适当的溶解配方/方案：
1、请先配制澄清的储备液(如：用DMSO配置50 或 100 mg/mL母液(储备液));
2、取适量母液，按从左到右的顺序依次添加助溶剂，澄清后再加入下一助溶剂。以 下列配方为例说明 (注意此配方只用于说明，并不一定代表此产品 的实际溶解配方):
10% DMSO → 40% PEG300 → 5% Tween-80 → 45% ddH2O (或 saline);
假设最终工作液的体积为 1 mL, 浓度为5 mg/mL: 取 100 μL 50 mg/mL 的澄清 DMSO 储备液加到 400 μL PEG300 中，混合均匀/澄清；向上述体系中加入50 μL Tween-80，混合均匀/澄清；然后继续加入450 μL ddH2O (或 saline)定容至 1 mL；
3、溶剂前显示的百分比是指该溶剂在最终溶液/工作液中的体积所占比例;
4、 如产品在配制过程中出现沉淀/析出，可通过加热(≤50℃)或超声的方式助溶;
5、为保证最佳实验结果，工作液请现配现用！
6、如不确定怎么将母液配置成体内动物实验的工作液，请查看说明书或联系我们;
7、 以上所有助溶剂都可在 Invivochem.cn网站购买。
制备储备液 1 mg 5 mg 10 mg
1 mM 3.9968 mL 19.9840 mL 39.9680 mL
5 mM 0.7994 mL 3.9968 mL 7.9936 mL
10 mM 0.3997 mL 1.9984 mL 3.9968 mL

1、根据实验需要选择合适的溶剂配制储备液 (母液)：对于大多数产品，InvivoChem推荐用DMSO配置母液 (比如：5、10、20mM或者10、20、50 mg/mL浓度），个别水溶性高的产品可直接溶于水。产品在DMSO 、水或其他溶剂中的具体溶解度详见上”溶解度 (体外)”部分;

2、如果您找不到您想要的溶解度信息，或者很难将产品溶解在溶液中，请联系我们;

3、建议使用下列计算器进行相关计算（摩尔浓度计算器、稀释计算器、分子量计算器、重组计算器等）;

4、母液配好之后，将其分装到常规用量，并储存在-20°C或-80°C，尽量减少反复冻融循环。

计算器
计算 重置

摩尔浓度计算器可计算特定溶液所需的质量、体积/浓度，具体如下：

  • 计算制备已知体积和浓度的溶液所需的化合物的质量
  • 计算将已知质量的化合物溶解到所需浓度所需的溶液体积
  • 计算特定体积中已知质量的化合物产生的溶液的浓度
使用摩尔浓度计算器计算摩尔浓度的示例如下所示：
假如化合物的分子量为350.26 g/mol，在5mL DMSO中制备10mM储备液所需的化合物的质量是多少？
  • 在分子量（MW）框中输入350.26
  • 在“浓度”框中输入10，然后选择正确的单位（mM）
  • 在“体积”框中输入5，然后选择正确的单位（mL）
  • 单击“计算”按钮
  • 答案17.513 mg出现在“质量”框中。以类似的方式，您可以计算体积和浓度。
计算 重置

稀释计算器可计算如何稀释已知浓度的储备液。例如，可以输入C1、C2和V2来计算V1，具体如下：

制备25毫升25μM溶液需要多少体积的10 mM储备溶液？
使用方程式C1V1=C2V2，其中C1=10mM，C2=25μM，V2=25 ml，V1未知：
  • 在C1框中输入10，然后选择正确的单位（mM）
  • 在C2框中输入25，然后选择正确的单位（μM）
  • 在V2框中输入25，然后选择正确的单位（mL）
  • 单击“计算”按钮
  • 答案62.5μL（0.1 ml）出现在V1框中
g/mol
计算 重置

