Efficacy and Safety of Crisugabalin for Inadequately Controlled Diabetic Peripheral Neuropathic Pain: A Randomized, Active‐Controlled, Phase 2 Trial

Abstract

AIMS: Crisugabalin (HSK16149), a selective γ-aminobutyric acid (GABA) analog, has shown preliminary efficacy in controlling diabetic peripheral neuropathic pain (DPNP), but efficacy in patients with inadequate response to prior pregabalin treatment remains unknown. MATERIALS AND METHODS: This multicentre randomized controlled trial was conducted from April 18, 2024 to July 18, 2024. Adults patients with DPNP and inadequate response to pregabalin were randomized at a 1:1 ratio to receive crisugabalin (40 mg/day) or pregabalin (300 mg/day) for 4 weeks. The primary endpoint was the mean change of SF-MPQ pain score from baseline to 4 weeks of treatment. RESULTS: Ninety-three patients were randomized: 47 and 46 in the crisugabalin and pregabalin groups, respectively. The efficacy analysis included 90 patients (mean age, 58.9 years; 49 men). The least square mean (LSM) difference in the mean change of SF-MPQ pain score was -7.2 (95% CI: -12.4, -2.0; ANCOVA p = 0.007) between the two groups. The rate of treatment-emergent adverse events was 29.5% (13/44) and 47.8% (22/46) in the crisugabalin and pregabalin groups, respectively. CONCLUSIONS: Treatment with crisugabalin 40 mg/day resulted in greater pain reduction in comparison to pregabalin 300 mg/day over a period of 4 weeks in DPNP patients with inadequate response to prior pregabalin treatment.