Mirogabalin for the treatment of diabetic peripheral neuropathic pain: A randomized, double-blind, placebo-controlled phase III study in Asian patients.

ABSTRACT:

Aims/introduction

This study evaluated the efficacy and safety of mirogabalin, a novel, potent, selective ligand of the α₂ δ subunit of voltage-dependent Ca²⁺ channels, for the treatment of diabetic peripheral neuropathic pain (DPNP).

Materials and methods

During this double-blind, multisite, placebo-controlled phase III study, Asian patients aged ≥20 years with type 1 or 2 diabetes and DPNP were randomized 2:1:1:1 to a placebo, mirogabalin 15, 20 or 30 mg/day for up to 14 weeks, with a 1- to 2-week titration (NCT02318706). The primary endpoint was the change from baseline in average daily pain score (ADPS) at week 14, defined as a weekly average of daily pain (0 = no pain to 10 = worst possible pain, for the past 24 h).

Results

Of 834 randomized

SUBMITTER: Baba M 

PROVIDER: S-EPMC6717827 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature