Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04952610 | Etripamil Nasal Spray in Patients With Paroxysmal Supraventricular Tachycardia | PHASE3 | COMPLETED | 130 | — | — | Dec 13, 2021 | Apr 10, 2026 | May 15, 2026 | 23 | United States, Canada |
| NCT04072835 | Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303 | PHASE3 | COMPLETED | 1,116 | — | — | Sep 23, 2019 | Jan 26, 2023 | May 23, 2024 | 124 | United States, Argentina +3 |
| NCT05763953 | The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients) | PHASE2 | RECRUITING | 60 | — | — | Dec 11, 2023 | Jun 30, 2027 | Aug 1, 2025 | 10 | United States, Canada +2 |
Number of participants with any adverse events experienced from baseline up to the final study visit including the treatment of up to 4 perceived PSVT episodes.
A successful conversion is defined as conversion of PSVT to SR that is maintained for at least 30 seconds
| Arm | Type | Description |
|---|---|---|
| Etripamil NS 70 mg | EXPERIMENTAL | Self- administration of a dose of 70 mg of etripamil. Patients will be provided with a maximum of 4 pre-filled devices at a time. If the symptoms of PSVT persist 10 minutes after the first dose of etripamil NS 70 mg, a second dose of etripamil NS 70 mg can be self-administered by the patient. A second dose of etripamil NS 70 mg should be taken not earlier than 10, and not later than 15 minutes after the first dose. |
| Etripamil NS | EXPERIMENTAL | Participants self-administered etripamil NS 70 mg. After implementation of protocol amendment 2.1 (16 March 2021), participants had the option to administer a second dose of etripamil 70 mg 10 minutes after the first dose, if PSVT symptoms persisted |
| Not Treated | NO_INTERVENTION | Participants not treated with etripamil NS for a PSVT episode. |
| Etripamil NS 70mg | EXPERIMENTAL | Patients will be administered by study site personnel |
| Name | Type | Description |
|---|---|---|
| Etripamil NS 70 mg | DRUG | Etripamil will be administered via the Aptar Pharma Nasal Spray Bidose System. |
| Aptar Pharma Nasal Spray Bidose System | DEVICE | Aptar Pharma Nasal Spray Bidose System will be supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box. |
| Etripamil NS | DRUG | Participants were provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS was self-applied by the participant, when PSVT symptoms begin. Participants self-administered etripamil NS if vagal maneuver was ineffective. After implementation of protocol amendment 2.1, participants had the option to administer a second dose of etripamil 70 mg 10 minutes after the first dose, if symptoms persisted. After an episode of PSVT where drug was administered, the participant returned to the investigative site for a study visit and was given the option to continue in NODE-303 and manage up to three subsequent episodes of PSVT with etripamil NS for a maximum of four episodes. |
Inclusion Criteria: A patient will be eligible for study participation if they meet all of the following criteria: 1. Has participated in a Milestone Pharmaceuticals Inc. clinical research trial of etripamil NS for the treatment of PSVT (NODE-301 Part1, RAPID (NODE-301 Part 2), NODE-302, or NODE-3...