A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Chronic Migraine (OASIS PEDIATRIC [CM])
This important study is investigating a new medication called Erenumab for children and teenagers between 6 and 17 years old who experience chronic migraines. Chronic migraine means getting migraines very often. The main goal is to find out if Erenumab safely and effectively reduces the number of migraine days these young people have each month, compared to a placebo (a dummy medicine with no active ingredients). Researchers will also look at how bad the migraines are and how much they affect daily life. This type of study, called a Phase 3 trial, is a crucial step to determine if new medicines are safe and work well before they can become widely available.
At a glance
What is this study about?
This research study is looking at a new medicine called Erenumab for young people who suffer from chronic migraines. Chronic migraine means you have headaches with migraine features for 15 or more days a month, for at least three months. This study includes children aged 6 to under 12 years and teenagers aged 12 to under 18 years. The main aim is to see if Erenumab can help reduce the number of days these young people experience migraines and how severe those migraines are.
To make sure the study is fair and accurate, some participants will receive Erenumab, while others will receive a 'placebo'. A placebo looks exactly like the study medicine but contains no active ingredients – it's like a dummy pill. Neither the participants, their families, nor the doctors treating them will know who is getting the real medicine and who is getting the placebo. This is called a 'double-blind' study and helps prevent bias. Researchers will carefully compare the two groups to understand if Erenumab is truly effective.
They will be looking at several things to judge if the medicine works. The main thing they'll measure is how much the number of migraine days per month changes after taking the study treatment for about three months. They'll also check how much the pain and other migraine symptoms improve and how much migraines affect daily activities, like school and hobbies. This study is a 'Phase 3' trial, which means it's one of the final steps to decide if Erenumab is a safe and helpful treatment for young people with chronic migraines.
Key takeaways
- This study evaluates Erenumab for chronic migraines in young people (6-17).
- It aims to reduce migraine frequency and severity.
- Participants will receive either Erenumab or a placebo (dummy medicine).
- Neither patient nor doctor will know which treatment is given ('double-blind').
- The study assesses changes in monthly migraine days over about three months.
- Full details about participation, risks, and benefits will be provided by the study team.
Who may be eligible?
To join this study, participants need to be children or teenagers between 6 and 17 years of age. They must have a diagnosis of chronic migraine, meaning they experience migraines very frequently. Both boys and girls can take part.
There will be other, more detailed criteria that determine who can and cannot join, based on their specific health conditions, other medicines they might be taking, and past medical history. These rules are important to make sure the study is safe for everyone involved and that the results are clear.
If you think your child might fit the main age and migraine criteria, a doctor involved in the study would need to review their full medical history to confirm they are suitable.
- Is your child aged between 6 and 17 years old?
- Does your child experience migraines frequently (chronic migraine)?
- Is your child able to attend regular clinic visits?
- Are you willing to keep a migraine diary for your child if required?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, your child would be randomly assigned to either receive the study medicine (Erenumab) or a placebo (a dummy medicine). Neither you nor the study doctors would know which one your child is receiving. You would have regular visits to the study clinic, likely for check-ups and to receive the study medicine.
During these visits, doctors would assess your child's migraines, general health, and any side effects. You would also likely need to keep a diary of migraine days and symptoms. The study involves taking the medication and having these assessments for several months. The total length of the study for each participant, including follow-up, would be fully explained by the study team.
Potential risks and benefits
Locations (5)
- —Italy
- —Germany
- —Hungary
- —Poland
- —Belgium
Common questions
What is Erenumab?
Erenumab is a study medicine being tested to see if it can help prevent migraines.
What is a 'placebo'?
A placebo is a dummy medicine that looks like the real medicine but has no active ingredients. It helps researchers compare the effects accurately.
What does 'double-blind' mean?
It means neither the patient nor the doctor knows whether the patient is receiving the study medicine or the placebo, to keep the results unbiased.
How long will my child need to be in the study?
The main part of the study involves treatment and checks for around three months, but the full duration would be explained by the study team.
Can my child leave the study at any time?
Yes, you are free to withdraw your child from the study at any point, without giving a reason.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.