GABA Analogue HSK16149 in Chinese Patients With Diabetic Peripheral Neuropathic Pain: A Phase 3 Randomized Clinical Trial
Authors' conclusion
Forty- and eighty-mg/d doses of HSK16149 were recommended for treating patients with DPNP in China. The efficacy of HSK16149 capsules was superior to placebo in all groups for relieving DPNP and appeared well tolerated.
Study context
- Population
- Chinese patients with diabetic peripheral neuropathic pain (DPNP); mean (SD) age 58.80 (9.53) years, 54.2% men644 completed
- Participants
- 725 patients
- Comparison
- HSK16149 vs pregabalin 300 mg/d vs placebo
- HSK16149 40 mg/dn = 178
- HSK16149 80 mg/dn = 179
- HSK16149 120 mg/dn = 66
- HSK16149 160 mg/dn = 63
- Pregabalinn = 62
- Placebon = 177reference
- Primary endpoint
- Change from baseline in average daily pain score (ADPS); stage 1 at week 5, stage 2 at week 13
- Follow-up
- Week 13 (stage 2)
Methodological detailsphase 2 to 3, adaptive, multicenter, double blind, placebo and pregabalin controlled, 40- and 80-mg/d doses recommended for stage 2, Stage 1: 363 patients randomized 1:1:1:1:1:1; stage 2: 362 randomized 1:1:1 to HSK16149 40 or 80 mg/d or placebo; data pooled
- Phase 2 to 3
- Adaptive
- Multicenter
- Double blind
- Placebo and pregabalin controlled
- 40- and 80-mg/d doses recommended for stage 2
- Stage 1: 363 patients randomized 1:1:1:1:1:1; stage 2: 362 randomized 1:1:1 to HSK16149 40 or 80 mg/d or placebo; data pooled
Primary result
As reported in the abstract
ADPS change from baseline · week 13
HSK16149 40 mg/d
−2.24
mean · SD 1.55
HSK16149 80 mg/d
−2.16
mean · SD 1.79
Placebo
−1.23
mean · SD 1.68
HSK16149 40 mg/d vs Placebo: P < 0.001 · HSK16149 80 mg/d vs Placebo: P < 0.001
Safety
- Patients with adverse events (safety set, n = 726)
- 545 (75.1%)
- Generally mild to moderate; dizziness and somnolence most common
Original publication
GABA Analogue HSK16149 in Chinese Patients With Diabetic Peripheral Neuropathic Pain: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. Published 1 August 2024. doi:10.
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