Trial reportJournal of pain research2026
Crisugabalin Combined with Acetyl-Levo-Carnitine for Diabetic Peripheral Neuropathic Pain: A Phase 2 Randomized Controlled Trial.
Trial report in Journal of pain research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06122012 (A Study to Evaluate the Efficacy and Safety of HSK16149 Capsule Combined With L-carnitine Hydrochloride Tablets and Lipoic Acid Combined With L-carnitine Hydrochloride Tablets in Diabetic Peripheral Neuralgia Patients in China), which is not on this map. Not yet cited in PubMed.
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A Study to Evaluate the Efficacy and Safety of HSK16149 Capsule Combined With L-carnitine Hydrochloride Tablets and Lipoic Acid Combined With L-carnitine Hydrochloride Tablets in Diabetic Peripheral Neuralgia Patients in China
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8 authors.
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Abstract
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 ( 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).
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