Safety of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia
Research type
Research Study
Full title
Multi-Centre, Multi-National, Open Label, Safety Study of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia
IRAS ID
1005215
Contact name
Guy Rousseau
Contact email
Sponsor organisation
Milestone Pharmaceuticals Inc.
Eudract number
2019-001857-13
Clinicaltrials.gov Identifier
Research summary
Paroxysmal Supraventricular Tachycardia (PSVT) is a relatively common disorder, which is characterised by episodes of tachyarrhythmia typically with a heart rate over 100 bpm and a QRS duration <120 msec.
Treatment of patients with PSVT has previously been treated with intravenous (IV) drugs, however this is not appropriate for patient self-administration outside a hospital/clinical setting. Etripamil nasal spray has been developed by Milestone Pharmaceuticals Inc. to provide patients with the ability to treat episodes of PSVT independent from the hospital/clinical setting.
The purpose of this clinical trial is to evaluate the safety and efficacy of the self-administered nasal spray (NS) over a maximum of 4 perceived PSVT episodes outside of a clinical setting. The duration of the study will depend on the frequency of a patient’s PSVT episodes.
Patients will be provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS will be self-applied by the patient when they feel the onset of PSVT symptoms. Patients will self-administer etripamil NS if the vagal maneuver (VM) is ineffective.
The study will consist of a screening visit to verify eligibility and sign the informed consent form; a baseline visit to train patients on study procedures, provide study drug, patient reported outcomes (PRO) materials and CMS materials. The treatment period consists of completing monthly PROs, self-identifying symptoms of PSVT, use CMS, perform VM and self administer etripamil. During the Treatment Period, Follow-up Visits will occur at the study site up to 14 days after a perceived episode of PSVT which is treated with etripamil NS, and during which the Investigator will evaluate the results of the last usage of etripamil NS and reassess patient’s eligibility to continue in the study based on study inclusion and exclusion criteria. A final study visit will occur along with 30 days of safety monitoring follow up for any adverse events.REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0599
Date of REC Opinion
20 Oct 2022
REC opinion
Further Information Favourable Opinion