Table 2: Summary of human clinical studies using intra-nasal etripamil for paroxysmal supraventricular tachycardia that are complete or are currently in progress18–24,26,27.
| Main outcomes measured | Status | |
|---|---|---|
| Phase I | ||
| First-in-human18,19 | Confirmed rapid absorption and elimination of IN etripamil. Dose-dependent effect on PR prolongation | Complete |
| NODE-10220 | No difference in pharmacodynamic outcomes between Caucasians and subjects of Japanese descent. Dose-dependent effect on PR prolongation | Complete |
| Phase II | ||
| NODE-1 (NCT02296190)21,22 | Significant difference in arrhythmia conversion rates compared to placebo, dose-effect plateau at 70 mg | Complete |
| Phase III | ||
| NODE-301 Part 1 (NCT03464019)20,23,24 | Superior conversion rates compared to placebo in post-hoc analysis at 45 minutes, but not for the pre-specified endpoint at 5 hours | Complete |
| NODE-301 Part 2 (RAPID; NCT03464019; EudraCT 2018-000308-41)20,22,23 | Time to arrhythmia conversion; efficacy of a repeat dosing protocol | Expected end January 2022 |
| NODE-302 (NCT03635996)26 | Safety and efficacy evaluation of self-administration for multiple PSVT episodes (extension of NODE-301) | Complete |
| NODE-303 (NCT04072835)27 | Safety and efficacy evaluation of self-administration outside of the clinical setting | Expected end August 2021 |
IN = intra-nasal; PSVT = paroxysmal supraventricular tachycardia