Efficacy and Safety of LX9211 for Relief of Diabetic Peripheral Neuropathic Pain (RELIEF-DPN 1): Results of a Double-Blind, Randomized, Placebo-Controlled, Proof-of-Concept Study
Authors' conclusion
These preliminary findings of improvement in DPNP with LX9211 support further investigation in larger trials.
Study context
- Population
- Individuals with diabetic peripheral neuropathic pain (DPNP)randomized 1:1:1
- Participants
- 319 individuals
- Comparison
- LX9211 10 mg or 20 mg once daily vs placebo for 6 weeks
- LX9211 10 mgn = 106
- LX9211 20 mgn = 106
- Placebon = 107reference
- Primary endpoint
- Change from baseline in average daily pain score (11-point numerical rating scale)
- Follow-up
- Week 6
Methodological detailsdouble-blind, multicenter, proof-of-concept, placebo-controlled
- Double-blind
- Multicenter
- Proof-of-concept
- Placebo-controlled
Primary result
As reported in the abstract
Change in average daily pain score
LX9211 10 mg
−1.39
points
LX9211 20 mg
−1.27
points
Placebo
−0.72
points
Each group vs placeboEstimate (95% CI)P value
LX9211 10 mgSE 0.249; primary end point achieved
least squares mean difference −0.67(−1.16 to −0.18)
P = 0.007LX9211 20 mgSE 0.254; did not reach prespecified statistical significance
LS mean difference −0.55(−1.06 to −0.05)
P = 0.030Secondary outcomes
Onset of treatment benefit
- Treatment benefit observed beginning at week 1 and maintained thereafter
Patient-reported secondary outcomes
- LX9211 improved several patient-reported secondary outcomes
Safety
Premature discontinuation of study drug due to AEs
| Outcome | LX9211 10 mg | LX9211 20 mg | Placebo |
|---|---|---|---|
| Serious AEsSerious AEs were uncommon | 0 events | 1.9% | 0.9% |
Most common adverse events (AEs)
- Most common AEs were dizziness, nausea and headache
Original publication
Efficacy and Safety of LX9211 for Relief of Diabetic Peripheral Neuropathic Pain (RELIEF-DPN 1): Results of a Double-Blind, Randomized, Placebo-Controlled, Proof-of-Concept Study. Diabetes Care. Published 19 June 2024. doi:10.
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