DS-5565 Phase III Study for Post-herpetic Neuralgia

Summary

Investigate the efficacy and safety of DS-5565 in subjects with Post-Herpetic Neuralgia (PHN) in comparison to placebo

Timeline

Start

2015-01

Primary completion

2017-05-25

Completion

2017-05-25

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs DS-5565 30 mg/Day; p <0.0001; Difference of least square means -0.77 (95% CI -1.10 to -0.44) NCT02318719 ↗

Publications

• Kato J, Baba M, Kuroha M, Kakehi Y, Murayama E, Wasaki Y, Ohwada S. Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies. Clin Ther. 2021 May;43(5):822-835.e16. doi: 10.1016/j.clinthera.2021.03.015. Epub 2021 May 29.
• Kato J, Matsui N, Kakehi Y, Murayama E, Ohwada S. Long-term safety and efficacy of mirogabalin in Asian patients with postherpetic neuralgia: Results from an open-label extension of a multicenter randomized, double-blind, placebo-controlled trial. Medicine (Baltimore). 2020 Sep 4;99(36):e21976. doi: 10.1097/MD.0000000000021976.

Drugs

Indications