EUCTR2004-000551-42-ES进行中（未招募）不适用
Estudio multicéntrico, abierto, de seguimiento para evaluar la seguridad y eficacia a largo plazo de lacosamide en sujetos con neuropatía diabética distal dolorosa, que incluye un subestudio de retirada aleatorizado, doble ciego de tiempo limitado. (A multicenter, open-label, follow-on trial to assess the long-term safety and efficacy of lacosamide in subjects with painful distal diabetic neuropathy including a double-blind, randomized time point withdrawal subtrial)
SCHWARZ BIOSCIENCES GmbH0 个研究点目标入组 530 人开始时间: 2006年8月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 530
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
- •A subject is considered eligible for participation in the trial if the following inclusion criteria are satisfied:
- •1. Subject is informed and has been given ample time and opportunity to think about her/his participation and has given her/his written informed consent. Note: subjects completing the double-blind trial must provide written informed consent at the start of the Transition Phase (Visit 9 of SP743 or Visit 8 of SP874).
- •2. Subject has completed SP743 or SP874 and, in the investigator’s opinion, might benefit from long-term administration of lacosamide. Exception: subjects who prematurely discontinued SP743 or SP874 due to lack of efficacy or due to intolerability to trial medication (after Visit 5 but prior to entering the Maintenance Phase) may be eligible to participate in SP746, after consultation with the medical monitor.
- •3. Subject is willing and able to comply with all trial requirements, including the completion of trial questionnaires.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject is not eligible for participation in the trial if any of the following exclusion criteria are met.
- •1. Subject has clinically relevant ECG abnormalities, or a QTc interval =500ms, and/or a QTc interval increase of =60ms from the mean pre-dose QTc value at Visit 2 of SP743 or SP874.
- •2. Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =3 times the upper limit of the normal range (ULN) with total bilirubin =2 times ULN or transaminases (AST and/or ALT) =5 times ULN.
- •3. Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject’s ability to participate in this trial.
- •4. Subject is a pregnant or nursing female, or is of childbearing potential and is not surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of contraception.
- •5. Subject has hypersensitivity to components of the trial medication.
- •6. Subject has previously participated in this or any other follow-on trial of lacosamide.
- •7. Subject has participated in another trial of an investigational drug or device within the last 30 days (except the prerequisite lacosamide trials) or is currently participating in another trial of an investigational drug or device.
- •8. Subject has an ongoing serious adverse event (SAE) assessed to be related to the trial medication either by the investigator or the sponsor.
- •9. Subject has sick sinus syndrome and does not have a pacemaker.
- •10. Subject has atrial fibrillation/flutter, ventricular tachyarrhythmia (eg, ventricular tachycardia, ventricular fibrillation, aborted cardiac arrest), symptomatic heart block at Visit 1, or is diagnosed with Brugada syndrome.
- •11. Subject has diagnosis of New York Heart Association Class III or Class IV heart failure.
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