A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age
This study is investigating a new treatment called Fremanezumab, or AJOVY, for children and teenagers between 6 and 17 years old who experience migraines. It's a long-term study aiming to understand if this medicine is safe and if it helps prevent migraines — both those that happen from time to time (episodic) and those that occur very often (chronic). Participants will receive the medicine as a monthly injection. Researchers will carefully monitor for any side effects and see if the medicine reduces the number of headache days, migraine days, and how much migraines affect daily life. This is a very important step to find better ways to help young people manage their migraines.
At a glance
What is this study about?
This research study is focused on a medicine called Fremanezumab, also known by its brand name AJOVY. It's designed specifically for young people, aged 6 to 17, who suffer from migraines. Migraines can be really tough, causing severe headaches along with other symptoms like sickness and sensitivity to light and sound. Some young people experience them occasionally (episodic migraines), while for others, they happen very frequently (chronic migraines).
The main goal of this study is to check the safety of Fremanezumab over a long period. This means doctors will be carefully looking for any side effects or changes in health that might happen while young people are using this medicine. They'll also be checking how well the medicine works to prevent migraines, hoping to reduce how often they occur and how severe they are.
This is a 'Phase III' study, which means it's a key stage where researchers gather a lot of information to confirm if the medicine is safe and effective before it can be widely used. The insights gained from this study could be very helpful in finding better ways to manage migraines for children and teenagers.
Key takeaways
- The study is for young people (6-17 years old) with migraines.
- It tests a monthly injection called Fremanezumab (AJOVY) to prevent migraines.
- The main focus is on safety, carefully tracking any side effects.
- It also checks if the medicine reduces migraine frequency and severity.
- This is a long-term study to gather important information for future migraine treatments.
- Participation involves regular clinic visits and health checks.
Who may be eligible?
This study is open to both boys and girls who are between 6 and 17 years old. You might be able to take part if you have been diagnosed with either episodic migraines (they happen sometimes) or chronic migraines (they happen very often).
There might be other health conditions or medicines that mean someone can't join the study, as the researchers need to make sure it's safe for everyone involved. For example, if you have certain other medical problems or are taking particular medications, you may not be able to participate.
The best way to find out if this study is right for you or your child is to talk to your doctor. They can go through all the details and see if you meet the specific requirements.
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.
- Am I, or is my child, between 6 and 17 years old?
- Has a doctor diagnosed me, or my child, with episodic (occasional) or chronic (frequent) migraines?
- Am I willing to have monthly injections?
- Am I able to attend regular clinic appointments for health checks?
- Do I have any other major health conditions that might prevent participation?
- Am I currently taking any medications that might conflict with the study drug?
What does participation involve?
If you decide to take part in this study, you would receive the study medicine, Fremanezumab, as an injection once a month using a pre-filled pen, which can be done under the skin. Over the course of the study, you'd have regular visits to the clinic. At these visits, doctors and nurses would check your health, which includes things like taking your blood pressure and pulse, and doing blood and urine tests. They'll also measure your height and weight.
Throughout the study, you would be asked to keep track of any headaches you have and any side effects you might experience. There will also be questionnaires to complete, like one about how migraines affect your daily life. Doctors will also check your heart with a simple test called an ECG. All these checks help the research team understand how the medicine is working and if it's causing any problems. The full duration of the study, including follow-up appointments, will be explained by the study team.
Potential risks and benefits
Locations (6)
- —UnverifiedFinland
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedNetherlands
- —UnverifiedPoland
Common questions
What is Fremanezumab?
Fremanezumab, also known as AJOVY, is a medicine being tested to help prevent migraines in young people.
How is the medicine given?
The medicine is given as an injection under the skin once a month using a special pen.
Who can take part in this study?
Children and teenagers aged 6 to 17 who have either occasional or frequent migraines can be considered for the study.
What will doctors be checking for?
They will be checking for side effects, how well the medicine prevents migraines, and your general health through tests like blood checks and heart scans.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.
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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