Mirogabalin phase 3 study for central neuropathic pai
- Conditions
- central neuropathic pain
- Registration Number
- JPRN-jRCT2080224584
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
In subjects with CNePSCI receiving flexible-dose mirogabalin (up to 30 mg/day for subjects with CLcr >=60 mL/min and 15 mg/day for subjects with CLcr 30 to <60 mL/min) for 14 weeks, including a 2-week titration period, mirogabalin resulted in a statistically significant improvement in weekly ADPS compared with placebo. The results of secondary endpoints were generally supportive of the results of primary endpoint. Mirogabalin was generally well-torelated without any significant specific safety concern.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 300
Spinal cord injury due to trauma
- American Spinal Injury Association (ASIA) impairment scale A, B, C, or D
- Other severe pain at screening or randomization, unrelated to central neuropathic pain after spinal cord injury, that may confound the assessment of central neuropathic pain after spinal cord injury
- Neurologic disorders at screening or randomization, unrelated to central neuropathic pain after spinal cord injury, that may confound the assessment of central neuropathic pain after spinal cord injury
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Average daily pain score
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>- Short-Form McGill Pain Questionnaire <br>- Average Daily Sleep Interference Score