The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
The NODE-202 study is a clinical trial exploring a new nasal spray treatment, Etripamil, for children and teenagers (aged 6-17 years old) who experience a rapid heart rate condition known as Paroxysmal Supraventricular Tachycardia (PSVT). This study is in its second phase, meaning it's still an early stage of testing. Researchers want to find out if the nasal spray is effective and safe to use as a single dose when someone is having a PSVT episode. It will involve different age groups, starting with older teenagers and then moving to younger children, carefully checking the right dose and how the body handles the treatment. The goal is to see if this easy-to-use spray could be a helpful option for managing PSVT.
At a glance
What is this study about?
This study, called NODE-202, is looking into a potential new treatment for a heart condition known as Paroxysmal Supraventricular Tachycardia, or PSVT. If you or your child has PSVT, you'll know that it causes your heart to suddenly beat very quickly. This study is testing a new medicine called Etripamil, which is given as a nasal spray, to see if it can help stop these fast heart episodes. It's a 'Phase 2' study, which means it's an early step in researching new medicines, focusing on whether it works and if it's safe for children and teenagers.
The study involves different age groups, starting with young people aged 12 to 17 years old, and then potentially moving on to younger children aged 6 to 11. The researchers will give a single dose of the nasal spray to participants when they are having a PSVT episode and watch closely to see if it brings their heart rate back to normal. They will also be checking for any side effects and how the body handles the medicine.
The main aim is to find the right dose and make sure the treatment is safe and tolerable for children. By taking part, you or your child could help doctors learn more about managing PSVT and potentially help develop a new, easier way to treat this condition at home.
Key takeaways
- This study is testing a new nasal spray for fast heartbeats (PSVT) in children and teenagers.
- It's an early-stage study to check if the medicine works and is safe.
- Participants will receive a single dose of the nasal spray if they have a PSVT episode.
- Different age groups from 6 to 17 years old are included.
- Participation will involve a few hospital visits.
- You can stop taking part in the study at any time.
Who may be eligible?
To join this study, participants generally need to be male or female, aged between 6 and 17 years old, and have a confirmed diagnosis of PSVT. Their heart condition must specifically involve a part of the heart called the AV node, and any past treatments for PSVT, like surgery, must show that the PSVT can still happen.
There are also some important health conditions that would prevent someone from joining. For example, if you or your child has other serious heart problems like certain types of irregular heartbeats (like atrial fibrillation or Wolff-Parkinson-White syndrome), or if they have had significant heart surgery that left major issues, they wouldn't be able to participate. It's important that participants are able and willing to follow the study's instructions.
For female participants who are old enough to have periods, they would need to have a negative pregnancy test at the start and agree to use effective contraception throughout the study, unless they are not sexually active. These checks are in place to ensure everyone's safety during the trial.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you or your child between 6 and 17 years old?
- Do you or your child have a confirmed diagnosis of PSVT?
- Is your PSVT related to the AV node in the heart?
- Do you or your child have other serious heart problems?
- Are you or your child able to come to all study appointments?
- For females of childbearing potential, are you able to use contraception during the study?
What does participation involve?
Taking part in this study would involve a few steps. First, there would be a 'Screening Visit' to check if you or your child meets all the criteria to join. If you're eligible, the main part is the 'Treatment Visit', where, if a PSVT episode occurs, a single dose of the Etripamil nasal spray will be given. During this visit, doctors will carefully monitor the heart and check for any changes or side effects. There might also be blood tests to see how the medicine is processed by the body. After the treatment, there will be a 'Follow-Up/End of Study Visit' to make sure everything is well.
The study itself is divided into different parts and age groups, but each participant will only receive a single dose if they experience a PSVT episode during the trial. The total duration of your individual participation would include these few visits, from the initial checks to the final follow-up, ensuring doctors have all the information they need about the medicine's effects.
Potential risks and benefits
Locations (10)
- Phoenix Children's HospitalVerified postcodePhoenix, United States· Recruiting
- Advocate Children's HospitalVerified postcodeOak Lawn, United States· Not yet recruiting
- Cincinnati Children's Hospital Medical CenterVerified postcodeCincinnati, United States· Not yet recruiting
- Oregon Health and Science UniversityVerified postcodePortland, United States· Recruiting
- Le Bonheur Children's HospitalVerified postcodeMemphis, United States· Not yet recruiting
- Baylor College of MedicineVerified postcodeHouston, United States· Not yet recruiting
- The University of British ColumbiaVerified postcodeVancouver, Canada· Not yet recruiting
- Universitätsmedizin Göttingen, Klinik für Pädiatrische Kardiologie, Intensivmedizin und NeonatologieVerified postcodeGöttingen, Germany· Not yet recruiting
- Hospital Sant Joan de DéuVerified postcodeBarcelona, Spain· Not yet recruiting
- Hospital Infantil Universitario La PazVerified postcodeMadrid, Spain· Recruiting
Common questions
What is PSVT?
PSVT stands for Paroxysmal Supraventricular Tachycardia, which is a condition where the heart suddenly beats very fast and then returns to a normal rhythm.
What is Etripamil nasal spray?
Etripamil nasal spray is a new medicine being tested in this study to see if it can help stop episodes of fast heartbeats caused by PSVT when sprayed into the nose.
Will I or my child definitely get the new medicine?
If eligible, participants will receive a single dose of the Etripamil nasal spray during the study, specifically when experiencing a PSVT episode.
How long does the study last for each person?
Each participant's involvement includes a screening visit, a treatment visit where the medicine is given (if a PSVT episode occurs), and a follow-up visit. The exact timeframe will vary but will be discussed with you.
Is this medicine available to the public?
No, Etripamil is currently an experimental medicine and is only available to patients participating in specific clinical trials like this one.
How to find out more
Cameron Szakacs, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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