Efficacy and Safety of Crisugabalin for Inadequately Controlled Diabetic Peripheral Neuropathic Pain: A Randomized, Active-Controlled, Phase 2 Trial.
Yaming Li, Fang Zhang, Wei Liu et al.
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In 30 seconds
This multicentre, randomised, active-controlled phase 2 trial compared crisugabalin with pregabalin in adults with diabetic peripheral neuropathic pain inadequately controlled by prior pregabalin. Participants received crisugabalin 40 mg/day or pregabalin 300 mg/day for 4 weeks. The least-squares mean difference between groups in change in SF-MPQ pain score was -7.2 (95% CI: -12.4, -2.0; ANCOVA p = 0.007), favouring crisugabalin. Treatment-emergent adverse events occurred in 29.5% (13/44) and 47.8% (22/46), respectively. The findings suggest greater short-term pain reduction with crisugabalin in this population.
Key findings
- The between-group least-squares mean difference in SF-MPQ pain-score change was -7.2 (95% CI: -12.4, -2.0; ANCOVA p = 0.007), favouring crisugabalin.
- Treatment-emergent adverse events occurred in 29.5% (13/44) with crisugabalin and 47.8% (22/46) with pregabalin.
Why it matters
Pain that remains inadequately controlled despite pregabalin is a clinically relevant treatment challenge. This trial provides comparative evidence that crisugabalin may reduce pain more over four weeks in this specific population, while also reporting fewer treatment-emergent adverse events. The short-term findings can inform understanding of a potential alternative, but do not establish longer-term effectiveness or safety.
What to keep in mind
Treatment and follow-up lasted only 4 weeks, so longer-term effectiveness and safety are not established.