Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy

Phase 2 Completed 450 enrolled Daiichi Sankyo

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.

Timeline

Start: 2012-01
Primary completion: 2013-06
Completion: 2013-06

Outcome

Missed primary endpoint

paper Although no significant differences were observed in the primary endpoint PMID 32052264 ↗

registry analysis (superiority test); Placebo vs DS-5565 10 mg/Day; p = 0.1995 NCT01504412 ↗

registry analysis (superiority test); Placebo vs DS-5565 20 mg/Day; p = 0.2886 NCT01504412 ↗

registry analysis (superiority test); Placebo vs DS-5565 30 mg/Day; p = 0.4704 NCT01504412 ↗

Publications

Baba M, Kuroha M, Ohwada S, Murayama E, Matsui N. Results of Mirogabalin Treatment for Diabetic Peripheral Neuropathic Pain in Asian Subjects: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study. Pain Ther. 2020 Jun;9(1):261-278. doi: 10.1007/s40122-020-00156-6. Epub 2020 Feb 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirogabalin	Small molecule	5 mg	Oral
Subject	Mirogabalin	Small molecule	10 mg	Oral
Subject	Mirogabalin	Small molecule	15 mg	Oral
Comparator	Pregabalin	Small molecule	150 mg	Oral