EUCTR2013-000717-20-ES进行中（未招募）1 期
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
CB Biosciences Inc.0 个研究点目标入组 244 人开始时间: 2015年6月1日最近更新:
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
- 244
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
- •-Subject is male or female from >=1 month (ie, 4 weeks after full term [37 weeks gestational age]) to <4 years of age.
- •-Subject has a diagnosis of epilepsy with partial-onset seizures. The results of >=1 prior EEG and >=1 magnetic resonance imaging/computerized tomography scan should be consistent with this diagnosis.
- •-Subject weighs >=4kg to <30kg at Visit 1.
- •- Subject has uncontrolled partial-onset seizures after an adequate course of treatment (in the opinion of the investigator) with >=2 AEDs (concurrently or sequentially).
- •-Subject has experienced >=2 partial-onset seizures with or without secondary generalization during each consecutive 7-day period during the 2 weeks prior to Visit 1.
- •- Subject has >=2 partial-onset seizures with or without secondary generalization during the 72-hour Baseline video-EEG.
- •-Subject is on a stable (concurrently or sequentially) dosage regimen of 1 to 3 AEDs. The dosage regimen of concomitant AED therapy must be kept constant for a period of >=2 weeks prior to Visit 1. A stable daily dosage regimen of a concomitant benzodiazepine (BZD) will be considered as a concomitant AED.
- •-Vagus nerve stimulation is allowed and will not be counted as a concomitant AED. The VNS device must have been implanted for >=6 months prior to Visit 1; device settings must be kept stable for >=2 weeks prior to Visit 1 and kept stable during the Baseline, Treatment, and Transition Periods. Use of the VNS device magnet is allowed.
- •-Subject is an acceptable candidate for venipuncture
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 244
- •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
- •-Subject has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to partial-onset seizures is not exclusionary.
- •-Subject is on a ketogenic or other specialized diet for the treatment of epilepsy. If the subject was on a ketogenic or other specialized diet in the past, they must be off this diet for >=2 months prior to Visit 1.
- •-Subject has an alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin level >=2 times the upper limit of normal (ULN), or creatinine clearance <30mL/minute.
- •- Subject has a clinically relevant ECG abnormality, in the opinion of the investigator (eg, second or third degree heart block at rest or a corrected QT interval [QTc] >=450ms).
- •-Subject has a hemodynamically significant congenital heart disease.
- •-Subject has an arrhythmic heart condition requiring medical therapy.
- •- Subject has a known history of severe anaphylactic reaction secondary to medication intake or serious blood dyscrasias.
- •-Subject has nonepileptic events that could be confused with seizures. Subjects may be included if epileptic events can be clearly distinguished and the frequency meets the study inclusion criteria.
- •-Subject has a current diagnosis of Lennox-Gastaut syndrome, epilepsia partialis continua, primary generalized epilepsy, or seizures that are not of partial-onset origin.
- •-Subject has a history of status epilepticus <=2 months prior to Screening (Visit 1).
- •-Subject has been treated with ethosuximide.
- •-Subject is currently being treated with vigabatrin or has discontinued use <12 months prior to Visit 1. Subjects who were previously treated with vigabatrin and have discontinued use >12 months prior to Visit 1 are eligible.
- •- Subject has been treated with felbamate and has experienced any serious toxicity issues (defined as liver failure, aplastic anemia) with this treatment. Subjects treated with felbamate for <12 months are excluded. Subjects treated with felbamate for >=12 months prior to Visit 1 and who have not experienced serious toxicity issues are eligible.
- •- Subject has an acute or subacutely progressive central nervous system disease. Subject has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease (malignant brain tumor or Rasmussen Syndrome).
- •-Subject has a known sodium channelopathy, such as Brugada syndrome.
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