Trial Outcomes & Findings for Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (PSVT). NODE-302 (NCT NCT03635996)
NCT ID: NCT03635996
Last Updated: 2024-11-05
Results Overview
The efficacy analyses were performed on the Efficacy Population. The primary efficacy variable was the time to conversion of an episode of PSVT to SR after study drug administration.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
169 participants
Primary outcome timeframe
18 months
Results posted on
2024-11-05
Participant Flow
All patients randomized in Part 1 of the NODE-301 study and who met the inclusion and exclusion criteria of the NODE-302 study were eligible for the NODE-302 study. This study was conducted only at clinical sites that participated in the NODE-301 Part 1 study. Study was initiated on December 10, 2018 and completed on November 13, 2020.
Of the 169 patients enrolled, 64 (37.9%) of 169 patients did not treat an episode with etripamil in this study.
Participant milestones
| Measure |
Etripamil NS 70 mg
The dose of etripamil evaluated in NODE-302 was 70 mg.
Etripamil NS 70 mg: All patients received a total of 200 micro-liters of etripamil NS 70 mg via the Aptar Pharma Nasal Spray Bidose System each time they self-administer study drug.
Aptar Pharma Nasal Spray Bidose System: Patients were self-administer the study drug using the Aptar Pharma Nasal Spray Bidose System. The devices were be prefilled and packaged into child-resistant boxes. Instructions for its use was provided in the study drug box.
|
|---|---|
|
Overall Study
STARTED
|
169
|
|
Overall Study
Patients Not Treated With Etripamil
|
64
|
|
Overall Study
Safety Population
|
105
|
|
Overall Study
Efficacy Population
|
92
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
167
|
Reasons for withdrawal
| Measure |
Etripamil NS 70 mg
The dose of etripamil evaluated in NODE-302 was 70 mg.
Etripamil NS 70 mg: All patients received a total of 200 micro-liters of etripamil NS 70 mg via the Aptar Pharma Nasal Spray Bidose System each time they self-administer study drug.
Aptar Pharma Nasal Spray Bidose System: Patients were self-administer the study drug using the Aptar Pharma Nasal Spray Bidose System. The devices were be prefilled and packaged into child-resistant boxes. Instructions for its use was provided in the study drug box.
|
|---|---|
|
Overall Study
Study terminated by Sponsor
|
94
|
|
Overall Study
Withdrawal by Subject
|
20
|
|
Overall Study
Ablation
|
26
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Prohibited medication
|
5
|
|
Overall Study
Did not meet eligibility criteria
|
5
|
|
Overall Study
Site closure (2), compliance with IP, directed by sponsor and site termination.
|
5
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Not all patients reported emergency department visit
Baseline characteristics by cohort
| Measure |
Etripamil NS 70 mg
n=105 Participants
The dose of etripamil evaluated in NODE-302 was 70 mg.
Etripamil NS 70 mg: All patients received a total of 200 micro-liters of etripamil NS 70 mg via the Aptar Pharma Nasal Spray Bidose System each time they self-administer study drug.
Aptar Pharma Nasal Spray Bidose System: Patients were self-administer the study drug using the Aptar Pharma Nasal Spray Bidose System. The devices were be prefilled and packaged into child-resistant boxes. Instructions for its use was provided in the study drug box.
|
|---|---|
|
Age, Continuous
Age at informed consent signed
|
58 years
STANDARD_DEVIATION 13.75 • n=105 Participants
|
|
Age, Continuous
Age at confirmation of PSVT
|
57.2 years
STANDARD_DEVIATION 13.79 • n=105 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=105 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=105 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=105 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=105 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=105 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=105 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=105 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=105 Participants
|
|
PSVT confirmation duration (years)
|
1.3 years
STANDARD_DEVIATION 1.73 • n=105 Participants
|
|
Number of patient-reported PSVT episodes in the year prior to NODE-301
|
9.7 episodes
STANDARD_DEVIATION 11.79 • n=105 Participants
|
|
Number of patient-reported emergency department visits for PSVT in lifetime
|
2.7 emergency department visits
STANDARD_DEVIATION 2.74 • n=103 Participants • Not all patients reported emergency department visit
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Primary analysis of the primary efficacy endpoint for each patient's first episode of PSVT confirmed by adjudication and treated with etripamil NS 70 mg. There were 92 patients who had a PSVT episode that was confirmed by adjudication and were included in the primary analysis.
