EUCTR2011-002461-37-AT进行中（未招募）不适用
A PROSPECTIVE, MULTINATIONAL, OPEN-LABEL, SINGLE-ARM, EXPLORATIVE STUDY TO EVALUATE THE TOLERABILITY AND EFFICACY OF LACOSAMIDE WHEN ADDED TO LEVETIRACETAM WITH WITHDRAWAL OF THE CONCOMITANT SODIUM CHANNEL BLOCKING ANTIEPILEPTIC DRUG IN SUBJECTS WITH UNCONTROLLED PARTIAL-ONSET SEIZURES - Optimising Combination Therapy On Partial Onset Seizures (OCToPOS)
CB BIOSCIENCES Inc0 个研究点目标入组 300 人开始时间: 2012年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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, at least 18 years of age.
- •2. Subject has a diagnosis of epilepsy with partial-onset seizures according to the International Classification of Epileptic Seizures (1981).
- •3. Subject is taking LEV in combination with 1 sodium channel blocking antiepileptic drug (defined as carbamazepine, lamotrigine, oxcarbazepine, phenytoin, or eslicarbazepine) as adjunctive treatment for epilepsy.
- •4. The minimum required seizure frequency during the 8-week Retrospective Seizure Baseline is on average =2 partial-onset seizures per 28 days with at least 1 seizure per 4 week period within the 8-week Retrospective Seizure Baseline. Additionally, subjects must experience at least 1 seizure during the 4-week Prospective Seizure Baseline.
- •5. Subject has been maintained on a stable dose of LEV and a sodium channel blocking antiepileptic drug for at least 4 weeks prior to the Screening Visit (Visit 1) and during the 4-week Prospective Seizure Baseline.
- •6. The minimum required seizure frequency during the 8-week Retrospective Seizure Baseline is on average =2 partial-onset seizures (IA, IB, or IC) per 28 days (based on investigator assessment of subject report) with at least 1 seizure per 4 week period within the 8-week Retrospective Seizure Baseline.
- •7. Subject has been maintained on a stable dose of LEV and a SCB-AED for at least 4 weeks prior to the Screening Visit (Visit 1) and during the 4-week Prospective Seizure Baseline, with or without additional concurrent stable vagal nerve stimulation (VNS). The VNS must have been in place for at least 6 months prior to the Screening Visit (Visit 1) with constant settings for at least 4-weeks prior to the Screening Visit (Visit 1) and throughout the duration of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 294
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Previous use of lacosamide.
- •2. History of alcohol or drug abuse.
- •3. History of seizure disorder characterized primarily by isolated auras.
- •4. History of primary generalized seizures.
- •5. History of status epilepticus within the 12-months.
- •6. History of clustering seizures.
- •7. Nonepileptic events, including pseudoseizures that could be confused with seizures
- •8. History of any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize the subject’s health or would compromise the subject’s ability to participate in this study.
- •9. Lifetime history of suicide attempt,or suicidal ideation in the past 6 months.
- •10. Hypersensitivity to any component of LCM.
- •11. History of acute or sub-acute progressive central nervous system disease.
- •12. History of severe anaphylactic reaction or serious blood dyscrasias.
- •13. Impaired renal function (ie, creatinine clearance [CLcr] is lower than 30mL/min) at Visit 1.
- •14. History of sick sinus syndrome without a pacemaker, or atrioventricular (AV) block, or subject has any other clinically significant ECG abnormalities.
- •15. History sodium channelopathy, such as Brugada syndrome.
- •16. History of myocardial infarction in the last 3 months.
研究者
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