Long-Term Safety and Efﬁcacy of Mirogabalin for Central Neuropathic Pain: A Multinational, Phase 3, 52-Week, Open-Label Study in Asia

Pain Ther, 2023 · DOI: https://doi.org/10.1007/s40122-023-00513-1 · Published: April 28, 2023

Pharmacology Pain Management Research Methodology & Design

Simple Explanation

This study investigated the long-term safety and effectiveness of mirogabalin in treating central neuropathic pain (CNeP) in patients with spinal cord injury, Parkinson's disease, or post-stroke pain. The study involved a 52-week open-label treatment where patients received mirogabalin, and their pain levels and side effects were monitored. The results showed that mirogabalin was generally safe and well-tolerated, and it helped reduce pain in patients with CNeP over the long term.

Study Duration

52 weeks

Participants

210 patients with CNePSCI, CPSP, or CNePPD

Evidence Level

Level 2: Phase 3, open-label study

Key Findings

1
Mirogabalin was generally safe and well-tolerated, with common side effects including somnolence, peripheral edema, edema, and dizziness, most of which were mild.
2
All patient groups (CNePSCI, CPSP, and CNePPD) experienced reductions in pain, as measured by SF-MPQ visual analog scores.
3
The study suggests that mirogabalin may be a promising treatment option for CNeP caused by spinal cord injury, Parkinson’s disease, or post-stroke pain.

Research Summary

This multinational, open-label study assessed the long-term safety and efficacy of mirogabalin for central neuropathic pain (CNeP) in Asian patients with spinal cord injury (CNePSCI), Parkinson's disease (CNePPD), or post-stroke pain (CPSP). Patients received mirogabalin for 52 weeks, with the primary endpoint being safety, assessed by treatment-emergent adverse events (TEAEs). Efficacy was assessed using the short-form McGill Pain Questionnaire (SF-MPQ). The study concluded that mirogabalin was generally safe, well-tolerated, and effective for the treatment of CNeP, suggesting it as a promising treatment option for these patient populations.

Practical Implications

Clinical Practice

Mirogabalin can be considered as a treatment option for long-term management of central neuropathic pain in patients with spinal cord injury, post-stroke pain, and Parkinson's disease.

Future Research

Further studies are needed to confirm the efficacy and safety of mirogabalin in diverse populations and to compare it with other treatments for central neuropathic pain.

Drug Development

The findings support the continued development and use of mirogabalin for neuropathic pain conditions, highlighting its potential benefits in pain management.

Study Limitations

1
Relatively small sample size, especially for patients with CNePPD.
2
Open-label design without a control group.
3
Exclusion of patients with CrCL < 30 mL/min, limiting generalizability to patients with severe renal impairment.

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