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已发表论文
Crisugabalin 联合乙酰左旋肉碱治疗糖尿病周围神经病理性疼痛：一项 2 期随机对照试验
Authors Fu L, Xu N, Shang J, Yang Q, Li Y, Huang Q, Li J, Jiang H
Received 12 December 2025
Accepted for publication 27 March 2026
Published 21 April 2026 Volume 2026:19 588472
DOI https://doi.org/10.2147/JPR.S588472
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Alaa Abd-Elsayed
Liujun Fu,1 Na Xu,2 Junjie Shang,3 Qiuwei Yang,4 Yaming Li,5 Qin Huang,5 Jing Li,5 Hongwei Jiang1
1Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, Henan, People’s Republic of China; 2Department of Endocrinology, Nanyang Central Hospital, Nanyang, Henan, People’s Republic of China; 3Department of Endocrinology, Nanyang Second General Hospital, Nanyang, Henan, People’s Republic of China; 4Department of Endocrinology, Luoyang First People’s Hospital, Luoyang, Henan, People’s Republic of China; 5Haisco Pharmaceutical Group Co., Ltd., Chengdu, Sichuan, People’s Republic of China
Correspondence: Hongwei Jiang, Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, Henan, 471003, People’s Republic of China, Email jianghw@haust.edu.cn
Purpose: To investigate the efficacy and safety of Crisugabalin combined with Acetyl-Levo-Carnitine (ALC) for treating Diabetic Peripheral Neuropathic Pain (DPNP) in Chinese adults.
Methods: This 16-week, multicenter, randomized, positive-controlled phase 2 trial was conducted from June 21, 2023, through February 22, 2024, employing a non-inferiority design with the non-inferiority limit set at 0.3 for the difference in Average Daily Pain Score (ADPS) change. A total of 137 Chinese adults with DPNP for at least 6 months were randomized to receive Crisugabalin with ALC or Alpha Lipoic Acid (ALA) with ALC. The primary endpoint was the change in ADPS from baseline at week 12. Secondary outcomes included sleep interference and quality of life measures.
Results: The Crisugabalin group showed a statistically significant reduction in ADPS compared to the ALA group (P< 0.0001). Specifically, the least square mean (LSM) change from baseline in the Crisugabalin group was − 4.0 (95% CI: − 4.405, − 3.620), while in the ALA group it was − 2.1 (95% CI: − 2.505, − 1.706). Secondary outcomes also demonstrated significant improvements in the Crisugabalin group. The treatment in the Crisugabalin group was well-tolerated, with adverse events primarily mild to moderate, and no serious related adverse events were reported.
Conclusion: Crisugabalin combined with ALC is a promising therapeutic option for DPNP, offering pain relief, improved sleep, and enhanced quality of life. This combination therapy may be more effective than standard ALA treatment. (Trial registration: ClinicalTrials.gov identifier, NCT06122012).
Keywords: diabetic peripheral neuropathy, Crisugabalin, combination treatment, pain management
1Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, Henan, People’s Republic of China; 2Department of Endocrinology, Nanyang Central Hospital, Nanyang, Henan, People’s Republic of China; 3Department of Endocrinology, Nanyang Second General Hospital, Nanyang, Henan, People’s Republic of China; 4Department of Endocrinology, Luoyang First People’s Hospital, Luoyang, Henan, People’s Republic of China; 5Haisco Pharmaceutical Group Co., Ltd., Chengdu, Sichuan, People’s Republic of China
Correspondence: Hongwei Jiang, Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, Henan, 471003, People’s Republic of China, Email jianghw@haust.edu.cn
Purpose: To investigate the efficacy and safety of Crisugabalin combined with Acetyl-Levo-Carnitine (ALC) for treating Diabetic Peripheral Neuropathic Pain (DPNP) in Chinese adults.
Methods: This 16-week, multicenter, randomized, positive-controlled phase 2 trial was conducted from June 21, 2023, through February 22, 2024, employing a non-inferiority design with the non-inferiority limit set at 0.3 for the difference in Average Daily Pain Score (ADPS) change. A total of 137 Chinese adults with DPNP for at least 6 months were randomized to receive Crisugabalin with ALC or Alpha Lipoic Acid (ALA) with ALC. The primary endpoint was the change in ADPS from baseline at week 12. Secondary outcomes included sleep interference and quality of life measures.
Results: The Crisugabalin group showed a statistically significant reduction in ADPS compared to the ALA group (P< 0.0001). Specifically, the least square mean (LSM) change from baseline in the Crisugabalin group was − 4.0 (95% CI: − 4.405, − 3.620), while in the ALA group it was − 2.1 (95% CI: − 2.505, − 1.706). Secondary outcomes also demonstrated significant improvements in the Crisugabalin group. The treatment in the Crisugabalin group was well-tolerated, with adverse events primarily mild to moderate, and no serious related adverse events were reported.
Conclusion: Crisugabalin combined with ALC is a promising therapeutic option for DPNP, offering pain relief, improved sleep, and enhanced quality of life. This combination therapy may be more effective than standard ALA treatment. (Trial registration: ClinicalTrials.gov identifier, NCT06122012).
Keywords: diabetic peripheral neuropathy, Crisugabalin, combination treatment, pain management