EUCTR2018-003110-40-DK进行中（未招募）1 期
The effect of lacosamide in peripheral neuropathic pain: a randomized, double-blind, placebo-controlled, phenotype-stratified study - The effect of lacosamide in peripheral neuropathic pain
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 108
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. Age = 18 years.
- •2. Probable or definite peripheral neuropathic pain for at least 3 months.
- •3. Average pain intensity of at least 4 and not above 9 on a 0-10 NRS during the 7-day baseline week.
- •3. Written informed consent.
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1. Other causes of pain in the same area or other concomitant pain that cannot be distinguished from the neuropathic pain.
- •2. Patients who cannot cooperate or are unable to complete the project and patients who do not speak Danish.
- •3. Known and current cardiac conduction disturbance (2nd or 3rd atrioventricular block, prolonged QTc interval >450 ms, heart rate <50 or >110 bpm, a QRS interval > 120 ms (12-lead ECG required)), significant cardiac disease (e.g. history of myocardial infarction, heart failure, or cardiovascular syncope), significant renal disease or liver disease or other severe illness (sodium, potassium, creatinine, eGRF, ALAT, basic phosphatase, LDH and for patients with diabetes: HA1c will be taken unless they are available within the past 3 months; the cut-off values for inclusion will be at the discretion of the investigator). Sitting diastolic blood pressure below 50 mm Hg or above 105 mm Hg. In patients treated with pregabalin also PQ interval >0.2s and cardiac disease.
- •4. Major depressive episode within 6 months, recurrent depressive disorder or other significant psychiatric disease, alcohol, illicit drug or drug abuse.
- •5. Pregnancy or lactation.
- •6. Women of child-bearing potential unless they use an acceptable effective contraception measure during the study and at least 2 weeks after or their male partner is vasectomized and their sole partner. Acceptable effective contraception is defined in the Clinical Trials Facilitation Group (CTFG) http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) and include intrauterine device or hormone-releasing system or hormonal contraception or total abstinence when this reflects their usual lifestyle or female sterilization (bilateral oophorectomy or total hysterectomy at least 6 weeks before). They should also have a negative pregnancy test.
- •7. Known allergy to lacosamide or excipients.
- •8. Concomitant pain treatment with tricyclic antidepressants (can be associated with PR prolongation), topical analgesics (lidocaine, capsaicin), cannabinoids, or strong opioids that cannot be discontinued. Other concomitant treatments for neuropathic pain are allowed in a stable dose (from 14 days before randomization to completion of the trial), if they cannot be tapered off completely.
- •9. Concomitant treatment with products known to be associated with PQ (PR) prolongation other than pregabalin.
- •9. Patients inappropriate for placebo.
- •10. Planned surgery.
- •11. Use of sodium channel blockers within at least five half-lives and investigational drugs within 30 days.
- •12. Patients on a controlled sodium diet, unless the amount of sodium in the capsules is acceptable for their diet.
- •13. The score yes” on item 4 or item 5 of the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS), if this ideation occurred in the past 6 months, or yes” on any item of the Suicidal Behavior section, except for the Non-Suicidal Self-Injurious Behavior” (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
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