EUCTR2011-001559-35-DE进行中（未招募）1 期
AN OPEN-LABEL STUDY TO DETERMINE SAFETY, TOLERABILITY, AND EFFICACY OF LONG-TERM ORAL LACOSAMIDE (LCM) AS ADJUNCTIVE THERAPY IN CHILDREN WITH EPILEPSY
CB BIOSCIENCES, Inc0 个研究点目标入组 354 人开始时间: 2013年4月30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
- 354
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
- •All subjects in SP848 must fulfill the following inclusion criteria:
- •- A signed informed consent form has been obtained from the parent/legal guardian and assent has been
- •obtained from the subject, as required
- •- Subject and caregiver (which may be a parent, legal guardian, or other delegated caregiver) are willing
- •and able to comply with all study requirements, including maintaining a daily seizure diary
- •Subjects who have participated in SP847 or other lacosamide (LCM) pediatric clinical studies in epilepsy
- •must fulfill the following inclusion criteria:
- •- Subject has completed SP847 (or the subject discontinued SP847 due to a dose reduction or status
- •epilepticus) for the treatment of uncontrolled partial-onset seizures, or subject has participated in other
- •LCM pediatric clinical studies in epilepsy
- •- Subject is expected to benefit from participation, in the opinion of the investigator
- •Subjects who enroll directly into SP848 without previous participation in a LCM clinical study must
- •fulfill the following inclusion criteria:
- •- Subject is >=4 years to <=17 years of age
- •- Subject has a diagnosis of epilepsy with partial-onset seizures
- •- Subject has been observed to have uncontrolled partial-onset seizures after an adequate course of
- •treatment (in the opinion of the investigator) with at least 2 Antiepileptic Drugs (AEDs) (concurrently or
- •sequentially)
- •- Subject has been observed to have at least 2 countable seizures in the 4 week period prior to Screening
- •- Subject is on a stable dosage regimen of 1 to 3 AEDs
- •- Subject is an acceptable candidate for venipuncture
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 354
- •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
- •Not permitted to enroll in the study if any of the following criteria are met:
- •- Subject is receiving any investigational drugs or using any experimental devices in addition to
- •Lacosamide (LCM)
- •- Subject >= 6 years of age has a lifetime history of suicide attempt, or has suicidal ideation in the past 6
- •Subjects who have participated in SP847 or other LCM pediatric clinical studies in epilepsy are not
- •permitted to enroll in the study if any of the following criteria are met:
- •- Subject meets either of the following:
- •a) Withdrawal criteria for the primary study (with the exception of subjects who discontinued due to a
- •dose reduction or status epilepticus). For subjects entering from EP0060, if the subject (or legal guardian)
- •withdraws consent solely due to route of LCM administration (iv) or if the subject requires more than 10
- •iv LCM infusions, the subject may be allowed to participant in SP848 after discussion with and
- •agreement from the Medical Monitor
- •b) Ongoing serious Adverse Event (SAE)
- •Subjects who enroll directly into SP848 without previous participation in a LCM clinical study are not
- •permitted to enroll in the study if any of the following criteria are met:
- •- Subject has ever received LCM
- •- 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.
- •- Subject has a medical condition that could reasonably be expected to interfere with drug absorption,
- •distribution, metabolism, or excretion
- •- Subject has a known hypersensitivity to any component of the investigational medicinal product
- •- Subject is a female of childbearing potential and does not practice an acceptable method of
- •contraception for the duration of the study
- •- Subject has a creatinine clearance less than 30mL/min
- •- Subject has a clinically relevant 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)
- •- Subject has hemodynamically significant heart disease (eg, heart failure)
- •- Subject has an arrhythmic heart condition requiring medical therapy
- •- Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias
- •- Subject has nonepileptic events, including psychogenic seizures, that could be confused with seizures.
- •If both epileptic and nonepileptic events are present, epileptic events must be
- •distinguished from nonepileptic phenomena
- •- Subject has a history of primary generalized epilepsy
- •- Subject is taking monoamine oxidase inhibitors-A (MAOI-A) or narcotic analgesics.
- •- Subject has epilepsy secondary to a progressing cerebral disease or any other progressively
- •neurodegenerative disease, such as Rasmussen syndrome
- •- Subject has a known sodium channelopathy, such as Brugada syndrome
- •- Subject has >2x upper limit of normal (ULN) of any of the following: alanine aminotransferase
- •(ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin
- •(1.5xULN total bilirubin if known Gilbert’s syndrome). If subject has elevations only in total bilirubin
- •that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert’s syndrome
- •(ie, direct bilirubin <35%)
- •Subjects who were directly enrolled in EP0060 for iv LCM replacement therapy or to initiate LCM
- •treatment are not permitted to enroll in the study if any of the following criteria are me
研究者
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