A multicenter, open-label study to investigate the pharmacokinetics of commercial lacosamide oral formulation as therapy in children (aged 1 month to 17 years) with epilepsy.

CB Biosciences, Inc0 个研究点目标入组 32 人开始时间: 2014年8月6日最近更新: 2014年8月11日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 32

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1.An Institutional Review Board /Independent Ethics Committee approved written Informed Consent form is signed and dated by the subject or by the parent(s) or legal representative. The Consent form or a specific Assent form, where required, will be signed and dated by minors.
•2. Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, or medication intake according to the judgment of the investigator.
•3. Subject is male or female, 1 month to 17 years of age. Note: For preterm infants <1 year old, the corrected gestational age should be used (calculated by subtracting the number of weeks born before 37 weeks of gestation from the chronological age).
•4. Subject must be a minimum of 3kg (6.6 pounds) in body weight.
•5. Subject has a diagnosis of epilepsy.
•6. Subject has been prescribed lacosamide (LCM) for the treatment of epilepsy for at least 1 month prior to Screening and has not been prescribed or maintained on LCM for the purposes of participating in this study. Lacosamide dose must be stable for at least 7 days, and intake of the prescribed total daily dose confirmed for at least 3 days prior to participation.
•7. Subject is on a stable AED dosage regimen. The daily dosage regimen of concomitant AED(s) therapy must be kept stable for a period of at least 1 week (7 days) prior to participation.
•8. Subject is an acceptable candidate for venipuncture.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 32
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Subject has previously participated in this study.
•2. Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within the last 30 days prior to Visit 1, or is currently participating in another study of an IMP or a medical device.
•3. Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject’s ability to participate in this study.
•4. The subject presents clinically significant abnormal BP and/or pulse rate, according to the investigator.
•5. Subject is pregnant and/or nursing.
•6. Subject is taking monoamine oxidase inhibitors (MAOIs) or narcotic analgesics.

研究者

发起方

CB Biosciences, Inc

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