Mirogabalin for Central Neuropathic Pain After Spinal Cord Injury: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study in Asia

Neurology® 2023 · DOI: 10.1212/WNL.0000000000201709 · Published: March 14, 2023

Spinal Cord Injury Neurology Pain Management

Simple Explanation

This study investigated the use of mirogabalin to treat central neuropathic pain (CNeP) in patients with spinal cord injuries (SCI). Mirogabalin is already used for peripheral neuropathic pain, but its effectiveness for CNeP was not yet well-established. The study found that mirogabalin significantly reduced pain in patients with CNeP after SCI, compared to a placebo. Patients reported less pain, better sleep, and improved quality of life. Mirogabalin was generally well-tolerated, with most side effects being mild. This suggests mirogabalin could be a useful treatment option for people with CNeP due to SCI.

Study Duration

14 weeks

Participants

300 adult patients with traumatic SCI

Evidence Level

Class I evidence

Key Findings

1
Mirogabalin significantly improved pain compared to placebo, as measured by the weekly average daily pain score (ADPS) at week 14.
2
Patients taking mirogabalin had higher responder rates (≥30% and ≥50% reduction in ADPS) at week 14 compared to those taking the placebo.
3
Mirogabalin resulted in statistically significant improvements in sleep interference, as well as neuropathic pain symptoms.

Research Summary

This phase 3 study evaluated the efficacy and safety of mirogabalin for treating central neuropathic pain (CNeP) in Asian patients with spinal cord injury (SCI). The study found that mirogabalin significantly improved pain scores, responder rates, sleep quality, and quality of life compared to placebo. Improvements in pain were observed early in the treatment period. Mirogabalin was generally well-tolerated, with most adverse events being mild. The findings suggest that mirogabalin is a promising treatment for CNeP due to SCI.

Practical Implications

Clinical Practice

Mirogabalin may be considered as a treatment option for central neuropathic pain in patients with spinal cord injury, particularly when other therapies are ineffective or poorly tolerated.

Future Research

Further studies should investigate the effectiveness of mirogabalin for CNeP with other etiologies beyond spinal cord injury.

Treatment Optimization

The early pain-relieving effects of mirogabalin may improve treatment adherence and overall efficacy in patients with CNeP.

Study Limitations

1
The study was conducted exclusively in Asia, limiting generalizability to other populations.
2
The study duration was short, precluding conclusions about long-term efficacy and safety.
3
The study used placebo as a comparator, limiting direct comparisons with existing therapies.

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