Ongoing, recruitingTherapeutic use (Phase IV)Interventional

The rimegePant in RElation to obeSiTy in mIGrainE study

This research, called 'The rimegePant in RElation to obeSiTy in mIGrainE study,' is exploring how a medicine for migraines, called rimegepant, might work differently in people with varying body weights. The study is particularly interested in understanding how this medication affects blood flow in the skin. Before and after taking rimegepant, participants will have their skin's blood flow measured after a special cream (capsaicin) is applied and after a small electrical pulse. Researchers will compare these measurements to see how rimegepant changes blood flow and whether this change is linked to a person's body weight. They will also look at hormone levels, rimegepant levels in the blood, and body composition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

13 Nov 2024

Obesity Migraine

What is this study about?

This study is called 'The rimegePant in RElation to obeSiTy in mIGrainE study'. It's looking into how a medication for migraines, called rimegepant, might work differently depending on a person's body weight. Migraines are a type of severe headache, and some people who experience them also live with obesity. Understanding how medicines affect different people is really important so doctors can give the best advice.

The main aim of this study is to measure how rimegepant affects blood flow in the skin. To do this, researchers will apply a special cream (capsaicin, which is found in chilli peppers) and use a small electrical pulse on the skin. They'll measure how blood flows in the skin before and after a person takes rimegepant. Then, they'll compare these measurements to see if the medication changes blood flow, and if this change is linked to the person's body weight.

Alongside these main measurements, the study will also collect information about blood hormone levels (like sex hormones), the amount of rimegepant in the blood, and a substance called CGRP (which is involved in migraines). They will also look at different aspects of a person's body composition, such as total body weight, fat, and muscle. By collecting all this information, researchers hope to get a better picture of how rimegepant works and whether different factors, like body weight or hormone levels, influence its effects.

Key takeaways

This study investigates how migraine medication (rimegepant) works in relation to body weight.
It involves measuring changes in skin blood flow before and after taking the medication.
Researchers will also collect blood samples and body composition data.
The goal is to understand how different factors might influence medication effects.
Participation helps improve future migraine treatments.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning people of any age above 18 can potentially join.

Anyone, whether male or female, is welcome to consider taking part. The study aims to include people of all sexes to get a broad understanding of the medication's effects.

Beyond age and sex, the researchers will also be looking for specific health information related to your migraine condition and body weight, which will be discussed with you by the study team to see if you're a good fit.

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 have migraines?
Are you comfortable with blood tests and skin measurements?
Are you able to attend multiple study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve several visits at a research centre. You would be given the study medication, rimegepant, and researchers would then carry out a number of assessments. These assessments include measuring blood flow in your skin after applying a special cream (capsaicin) and using a small electrical pulse. These measurements would be done both before and after you take the rimegepant. You would also have blood samples taken to check for things like hormone levels, the amount of rimegepant in your system, and other substances related to migraines. Additionally, your body composition (like weight, fat, and muscle mass) would be measured. There would be follow-up appointments to monitor your health and gather more data. The total duration of your participation would be explained fully by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to a better understanding of how migraine medications work, which could help improve treatments for others in the future. As with any medication, there may be side effects from rimegepant, and the procedures like blood draws or skin measurements might cause some mild discomfort. All specific risks will be fully explained to you before you agree to take part. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is rimegepant?

Rimegepant is a medication used to treat migraines.

What is 'capsaicin'?

Capsaicin is a substance found in chilli peppers that can be used on the skin to help measure blood flow.

Why are they looking at body weight?

Researchers want to see if body weight affects how the migraine medication works in your body.

Will I get free treatment for my migraines?

This study is focused on understanding how a medication works, not primarily on offering free treatment. The study team can give you more details.

How long does the study last?

The total time you'd be involved in the study will be explained in detail by the research team.