H8H-MC-LAHW: A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients with Migraine - PIONEER-PEDS2
The PIONEER-PEDS2 study is an important research project investigating a medication called Lasmiditan for young people who suffer from migraine headaches. This study is in its third phase, which means it's a key step to confirm if the treatment works well and is safe for general use. For a whole year, researchers will be carefully checking how many children and teenagers experience any side effects after taking Lasmiditan for a migraine attack. They will also keep track of how many participants might need to stop using the medicine because of these effects. The main goal is to understand the safety of Lasmiditan for pediatric patients with migraine.
At a glance
What is this study about?
This research study, known as PIONEER-PEDS2, is focused on exploring a medication called Lasmiditan for children and teenagers who experience migraine headaches. Migraines can be really disruptive for young people, often causing severe head pain, sickness, and sensitivity to light and sound. Finding effective and safe treatments is very important to help them live more comfortably.
The study aims to see how safe Lasmiditan is when young people use it to treat their migraine attacks over a year. The researchers will be closely monitoring any side effects that might happen after someone takes the medicine for a migraine. This type of study is called 'open-label,' which means both the patients and the doctors will know they are receiving Lasmiditan. It's a 'Phase 3' study, which is a big step towards understanding if a new medication should be more widely available.
Every time a migraine attack is treated with Lasmiditan, the research team will record details about any new or worsening health problems. They will also track how many young people need to stop taking part in the study because of these effects. This information helps doctors understand how well the medicine is tolerated and helps decide if it's a good option for managing migraines in younger patients. Your participation could help improve future treatments for children with migraines.
Key takeaways
- It's a study testing a migraine medicine called Lasmiditan in children and teenagers.
- The main focus is to check how safe the medicine is over a year.
- Participants will take the medicine for their migraine attacks.
- Both boys and girls with migraines can potentially join.
- The study helps us understand better ways to treat migraines in young people.
Who may be eligible?
This study is designed for children and teenagers who experience migraine headaches. The good news is that both boys and girls are welcome to take part. Researchers are looking for a wide range of ages for this study, so there's no specific age limit mentioned here.
However, even if you or your child has migraines and fits the age and sex criteria, there are usually other specific health requirements or conditions that need to be met. These are carefully checked by the study doctor to make sure the study is safe for everyone involved and that the results are clear.
If you're interested, the first step is to talk to your doctor or the research team. They can go through all the detailed requirements with you to see if this study could be right for you or your child.
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 I/does my child get migraine headaches?
- Am I/is my child a child or teenager?
- Am I/is my child able to take study medication for a year?
- Am I/is my child willing to attend regular check-ups?
What does participation involve?
If you or your child decides to take part in this study, it would involve taking the study medication, Lasmiditan, when a migraine attack occurs. This is an 'open-label' study, meaning everyone will know they are receiving Lasmiditan. The study will last for 12 months, which is a full year. During this time, you would regularly report any side effects or health changes you notice after taking the medication for a migraine. There would likely be scheduled visits to the clinic for check-ups and to discuss how you're feeling and how the medication is working. These visits might involve physical examinations and possibly blood tests. You'd also be asked to inform the study team if you stop taking the medication for any reason, particularly if it's due to side effects. The study team will provide all the necessary medication and guidance throughout the entire year.
Potential risks and benefits
Locations (7)
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedNetherlands
- —UnverifiedRomania
Common questions
What is the main goal of this study?
The main goal is to find out how safe the medicine Lasmiditan is for children and teenagers who get migraines over a one-year period, by looking at any side effects that happen with each treated migraine attack.
Who can take part in this study?
Children and teenagers of any age who experience migraines, both boys and girls, might be able to take part. There will be other health checks to make sure it's suitable.
What does 'Phase 3' mean for a study?
Phase 3 means this study is a big step to confirm if a medicine works and is safe for general use, usually after earlier studies have shown promising results.
Will I know if I'm getting the active medication?
Yes, this is an 'open-label' study, which means both you/your child and the doctors will know that the study medication being given is Lasmiditan.
How long will the study last if I join?
If you or your child joins the study, it will last for 12 months, which is one year.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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