Pain Ther. 2026 Mar 18. doi: 10.1007/s40122-026-00827-w. Online ahead of print.
ABSTRACT
INTRODUCTION: Mirogabalin is an oral Ca2+ channel α2δ ligand used for treating diabetic peripheral neuropathic pain (DPNP) in China. However, there is limited real-world evidence on its safety and effectiveness in treating adult patients with DPNP in China. This study aims to evaluate the safety and effectiveness of mirogabalin in patients with DPNP treated in a routine clinical practice in China.
METHODS: The ReMIssion study is a multicenter, prospective, observational study that aims to enroll 720 patients from around 36 centers. The study population will consist of patients aged ≥ 18 years, who are treatment-naïve, and have a visual analog scale (VAS) score of ≥ 40 mm. Patients will be observed for 15 weeks, including 14 weeks of mirogabalin treatment and a 1-week follow-up.
PLANNED OUTCOMES: The primary endpoint is to evaluate the real-world safety of mirogabalin, whereas the secondary endpoint is to evaluate the real-world effectiveness of mirogabalin in Chinese patients with DPNP. Exploratory endpoints will investigate the real-world usage pattern and patient-reported outcomes (PRO) associated with mirogabalin treatment in Chinese adult patients with DPNP. In China, this is the first observational study focusing on the safety and effectiveness of mirogabalin in real-world clinical practice. Mirogabalin may offer clinical benefits for DPNP management, including improved real-world effectiveness, tolerable safety, and favorable usage patterns, potentially enhancing patient-reported outcomes.
TRIAL REGISTRATION: Clinicaltrial.gov/NCT06812117.
PMID:41849003 | DOI:10.1007/s40122-026-00827-w