Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine
This study explores the long-term safety of a drug called atogepant in children and teenagers aged 6 to 17 who experience migraines. Migraines are severe headaches that can come with other symptoms like sickness and light sensitivity. There aren't many approved medicines for young people with migraines. Atogepant is already used to prevent migraines in adults, and this study aims to find out if it's safe for younger patients. Participants will take atogepant daily for about a year and have regular check-ups, including medical assessments and blood tests, to monitor how they respond and if they have any side effects. All participants will have already taken part in a previous study of atogepant.
At a glance
What is this study about?
Migraines are more than just a bad headache; they can be very painful and make you feel sick, dizzy, and sensitive to light and sound. They can stop you from doing everyday things. While there are several treatments for adults, there aren't as many approved options for children and teenagers.
This study is looking at a medicine called atogepant. It's already available for adults in the UK to help prevent migraines, meaning it can reduce how often and how severely migraines happen. Doctors want to understand if atogepant can also be a safe and helpful long-term option for young people aged 6 to 17 who get migraines.
Taking part in this study means you would be helping doctors learn more about how to best treat migraines in young people. This information could lead to more treatment choices for children and teenagers with migraines in the future.
Key takeaways
- This study is for children and teenagers aged 6-17 with migraines.
- It's looking at the long-term safety of a migraine prevention medicine called atogepant.
- Participants must have already taken part in a previous atogepant study.
- The medicine is a tablet taken daily for about a year.
- Regular hospital visits and health checks are part of the study.
- It aims to find new treatment options for young people with migraines.
Who may be eligible?
To join this study, a young person must have already taken part in another atogepant study. They need to be aged between 6 and 17 years old and have had migraines for at least six months. This includes those who get migraines occasionally (episodic) or very often (chronic, for those aged 12-17). Their weight also needs to be between 20 kg (about 3 stone 2 pounds) and 135 kg (about 21 stone 3 pounds).
There are also some reasons why someone might not be able to join. For example, if they have other types of severe headaches that aren't migraines, or if they have serious medical conditions affecting their blood, hormones, lungs, kidneys, liver, digestive system, heart, or brain. The research team will check all these details carefully.
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?
- Have you already been in an atogepant study?
- Do you get migraines regularly, even if sometimes for younger ages?
- Do you weigh between about 3 stone 2 pounds and 21 stone 3 pounds?
- Do you have any serious long-term health problems?
What does participation involve?
If you join this study, you'll be taking atogepant once a day as a tablet. If you're aged 12 to 17, you'll receive a specific dose. If you're 6 to 11, the dose will be based on what was found in the previous study you participated in. You'll take the medicine for about a year (52 weeks).
You'll need to attend regular visits at a hospital or clinic. During these visits, the study team will carry out medical checks, take blood samples, and ask you about any side effects you might be experiencing. You'll also complete questionnaires (like on a tablet or smartphone) to help track your migraines and how you're feeling. This helps the doctors understand how the medicine is affecting you over time.
Potential risks and benefits
Locations (86)
- Rehabilitation & Neurological Services /ID# 250910Verified postcodeHuntsville, United States
- Preferred Research Partners /ID# 250937Verified postcodeLittle Rock, United States
- Advanced Research Center /ID# 251616Verified postcodeAnaheim, United States
- Sunwise Clinical Research /ID# 250913Verified postcodeLafayette, United States
- Alliance for Research Alliance for Wellness /ID# 250911Verified postcodeLong Beach, United States
- Excell Research, Inc /ID# 251611Verified postcodeOceanside, United States
- Lumos Clinical Research Center /ID# 251608Verified postcodeSan Jose, United States
- Advanced Neurosciences Research, LLC /ID# 250925Verified postcodeFort Collins, United States
- Northwest Florida Clinical Research Group, LLC /ID# 251614Verified postcodeGulf Breeze, United States
- Advanced Research Institute of Miami /ID# 250916Verified postcodeHomestead, United States
- My Preferred Research LLC /ID# 250931Verified postcodeMiami, United States
- Asclepes Research Centers - Spring Hill /ID# 250912Verified postcodeSpring Hill, United States
Common questions
What is atogepant?
Atogepant is a medicine taken as a tablet to help prevent migraines. It's already used for adults and is being studied for children and teenagers.
Why is this study specifically for children and teenagers?
There aren't many approved medicines for younger people with migraines, so this study aims to see if atogepant is safe and works well for them.
How long will I take the medicine?
You will take the atogepant tablet once a day for about one year (52 weeks).
What kind of check-ups will I have?
You'll have regular hospital visits for medical checks, blood tests, and to discuss any side effects with the study team.
Can I leave the study if I change my mind?
Yes, you can choose to stop participating in the study at any time, and it won't affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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