分子量计算器可计算化合物的分子量 (摩尔质量)和元素组成，具体如下：

注：化学分子式大小写敏感：C12H18N3O4  c12h18n3o4
计算化合物摩尔质量（分子量）的说明：
  • 要计算化合物的分子量 (摩尔质量)，请输入化学/分子式，然后单击“计算”按钮。
分子质量、分子量、摩尔质量和摩尔量的定义：
  • 分子质量（或分子量）是一种物质的一个分子的质量，用统一的原子质量单位（u）表示。（1u等于碳-12中一个原子质量的1/12）
  • 摩尔质量（摩尔重量）是一摩尔物质的质量，以g/mol表示。
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计算 重置

配液计算器可计算将特定质量的产品配成特定浓度所需的溶剂体积 (配液体积)

  • 输入试剂的质量、所需的配液浓度以及正确的单位
  • 单击“计算”按钮
  • 答案显示在体积框中
动物体内实验配方计算器（澄清溶液）
第一步：请输入基本实验信息（考虑到实验过程中的损耗，建议多配一只动物的药量）
第二步：请输入动物体内配方组成（配方适用于不溶/难溶于水的化合物），不同的产品和批次配方组成不同，如对配方有疑问，可先联系我们提供正确的体内实验配方。此外，请注意这只是一个配方计算器，而不是特定产品的确切配方。
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计算 重置

计算结果:

工作液浓度： mg/mL；

DMSO母液配制方法： mg 药物溶于 μL DMSO溶液（母液浓度 mg/mL)。如该浓度超过该批次药物DMSO溶解度，请首先与我们联系。

体内配方配制方法：取 μL DMSO母液，加入 μL PEG300，混匀澄清后加入μL Tween 80，混匀澄清后加入 μL ddH2O，混匀澄清。

(1) 请确保溶液澄清之后，再加入下一种溶剂 (助溶剂) 。可利用涡旋、超声或水浴加热等方法助溶；
            (2) 一定要按顺序加入溶剂 (助溶剂) 。

临床试验信息
Population Pharmacokinetics of Antiepileptic in Pediatrics
CTID: NCT03196466
Phase:    Status: Recruiting
Date: 2024-10-30
STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis
CTID: NCT05603702
Phase: Phase 1    Status: Recruiting
Date: 2024-10-23
Combined Effect of Pregabalin and Oxycodone, and Lacosamide and Oxycodone, on Breathing
CTID: NCT05598905
Phase: Phase 4    Status: Completed
Date: 2024-06-04
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures
CTID: NCT04519645
Phase: Phase 2    Status: Recruiting
Date: 2024-05-09
Lacosamide Versus Propranolol in Migraine
CTID: NCT05851781
Phase: Phase 3    Status: Completed
Date: 2024-05-01
View More

Lacosamide Versus Topiramate in Migraine
CTID: NCT06243692
Phase: Phase 3    Status: Recruiting
Date: 2024-03-29

The Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients
CTID: NCT05632133
Phase: Phase 3    Status: Completed
Date: 2024-03-21
Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures
CTID: NCT02408549
Phase: Phase 3    Status: Completed
Date: 2023-12-14
A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment
CTID: NCT04627285
Phase: Phase 3    Status: Active, not recruiting
Date: 2023-11-27
Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.
CTID: NCT00546351
Phase: Phase 3    Status: Completed
Date: 2023-09-21
Improvement Effect of Lacosamide and Levetiracetam on Cognitive in Alzheimer's Disease Patients With Epilepsy
CTID: NCT05969054
Phase: Phase 4    Status: Recruiting
Date: 2023-08-04
A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
CTID: NCT00220337
Phase: Phase 3    Status: Completed
Date: 2023-07-24
Acute Sympotomatic Seizure Secondary to Autoimmune Encephalitis and Autoimmune-associated Epilepsy
CTID: NCT05422664
Phase:    Status: Enrolling by invitation
Date: 2023-07-14
A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
CTID: NCT02582866
Phase: Phase 3    Status: Completed
Date: 2023-06-06
Seizure Prophylaxis in Patients With Glioma or Brain Metastasis
CTID: NCT03436433
Phase: Phase 2    Status: Terminated
Date: 2023-04-13
An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Two-way Crossover, Oralcomparative Pharmacokinetic（PK）Study of Lacosamide Extended-Release Tablets , Adult, Human Subjects Under Fasting Conditions.
CTID: NCT05788159
Phase: Phase 1    Status: Not yet recruiting
Date: 2023-03-28
Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children.
CTID: NCT02710890
Phase: Phase 2/Phase 3    Status: Completed
Date: 2023-02-23
The Effect of Lacosamide in Peripheral Neuropathic Pain
CTID: NCT03777956
Phase: Phase 2    Status: Terminated
Date: 2023-02-16
COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA
CTID: NCT05626140
Phase: Phase 3    Status: Completed
Date: 2022-11-23
A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
CTID: NCT01964560
Phase: Phase 3    Status: Completed
Date: 2022-10-25
Pilot Human Lab Study of Lacosamide in Alcohol Use Disorder (AUD)
CTID: NCT03897348
Phase: Phase 2    Status: Completed
Date: 2022-06-28
Lacosamide in Neonatal Status Epilepticus
CTID: NCT05291455
Phase: Phase 3    Status: Unknown status
Date: 2022-03-22
An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy
CTID: NCT00938912
Phase: Phase 2    Status: Completed
Date: 2022-01-18
Pharmacokinetics of Antiepileptics in Patients on CRRT
CTID: NCT03632915
Phase:    Status: Completed
Date: 2021-10-05
Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
CTID: NCT01832038
Phase: Phase 3    Status: Completed
Date: 2021-08-17
Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures
CTID: NCT02477839
Phase: Phase 3    Status: Completed
Date: 2021-07-01
Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers
CTID: NCT03271528
Phase: Phase 1    Status: Completed
Date: 2021-06-03
A Real World Study on the Efficacy and Safety of Lacosamide as Add-on Therapy for Focal-onset Epilepsy
CTID: NCT04737837
Phase:    Status: Unknown status
Date: 2021-02-04
Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older
CTID: NCT01243177
Phase: Phase 3    Status: Completed
Date: 2021-02-02
A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications
CTID: NCT02408523
Phase: Phase 3    Status: Completed
Date: 2020-12-17
The Safety of Intravenous Lacosamide
CTID: NCT00832884
Phase: Phase 4    Status: Completed
Date: 2020-09-22
Open-label Clinical Trial of Lacosamide in ALS
CTID: NCT03186040
Phase: Phase 1/Phase 2    Status: Completed
Date: 2020-07-15
Evaluation of the Efficacy and Safety of Lacosamide in Pediatric Patients With Epilepsy
CTID: NCT04144218
