DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

Phase 3 Completed 854 enrolled Daiichi Sankyo CMIC Co, Ltd. Japan · collab Quintiles Malaysia Sdn Bhd · collab Quintiles, Inc. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral Neuropathic Pain (DPNP) in comparison to placebo

Timeline

Start: 2015-01
Primary completion: 2017-06-29
Completion: 2017-06-29

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs DS-5565 30 mg (15 mg BID); p = 0.0027; Hazard Ratio (HR) -0.50 (95% CI -0.82 to -0.17); Mixed Models Analysis NCT02318706 ↗

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.

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