drugset / Trial / NCT02318719
DS-5565 Phase III Study for Post-herpetic Neuralgia
RandomizedParallel-groupDouble-blindTreatment
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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirogabalin | Small molecule | 15 mg | Oral |
| Subject | Mirogabalin | Small molecule | 20 mg | Oral |
| Subject | Mirogabalin | Small molecule | 30 mg | Oral |