EUCTR2005-005788-27-IT进行中（未招募）不适用
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 - 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
- 765
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 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, 61619;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 61619;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? 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 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 61619;2 times the upper limit of normal ULN or has alkaline phosphatase levels 61619;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 61619;470ms at Visit 1, where QTc is based on a central cardiologist overread. 13. Subject has 2 61616; or 3 61616; 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 known hypersensitivity to any components of the trial medication or rescue medication as stated in this protocol. 16. Subject is a pregnant or nursing female, or is of childbearing potential and does not practice adequate methods of contraception eg, implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or vasectomized partner . Women who are surgically sterile uterus removed or both tubes tied or postmenopausal at least 2 years without periods are allowed to participate in this trial.
研究者
相似试验
进行中（未招募）
不适用
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 SCHEMESPainful distal diabetic neuropathyMedDRA version: 6.0Level: LLTClassification code 10012680EUCTR2005-005788-27-CZSCHWARZ BIOSCIENCES GmbH537
进行中（未招募）
1 期
Safety Efficacy Study in 12-30y old Down Syndrome subjectsEUCTR2013-001263-23-ESRoche Farma, S.A. en nombre de F. Hoffmann-La Roche Ltd180
进行中（未招募）
1 期
A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s SyndromePrimary Sjögren’s syndromeMedDRA version: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2015-004476-30-FRF. Hoffmann-La Roche Ltd70
进行中（未招募）
1 期
Safety Efficacy Study in 12-30y old Down Syndrome subjectsDown SyndromeMedDRA version: 17.0Level: PTClassification code 10044688Term: Trisomy 21System Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2013-001263-23-GBF. Hoffmann-La Roche Ltd180
进行中（未招募）
不适用
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 SCHEMESPainful distal diabetic neuropathyMedDRA version: 6.0Level: LLTClassification code 10012680EUCTR2005-005788-27-FISCHWARZ BIOSCIENCES GmbH537