EUCTR2014-003294-42-IT进行中（未招募）1 期
A MULTICENTER, OPEN-LABEL STUDY TO INVESTIGATETHE SAFETY AND TOLERABILITY OF INTRAVENOUSLACOSAMIDE AS REPLACEMENT FOR ORAL LACOSAMIDEIN CHILDREN (=4 TO <17 YEARS OF AGE) WITH EPILEPSY
CB BIOSCIENCES Inc.0 个研究点目标入组 75 人开始时间: 2016年3月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
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. Subject is male or female from =4 to <17 years of age.
- •2. Subject is participating in a long-term, open-label study with lacosamide (LCM) or is currently prescribed
- •oral VIMPAT and needs to undergo a procedure, is admitted to an epilepsy monitoring unit (EMU) or health care facility, or other situations where intravenous (iv) administration of LCM is clinically appropriate.
- •3. Subject is an acceptable candidate for venipuncture and iv infusion.
- •Subjects who are participating in a long-term, open-label study with LCM must fulfill the
- •following additional inclusion criteria:
- •4. Subject is currently enrolled in a long-term, open-label study, receiving oral LCM for the
- •treatment of epilepsy.
- •5. Subject has been on a stable bid dosage regimen of oral LCM for the last 3 days in their
- •long-term, open-label study.
- •Subjects who are currently prescribed oral VIMPAT and enroll directly into EP0060 must fulfill
- •the following additional inclusion criteria:
- •6. Subject has been prescribed oral VIMPAT at a dose of 2mg/kg/day to 12mg/kg/day (for
- •subjects <50kg) or 100mg/day to 600mg/day (for subjects =50kg).
- •7. Subject has been prescribed oral VIMPAT for the treatment of epilepsy for at least 1 month
- •prior to Screening and has not been prescribed or maintained on VIMPAT for the purposes of
- •participating in EP0060. Prescribed oral VIMPAT 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 first infusion.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 75
- •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 received intravenous (iv) lacosamide (LCM) in this study.
- •2. Subject has any medical, neurological, or psychiatric condition that, in the opinion of the
- •investigator, could jeopardize the subject’s health or compromise the subject’s ability to
- •participate in EP0060.
- •3. Subject has clinically significant hypotension or bradycardia.
- •4. Subject =6 years of age has a lifetime history of suicide attempt (including an actual attempt,
- •interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as
- •indicated by positive responses (Yes”) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening.
- •5. Subject does not have a diagnosis of epilepsy.
- •6. Subject is taking monoamine oxidase inhibitors (MAOIs).
- •Subjects who are participating in a long-term, open-label study with LCM are not permitted to
- •enroll in EP0060 if any of the following additional criteria are met:
- •7. Subject has any ongoing Adverse Event (AE) in their long-term, open-label study that, in the opinion of the investigator, could jeopardize or would compromise the subject’s ability to participate
- •Subjects who are currently prescribed oral VIMPAT are not permitted to directly enroll in
- •EP0060 if any of the following additional criteria are met:
- •8. Subject has a medical condition that could reasonably be expected to interfere with drug
- •distribution, metabolism, or excretion.
- •9. Subject has a known hypersensitivity to any component of the investigational medicinal
- •product (IMP).
- •10. Subject is a female of childbearing potential and does not practice an acceptable method of
- •contraception for the duration of participation in EP0060.
- •11. Subject has an alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total
- •bilirubin level greater than or equal to 2 times the upper limit of normal (ULN), or creatinine
- •clearance less than 30mL/min.
- •12. Subject has a clinically relevant electrocardiogram (ECG) abnormality, in the opinion of the principal investigator
- •(ie, second or third degree heart block at rest or a QT prolongation greater than 450ms).
- •13. Subject has hemodynamically significant heart disease (eg, heart failure).
- •14. Subject has an arrhythmic heart condition requiring medical therapy.
- •15. Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias.
- •16. Subject has only nonepileptic events, including psychogenic seizures, which could be
- •confused with seizures. If both epileptic and nonepileptic events are present, epileptic events
- •must be distinguished from nonepileptic phenomena.
- •17. Subject has been treated with felbamate for at least 12 months prior to entering EP0060 and
- •has experienced any toxicity issues with this treatment. Note: Any subject who is currently treated with felbamate, and has received felbamate for a period of less than 12 months, is
- •excluded from EP0060.
- •18. Subject has an acute or subacutely progressive central nervous system disease. Subject has
- •epilepsy secondary to a progressing cerebral disease or any other progressive or
- •neurodegenerative disease (malignant brain tumor or Rasmussen syndrome).
- •19. Subject has a known cardiac sodium channelopathy, such as Brugada syndrome.
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