The efficacy analyses were performed on the Efficacy Population. The primary efficacy variable was the time to conversion of an episode of PSVT to SR after study drug administration.
Outcome measures
| Measure |
Etripamil NS 70 mg
n=92 Participants
The dose of etripamil evaluated in NODE-302 was 70 mg.
Etripamil NS 70 mg: All patients received a total of 200 micro-liters of etripamil NS 70 mg via the Aptar Pharma Nasal Spray Bidose System each time they self-administer study drug.
Aptar Pharma Nasal Spray Bidose System: Patients were self-administer the study drug using the Aptar Pharma Nasal Spray Bidose System. The devices were prefilled and packaged into child-resistant boxes. Instructions for its use was provided in the study drug box.
|
|---|---|
|
Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration.
|
21.1 minutes
Interval 11.6 to 35.5
|
Adverse Events
Etripamil NS 70 mg
Serious events: 8 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etripamil NS 70 mg
n=105 participants at risk
The dose of etripamil evaluated in NODE-302 was 70 mg.
Etripamil NS 70 mg: All patients received a total of 200 micro-liters of etripamil NS 70 mg via the Aptar Pharma Nasal Spray Bidose System each time they self-administer study drug.
Aptar Pharma Nasal Spray Bidose System: Patients were self-administer the study drug using the Aptar Pharma Nasal Spray Bidose System. The devices were prefilled and packaged into child-resistant boxes. Instructions for its use was provided in the study drug box.
|
|---|---|
|
Cardiac disorders
Bradycardia
|
0.95%
1/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.9%
3/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Nervous system disorders
Ataxia
|
0.95%
1/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Nervous system disorders
Syncope
|
0.95%
1/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.95%
1/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Investigations
Troponin increased
|
0.95%
1/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
Other adverse events
| Measure |
Etripamil NS 70 mg
n=105 participants at risk
The dose of etripamil evaluated in NODE-302 was 70 mg.
Etripamil NS 70 mg: All patients received a total of 200 micro-liters of etripamil NS 70 mg via the Aptar Pharma Nasal Spray Bidose System each time they self-administer study drug.
Aptar Pharma Nasal Spray Bidose System: Patients were self-administer the study drug using the Aptar Pharma Nasal Spray Bidose System. The devices were prefilled and packaged into child-resistant boxes. Instructions for its use was provided in the study drug box.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
21.9%
23/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.2%
17/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
15.2%
16/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
5/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
4.8%
5/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
2/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
2/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Nervous system disorders
Headache
|
4.8%
5/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Nervous system disorders
Dizziness
|
3.8%
4/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Nervous system disorders
Paresthesia
|
1.9%
2/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
General disorders
Mucosal hypertrophy
|
4.8%
5/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Eye disorders
Lacrimation increased
|
2.9%
3/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Investigations
Heart rate increased
|
2.9%
3/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
3/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Eye disorders
Eye irritation
|
1.9%
2/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
3.8%
4/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
2.9%
3/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
1.9%
2/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of upper respiratory secretion
|
2.9%
3/105 • 18 months.
TEAEs in this study are defined as AEs with a start date occurring 0 to 24 hours after a dose of study drug dose. In the text these are referred to as TEAE24.
|
Additional Information
Cameron Szakacs _PhD_VP Drug Development
Milestone Pharmaceuticals Inc.
Phone: 1 704-594-4102
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER