Trial reportDiabetes, obesity & metabolism2026
Efficacy and Safety of Crisugabalin for Inadequately Controlled Diabetic Peripheral Neuropathic Pain: A Randomized, Active-Controlled, Phase 2 Trial.
Trial report in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Efficacy and Safety of Crisugabalin for Inadequately Controlled Diabetic Peripheral Neuropathic Pain: A Randomized, Active-Controlled, Phase 2 Trial.Diabetes, obesity & metabolism · 2026Trial
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
aimsCrisugabalin (HSK16149), a selective γ-aminobutyric acid (GABA) analog, has shown preliminary efficacy in controlling diabetic peripheral neuropathic pain (DPNP), but efficacy in patients with inadequate response to prior pregabalin treatment remains unknown. MATERIALS AND
methodsThis multicentre randomized controlled trial was conducted from April 18, 2024 to July 18, 2024. Adults patients with DPNP and inadequate response to pregabalin were randomized at a 1:1 ratio to receive crisugabalin (40 mg/day) or pregabalin (300 mg/day) for 4 weeks. The primary endpoint was the mean change of SF-MPQ pain score from baseline to 4 weeks of treatment.
resultsNinety-three patients were randomized: 47 and 46 in the crisugabalin and pregabalin groups, respectively. The efficacy analysis included 90 patients (mean age, 58.9 years; 49 men). The least square mean (LSM) difference in the mean change of SF-MPQ pain score was -7.2 (95% CI: -12.4, -2.0; ANCOVA p = 0.007) between the two groups. The rate of treatment-emergent adverse events was 29.5% (13/44) and 47.8% (22/46) in the crisugabalin and pregabalin groups, respectively.
conclusionsTreatment with crisugabalin 40 mg/day resulted in greater pain reduction in comparison to pregabalin 300 mg/day over a period of 4 weeks in DPNP patients with inadequate response to prior pregabalin treatment.
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