A crossover study of a novel dosage form of mirogabalin for the treatment of peripheral neuropathic pain

JRCT ID: jRCTs041210001

Registered date:01/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Neuropathic pain (diabetic neuropathy, traumatic neuropathy, post-infection neuropathy)
• Date of first enrollment: 01/04/2021
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Allocation of mirogabalin 0.05% topical agent prior administration group and placebo prior administration group

Outcome(s)

• Primary Outcome: Average weekly pain score [NRS (numerical rating scale): 0 (no pain) to 10 (worst imaginable pain) ) Evaluate on a scale of 11] when mirogabalin 0.05% topical agent was administered to patients with neuropathic pain three times a day. Compare the amount of change from baseline with the placebo group
• Secondary Outcome: Compare the proportion of subjects with a weekly mean pain score of 30% or more and 50% or more lower than baseline in the mirogabalin 0.05% topical group compared to the placebo group.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Diabetic patients with diabetic peripheral neuropathy and patients with neuropathic pain after trauma or infection who are visiting or hospitalized at Fujita Health University Hospital and Sakura General Hospital

Exclude criteria

1. Patients who have been treated with mirogabalin 30 mg / day in the past and are judged to be ineffective
2. Patients with hypersensitivity to mirogabalin, pregabalin, or gabapentin
3. Patients with the following abnormalities before participating in the study or by screening test
AST / ALT> 2.0 x upper limit of standard value
ALP> 1.5 x upper limit of standard value
Total bilirubin> 1.2 x upper limit of standard value
4. Patients who are likely to start other analgesics (gabapentinoids, anticonvulsants, serotonin-noradrenaline reuptake inhibitors, hypnotic sedatives, anxiolytics, opioids) during the study period and change doses
5. Pregnant or potentially pregnant patients, lactating patients
6. Other patients who are judged to be inappropriate by the investigator and the investigator

Related Information

• Primary Sponsor: Suzuki Atsushi
• Source(s) of Monetary Support: Fujita Health University Hospital