EUCTR2011-001559-35-FR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 192 人开始时间: 2015年9月25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
- 192
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 (when possible or as required according to local Institutional Review Boards [IRBs]/Independent Ethics Committees [IECs]).
- •- 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 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 male or female and =4 years to =17 years of age.
- •- Subject has a diagnosis of epilepsy with partial-onset seizures.
- •a.The results of at least 1 prior electroencephalogram (EEG) AND 1 prior magnetic resonance imaging/computerized tomography scan should be consistent with the above diagnosis.
- •- 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 AEDs (concurrently or sequentially).
- •- Subject has been observed to have at least 2 countable seizures in the 4 week period prior to Screening.
- •b. In the case of simple partial seizures, only those with motor signs will be counted towards meeting the inclusion criteria (only partial seizures with a recognizable and countable manifestation).
- •- Subject is on a stable dosage regimen of 1 to 3 AEDs. The daily dosage regimen of concomitant AED therapy must be kept constant for a period of at least 1 week prior to Screening. Vagal nerve stimulation is not counted as medical therapy; however, VNS settings must be kept constant for a period of at least 1 week prior to Screening.
- •- Subject is an acceptable candidate for venipuncture.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 192
- •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
- •Subjects are 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 LCM.
- •- 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 a positive response (Yes”) to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening.
- •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 the withdrawal criteria for the primary study (with the exception of subjects who discontinued due to a dose reduction or status epilepticus), or is experiencing an ongoing serious AE (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.
- •Medically acceptable contraceptive method includes oral or depot contraceptive treatment with at least 30µg ethinylestradiol per intake (or 50µg if associated with carbamazepine [or other strong enzyme inducers, eg, phenobarbital, primidone, oxcarbazepine]) which must be used in conjunction with a barrier method. Sexual abstinence is also an acceptable method of contraception.
- •The subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and undertake to inform the investigator of any potential change in status. Females of childbearing potential must have a negative pregnancy test at the Screening Visit.
- •- 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 50mL/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 has been treated with vigabatrin or felbamate for at least 12 months prior to entering the study and has experienced
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