Trial Outcomes & Findings for ReVeRA-201: Etripamil in Atrial Fibrillation, Phase 2 (NCT NCT04467905)

Last Updated: 2024-09-19

Results Overview

Baseline ventricular rate is defined as the average heart rate over 5 minutes immediately prior to drug administration. Nadir is defined as the lowest moving average heart rate over 5 minutes recorded in the 60 minutes post drug administration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

69 participants

Primary outcome timeframe

60 minutes post drug administration

Results posted on

2024-09-19

Participant Flow

Participants with atrial fibrillation and ventricular rate =\>110bpm over 1 minute were screened to participate in the study (first participant enrolled on 19-Nov-2020, last participant completed 10-Aug-2023). Overall, 87 participants were screened and from those, 69 participants were randomized. From those participants, 56 participants received etripamil or placebo.

Of the 69 participants randomized, 13 (18.8%) did not receive etripamil/placebo because of the following reasons: baseline heart rate \<110bpm (n=5), converted to sinus rhythm (n=3), technical issue with Holter and ECGs were missing (n=3), hemodynamic instability (n=1), site misinterpretation of protocol (n=1).

Participant milestones

Participant milestones
Measure	Placebo Participants randomized who received the placebo	Etripamil Participants randomized who received etripamil NS	Randomized But Did Not Receive Drug Participants randomized but did not receive placebo or etripamil
Overall Study STARTED	29	27	13
Overall Study Medication Was Administered	29	27	0
Overall Study Medication Was Not Administered	0	0	13
Overall Study Safety Population	29	27	0
Overall Study mITT Population	29	27	0
Overall Study Efficacy Population	25	24	0
Overall Study COMPLETED	29	27	0
Overall Study NOT COMPLETED	0	0	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants randomized who received the placebo	Etripamil Participants randomized who received etripamil NS	Randomized But Did Not Receive Drug Participants randomized but did not receive placebo or etripamil
Overall Study Baseline heart rate <110 bpm	0	0	5
Overall Study Conversion to SR	0	0	3
Overall Study Technical issue with Holter ECG	0	0	3
Overall Study Hemodynamic instability	0	0	1
Overall Study Site misinterpretation of protocol	0	0	1

Baseline Characteristics

ReVeRA-201: Etripamil in Atrial Fibrillation, Phase 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=29 Participants Administration of placebo at the emergency department for an episode of atrial fibrillation Placebo: The formulation of placebo nasal spray consists of water, sodium acetate, disodium, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid to reproduce the same pH as the etripamil formulation.	Etripamil n=27 Participants Administration of 70 mg etripamil at the emergency department for an episode of atrial fibrillation Etripamil: The formulation of etripamil nasal spray consists of MSP-2017 (etripamil), water, acetic acid, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid. The dose of etripamil to be evaluated in this study is 70 mg.	Total n=56 Participants Total of all reporting groups
Age, Customized Age at Informed Consent	64.6 years STANDARD_DEVIATION 10.5 • n=5 Participants	64.6 years STANDARD_DEVIATION 10.6 • n=7 Participants	64.6 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	24 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Participant symptomatic during AF episode No	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Participant symptomatic during AF episode Yes	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Type of AF Paroxysmal	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Type of AF Persistent	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Type of AF Permanent	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Participant had pacemaker No	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Participant had pacemaker Yes	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
AF diagnosis confirmed by ECG No	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
AF diagnosis confirmed by ECG Yes	29 Participants n=5 Participants	27 Participants n=7 Participants	56 Participants n=5 Participants
Systolic blood pressure (mmHg)	125.6 mmHg STANDARD_DEVIATION 17.3 • n=5 Participants	130.0 mmHg STANDARD_DEVIATION 19.8 • n=7 Participants	127.7 mmHg STANDARD_DEVIATION 18.5 • n=5 Participants
Diastolic blood pressure (mmHg)	85 mmHg STANDARD_DEVIATION 15.5 • n=5 Participants	85.6 mmHg STANDARD_DEVIATION 18.6 • n=7 Participants	85.3 mmHg STANDARD_DEVIATION 16.9 • n=5 Participants
Heart rate (bpm)	134.9 bpm STANDARD_DEVIATION 22.9 • n=5 Participants	129.2 bpm STANDARD_DEVIATION 13.0 • n=7 Participants	132.1 bpm STANDARD_DEVIATION 18.8 • n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes post drug administration

Population: The primary efficacy analysis was performed on the 49 participants in the Efficacy Population.

