NCT03901352

Study of Mirogabalin for Central Neuropathic Pain

An Asian, Multicenter, Randomized, Double-blind, Placebo-controlled, 14-week Study of Mirogabalin in Participants With Central Neuropathic Pain Followed by a 52-week, Open-label Extension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Investigate the efficacy and safety of mirogabalin in participants with central neuropathic pain in comparison to placebo

Detailed description

\[Double Blind Phase\] The primary objective is to compare change in the Average Daily Pain Score (ADPS) from baseline to Week 14 in Asian participants with central neuropathic pain (central neuropathic pain after spinal cord injury) receiving mirogabalin versus placebo. \[Open Extension Phase\] The objective is to assess the long-term safety and efficacy of mirogabalin in participants with central neuropathic pain (central neuropathic pain after spinal cord injury, central post stroke pain, and central neuropathic pain in Parkinson's disease).

Conditions

• Central Neuropathic Pain

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo tablets for oral administration
DRUG	Mirogabalin	Mirogabalin tablets for oral administration

Timeline

• Start date: 2019-03-12
• Primary completion: 2020-12-28
• Completion: 2020-12-28
• First posted: 2019-04-03
• Last updated: 2024-10-21
• Results posted: 2024-09-23

Locations

118 sites across 3 countries: Japan, South Korea, Taiwan