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Mirogabalin for the management of postherpetic neuralgia: a randomized, double-blind, placebo-controlled phase 3 study in Asian patients.
Pain 2019; 160(5):1175-1185PAIN

Abstract

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). Of 765 patients randomized, 763 received ≥ 1 dose of the study drug and were included in the analysis; 303, 152, 153, and 155 received placebo, mirogabalin 15, 20, or 30 mg/day, respectively. A total of 671 (87.7%) patients completed the study. 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.

Authors+Show Affiliations

Department of Anesthesiology, Nihon University School of Medicine, Tokyo, Japan.Clinical Development Department, Daiichi Sankyo Co, Ltd, Tokyo, Japan.Clinical Development Department, Daiichi Sankyo Co, Ltd, Tokyo, Japan.Asia Development Department, Daiichi Sankyo Co, Ltd, Tokyo, Japan.Biostatistics and Data Management Department, Daiichi Sankyo Co, Ltd, Tokyo, Japan.Biostatistics and Data Management Department, Daiichi Sankyo Co, Ltd, Tokyo, Japan.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

30913164

Citation

Kato, Jitsu, et al. "Mirogabalin for the Management of Postherpetic Neuralgia: a Randomized, Double-blind, Placebo-controlled Phase 3 Study in Asian Patients." Pain, vol. 160, no. 5, 2019, pp. 1175-1185.
Kato J, Matsui N, Kakehi Y, et al. Mirogabalin for the management of postherpetic neuralgia: a randomized, double-blind, placebo-controlled phase 3 study in Asian patients. Pain. 2019;160(5):1175-1185.
Kato, J., Matsui, N., Kakehi, Y., Murayama, E., Ohwada, S., & Sugihara, M. (2019). Mirogabalin for the management of postherpetic neuralgia: a randomized, double-blind, placebo-controlled phase 3 study in Asian patients. Pain, 160(5), pp. 1175-1185. doi:10.1097/j.pain.0000000000001501.
Kato J, et al. Mirogabalin for the Management of Postherpetic Neuralgia: a Randomized, Double-blind, Placebo-controlled Phase 3 Study in Asian Patients. Pain. 2019;160(5):1175-1185. PubMed PMID: 30913164.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Mirogabalin for the management of postherpetic neuralgia: a randomized, double-blind, placebo-controlled phase 3 study in Asian patients. AU - Kato,Jitsu, AU - Matsui,Norimitsu, AU - Kakehi,Yoshihiro, AU - Murayama,Emiko, AU - Ohwada,Shoichi, AU - Sugihara,Masahiro, PY - 2019/3/27/pubmed PY - 2019/6/14/medline PY - 2019/3/27/entrez SP - 1175 EP - 1185 JF - Pain JO - Pain VL - 160 IS - 5 N2 - 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). Of 765 patients randomized, 763 received ≥ 1 dose of the study drug and were included in the analysis; 303, 152, 153, and 155 received placebo, mirogabalin 15, 20, or 30 mg/day, respectively. A total of 671 (87.7%) patients completed the study. 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. SN - 1872-6623 UR - https://www.unboundmedicine.com/medline/citation/30913164/Mirogabalin_for_the_management_of_postherpetic_neuralgia:_a_randomized,_double-blind,_placebo-controlled_phase_3_study_in_Asian_patients L2 - http://Insights.ovid.com/pubmed?pmid=30913164 DB - PRIME DP - Unbound Medicine ER -