Etripamil nasal spray in Patients with 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
273551
Contact name
Dhiraj Gupta
Contact email
Sponsor organisation
Milestone Pharmaceuticals Inc
Eudract number
2019-001857-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
This is a Phase 3 open-label, safety study of Etripamil Nasal Spray. This study will be run at about 400 research sites around the world. Up to 3000 patients with Paroxysmal Supraventricular Tachycardia (PSVT) will take part.
This study is recruiting patients with a heart rhythm disorder (or arrhythmia) called Paroxysmal Supraventricular Tachycardia (PSVT). PSVT results in sudden episodes of a very fast heart rate, usually at a rate greater than 100 beats per minute. A normal heart rate is about 60-90 beats per minute. This happens when the electrical signals controlling the heartbeat are not working properly. During a PSVT episode, patients may feel palpitations (rapid heartbeat) caused by an increased heart rate of more than 100 beats per minute. Although PSVT is typically not a life-threatening condition, it may result in a trip to hospital/A&E to receive intravenous treatment (and possibly other treatments) to get the heartbeat back to normal. The study is being done to collect data that may determine whether an investigational study drug known as etripamil nasal spray (NS), is able to safely and effectively stop an episode of PSVT when taken by a patient to self-treat his/her PSVT episode.
When the patient identifies symptoms of a PSVT episode, the patient will attach the Cardiac Monitoring System (CMS). They will then perform a vagal maneuver. If the vagal maneuver relieves their symptoms, they will not take the study drug and can remove the CMS. If their symptoms do not stop, they will immediately treat themselves with the study drug and record the time of taking the drug on the CMS. If PSVT symptoms have not resolved within 20 minutes after taking the study drug, they should seek medical care.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
20/NW/0067
Date of REC Opinion
14 Feb 2020
REC opinion
Favourable Opinion