HSK16149 (high-dose)
Trial question
What is the effect of crisugabalin in patients with postherpetic neuralgia?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 245
245 patients (115 female, 130 male).
Inclusion criteria: adult patients with postherpetic neuralgia.
Key exclusion criteria: peripheral neuropathy or pain unrelated to postherpetic neuralgia or any other conditions that could confound assessment; previous use of pregabalin ≥ 300 mg daily or gabapentin ≥ 1,200 mg daily with lack of effect; uncontrolled diabetes; history of substance or alcohol abuse; any active infections.
Interventions
N=121 crisugabalin (at a dose of 40 mg BID for 12 weeks).
N=124 placebo (matching placebo BID for 12 weeks).
Primary outcome
Reduction in least squares mean average daily pain score at week 12
2.6 points
1.1 points
2.6 points
2.0 points
1.3 points
0.7 points
0.0 points
Crisugabalin
Placebo
Significant
increase ▲
Significantly greater reduction in least squares mean average daily pain score at week 12 (2.6 points vs. 1.1 points; MD 1.5, 95% CI 1 to 2).
Secondary outcomes
Significant increase in the percentage of patients achieving at least 30% reduction in average daily pain score at week 12 (54.5% vs. 35.5%; OR 2.93, 95% CI 1.58 to 5.44).
Significant increase in the percentage of patients achieving at least 50% reduction in average daily pain score at week 12 (38% vs. 20.2%; OR 3.84, 95% CI 1.88 to 7.87).
Significantly greater reduction in least squares mean Short-Form McGill Pain Questionnaire Present Pain Intensity scores at week 12 (1.2 points vs. 0.5 points; MD 0.7, 95% CI 0.5 to 0.9).
Safety outcomes
No significant difference in serious treatment-emergent adverse events.
Conclusion
In adult patients with postherpetic neuralgia, crisugabalin was superior to placebo with respect to reduction in least squares mean average daily pain score at week 12.
Reference
Daying Zhang, Tiechi Lei, Lanying Qin et al. Efficacy and Safety of Crisugabalin (HSK16149) in Adults with Postherpetic Neuralgia: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2024 Nov 1;160(11):1182-1191.
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