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Updated: Apr 28, 2026
Author Spotlight: Methodologies and Advancements of Chronic Pain Management Research
Published on: January 5, 2024
Crisugabalin Combined with Acetyl-Levo-Carnitine for Diabetic Peripheral Neuropathic Pain: A Phase 2 Randomized
Liujun Fu1, Na Xu2, Junjie Shang3
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.
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).
