A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine
This study is testing a medicine called atogepant for children and teenagers aged 6 to 17 who experience migraines. Migraines are severe headaches that can also come with feeling sick, throwing up, and being sensitive to light and noise. While atogepant is already used by adults, there aren't many approved medicines specifically for young people with migraines. Researchers want to see if different doses of atogepant are safe and effective in this age group. Participants will take either the study medicine or a dummy pill (placebo) every day for 12 weeks. They will have regular check-ups, and their migraines and any side effects will be carefully monitored to understand how well the treatment works.
At a glance
What is this study about?
You might be reading this because you, or someone you know, gets migraines. Migraines are more than just a bad headache; they can be very painful, often affecting one side of the head, and can make you feel unwell with sickness, vomiting, and a dislike of bright lights or loud sounds. For adults, there are various treatments available for migraines, but for children and teenagers, there are far fewer approved options.
This study is focusing on a medicine called atogepant. It's already approved and helps adults who get migraines up to 14 days a month. This research aims to find out if atogepant can also be a safe and helpful treatment for young people between 6 and 17 years old who experience episodic migraines, which means they get migraines sometimes but not every day.
The main goal is to carefully check if atogepant is safe for children and teenagers, and if it can reduce how often they get migraines and how bad they are. Participants will be organised into different groups, some taking a lower dose of atogepant, some a higher dose, and some taking a dummy pill (placebo). This is done to accurately compare the effects and clearly see if the medicine is making a difference. The study will last 12 weeks, with an option to continue taking the medicine in an extension study afterwards.
Key takeaways
- This study is testing a migraine medicine called atogepant for young people aged 6-17.
- It aims to find out if the medicine is safe and helps reduce migraines in this age group.
- Participants will take a tablet daily for 12 weeks, either the study drug or a placebo.
- Regular hospital visits, medical checks, and questionnaires will be part of taking part.
- There's an option to continue with the medicine in an extension study after 12 weeks.
Who may be eligible?
To join this study, children and teenagers need to be between 6 and 17 years old. They should weigh at least 20 kg (about 3 stone 2 pounds) but less than 135 kg (about 21 stone 3 pounds). They must have had migraines on and off for at least six months. During a specific 28-day period before the study, they should typically have had between 4 and 14 migraine days, but fewer than 15 headache days in total. For children aged 6 to 11 particularly, doctors will also check if they think preventative migraine treatment would be a good idea for them.
There are also some reasons why someone might not be able to join. This includes if they have certain types of very specific or rare migraines like 'migraine with brainstem aura' or 'hemiplegic migraine'. Also, if they currently have 'chronic migraine' (which means migraines very frequently), or other specific headache types like 'cluster headache', they won't be able to take part.
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 between 6 and 17 years old?
- Do you weigh at least 20 kg (44 lbs) and less than 135 kg (298 lbs)?
- Have you had migraines on and off for at least 6 months?
- Do you usually have between 4 and 14 migraine days, but fewer than 15 headache days in total, within a 28-day period?
- Do you *not* have frequent migraines (chronic migraine) or other specific types like cluster headaches?
What does participation involve?
If you decide to take part, you'll be given either the study medicine (atogepant) or a dummy pill (placebo) in tablet form, which you will take by mouth once a day for 12 weeks. You'll be assigned to one of six different groups by chance. For children specifically aged 6 to 11, the exact dose of atogepant will be decided after some initial medical checks.
Throughout the 12 weeks, you'll need to attend regular appointments at a hospital or clinic. These visits are important for the study team to carefully check how you are doing. They will involve medical assessments, like checking your general health, and some blood tests. You'll also be asked to complete questionnaires about your migraines and any side effects you might be experiencing. This helps the doctors understand if the treatment is working and if it's safe. After the 12 weeks, you'll either have a follow-up visit four weeks later, or you might be able to join an extension study where you could continue taking atogepant for another 52 weeks.
Potential risks and benefits
Locations (98)
- Rehabilitation & Neurological Services /ID# 248517Verified postcodeHuntsville, United States· Recruiting
- The Center for Clinical Trials - Saraland /ID# 271604Verified postcodeSaraland, United States· Recruiting
- Preferred Research Partners /ID# 249729Verified postcodeLittle Rock, United States· Recruiting
- Preferred Research Partners /ID# 270406Verified postcodeLittle Rock, United States· Completed
- Advanced Research Center /ID# 251381Verified postcodeAnaheim, United States· Recruiting
- Alliance for Research Alliance for Wellness /ID# 248521Verified postcodeLong Beach, United States· Recruiting
- Excell Research, Inc /ID# 247532Verified postcodeOceanside, United States· Recruiting
- Lumos Clinical Research Center /ID# 249731Verified postcodeSan Jose, United States· Recruiting
- Sunwise Clinical Research /ID# 248529Verified postcodeWalnut Creek, United States· Recruiting
- Advanced Neurosciences Research, LLC /ID# 247592Verified postcodeFort Collins, United States· Completed
- Northwest Florida Clinical Research Group, LLC /ID# 251382Verified postcodeGulf Breeze, United States· Recruiting
- Advanced Research Institute of Miami /ID# 248539Verified postcodeHomestead, United States· Completed
Common questions
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It's used to fairly compare the effects of the real medicine.
What does 'randomized, double-blind' mean?
Randomized means the treatment you get (study medicine or placebo) is chosen by chance. Double-blind means neither you, your family, nor your study doctor will know which treatment you are receiving until the study is over. This helps make the study as fair and accurate as possible.
How long will I take the study medicine?
You will take the study medicine or placebo for 12 weeks. After that, you may have the option to join an extension study and continue for another 52 weeks.
Will I have to pay to be in the study?
No, you will not have to pay for the study medicine or any of the study-related visits or tests.
What if I get side effects?
The study team will closely monitor you for any side effects. It's important to tell them about anything you experience, even if you don't think it's related to the medicine.
How to find out more
ABBVIE CALL CENTER
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.