Phase: Phase 4    Status: Unknown status
Date: 2020-05-12
Compassionate Use Program With Lacosamide in Patients With Partial-onset or Generalized Tonic-clonic Seizures
CTID: NCT03559673
Phase:    Status: No longer available
Date: 2019-10-31
A Trial to Evaluate the Long Term Safety and Tolerability of Lacosamide Taken as Monotherapy in Adults With Partial-onset Seizures
CTID: NCT02124564
Phase: Phase 3    Status: Completed
Date: 2019-10-28
A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures.
CTID: NCT01969851
Phase: Phase 2    Status: Completed
Date: 2019-05-07
A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
CTID: NCT00938431
Phase: Phase 2    Status: Completed
Date: 2019-03-19
Lacosamide in Preventing Seizures in Participants With Malignant Glioma
CTID: NCT01432171
Phase: N/A    Status: Terminated
Date: 2018-12-19
Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures
CTID: NCT00520741
Phase: Phase 3    Status: Completed
Date: 2018-07-19
Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
CTID: NCT00530855
Phase: Phase 3    Status: Completed
Date: 2018-07-18
Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
CTID: NCT01465997
Phase: Phase 3    Status: Completed
Date: 2018-07-18
Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures
CTID: NCT01921205
Phase: Phase 3    Status: Completed
Date: 2018-07-18
eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam
CTID: NCT01484977
Phase: Phase 3    Status: Completed
Date: 2018-07-18
Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.
CTID: NCT00401830
Phase: Phase 2    Status: Completed
Date: 2018-07-18
Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
CTID: NCT00522275
Phase: Phase 3    Status: Completed
Date: 2018-07-18
A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
CTID: NCT00235443
Phase: Phase 2/Phase 3    Status: Completed
Date: 2018-07-17
Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
CTID: NCT00655486
Phase: Phase 3    Status: Completed
Date: 2018-07-17
Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
CTID: NCT01118949
Phase: Phase 2    Status: Completed
Date: 2018-07-17
Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures
CTID: NCT00655551
Phase: Phase 3    Status: Completed
Date: 2018-07-17
Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
CTID: NCT01118962
Phase: Phase 2    Status: Completed
Date: 2018-07-17
Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
CTID: NCT00955357
Phase
A randomized, double-blind, placebo-controlled, cross-over, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin and tapentadol on biomarkers of pain processing observed by Peripheral Nerve Excitability Testing (NET)
CTID: null
Phase: Phase 2    Status: Prematurely Ended, Completed
Date: 2019-09-06
A randomized, double-blind, placebo-controlled, cross-over, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin and tapentadol on biomarkers of pain processing observed by electro-encephalography (EEG)
CTID: null
Phase: Phase 2    Status: Prematurely Ended, Completed
Date: 2019-09-06
A randomized, double-blind, placebo-controlled, cross-over, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin and tapentadol on biomarkers of pain processing observed by non-invasive neurophysiological measurements of human spinal cord and brainstem activity
CTID: null
Phase: Phase 2    Status: Completed
Date: 2019-09-06
The effect of lacosamide in peripheral neuropathic pain:
CTID: null
Phase: Phase 2    Status: Prematurely Ended
Date: 2018-09-11
Pathophysiology-based therapy of epileptic encephalopathies
CTID: null
Phase: Phase 2    Status: Prematurely Ended
Date: 2018-07-24
Analgesic efficacy of intravenous lacosamide administered perioperatively for thoracic surgery with thoracotomy approach.
CTID: null
