None listed
Conditions
Interventions
Drug : One tablet of either mirogabalin or matching placebo will be administered orally twice daily (BID) (in the morning and at bedtime).
In mirogabalin group, patients with CLcr = 60 mL/min at scree
60 mL/min at screening, will start 2.5 mg BID of mirogabalin at first week, followed by 5 mg BID at second week as titration phase. From the third week, if there are no problems in safety, the patient
Sponsors
Daiichi-Sankyo Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the weekly ADPS | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in parameters assessed using the SF-MPQ | — |
Countries
Korea, Republic of
Contacts
Public ContactChang-Won Moon
Chungnam National University Hospital
Outcome results
None listed