EUCTR2005-005788-27-ES进行中（未招募）1 期
Ensayo multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y seguridad de Lacosamide 400mg/día en sujetos con neuropatía diabética distal dolorosa utilizando dos estrategias diferentes de titulación. (A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO ASSESS THE EFFICACY AND SAFETY OF 400MG/DAY LACOSAMIDE IN SUBJECTS WITH PAINFUL DISTAL DIABETIC NEUROPATHY USING TWO DIFFERENT TITRATION SCHEMES)
SCHWARZ BIOSCIENCES GmbH0 个研究点目标入组 537 人开始时间: 2006年5月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 537
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
- •Subjects must fulfill the following inclusion criteria:
- •1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
- •2. Subject is willing and able to comply with all trial requirements.
- •3. Subject is male or female, >=18 years of age.
- •4. Subject has had symptoms of painful diabetic neuropathy for at least 6 months and has a diagnosis of diabetes mellitus (Type I or Type II). Subjects who have had symptoms of painful diabetic neuropathy for longer than 5 years may only be enrolled after consultation with the Medical Monitor.
- •5. Subject has good to fair diabetic control (glycosylated hemoglobin A1c [HbA1c] levels <12%), which is optimized (best effort to achieve best control) for at least 3 months prior to Visit 1.
- •6. Subject has at least moderate pain that is defined as an average pain intensity of >=4 on an 11 point Likert scale (0-10) during the 7 days prior to Visit 2, where at least 4 out of the 7 days have both the morning and evening scores recorded.
- •Are the trial subjects under 18?
- •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
- •Subjects are not permitted to enroll in the trial if any of the following criteria are met:
- •1. Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial.
- •2. Subject has participated in another trial of an investigational drug (or a medical device) within the last 30 days or is currently participating in another trial of an investigational drug or medical device.
- •3. Subject has other conditions that cause chronic pain at least as severe as the diabetic neuropathy pain, unless subject can clearly distinguish the different types of pain. These cases should be discussed with the medical monitor.
- •4. Subject is expected to take within 7 days prior to randomization or during the trial AEDs, muscle relaxants, mexiletine, topical analgesics, opioids or unstable doses of tricyclic antidepressants (TCAs), or any other approved therapy for treating painful diabetic neuropathy (such as duloxetine). Paracetamol up to 2g/day is allowed as rescue medication during the entire trial.
- •5. Subject is receiving treatment with neurostimulating devices such as spinal cord stimulation (SCS) or peripheral nerve stimulation (PNS). Treatment for pain with acupuncture, surgery, or blockade not allowed.
- •6. Subject has had an amputation related to diabetes, other than toe amputations.
- •7. Subject has major skin ulcers.
- •8. Subject has aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin levels >=2 times the upper limit of normal (ULN) or has alkaline phosphatase levels >=3 times the ULN at Visit 1.
- •9. Subject has impaired renal function, ie, creatinine clearance (Ccr) is lower than 50mL/min at Visit 1. Creatinine clearance will be estimated as follows:
- •Adult males: Ccr = (140-age) x weight in kg/(72 x serum creatinine in mg/dL)
- •Adult females: Ccr = [(140-age) x weight in kg/(72 x serum creatinine in mg/dL)] x .85.
- •10. Subject has other laboratory values, which are outside the normal range at Visit 1 and judged by the investigator as clinically relevant. Exceptions are out-of-range values that are expected in this diabetic population (eg, elevated glucose).
- •11. Subject has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months, or has any cardiac disorder that, in the opinion of the investigator, would put the subject at risk of clinically relevant arrhythmia and/or myocardial infarction.
- •12. Subject has a QTc >=470ms at Visit 1, where QTc is based on a central cardiologist overread.
- •13. Subject has 2° or 3° atrioventricular block or sinus bradycardia (heart rate <50 beats per minute [bpm]) or sinus tachycardia (heart rate >110bpm) at Visit 1, based on a central cardiologist overread.
- •14. Subject has diastolic blood pressure <50mm Hg or >105mm Hg, measured in a sitting position after 3 minutes at rest.
- •15. Subject has a history of alcohol or drug abuse within the last year.
- •16. Subject has scheduled or expects to schedule a surgical procedure during the course of the trial.
- •17. Subject has any medical or psychiatric condition that, in the opinion of the investigator, would jeopardize or compromise the subject’s ability to participate in this trial or could confound the analysis of efficacy.
- •18. Subject has known hypersensitivity to any components of the trial medication (or rescue medication) as stated in this protocol.
- •19. Subject is a pregnant or nursing female, or is o
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