Phase: Phase 3    Status: Ongoing
Date: 2017-02-13
A MULTICENTER, OPEN-LABEL STUDY TO INVESTIGATE
CTID: null
Phase: Phase 2, Phase 3    Status: Completed
Date: 2016-05-09
A MULTICENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM USE OF LACOSAMIDE (FLEXIBLE DOSE FROM 200 TO 600 MG/DAY) USED AS MONOTHERAPY IN SUBJECTS WHO COMPLETED SP0994 AND RECEIVED LACOSAMIDE MONOTHERAPY TREATMENT
CTID: null
Phase: Phase 3    Status: Completed
Date: 2016-03-17
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY FOR UNCONTROLLED PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN SUBJECTS WITH IDIOPATHIC GENERALIZED EPILEPSY
CTID: null
Phase: Phase 3    Status: Completed
Date: 2015-10-02
Efficacy, safety and tolerability of lacosamide in patients with gain-of-function Nav1.7 mutations related small fiber neuropathy:
CTID: null
Phase: Phase 3    Status: Completed
Date: 2015-08-05
AN OPEN-LABEL, MULTICENTER EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF LACOSAMIDE AS ADJUNCTIVE THERAPY FOR UNCONTROLLED PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN SUBJECTS WITH IDIOPATHIC GENERALIZED EPILEPSY
CTID: null
Phase: Phase 3    Status: Ongoing, Completed
Date: 2015-07-06
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS WITH EPILEPSY ≥1 MONTH TO <4 YEARS OF AGE WITH PARTIAL-ONSET SEIZURES
CTID: null
Phase: Phase 3    Status: Prematurely Ended, Completed
Date: 2015-06-03
A randomised controlled trial of the ketogenic diet in the treatment of epilepsy in children under the age of two years
CTID: null
Phase: Phase 4    Status: GB - no longer in EU/EEA
Date: 2014-09-02
A MULTI-CENTER, OPEN-LABEL, EXPLORATORY STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS ≥1 MONTH TO <18 YEARS WITH EPILEPSY SYNDROMES ASSOCIATED WITH GENERALIZED SEIZURES
CTID: null
Phase: Phase 2    Status: Completed
Date: 2014-02-11
A MULTICENTER, OPEN-LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS WITH EPILEPSY WITH PARTIAL ONSET SEIZURES
CTID: null
Phase: Phase 3    Status: Ongoing, GB - no longer in EU/EEA, Prematurely Ended, Completed
Date: 2014-02-11
EVALUATION OF SEIZURE CONTROL AND QUALITY OF LIFE IN PATIENTS WITH BRAIN TUMOR RELATED EPILEPSY TREATED WITH LACOSAMIDE AS ADD-ON THERAPY: A PROSPECTIVE EXPLORATIVE STUDY
CTID: null
Phase: Phase 4    Status: Ongoing
Date: 2014-01-10
A MULTICENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS WITH EPILEPSY ≥4 YEARS TO <17 YEARS OF AGE WITH PARTIAL ONSET SEIZURES
CTID: null
Phase: Phase 3    Status: Completed
Date: 2013-11-25
AN OPEN-LABEL STUDY TO DETERMINE SAFETY, TOLERABILITY, AND EFFICACY OF LONG-TERM ORAL LACOSAMIDE (LCM) AS ADJUNCTIVE THERAPY IN CHILDREN WITH EPILEPSY
CTID: null
Phase: Phase 2    Status: Completed
Date: 2012-06-11
A MULTICENTER, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF LACOSAMIDE (LCM) ORAL SOLUTION (SYRUP) AS ADJUNCTIVE THERAPY IN CHILDREN WITH PARTIAL ONSET SEIZURES
CTID: null
Phase: Phase 2    Status: Completed
Date: 2012-06-07
A PROSPECTIVE, MULTINATIONAL, OPEN-LABEL, SINGLE-ARM, EXPLORATIVE STUDY TO EVALUATE THE TOLERABILITY AND EFFICACY OF LACOSAMIDE WHEN ADDED TO LEVETIRACETAM WITH WITHDRAWAL OF THE CONCOMITANT SODIUM CHANNEL BLOCKING ANTIEPILEPTIC DRUG IN SUBJECTS WITH UNCONTROLLED PARTIAL-ONSET SEIZURES
CTID: null
Phase: Phase 3    Status: Prematurely Ended, Completed
Date: 2012-04-05
A multi-center, open-label, single-arm study to evaluate hormone and lipid levels in male subjects with partial onset seizures after a switch of treatment from carbamazepine as adjunctive treatment to levetiracetam to lacosamide as adjunctive treatment to levetiracetam.
CTID: null
Phase: Phase 3    Status: Completed, Prematurely Ended
Date: 2011-05-10
