868-P: Efficacy and Safety of Crisugabalin with Acetyl-Levo-Carnitine in Chinese Patients with Diabetic Peripheral Neuropathic Pain—A Multicentre, Randomized, Open-Label, Positive-Controlled, Parallel-Group, Phase 2 Trial

Background: Crisugabalin (HSK16149) was found to be a novel, potent treatment option for patients with diabetic peripheral neuropathic pain (DPNP); However, efficacy and safety data specifically for Chinese individuals were limited to several researches, and there was no comparative evidence on whether drugs should be combined. This study aimed to assess the efficacy and safety of Crisugabalin combined with acetyl-levo-carnitine (ALC) and lipoic acid (LA) combined with ALC for treatment of DPNP in China.

Methods: Adults (≥18 years) with DPNP, 40 mm≤VAS≤90 mm at screening were eligible for study participation. Subjects were randomized (1:1) to Crisugabalin (20mg, bid) combined with ALC (0.5g, tid), and LA (0.6g, qd, iv in 1 week, po in 2-12 week) combined with ALC (0.5g, tid) for 12 weeks. The primary endpoint was the change in average daily pain score (ADPS) from baseline to week 12. Key safety endpoints were the types and incidence of treatment-emergent adverse events (TEAEs) monitored throughout the trial.

Results: A total of 134 patients were randomized to receive Crisugabalin with ALC (n=68) or LA with ALC (n=65). Here we report initial results from interim analysis of the trial. At week 12, the mean ADPS change from baseline was -2.1 and -4.1 for LA (n=42) and Crisugabalin (n=44) group, showing statistical significance for Crisugabalin versus LA group (P<0.0001). Most TEAEs in two groups were mild to moderate, and no investigational drugs-related TEAEs CTCAE≥3 happened throughout the study. The most frequent TEAEs in Crisugabalin group were dizziness (9/68, 13.2%) and somnolence (6/68, 8.8%).

Conclusion: These preliminary data demonstrated that Crisugabalin with ALC was superiority to LA with ALC in relieving pain and well tolerated in Chinese patients with DPNP.