What question did this study set out to answer?

The study aims to evaluate the long-term safety and efficacy of crisugabalin in managing diabetic peripheral neuropathic pain.

March 25, 2026Open Access

Long‐Term Safety and Efficacy of Crisugabalin for Diabetic Peripheral Neuropathic Pain: A 52‐Week, Multicenter, Single‐Arm Trial

Key Points

The study aims to evaluate the long-term safety and efficacy of crisugabalin in managing diabetic peripheral neuropathic pain.
Administered 80 mg/day of crisugabalin for 52 weeks to previous trial participants.
Assessed safety as the primary endpoint and pain control using SF-MPQ as the secondary endpoint.
Enrolled 301 patients with a mean age of 59.7 years.
38.9% of patients experienced treatment-related adverse events.
Dizziness was the most common adverse event, occurring in 27.2% of patients.
Significant reductions in pain scores were observed, with SF-MPQ PRI decreasing by −2.5.

Abstract

Introduction The HSK16149‐201/301 trial demonstrated short‐term efficacy of the GABA analog crisugabalin for diabetic neuropathic pain. Methods In the current study, patients in both the crisugabalin and placebo control groups of the HSK16149‐201/301 trial were invited to receive 80 mg/day crisugabalin for an additional 52 weeks. The primary end point was safety. The secondary end point was pain control as measured using the Short‐Form McGill Pain Questionnaire (SF‐MPQ). A total of 301 patients (mean age 59.7 years and males 58.1%) were enrolled. Results The rate of treatment‐related adverse events (TRAEs) was 38.9% (117/301). The most frequent TRAEs were dizziness (27.2%), somnolence (8.3%), and peripheral edema (3.0%). The rate of Grade 3 or higher TRAEs was 1.7%. TRAEs led to dose reduction in 41 patients (13.6%), treatment interruption and discontinuation each in three patients (1.0%). At week 52, the mean difference in SF‐MPQ pain rating index (PRI) and visual analog scale pain score from baseline was −2.5 (95% CI −2.9 to −2.0; paired t ‐test p < 0.0001) and −23.4 (95% CI −25.6 to −21.2; paired t ‐test p < 0.0001), respectively. The proportion of patients with SF‐MPQ PPI score ≤ 1 increased by 19.0% over baseline ( p < 0.0001). Conclusions In summary, crisugabalin at 80 mg/day was well tolerated and demonstrated sustained analgesic activities. Trial Registration ClinicalTrials.gov identifier: NCT05890053

Long‐Term Safety and Efficacy of Crisugabalin for Diabetic Peripheral Neuropathic Pain: A 52‐Week, Multicenter, Single‐Arm Trial

Key Points

Abstract

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