EUCTR2004-000551-42-IT进行中（未招募）不适用
A MULTI-CENTER, 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 - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 751
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 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
- •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.**
- •*Brugada syndrome: an inherited form of cardiac arrhythmia which can lead to life threatening ventricular fibrillation. This condition is also known as Sudden Unexpected Death Syndrome.
- •**New York Heart Association Criteria
- •Class I:Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
- •Class II:Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
- •Class III:Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.
- •Class IV:Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
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