To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain

Summary

Investigate the efficacy and safety of HSK16149 capsules in Chinese diabetic peripheral neuropathic pain (DPNP) following 13 weeks treatment in comparison to placebo.

Timeline

Start

2020-12-02

Primary completion

2022-11-09

Completion

2022-11-16

Publications

• Pan T, Ma J, Li Y, Wang K, Jiang C, Zhang Y, Liu J, Du R, Zhang W, Bian F, Zhang F, Wang L, Pang S, Ning T, Wang B, Li Y, Wu X, Zhang K, Tang X, Hu H, Sun X, Li P, Cheng Z, Sun J, Yang J, Wang Y, Gao J, Mao H, Li F, Huang Q, Li Y, Peng Z, Guo X. Rapid Onset of Pain Relief with Crisugabalin in Patients with Diabetic Peripheral Neuropathic Pain: Findings from a Multicenter, Randomized, Double-Blind, Controlled Study. Pain Ther. 2025 Aug;14(4):1311-1329. doi: 10.1007/s40122-025-00745-3. Epub 2025 May 16.
• Guo X, Zhang T, Yuan G, Zeng W, Hu Q, Ma J, Li Y, Li H, Zhang Y, Liu J, Bian F, Zhang W, Zhang F, Pang S, Li Y, Wu X, Tang X, Zhang K, Pan T, Hu H, Cheng Z, Wang Y, Gao J, Sun J. GABA Analogue HSK16149 in Chinese Patients With Diabetic Peripheral Neuropathic Pain: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2425614. doi: 10.1001/jamanetworkopen.2024.25614.

Drugs

Indications