Pain
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Randomized Controlled Trial Multicenter Study
Mirogabalin for the management of postherpetic neuralgia: a randomized, double-blind, placebo-controlled phase 3 study in Asian patients.
This study investigated the safety and efficacy of mirogabalin, a novel, potent, selective ligand of the α2δ subunit of voltage-dependent Ca channels, for the treatment of postherpetic neuralgia (PHN). In this multicenter, double-blind, placebo-controlled phase 3 study, Asian patients ≥20 years with PHN were randomized 2:1:1:1 to placebo or mirogabalin 15, 20, or 30 mg/day for up to 14 weeks (NCT02318719). The primary efficacy endpoint was the change from baseline in average daily pain score at week 14, defined as a weekly average of daily pain (0 = "no pain" to 10 = "worst possible pain," for the last 24 hours). ⋯ At week 14, the difference in average daily pain score least squares mean vs placebo was -0.41, -0.47, and -0.77, respectively; all mirogabalin groups showed statistical significance. The most common treatment-emergent adverse events were somnolence, nasopharyngitis, dizziness, weight increase, and edema, and all of them were mild or moderate in severity. Mirogabalin was superior to placebo in all groups for relieving PHN and appeared well tolerated.
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Multicenter Study
Normative data for common pain measures in chronic pain clinic populations: closing a gap for clinicians and researchers.
Normative data for chronic pain questionnaires are essential to the interpretation of aggregate scores on these questionnaires, for both clinical trials and clinical practice. In this study, we summarised data from 13,343 heterogeneous patients on several commonly used pain questionnaires that were routinely collected from 36 pain clinics in Australia and New Zealand as part of the electronic Persistent Pain Outcomes Collaboration (ePPOC) including the Brief Pain Inventory (BPI); the Depression Anxiety and Stress Scales (DASS); the Pain Self-Efficacy Questionnaire (PSEQ); and the Pain Catastrophizing Scale (PCS). The data are presented as summarised normative data, broken down by demographic (age, sex, work status, etc) and pain site/medical variables. ⋯ Scores tended to worsen with age until 31 to 50 years, after which they improved. Scores were worse for those who had a greater number of pain sites, were unemployed, were injury compensation cases, or whose triggering event was a motor vehicle accident or injury at work or home. These results and comparisons with data on the same measures from other countries, as well as their uses in both clinical practice and clinical trials, are discussed.