KCT0004730招募中未知
An Asian, multicenter, randomized, double-blind, placebo controlled 14-week study of mirogabalin in patients with central neuropathic pain followed by a 52-week open-label extension
Daiichi-Sankyo Korea0 个研究点目标入组 3 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Age = 20 years at informed consent
- •2. Able to give informed consent for the study participation, understand procedures of this study, and complete patient-reported questionnaires adequately
- •3. Spinal cord injury due to trauma (eg, turnover, fall, traffic accident, sports accident)
- •4. C4-T12 spinal cord injury identified on MRI
- •5. American Spinal Injury Association (ASIA) impairment scale A, B, C, or D
- •6. Neuropathic pain region expressed at level and/or below level of spinal cord injury
- •7. = 6 months after SCI at screening
- •8. Stable CNePSCI at least for 3 months prior to screening
- •9. At screening, a pain scale of = 40 mm on Visual Analog Scale (VAS) of SF-MPQ
- •10. At randomization, a pain scale of = 40 mm on VAS of SF-MPQ, and completion of at least 4 days of daily pain diaries with an ADPS of = 4 over the past
排除标准
- •1. On any one day during the observation period, pain score of 10 on a scale of 0 (no pain) to 10 (worst possible pain)
- •2. Other severe pain at screening or randomization,unrelated to CNePSCI, that may confound the assessment of CNePSCI
- •3. Neurologic disorders at screening or randomization,unrelated to CNePSCI, that may confound the assessment of CNePSCI
- •4. Major psychiatric disorders within 1 year prior to screening
- •5. Patient who has secondary-gain from CNePSCI (eg, legal dispute, settlement negotiations) at screening or randomization
- •6. Spinal cord injury due to suicidal behavior
- •7. Patient who blames the third party for his/her spinal cord injury, in the case of spinal cord injury due to the third party act (Those patients can rarely overcome the pain due to the psychiatric factor)
- •8. Previous administration of pregabalin = 300 mg/day for subjects with creatinine clearance (CLcr: using the Cockcroft-Gault equation) = 60 mL/min or pregabalin = 150 mg/day for subjects with CLcr 30 to < 60 mL/min for at least 4 weeks, declared
- •lack of effect
- •9. Previous administration of gabapentin = 1200 mg/day for subjects with CLcr = 60 mL/min or gabapentin = 600 mg/day for subjects with CLcr 30 to < 60, for at least 4 weeks, declared lack of effect
- •10. Use of mirogabalin, pregabalin, or gabapentin within 28 days prior to screening
- •11. Use of strong opioids for analgesic of CNePSC within 3 months prior to screening
- •12. CLcr (using the Cockcroft-Gault equation) < 30 mL/min at screening
- •13. Malignancy other than basal cell carcinoma within the past 2 years prior to screening
- •14. Clinically significant unstable endocrine (eg, diabetes mellitus), neurologic, ophthalmologic, hepatobiliary, respiratory, hematologic illness, or cardiovascular disease (eg, uncontrolled cardiac arrhythmia, or myocardial infarction) at screening
- •or randomization
- •15. Clinically significant findings on ECG at screening
- •16. History of pernicious anemia, untreated hypothyroidism, or human immunodeficiency virus infection
- •17. Pregnancy, potential pregnancy, breast feeding, or subject unwilling to take reliable contraceptive measures during the study or for 4 weeks after study completion
- •18. Known hypersensitivity to mirogabalin, pregabalin, or gabapentin
- •19. Participation in another clinical study, either currently or within 30 days prior to providing of informed consent
- •20. Experience of participating mirogabalin clinical study and receiving investigational product
- •21. Abuse of illicit drugs or alcohol history
- •22. Response of yes” to any of the questions on the CSSRS at screening or randomization in relation to events occurring within the past 12 months
- •23. At screening, clinical laboratory values exceeding limits listed in Table 4.1
- •24. The subject who is considered inappropriate for the study at the discretion of the investigator or subinvestigator
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