Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine
This study is looking at two medicines, atogepant and topiramate, to prevent migraines in adults. Migraines are severe headaches often with other symptoms like sickness or sensitivity to light. Atogepant is already approved for some types of migraine prevention, and topiramate is a common migraine prevention medicine. The main goal is to find out which medicine is better tolerated and safer for patients. Participants will be randomly given either atogepant or topiramate for 24 weeks. After this, everyone eligible will switch to atogepant for another 52 weeks. Doctors will closely monitor participants for any side effects and overall health through regular visits to clinics or hospitals, blood tests, and questionnaires. The study aims to involve about 520 adults aged 18 and older globally.
At a glance
What is this study about?
Migraines are more than just a headache; they can be very painful and often come with other upsetting symptoms like feeling sick, being sick, or being very sensitive to light and sound. These can make daily life very difficult. This study is exploring two different medicines that help prevent migraines before they even start.
One medicine is called atogepant. It's already approved for people who get migraines fairly often (up to 14 migraine days a month). The other medicine is topiramate, which is also a common treatment for preventing migraines. Doctors want to see how well people cope with each medicine and which one causes fewer problems or side effects. This is really important because medicines that are well-tolerated are more likely to be taken regularly, leading to better migraine control.
The study is split into two main parts. In the first part, for about 24 weeks, new participants will be randomly assigned to take either atogepant or topiramate. They won't know which one they're getting, and neither will the doctors giving it. This helps make the study fair. After these 24 weeks, if they're still suitable, all participants will then take atogepant for a longer period of 52 weeks. Throughout the entire study, doctors will keep a close eye on everyone to ensure their safety and track how they're feeling.
Key takeaways
- Compares two migraine prevention medicines, atogepant and topiramate.
- Aims to understand side effects and how people cope with each medicine.
- Involves taking pills daily for over a year.
- Requires regular clinic visits and health assessments.
- Participation includes a 24-week initial phase, followed by a 52-week phase of atogepant for eligible participants.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult between 18 and 80 years old and have had migraines for at least a year. You should also be someone who gets migraines often enough (at least 4 days a month) that your doctor thinks you need regular medicine to prevent them.
However, you won't be able to join if you've already taken topiramate or atogepant in the past. Also, if you have certain other health problems, like serious heart, liver, kidney, or other significant long-term illnesses, you 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 18 and 80 years old?
- Have you had migraines for at least the past year?
- Do you experience at least 4 migraine days per month?
- Have you *not* taken topiramate or atogepant before?
- Do you have no serious other long-term health conditions (like severe heart, liver, or kidney problems)?
What does participation involve?
If you decide to take part, you'll visit a hospital or clinic regularly. For the first 24 weeks, you'll be given either atogepant or topiramate pills to take daily. You won't know which one you're getting, and sometimes you might be given a dummy pill (placebo) alongside the active medicine – this is to make sure the study results are fair. After this initial period, if you're still eligible, you'll switch to taking atogepant pills for another 52 weeks. Throughout the study, doctors and nurses will check your safety and how you're feeling through medical assessments, blood tests, asking about any side effects, and having you fill out questionnaires. After your last study medicine dose, you'll be monitored for another 4 weeks to ensure everything is well. This study will involve many visits and checks over a long period, which might be more than your usual medical care.
Potential risks and benefits
Locations (81)
- Medizinische Universitaet Wien /ID# 247119Verified postcodeVienna, Austria
- Medizinische Universitaet Innsbruck /ID# 247213Verified postcodeInnsbruck, Austria
- Konventhospital Barmherzige Brueder Linz /ID# 247217Verified postcodeLinz, Austria
- Universitair Ziekenhuis Brussel /ID# 246959Verified postcodeJette, Belgium
- Jessa Ziekenhuis /ID# 246954Verified postcodeHasselt, Belgium
- UZ Gent /ID# 246957Verified postcodeGhent, Belgium
- AZ Sint-Jan Brugge /ID# 246962Verified postcodeBruges, Belgium
- CHR de la Citadelle /ID# 246964Verified postcodeLiège, Belgium
- Vancouver Island Health Authority /ID# 247733Verified postcodeVictoria, Canada
- Maritime Neurology /ID# 247728Verified postcodeHalifax, Canada
- Aggarwal and Associates Limited /ID# 247727Verified postcodeBrampton, Canada
- CCR Ostrava, s.r.o. /ID# 245924Verified postcodeOstrava, Czechia
Common questions
What exactly is a 'placebo'?
A placebo is a dummy pill that looks just like the real medicine but contains no active drug. It helps researchers understand if the medicine itself is causing effects, or if other factors are at play.
Will I know which medicine I'm taking?
For the first part of the study (24 weeks), you won't know whether you're taking atogepant or topiramate (or their placebos). This is called a 'blinded' study and helps ensure fair results. In the second part, all eligible participants will take atogepant.
How long will I be in the study?
You'll be taking study medicine for a total of 76 weeks (24 weeks in Period 1, then 52 weeks in Period 2), plus a 4-week safety follow-up after your last dose. So, the total time will be around 80 weeks (about 1.5 years).
Why can't I join if I've used topiramate or atogepant before?
The study wants to see how people react to these medicines when they haven't taken them previously. Having prior experience with these specific drugs could affect how the results are interpreted.
What if I have side effects during the study?
Your safety is the main concern. You will have regular medical appointments, blood tests, and health checks throughout the study to monitor for any side effects or changes in your health. You should always tell the study team about any concerns.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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