C4951012 - BHV3000-407: A Phase 4, Randomized, Double-blind, Placebo controlled Study to Evaluate the Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults with a History of Inadequate Response to Oral Preventive Medications
This study, called C4951012, is looking at a medicine called Rimegepant, also known as VYDURA, to see how well it works at preventing migraine headaches. It's for adults aged 18 and older who experience migraines, with or without aura, and haven't found other prevention medicines very helpful. Some participants will receive the active medicine (VYDURA 75 mg), while others will receive a placebo (a dummy pill with no active ingredient). This allows researchers to fairly compare the effects. The main goal is to see if taking Rimegepant reduces the number of migraine days a person experiences each month. They will also look at how many people have a big reduction in their migraines and how the medicine affects daily life.
At a glance
What is this study about?
This study is a special kind of clinical trial, known as a Phase 4 study. This means the medicine, VYDURA (Rimegepant), is already approved for some uses, but researchers want to learn more about its effectiveness specifically for preventing migraines in people who haven't had good results with other preventive treatments. Imagine you've tried a few different ways to stop migraines from happening, but they haven't quite worked for you. This study is designed to explore if VYDURA could be a better option.
The main question the researchers are trying to answer is: Does VYDURA reduce the number of migraine days a person has each month? To figure this out fairly, some people in the study will get VYDURA, and others will get a 'dummy pill' (placebo). Neither the patient nor the doctor will know who is getting which, which helps make sure the results are unbiased. They will compare the average change in migraine days from before the study started to the end of the treatment period.
Beyond just counting migraine days, the study will also look at other important things. For example, they'll check if a significant number of people experience a 50% or more reduction in their migraine days. They'll also explore how migraines impact people's daily activities and how they feel about their condition, to get a full picture of the medicine's potential benefits.
Key takeaways
- Tests Rimegepant (VYDURA) for migraine prevention.
- For adults whose current preventive medicines aren't working.
- Compares VYDURA to a 'dummy pill' (placebo).
- Mainly measures the reduction in monthly migraine days.
- Participation involves observation and a 12-week treatment phase.
Who may be eligible?
To join this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.
The most important thing to remember is that this study is specifically for people who experience migraine headaches (with or without visual disturbances like aura) and have tried other medicines to prevent migraines, but haven't found them effective enough. So, if you're struggling to control your migraines with current preventive treatments, this study might be for you.
There might be other specific health requirements or conditions that would prevent someone from joining, but these will be discussed in detail by the study team. You won't know for sure if you're eligible until you've had a detailed conversation with the study doctors.
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 experience migraine headaches?
- Have you tried other medicines to prevent migraines that haven't worked well for you?
- Are you able to attend regular clinic visits?
What does participation involve?
If you decide to take part in this study, you would first go through an 'Observation Phase'. This is where doctors would monitor your current migraine patterns for a period without any new study medicine, to get a clear starting point. After that, you would enter the 'Double-Blind Treatment Phase'. During this phase, you would take either the active medication (VYDURA 75 mg) or a placebo (a dummy pill) for about 12 weeks.
You would have regular visits to the study clinic where doctors would check your health, ask about your migraine symptoms, and monitor any side effects. You'd likely be asked to keep a diary of your migraines. The study involves taking medication regularly as instructed. The total duration of your participation, including the observation and treatment phases, would typically be a few months. All details, including the number of visits and specific tests, would be fully explained before you agree to participate.
Potential risks and benefits
Locations (9)
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedSweden
- —UnverifiedAustria
- —UnverifiedDenmark
- —UnverifiedFinland
- —UnverifiedSpain
- —UnverifiedPoland
- —UnverifiedItaly
Common questions
What is Rimegepant / VYDURA?
Rimegepant, also known as VYDURA, is a medicine being studied to see if it can help prevent migraine headaches.
Who is this study for?
It's for adults (18+) who get migraines and haven't found other migraine prevention medicines to be very effective.
What does 'placebo-controlled' mean?
It means some people will get the active medicine, and others will get a non-active 'dummy pill' (placebo), so researchers can compare the effects fairly.
What will researchers be looking for?
The main goal is to see if the medicine reduces how many migraine days a person has each month.
How long does the study last?
The main treatment part of the study lasts for about 12 weeks, following an initial observation period.
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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