drugset

drugset / Trial / NCT04094662

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain

NCT04094662 ↗

Phase 3 Completed 393 enrolled Daiichi Sankyo

RandomizedParallel-groupTriple-blindTreatment

Summary

Investigate the efficacy and safety of mirogabalin in Chinese participants with diabetic peripheral neuropathic pain in comparison to placebo.

Timeline

Start: 2019-09-18
Primary completion: 2022-01-17
Completion: 2022-01-24

Outcome

Met primary endpoint

paper Mirogabalin elicited a greater change from baseline in the weekly ADPS vs. placebo at week 14: PMID 38896199 ↗

paper least-squares mean difference (95% confidence interval) vs. placebo - 0.39 (- 0.74, - 0.04), p = 0.0301. PMID 38896199 ↗

Publications

Guo X, Yu Y, Zhang Y, Sun L, Li Y, Song B, Hang L, Baba M, Wasaki Y, Kikumori K, Murayama E. A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled 14-Week Study of Mirogabalin in Chinese Patients with Diabetic Peripheral Neuropathic Pain. Pain Ther. 2024 Aug;13(4):937-952. doi: 10.1007/s40122-024-00617-2. Epub 2024 Jun 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirogabalin	Small molecule	15 mg	Oral

Indications