Ongoing, recruitingTherapeutic use (Phase IV)Interventional

C4951004 - BHV3000-406: A Phase 4, Randomized, Double-blind Placebo Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

This research study is for adults who experience migraine headaches, both with and without visual changes (aura), and who can't take certain other common migraine medicines called triptans. The study aims to find out if a medication called VYDURA (rimegepant) at a 75mg dose can help relieve migraine pain. Researchers also want to see if it reduces other migraine symptoms and how safe it is. Participants will either receive the active medication or a dummy pill (placebo). They will report how their pain feels and if they can carry out their usual activities after taking the study drug. This is a later-stage study, meaning the drug has already undergone previous testing.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Pfizer Inc.

Enrolment target

397

Start

02 Aug 2024

Migraine attacks with or without aura

What is this study about?

This study is investigating a medication called VYDURA, which contains the active ingredient rimegepant. It's designed for people who suffer from migraine headaches, whether they experience visual disturbances (known as 'aura') before or during their migraine, or not. The main focus of this study is for adults who, for various reasons, cannot take a common type of migraine medication called triptans.

The main goal is to see how effectively VYDURA 75mg helps to reduce migraine pain within two hours of taking it. The researchers will also be looking at whether your pain completely disappears or lessens significantly. They will also check if you need to take any other pain medicine within 24 hours of the study drug, and if your normal daily activities improve after taking the medicine.

By comparing VYDURA to a dummy pill (placebo), the study helps doctors understand if VYDURA is genuinely helping to ease migraine symptoms and if it's safe to use. This kind of research is important to get new, effective, and safe treatments to people who need them.

Key takeaways

This study is for adults with migraines who can't use triptan medications.
It tests a new migraine drug called VYDURA against a dummy pill.
Researchers want to see if VYDURA reduces migraine pain and other symptoms within 2 hours.
Your ability to do daily activities after taking the drug will also be checked.
Participation involves taking medication and recording your symptoms and wellbeing.
You can stop participating at any time.

Who may be eligible?

This study is specifically for adults who are 18 years old or older. Both men and women are welcome to take part.

One of the most important things is that you must be a person who experiences migraines but cannot use triptan medications. Your doctor will be able to tell you if this applies to you.

There might be other health conditions or medications that would prevent you from joining, so it's essential to discuss your full medical history with the study team.

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 migraine headaches (with or without 'aura')?
Has your doctor told you that you cannot take triptan medications for your migraines?
Are you able to follow instructions and record information about your symptoms?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the active study drug, VYDURA 75mg, or a matching dummy pill (placebo). You won't know which one you are taking, and neither will your study doctor – this is done to make the results as fair as possible.

When you get a migraine attack, you will take the study medication. You'll then be asked to keep track of your headache pain and other symptoms, like feeling sick, being sensitive to light, or sensitive to sound. You'll also report how well you can do your daily activities. You'll need to use a simple rating scale for pain (from none to severe) and for how much your daily life is affected (from normal to needing bedrest) at specific times after taking the medication, especially at 2 hours post-dose. The study team will explain exactly how to record this information. The overall duration of your participation will be discussed with the study team.

Potential risks and benefits

Taking part in this study may offer a potential benefit if VYDURA helps to relieve your migraine symptoms, especially if other treatments haven't worked or aren't suitable for you. However, there's also a chance you might receive the dummy pill, and your migraine might not improve. As with any medication, VYDURA could have side effects, which the study team will explain in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Finland
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Unverified
Germany
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Unverified
Sweden
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Unverified
Austria
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Unverified
Belgium
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Unverified
France
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Unverified
Poland
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Unverified
Denmark
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Unverified
Italy
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Unverified
Spain

Common questions

What is a 'migraine with aura'?

A migraine with aura means you get specific warning signs, like flashing lights or wavy lines in your vision, before or during your headache. A migraine without aura just means you have the headache without these warning signs.

What are triptans and why might I be 'unsuitable' for them?

Triptans are a common type of medication used to treat migraines. Some people might not be able to take them due to other health conditions or because they haven't worked for them in the past. Your doctor can tell you if triptans are not suitable for you.

What does a 'dummy pill' (placebo) mean?

A dummy pill looks exactly like the study medication but contains no active drug. This helps researchers compare the real drug's effects to what happens when no active treatment is given, ensuring fair results.

How will my pain be measured?

You'll use a simple scale to rate your pain from 'none' (0) to 'severe' (3) at different times after taking the study medication. This helps the researchers understand how well the drug works.

What does 'Functional Disability' mean in this study?

It means how much your migraine affects your ability to do your normal daily tasks. The study will check if the medication helps you get back to your usual activities.