1770-P: The Efficacy of Crisugabalin for Sensory Symptoms in Diabetic Peripheral Neuropathy: A Single-Center, Single-Arm, Exploratory Study

Introduction and Objective: Sensory abnormalities in diabetic peripheral neuropathy (DPN) present a major therapeutic challenge. The pathophysiology involves dysregulated calcium influx via voltage-gated calcium channels on afferent neurons, driving neuronal hyperexcitability. Crisugabalin, a novel calcium channel modulator and third-generation GABA analog approved in China for Diabetic Peripheral Neuropathic Pain (DPNP), is hypothesized to alleviate these sensory symptoms by normalizing calcium channel activity. This exploratory study sought to evaluate this hypothesis by assessing the preliminary efficacy and safety of crisugabalin in Chinese patients with DPN related sensory symptoms. Methods: This exploratory single-arm trial enrolled participants with type 1 or type 2 diabetes (T1D/T2D), stable antidiabetic treatment (≥3 months), and clinically significant DPN, defined by a primary complaint of paresthesia along with a Toronto Clinical Neuropathy Score (TCNS) ≥6. All participants received crisugabalin 40 mg/day for 4 weeks. The primary endpoint was the change in the TCNS from baseline to week 4. Secondary endpoint was the change in the TCNS from baseline to week 8. Results: A total of 28 subjects were enrolled (median age 57 years). The mean baseline TCNS was 9.9±7.2 and NRS was 1.2±1.8. At week 4, the mean TCNS decreased to 4.8±2.4 (P<0.001), with a mean improvement of -5.12±5.2. By week 8, the TCNS further decreased to 3.5±2.3 (P<0.001), with a mean improvement of -6.4±6.6. Crisugabalin was well-tolerated in this study. Treatment-emergent adverse events (TEAEs) were predominantly mild to moderate in severity. The most frequently reported TEAEs were dizziness and somnolence. These events were generally self-limiting and did not necessitate specific therapeutic intervention. Conclusion: Crisugabalin demonstrated significant improvement in TCNS and favorable tolerability in Chinese patients with DPN-related sensory abnormalities, suggesting its potential as a therapeutic option. Disclosure S. Shao: None. Q. Yu: None. Z. Zhao: None.