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Administration of placebo at the emergency department for an episode of atrial fibrillation Placebo: The formulation of placebo nasal spray consists of water, sodium acetate, disodium, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid to reproduce the same pH as the etripamil formulation.	Etripamil n=24 Participants Administration of 70 mg etripamil at the emergency department for an episode of atrial fibrillation Etripamil: The formulation of etripamil nasal spray consists of MSP-2017 (etripamil), water, acetic acid, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid. The dose of etripamil to be evaluated in this study is 70 mg.
The Maximum Reduction in Ventricular Rate, Measured on Holter Monitoring, Within 60 Minutes From Drug Administration. Baseline Ventricular Rate (bpm)	135.5 bpm Standard Deviation 13.9	130.3 bpm Standard Deviation 15.3
The Maximum Reduction in Ventricular Rate, Measured on Holter Monitoring, Within 60 Minutes From Drug Administration. Nadir (bpm)	130.7 bpm Standard Deviation 16.4	95.2 bpm Standard Deviation 23.7

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Etripamil

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=29 participants at risk Administration of placebo at the emergency department for an episode of atrial fibrillation Placebo: The formulation of placebo nasal spray consists of water, sodium acetate, disodium, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid to reproduce the same pH as the etripamil formulation.	Etripamil n=27 participants at risk Administration of 70 mg etripamil at the emergency department for an episode of atrial fibrillation Etripamil: The formulation of etripamil nasal spray consists of MSP-2017 (etripamil), water, acetic acid, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid. The dose of etripamil to be evaluated in this study is 70 mg.
Cardiac disorders Intracardiac thrombus	3.4% 1/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	0.00% 0/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Vascular disorders Peripheral artery occlusion	3.4% 1/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	0.00% 0/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Cardiac disorders Atrial fibrillation	6.9% 2/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	0.00% 0/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Cardiac disorders Myocardial ischaemia	3.4% 1/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	0.00% 0/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Cardiac disorders Cardiac failure	3.4% 1/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	0.00% 0/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Cardiac disorders Bradyarrhythmia	0.00% 0/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	3.7% 1/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Nervous system disorders Syncope	0.00% 0/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	3.7% 1/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).

Other adverse events

Other adverse events
Measure	Placebo n=29 participants at risk Administration of placebo at the emergency department for an episode of atrial fibrillation Placebo: The formulation of placebo nasal spray consists of water, sodium acetate, disodium, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid to reproduce the same pH as the etripamil formulation.	Etripamil n=27 participants at risk Administration of 70 mg etripamil at the emergency department for an episode of atrial fibrillation Etripamil: The formulation of etripamil nasal spray consists of MSP-2017 (etripamil), water, acetic acid, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid. The dose of etripamil to be evaluated in this study is 70 mg.
Cardiac disorders Intracardiac thrombus	6.9% 2/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	0.00% 0/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Eye disorders Lacrimation increased	17.2% 5/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	29.6% 8/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Infections and infestations Nasopharyngitis	0.00% 0/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	7.4% 2/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Nervous system disorders Dizziness	10.3% 3/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	18.5% 5/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Nervous system disorders Headache	0.00% 0/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	11.1% 3/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Nervous system disorders Paraesthesia	6.9% 2/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	3.7% 1/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	11.1% 3/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.4% 1/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	7.4% 2/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Respiratory, thoracic and mediastinal disorders Nasal discomfort	37.9% 11/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	59.3% 16/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	7.4% 2/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.4% 1/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	33.3% 9/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	18.5% 5/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Vascular disorders Hot flush	3.4% 1/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	7.4% 2/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Cardiac disorders Bradyarrhythmia	0.00% 0/29 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).	7.4% 2/27 • 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up. An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).

Additional Information

Leonid Kokovin-Sher

Milestone Pharmaceuticals Inc.

Phone: 1 450-912-6783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER