Efficacy and Safety of Crisugabalin (HSK16149) in Adults with Postherpetic Neuralgia

作者：Daying Zhang, Tiechi Lei, Lan-Ying Qin, Chenyu Li, Xuewu Lin, Huiping Wang, Guoqiang Zhang, Zhang Shoumin, Kemei Shi, Linfeng Li, Zhenling Yang, Xiumin Yang, Xiaohong Ba, Ying Gao, Zhuobo Zhang, Guonian Wang, Liming Wu, Yaping Wang, Yu Wang, Zhu Shoumin, Jihai Shi, Zhijian Ye, Chunjun Yang, Changyi Liu, Tong Zhang, Shousi Lu, Nan Yu, Xiangkui Li, Xiuping Han, Xiaoyan Chen, Li Wan, Zhigang Cheng, Nianyue Bai, Zhehu Jin, Chunshui Yu, Weiyi Zhang, Jianyun Lu, Dongmei Wang, Hui Sun, Wenzhong Wu, Pingping Qin, Zhiying Feng, Rixin Chen, Tangde Zhang, Dong Yang, Wenhao Yin, Jianglin Zhang, Xin Li, Fangqiong Li, Tingting Wu, Qianjin Lu · 发表于：JAMA Dermatology · 年份：2024 · DOI：10.1001/jamadermatol.2024.3410 · 被引用次数：22 · 研究领域：Pain Mechanisms and Treatments、Trigeminal Neuralgia and Treatments、Spine and Intervertebral Disc Pathology

Importance: China carries a heavy burden of postherpetic neuralgia, with an unmet need for novel drugs with greater efficacy and less prominent neurotoxic effects than existing calcium channel ligands. Objective: To investigate the efficacy and safety of crisugabalin, an oral calcium channel α2δ-1 subunit ligand, for postherpetic neuralgia. Design, Setting, and Participants: This randomized clinical trial, carried out between November 9, 2021, and January 5, 2023, at 48 tertiary care centers across China had 2 parts. Part 1 was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study consisting of a 2-week screening period, a 7-day run-in period, and a 12-week double-blind treatment period. Part 2 was a 14-week open-label extension study. Investigators, statisticians, trial clinicians, and patients were blinded to trial group assignments. Participants included adults with postherpetic neuralgia with an average daily pain score (ADPS) of at least 4 on the 11-point Numeric Pain Rating Scale over the preceding week, with the exclusion of patients with pain not controlled by prior therapy with pregabalin (≥300 mg/d) or gabapentin (≥1200 mg/d). Interventions: Patients were randomized 1:1:1 to receive crisugabalin, 20 mg twice daily (ie, 40 mg/d), and crisugabalin, 40 mg twice daily (ie, 80 mg/d), or placebo for 12 weeks. Eligible patients received crisugabalin, 40 mg, twice daily during extension. Main Outcome and Measure: The primary efficacy end...