To evaluate the efficacy and safety of crisugabalin in patients with moderate-to-severe central neuropathic pain (cNP).

CNP, such as pain following spinal cord injury (SCI) or stroke, severely impairs life quality and presents a significant therapeutic challenge due to limited optimal treatments. Crisugabalin, a novel third-generation calcium channel α2δ-1 subunit ligand approved in China, offers rapid onset and doesn’t require dose titration in peripheral neuropathic pain (pNP).

In this multicenter, randomized, double-blind, placebo-controlled Phase 3 trial (NCT06422117), 408 cNP patients were randomized to crisugabalin (20-40 mg BID) or placebo for 12 weeks in China. The primary endpoint was the change from baseline in Average Daily Pain Score (ADPS) at Week 12.

At Week 12, crisugabalin demonstrated a statistically significant reduction in ADPS change from baseline versus placebo in the overall population (LS mean difference: -2.39 vs. -1.15; p<0.0001) and subgroups (SCI: -2.48 vs. -1.20, p<0.0001; post-stroke -2.32 vs. -1.07, p<0.0001) in FAS. PPS results were consistent. There was a significant ADPS reduction starting from Week 1. ADPS response rates were significantly higher with crisugabalin for both ≥30% and ≥50% pain reduction in the overall population and subgroups (all p<0.01). Improvements in Visual Analogue Scale (VAS), Average Daily Sleep Interference Scale (ADSIS), Short-Form McGill Pain Questionnaire (SF-MPQ), Patient Global Impression of Change (PGIC), 5-level EQ-5D (EQ-5D-5L), Chinese Profile of Mood State (POMS-C), and Hospital Anxiety and Depression Scale (HADS) all significantly favored crisugabalin (all p<0.01). Treatment-related adverse events (TEAEs) were mostly mild to moderate and needed no additional treatment; the most common were dizziness, somnolence, and peripheral edema, with incidence comparable to placebo. No new safety signals emerged.

Crisugabalin significantly reduced pain, improved sleep, mood and quality of life with a well-tolerated safety profiles in cNP patients. These results support crisugabalin as an effective and safe therapeutic option for cNP patients.