A Phase 3, Multicenter, Open-Label 156-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Chronic Or Episodic Migraine
This research is a continuation study (meaning it follows on from earlier research) to check how safe a new medicine, called atogepant, is when taken over a longer period, up to three years. It's for people who experience different types of migraines, whether often (chronic) or sometimes (episodic). The main goal is to see how many people experience any side effects while taking the medication. We'll also be looking closely at blood and urine tests, heart readings (ECGs), and other body measurements like blood pressure to make sure the medicine is well-tolerated and doesn't cause any unexpected health issues. This helps doctors understand if atogepant is a safe option for long-term migraine prevention.
At a glance
What is this study about?
This study focuses on a medicine called atogepant, which is being tested to see if it can help prevent migraine headaches. Migraines are a type of headache that can be very painful and often come with other symptoms like feeling sick, being sensitive to light or sound, and can really impact your daily life.
Doctors are already looking into how well atogepant works, and this particular part of the research is to understand its long-term safety. This means people will take the medicine for a longer time – up to three years – so we can be sure it's safe and doesn't cause any unexpected problems when used over an extended period. This is really important because if a medicine is going to be used to prevent a condition like migraine, people might need to take it regularly.
The main thing researchers want to find out is how often people experience any side effects while taking atogepant. They will also be carefully monitoring people's general health, including blood tests, urine tests, heart recordings (ECGs), and vital signs like blood pressure, to make sure the medicine is well-tolerated. This information helps doctors understand if atogepant is a safe and suitable option for many people living with migraines.
Key takeaways
- This study looks at the long-term safety of a new migraine prevention medicine.
- It's for adults who experience chronic (frequent) or episodic (occasional) migraines.
- Participants will take the medicine atogepant for up to three years.
- Regular health checks, blood tests, and heart monitoring will be part of the study.
- The main aim is to understand possible side effects over a longer period.
- You can stop participating at any time.
Who may be eligible?
This study is particularly looking for adults, from 18 years old and up, who experience migraines. This includes people who have migraines quite often (called chronic migraines) or those who get them from time to time (called episodic migraines). It doesn't matter if your migraines are with or without auras (those visual or sensory disturbances you sometimes get before a headache).
Both men and women are welcome to take part in this study. The most important thing is that you have a history of migraines and are an adult.
There might be other specific health requirements or conditions that would mean you can't join, but generally, if you're an adult living with migraines, you could be a candidate.
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 18 years old or older?
- Do you get migraines, either often or sometimes?
- Are you comfortable with taking a new medicine for up to three years?
- Are you able to attend regular clinic visits for health checks?
What does participation involve?
If you decide to take part in this study, you would be given the medication atogepant to take regularly for up to three years. Throughout this time, you would have regular visits to the study clinic. During these visits, the study team would check your general health, ask about any side effects you might be having, and perform various tests.
These tests would include blood tests and urine tests to check your body's functions, and you would also have heart recordings (ECGs) and vital signs (like your blood pressure and pulse) measured. These checks are to make sure the medicine is not causing any unexpected problems and that you are tolerating it well. The study team would be there to support you and answer any questions you have during your participation.
Potential risks and benefits
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Common questions
What is atogepant?
Atogepant is a new medicine being studied to see if it can help prevent migraine headaches.
How long will I take the medicine for?
You would take the medicine for an extended period, up to three years, to assess its long-term safety.
What will happen during clinic visits?
During clinic visits, you'll have health checks, including blood tests, urine tests, heart recordings (ECGs), and have your vital signs measured.
Does this study test how well the medicine works?
The main focus of this particular study is to check the long-term safety of the medicine, rather than how well it stops migraines.
Can I stop taking part if I change my mind?
Yes, you can choose to leave the study at any time, for any reason.
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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