A MULTICENTER, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, POSITIVE CONTROLLED STUDY COMPARING THE EFFICACY AND SAFETY OF LACOSAMIDE (200 TO 600MG/DAY) TO CONTROLLED RELEASE CARBAMAZEPINE (400 TO 1200MG/DAY), USED AS MONOTHERAPY IN SUBJECTS (≥16 YEARS) NEWLY OR RECENTLY DIAGNOSED WITH EPILEPSY AND EXPERIENCING PARTIAL ONSET OR GENERALIZED TONIC CLONIC SEIZURES
CTID: null
Phase: Phase 3    Status: Completed
Date: 2011-02-08
A MULTI-CENTER, OPEN-LABEL STUDY TO EVALUATE THE TOLERABILITY, SAFETY AND EFFICACY OF LACOSAMIDE (200 mg - 400mg/day) AS ADD-ON THERAPY FOR PATIENTS WITH PARTIAL ONSET EPILEPSY USING A FLEXIBLE DOSE-ESCALATION SCHEDULE AND INDIVIDUALIZED MAINTENANCE DOSES
CTID: null
Phase: Phase 4    Status: Completed
Date: 2010-05-07
An open-label, multicenter, multinational study of lacosamide as first add-on anti epileptic drug (AED) treatment in subjects with partial onset seizures.
CTID: null
Phase: Phase 3    Status: Ongoing, Prematurely Ended, Completed
Date: 2009-11-02
A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400mg/day Monotherapy in Subjects with Partial-onset Seizures
CTID: null
Phase: Phase 3    Status: Not Authorised, Completed
Date: 2009-02-16
A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-onset Seizures
CTID: null
Phase: Phase 3    Status: Not Authorised, Completed
Date: 2009-02-16
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO ASSESS THE EFFICACY AND SAFETY OF 400MG/DAY LACOSAMIDE IN SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE
CTID: null
Phase: Phase 2    Status: Completed, Prematurely Ended
Date: 2007-05-03
Estudio multicéntrico, abierto, de seguimiento para evaluar la seguridad y eficacia a largo plazo de lacosamide en sujetos con neuropatía diabética distal dolorosa, que incluye un subestudio de retirada aleatorizado, doble ciego de tiempo limitado. (A multicenter, open-label, follow-on trial to assess the long-term safety and efficacy of lacosamide in subjects with painful distal diabetic neuropathy including a double-blind, randomized time point withdrawal subtrial)
CTID: null
Phase: Phase 3    Status: Completed
Date: 2006-10-01
A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO ASSESS THE EFFICACY AND SAFETY OF 400MG/DAY LACOSAMIDE IN SUBJECTS WITH PAINFUL DISTAL DIABETIC NEUROPATHY USING TWO DIFFERENT TITRATION SCHEMES
CTID: null
Phase: Phase 3    Status: Completed
Date: 2006-06-16
A multi-center, open-label trial to investigate the safety and tolerability of intravenous SPM 927 as replacement for oral SPM 927 in subjects with partial seizures with or without secondary generalization.
CTID: null
Phase: Phase 3    Status: Completed
Date: 2005-01-12
A multi-center, open-label trial to assess the long-term safety and efficacy of SPM 927 in subjects with painful diabetic neuropathy
CTID: null
Phase: Phase 3    Status: Completed
Date: 2004-11-15
An international open-label extension trial to determine safety and efficacy of longterm oral SPM 927 in patients with partial seizures
CTID: null
Phase: Phase 3    Status: Completed
Date: 2004-10-13
A MULTICENTER, DOUBLE-BLIND, DOUBLE-DUMMY, FOLLOW UP STUDY EVALUATING THE LONG TERM SAFETY OF LACOSAMIDE (200 TO 600MG/DAY) IN COMPARISON WITH CONTROLLED RELEASE CARBAMAZEPINE (400 TO 1200MG/DAY), USED AS MONOTHERAPY IN SUBJECTS WITH PARTIAL ONSET OR GENERALIZED TONIC CLONIC SEIZURES ≥16 YEARS OF AGE COMING FROM THE SP0993 STUDY
CTID: null
Phase: Phase 3    Status: Completed
Date:
Estudio multicéntrico, doble ciego, aleatorizado, controlado con placebo, en grupos paralelos, para investigar la eficacia y la seguridad de SPM927 (200 mg y 400 mg/día)como tratamiento complementario en pacientes con crisis parciales, con o sin generalización secundaria
CTID: null
Phase: Phase 3    Status: Ongoing
Date:

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