Table 5.
Responder analysis (≥30% improvement in pain score).
| TTX Dosage | |||||
|---|---|---|---|---|---|
| Responders | 7.5 µg BID (n = 25) |
15 µg BID (n = 24) |
30 µg QD (n = 25) |
30 µg BID (n = 26) |
Placebo (n = 25) |
| Any timepoint, n (%) a | 9 (36.0%) | 11 (45.8%) | 10 (40.0%) | 15 (57.7%) | 8 (32.0%) |
| Odds ratio vs. placebo | 1.12 | 1.99 | 1.65 | 3.39 a | |
| (95% CI) | (0.32, 3.96) | (0.56, 7.13) | (0.46, 5.90) | (0.96, 11.97) | |
| 5-day rolling averages, n (%) b | 10 (40.0%) | 12 (50.0%) | 10 (40.0%) | 16 (61.5%) | 8 (32.0%) |
| Odds ratio vs. placebo | 1.33 | 2.54 | 1.58 | 3.87 b | |
| (95% CI) | (0.38, 4.65) | (0.71, 9.06) | (0.45, 5.62) | (1.10, 13.61) | |
| 10-day rolling averages, n (%) c | 8 (32.0%) | 10 (41.7%) | 10 (40.0%) | 15 (57.7%) | 8 (32.0%) |
| Odds ratio vs. placebo | 0.90 | 1.68 | 1.63 | 3.90 c | |
| (95% CI) | (0.25, 3.24) | (0.47, 6.06) | (0.45, 5.83) | (1.08, 14.09) | |
| 15-day rolling averages, n (%) | 8 (32.0%) | 10 (41.7%) | 10 (40.0%) | 12 (46.2%) | 8 (32.0%) |
| Odds ratio vs. placebo | 0.92 | 1.59 | 1.66 | 2.50 | |
| (95% CI) | (0.26, 3.29) | (0.45, 5.69) | (0.47, 5.92) | (0.70, 8.91) | |
| 20-day rolling averages, n (%) d | 7 (28.0%) | 6 (25.0%) | 10 (40.0%) | 12 (46.2%) | 7 (28.0%) |
| Odds ratio vs. placebo | 1.03 | 0.93 | 1.68 | 2.90 d | |
| (95% CI) | (0.26, 4.04) | (0.23, 3.79) | (0.45, 6.24) | (0.77, 10.93) | |
CI: confidence interval; NPRS: Numerical Pain Rating Scale; SD: standard deviation; TTX: tetrodotoxin; BID: twice daily; QD: once daily; n: number of subjects. Pain measured with NPRS. Odds ratios, 95% confidence intervals, and p-values were obtained from a logistic regression model by visit with treatment, gender, and baseline numerical pain scale score as covariates. Rolling day averages are based on consecutive days. a Statistically significant at p = 0.072. b Statistically significant at p = 0.059. c Statistically significant at p = 0.027. d Statistically significant at p = 0.071.