A Randomized, Double-blind, Parallel-group, Active Controlled Trial with Open-label Safety Extension to Evaluate the Tolerability, Safety, and Efficacy of Atogepant versus Topiramate in Subjects Requiring Preventive Treatment of Migraine (TEMPLE)
The TEMPLE study is looking at two medicines, Atogepant and Topiramate, to prevent migraines in people who experience them often. migraines can be very disruptive, so finding effective ways to reduce their frequency and severity is important. In this study, some people will receive Atogepant, some will receive Topiramate, and some will receive a dummy pill (placebo) to see which is more helpful. We're mainly looking at whether people can stick with the treatment without too many side effects over 24 weeks. We're also checking if the medicines reduce the number of migraine days and how they affect daily life. The goal is to provide new information that could lead to better choices for migraine prevention.
At a glance
What is this study about?
This study, called TEMPLE, is designed to find out the best way to prevent migraines for people who get them regularly, whether it's chronic (very frequent) or episodic (less frequent but still impactful). Migraines can significantly affect a person's life, so researchers are always looking for better treatments.
The main aim of this study is to compare a newer medicine, Atogepant, with a commonly used medicine, Topiramate. We also use a 'dummy pill' (placebo) in some parts of the study to help us understand the true effects of the medicines. This comparison will help doctors and patients understand which treatment might work best, how well they are tolerated, and what side effects they might have.
Specifically, the researchers are very interested in how many people stop taking the medicine because of side effects. They also want to see if the medicines reduce the number of migraine days each month and if they improve how people feel overall. This could lead to more effective and comfortable ways for people to manage their migraines in the future.
Key takeaways
- The TEMPLE study compares new and existing migraine prevention medicines.
- It aims to find out which medicine is better tolerated and more effective at reducing migraines.
- Adults (18+) with chronic or episodic migraines can participate.
- You won't know if you're getting the new medicine, existing medicine, or a placebo.
- The study lasts for about 6 months, with regular checks by doctors.
- Your safety and comfort are top priorities throughout the study.
Who may be eligible?
This study is looking for adults who are 18 years old or older. Both men and women can take part.
To be considered, you must experience migraines regularly, whether they are chronic (meaning you get them very often) or episodic (meaning you get them less frequently, but they are still a problem for you).
There might be other health requirements or certain medications you're taking that would mean you can't join the study, but the study team will discuss all of these details with you if you're interested.
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 18 years old or older?
- Do I experience migraines regularly?
- Am I willing to take study medication for about six months?
- Am I able to attend regular clinic visits?
- Do I understand that I might receive a placebo?
What does participation involve?
If you decide to join the TEMPLE study, it will last for a total of 24 weeks, which is about six months. You will be given either Atogepant, Topiramate, or a placebo (a dummy pill that looks like the real medicine but contains no active ingredients). You won't know which one you're taking, nor will your doctor, which helps us get unbiased results.
You'll have regular visits to the clinic where the study doctors and nurses will check on your health and how you're feeling. They will ask you questions about your migraines, how often you get them, and any side effects you might be experiencing. You'll also likely need to fill out questionnaires about your quality of life and migraine symptoms. All these assessments help the researchers understand how the treatments are working.
Potential risks and benefits
Locations (9)
- —UnverifiedBelgium
- —UnverifiedAustria
- —UnverifiedPoland
- —UnverifiedCzechia
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedHungary
- —UnverifiedFrance
- —UnverifiedPortugal
Common questions
What is the main purpose of this study?
The main purpose is to compare a new migraine prevention medicine (Atogepant) with an existing one (Topiramate) in adults who get frequent migraines, to see which is more effective and easier to tolerate.
Who can join this study?
Adults aged 18 or older, both men and women, who experience chronic or episodic migraines can potentially join this study.
Will I know if I'm getting the new medicine or the old one?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving (Atogepant, Topiramate, or a placebo) until the study is over.
What does 'placebo' mean?
A placebo is a 'dummy' pill that looks just like the study medicine but contains no active ingredients. It's used to help researchers understand the true effects of the active medicines.
How long will I be in the study?
You will be in the core treatment part of the study for 24 weeks, which is about six months.
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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