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Introduction <p>This study aims to evaluate the efficacy and safety of Crisugabalin in patients with diabetic peripheral neuropathic pain (DPNP), with a focus on its rapid onset of action.</p> Methods <p>All the analyses in this study were based on data from a phase 2/3 adaptive randomized clinical trial that enrolled 596 patients. Participants were categorized into four treatment groups according to the intervention received: Crisugabalin 40&#xa0;mg/day, Crisugabalin 80&#xa0;mg/day, placebo, and Pregabalin 300&#xa0;mg/day. The primary endpoint was the change in the average daily pain score (ADPS) over a 13-week treatment period. Secondary endpoints included changes in the Numeric Rating Scale (NRS) and the daily sleep interference score (DSIS) during the first two weeks of treatment.</p> Results <p>Both Crisugabalin treatment groups (40&#xa0;mg/day and 80&#xa0;mg/day) demonstrated statistically significant reductions in ADPS compared to the placebo group starting from week 1 and continuing through week 13 (<i>P</i>&#xa0;&lt;&#xa0;0.05). Significant differences in pain relief for the Pregabalin group were observed only from week 6. Improvements in NRS and DSIS scores were also noted in both Crisugabalin groups, with statistically significant enhancements evident as early as day 2 of administration. Safety assessments indicated that Crisugabalin was well-tolerated, with a low incidence of serious adverse events and no significant increase in dropout rates among participants.</p> Conclusion <p>The findings suggest that Crisugabalin offers effective pain relief with an acceptable safety profile, highlighting its rapid onset in patients with DPNP.</p> Clinical Trial Registration <p>Clinical trial registration number derived from our parent project, we have retained the original registration identifier: NCT04647773.</p>

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Rapid Onset of Pain Relief with Crisugabalin in Patients with Diabetic Peripheral Neuropathic Pain: Findings from a Multicenter, Randomized, Double-Blind, Controlled Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月16日

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  • Tianrong Pan,
  • Jianhua Ma,
  • Yukun Li,
  • Kailiang Wang,
  • Chengxia Jiang,
  • Yawei Zhang,
  • Jie Liu,
  • Ruiqin Du,
  • Wei Zhang,
  • Fang Bian,
  • Fang Zhang,
  • Lijun Wang,
  • Shuguang Pang,
  • Tao Ning,
  • Bangqiong Wang,
  • Ya Li,
  • Xiaohong Wu,
  • Keqin Zhang,
  • Xulei Tang,
  • Honglin Hu,
  • Xin Sun,
  • Ping Li,
  • Zhifeng Cheng,
  • Jia Sun,
  • Jing Yang,
  • Yanjun Wang,
  • Jialin Gao,
  • Hong Mao,
  • Fangqiong Li,
  • Qin Huang,
  • Yaming Li,
  • Zhixin Peng,
  • Xiaohui Guo

摘要

Introduction

This study aims to evaluate the efficacy and safety of Crisugabalin in patients with diabetic peripheral neuropathic pain (DPNP), with a focus on its rapid onset of action.

Methods

All the analyses in this study were based on data from a phase 2/3 adaptive randomized clinical trial that enrolled 596 patients. Participants were categorized into four treatment groups according to the intervention received: Crisugabalin 40 mg/day, Crisugabalin 80 mg/day, placebo, and Pregabalin 300 mg/day. The primary endpoint was the change in the average daily pain score (ADPS) over a 13-week treatment period. Secondary endpoints included changes in the Numeric Rating Scale (NRS) and the daily sleep interference score (DSIS) during the first two weeks of treatment.

Results

Both Crisugabalin treatment groups (40 mg/day and 80 mg/day) demonstrated statistically significant reductions in ADPS compared to the placebo group starting from week 1 and continuing through week 13 (P < 0.05). Significant differences in pain relief for the Pregabalin group were observed only from week 6. Improvements in NRS and DSIS scores were also noted in both Crisugabalin groups, with statistically significant enhancements evident as early as day 2 of administration. Safety assessments indicated that Crisugabalin was well-tolerated, with a low incidence of serious adverse events and no significant increase in dropout rates among participants.

Conclusion

The findings suggest that Crisugabalin offers effective pain relief with an acceptable safety profile, highlighting its rapid onset in patients with DPNP.

Clinical Trial Registration

Clinical trial registration number derived from our parent project, we have retained the original registration identifier: NCT04647773.