Nasal spray may offer quick fix for Children's racing heart
NCT ID NCT05763953
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
Summary
This study tests whether etripamil nasal spray can safely and quickly stop episodes of paroxysmal supraventricular tachycardia (PSVT) in children aged 6 to 17. PSVT causes sudden rapid heartbeats that can be frightening and require medical attention. The spray is designed to be used at the onset of symptoms, potentially avoiding emergency room visits. The trial will evaluate how well the spray restores normal heart rhythm within 15 minutes and monitor for any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- etripamil nasal spray
- What this could lead to
- If successful, this could provide a fast, needle-free way for children to stop PSVT episodes at home, reducing emergency visits.
- What could go wrong
- This is an early-phase study with a small number of children, so results may not confirm safety or effectiveness. Side effects from the nasal spray are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients will be eligible for study participation if they meet all of the following criteria at screening: 1. Male or female patients 1. Part 1: patients 12 to \<18 years of age 2. Part 2: patients 6 to \<12 years of age 2. Body mass index (BMI) between the 5th and the 85th percentiles interpreted relative sex and age 3. History of PSVT documented by ECG or other monitoring modality (e.g., Holter monitor, event recorder) showing SVT involving the Atrioventricular (AV) node (i.e., Atrioventricular nodal reentry tachycardia (AVNRT) or Atrioventricular reentrant tachycardia (AVRT)). If patient had a prior ablation for PSVT, patient must have documented evidence of PSVT post-ablation 4. Signed written informed consent/assent obtained 5. Per Investigator's decision, females of childbearing potential (defined as any woman or adolescent who has begun menstruation) must additionally satisfy the following criteria: 1. Negative pregnancy test at screening 2. Adequate contraception, unless total abstinence is used 6. Willing and able to comply with study procedures. Exclusion Criteria: Patients will be excluded from the study if they meet any of the following criteria: 1. History or presence of any of the following at the screening visit: 1. Patients with a history of atrial arrhythmia that does not involve the AV node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, atrial tachycardia) are not eligible 2. Permanent junctional reciprocating tachycardia 3. Ventricular pre-excitation (e.g., delta wave on ECG, Wolff Parkinson White syndrome) 4. Second- or third-degree AV block 5. Sick sinus syndrome or clinically significant bradycardia (\<50 bpm or equivalent in this patient population) on the resting ECG 6. Ventricular tachycardia 7. Long QT syndrome 8. Major structural heart disease (e.g., Ebstein's anomaly, corrected congenital heart disease) or symptoms of congestive heart failure (New York Heart Association class II to IV). 2. Evidence of impaired liver function (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] \>3 x upper limit of normal for age and gender) at the Screening Visit 3. Evidence of End-Stage Renal Disease as determined by an estimated glomerular filtration rate assessed at the Screening Visit of \<15 mL/min/1.73m2, or requiring hemodialysis; 4. Treatment with any of the following that cannot or will not be discontinued during study participation: 1. Any investigational drug within 60 days prior to study drug administration 2. IV beta-adrenergic blocking drugs (e.g., propranolol, esmolol), calcium channel blocking drugs (e.g., verapamil, diltiazem) or amiodarone within 24 hours prior to study drug administration 3. Oral amiodarone within 30 days prior to study drug administration 4. Class I or III antiarrhythmic agents (e.g., flecainide, propafenone, sotalol) within five half-lives prior to study drug administration 5. Any other drug that has a contraindication with verapamil 5. Known hypersensitivity to verapamil or to any of the excipients of the study drug 6. Any other significant co-morbid condition that may have a negative impact on the patient's participation in the study or likely to result in non-compliance 7. History of hyperthyroidism 8. Current pregnancy or breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Advocate Children's Hospital
NOT_YET_RECRUITINGOak Lawn, Illinois, 60453, United States
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Baylor College of Medicine
NOT_YET_RECRUITINGHouston, Texas, 77030, United States
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Cincinnati Children's Hospital Medical Center
NOT_YET_RECRUITINGCincinnati, Ohio, 45229, United States
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Hospital Infantil Universitario La Paz
RECRUITINGMadrid, 28046, Spain
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Hospital Sant Joan de Déu
NOT_YET_RECRUITINGBarcelona, 08950, Spain
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Le Bonheur Children's Hospital
NOT_YET_RECRUITINGMemphis, Tennessee, 38103, United States
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Oregon Health and Science University
RECRUITINGPortland, Oregon, 97239, United States
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Phoenix Children's Hospital
RECRUITINGPhoenix, Arizona, 85016, United States
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The University of British Columbia
NOT_YET_RECRUITINGVancouver, V6H3V4, Canada
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Universitätsmedizin Göttingen, Klinik für Pädiatrische Kardiologie, Intensivmedizin und Neonatologie
NOT_YET_RECRUITINGGöttingen, 37075, Germany
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