EUCTR2014-004378-40-Outside-EU/EEA进行中（未招募）不适用
A Multicenter, Open-label Trial to Assess the Safety and Tolerability of a Single Intravenous Loading Dose of Lacosamide Followed by Oral Lacosamide Maintenance as Adjunctive Therapy in Subjects With Partial-onset Seizures
CB BIOSCIENCES Inc.0 个研究点目标入组 100 人开始时间: 2015年3月10日最近更新:
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
- 100
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
- •- Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures
- •- Stable dose regimen of 1 to 2 marketed antiepileptic drug(s) (AED(s)) for 28 days prior to screening and duration of trial
- •- Acceptable candidate for venipuncture and intravenous (iv) infusion
- •- At least 1 partial seizure with motor component per 90 days
- •- Maximum allowed seizure frequency during 28 days prior to screening is 40 partial seizures of any type
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •- Previous use of lacosamide
- •- History of primary generalized seizures
- •- History of status epilepticus within last 12 months
- •- History of cluster seizures during 8 week period prior to screening
- •- Non-epileptic events, including psychogenic seizures that could be confused with seizures
- •- Use of neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening
- •- Received any rescue benzodiazepines more than once during the 28 days prior to screening
- •- Concomitant treatment of felbamate or previous felbamate therapy within last 6 months
- •- Prior or concomitant vigabatrin use
研究者
相似试验
招募中
1 期
A Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms of Radiprodil in Patients with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) Type IITuberous Sclerosis Complex (TSC), Focal Cortical Dysplasia (FCD) Type IIMedDRA version: 20.0Level: LLTClassification code: 10070672Term: Focal cortical dysplasia Class: 10010331MedDRA version: 21.0Level: PTClassification code: 10080584Term: Tuberous sclerosis complex Class: 100000004850CTIS2023-506301-20-00Grin Therapeutics Inc.34
已完成
3 期
A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGYTM Stent System) for the Treatment of Atherosclerotic Lesion(s)Symptomatic coronary artery disease or documented silent ischemia10011082NL-OMON39360Boston Scientific International S.A.200
进行中（未招募）
不适用
Contrast-Enhanced MRI of the supra-aortic vesselsSubjects with known or suspected vascular disease of the supra-aortic vesselsMedDRA version: 16.0Level: PTClassification code 10007687Term: Carotid artery stenosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2010-023001-36-SEBayer Health Care AG398
进行中（未招募）
不适用
Contrast-Enhanced MRI of the supra-aortic vesselsEUCTR2010-023001-36-DEBayer Health Care AG398
进行中（未招募）
不适用
Contrast-Enhanced MRI of the supra-aortic vesselsSubjects with known or suspected vascular disease of the supra-aortic vesselsMedDRA version: 16.0Level: PTClassification code 10007687Term: Carotid artery stenosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2010-023001-36-CZBayer Health Care AG398