2026 American Academy of Neurology Abstract Website

Xiaochong Fan¹, Youxiang Cui², Yufeng Tang³, Bo Liu⁴, Songbo Li⁵, Yangkun Chen⁵, Qinglai Wang⁶, Yaming Li⁷, Shiyu Yan⁷, Qiuyue Pan⁷, Dongsheng Fan⁸
¹The First Affiliated Hospital of Zhengzhou University, ²Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine, ³Mianyang Central Hospital, ⁴The First Affiliated Hospital of Baotou Medical College, ⁵The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital), ⁶Wenzhou TCM Hospital of Zhejiang Chinese Medical University, ⁷Haisco Pharmaceutical Group Co., Ltd., ⁸Peking University Third Hospital

Objective:

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

Background:

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).

Design/Methods:

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.

Results:

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.

Conclusions:

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.