H8H-MC-LAHV: Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1
The PIONEER-PEDS1 study is a research project focusing on children and teenagers who experience migraine headaches. Researchers are testing a potential new medicine called lasmiditan to see how effective it is at stopping migraine pain once it starts. They are comparing different strengths of lasmiditan against a placebo, which is a tablet that looks the same but contains no active medicine. This helps them understand if lasmiditan truly works better than nothing. This study is in its final phase (Phase III), meaning it's a large and important step to confirm if the treatment is safe and effective before it can be considered for wider use. Participants will be monitored closely to see if the medicine can make them pain-free.
At a glance
What is this study about?
This research study, called PIONEER-PEDS1, is looking for better ways to treat migraine headaches in children and teenagers. Migraines are severe headaches that can cause throbbing pain, sickness, and sensitivity to light and sound. Finding quick and effective relief is very important for young people who suffer from them.
The study is testing a specific medicine called lasmiditan. It’s designed to help stop a migraine attack once it has started. Researchers want to find out if lasmiditan can make young people completely pain-free during a migraine, and how different doses compare. They are also comparing it to a 'placebo', which is a pill that looks identical but doesn’t contain any medicine. This helps the researchers know for sure if any improvements seen are due to the actual medicine or something else.
This kind of study is called a 'Phase III' study, which means it’s one of the final and most important steps before a new medicine can be considered for approval. It’s a large-scale study designed to confirm how well the medicine works and if it’s safe for the age group being studied.
Key takeaways
- The study is for children and teenagers with migraine headaches.
- It's testing a new medicine called lasmiditan to stop migraine pain.
- Participants will receive either lasmiditan or a dummy pill (placebo).
- This is a large, final-stage study (Phase III).
- Participation involves taking medication and keeping track of migraine symptoms.
- You can stop participating at any time.
Who may be eligible?
This study is open to both boys and girls of all ages who suffer from migraine headaches. If you or your child gets migraines, this study might be an option to consider.
Before anyone can join, the study team will need to check some things to make sure it's safe and appropriate. This usually involves reviewing medical history and making sure the migraine condition fits the study's requirements.
It's important to remember that even if you meet the basic age and sex criteria, there might be other specific health conditions or medications that would prevent someone from joining. The study team will discuss all of these details with you.
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.
- Do you or your child get migraine headaches?
- Are you a boy or a girl of any age?
- Are you able to attend study appointments as required?
- Are you willing to take a study medicine or a placebo?
- Are you willing to track your migraine symptoms carefully?
What does participation involve?
If you or your child decides to take part in this study, you would first have a screening visit. During this visit, the study team would check if you meet all the requirements. If eligible, you would then be given either the study medicine (lasmiditan) or a dummy pill (placebo) to take when a migraine starts. You wouldn't know which one you're taking, which is common in these types of studies.
You would need to record information about your migraines and how you feel after taking the medication. There will be regular follow-up visits or phone calls to check on your progress and any side effects. The total duration of participation would be explained fully by the study team, but typically these studies involve several months of monitoring.
Potential risks and benefits
Locations (7)
- —UnverifiedNetherlands
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedBelgium
- —UnverifiedRomania
- —UnverifiedItaly
- —UnverifiedFrance
Common questions
What is a 'placebo'?
A placebo is a pill or treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'blinded' study. Neither you nor your doctor will know if you're taking the study medicine or the placebo. This helps make the study results fair.
What does 'Phase III' mean for a medicine?
Phase III is a late stage of research where a new medicine is tested on a large number of people to confirm its effectiveness and safety before it can be considered for approval.
How long will I be in the study?
The exact duration for each participant will be explained by the study team, but typically these studies involve several months of participation and follow-up.
Do I have to pay to be in the study?
No, participation in clinical trials is generally free. The study will cover costs related to the research treatment and visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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