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Study on Rimegepant and Capsaicin for Migraine in Lean and Obese Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication Rimegepant on individuals with migraine and obesity. Rimegepant, also known by its code names BMS927711 and BHV-3000, is taken orally and is being tested to see how it affects certain body responses in people with different body weights. The study also involves the use of Capsaicin, a substance applied to the skin, which is commonly used in pain relief treatments.

The purpose of the study is to explore how Rimegepant influences the body's reaction to certain stimuli in both lean and obese individuals. Participants will receive a dose of Rimegepant and their body's response to Capsaicin and other stimuli will be measured. The study will look at changes in blood flow in the skin and other body measurements, such as body weight and muscle mass, to understand how these factors might affect the medication's impact.

The trial will take place over a short period, with participants receiving the medication and undergoing various assessments to monitor changes in their body's responses. The study aims to provide insights into how Rimegepant works in people with different body compositions, which could help in understanding its potential benefits for treating migraine in individuals with obesity.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants will provide written informed consent. This is a document that confirms understanding of the study and agreement to participate.

    Participants must meet specific criteria, including a body mass index (BMI) between 18.5 to 22 kg/m² or 30 kg/m² and above, and be aged between 18 and 30 years.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure general good health. This includes reviewing self-reported medical history.

    For females, it is important to have a regular menstrual cycle or to use oral hormonal contraceptives consistently for at least one month.

  3. Step 3

    Medication administration

    Participants will receive a dose of rimegepant, which is taken orally. The dosage is 75 mg.

    The purpose of this medication is to investigate its effects on certain bodily responses related to migraines and obesity.

  4. Step 4

    Application of topical solution

    A capsaicin cutaneous solution will be applied topically. This is a solution applied to the skin.

    The application is part of the study to observe changes in skin responses.

  5. Step 5

    Monitoring and testing

    Participants will undergo monitoring to measure changes in dermal blood flow (DBF) before and after taking rimegepant.

    Additional tests will measure blood levels of certain substances, including sex steroids and rimegepant concentration.

  6. Step 6

    Body composition analysis

    Body composition parameters will be assessed, including total body weight, total body water, and fat mass.

    These measurements help understand the effects of the medication in relation to body composition.

  7. Step 7

    Completion of study

    The study is expected to conclude by September 1, 2025.

    Participants will be informed of the study's findings and any relevant information regarding their health.

Who can join the trial?

5 criteria

  • Must provide written informed consent before starting any study procedures. This means you agree to participate after understanding the study details.
  • Body mass index (BMI) must be between 18.5 to 22 kg/m2 or 30 kg/m2 or higher. BMI is a measure of body fat based on height and weight.
  • Must be a male or female aged between 18 and 30 years.
  • Must be in general good health based on your own medical history.
  • All females must have a regular menstrual cycle of 25-35 days or use oral hormonal contraceptives regularly and consistently for at least one month. This means having a predictable monthly period or taking birth control pills as directed.

Who cannot join the trial?

8 criteria

  • People who are not in the age range specified for the study cannot participate.
  • Individuals who are not considered healthy, meaning they have other medical conditions that could affect the study, are excluded.
  • Participants who are not able to follow the study procedures or take the study medication as directed will not be allowed to join.
  • Women who are pregnant or breastfeeding cannot take part in the study.
  • Anyone who has a known allergy or adverse reaction to the study medication, rimegepant, will be excluded. Rimegepant is a medication used to treat migraines.
  • Individuals who are currently participating in another clinical trial or have recently participated in one may not be eligible.
  • People with a history of drug or alcohol abuse may be excluded from the study.
  • Participants who have a significant medical condition that the study doctors believe could interfere with the study results will not be allowed to join.
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Investigated drugs

Rimegepant is a medication used in this study to explore its effects on migraine headaches. It works by blocking a specific protein in the brain that is involved in the development of migraines. This protein is called the calcitonin gene-related peptide (CGRP) receptor. By blocking this receptor, rimegepant can help reduce the frequency and severity of migraine attacks. In this trial, researchers are looking at how rimegepant affects people with different body weights, specifically those who are lean and those who are obese, to see if weight influences the medication's effectiveness in preventing migraines.

What is already known about the treatment

Rimegepant – Rimegepant is administered orally in the form of a tablet. It is currently being studied for its effects on obesity and migraine, with a focus on how it affects the body's response to certain triggers in the nervous system. The main therapeutic use of rimegepant is to treat migraines, and it is being explored for its potential benefits in managing obesity-related migraine issues. At the molecular level, rimegepant works by blocking a specific receptor in the brain that is involved in the development of migraine headaches. It is classified as a calcitonin gene-related peptide (CGRP) receptor antagonist, which means it helps prevent the chain of events that lead to migraines.

Investigated diseases

  • Obesity

    Obesity is a condition characterized by excessive body fat accumulation that may negatively impact health. It develops when calorie intake consistently exceeds calorie expenditure, leading to an energy imbalance. Over time, this excess energy is stored as fat, resulting in increased body weight. The progression of obesity can lead to changes in body composition, including increased fat mass and altered distribution of body fat. As obesity progresses, it can affect various bodily systems, potentially leading to metabolic changes and increased strain on the cardiovascular system. The condition is often associated with other health issues, such as insulin resistance and inflammation.

  • Migraine

    Migraine is a neurological disorder characterized by recurrent, often severe headaches, typically affecting one side of the head. The progression of a migraine attack can include a prodrome phase with early warning symptoms, followed by an aura phase in some individuals, which may involve visual disturbances. The headache phase is marked by intense, throbbing pain, often accompanied by nausea, vomiting, and sensitivity to light and sound. The attack can last from a few hours to several days. After the headache subsides, a postdrome phase may occur, where individuals feel drained or fatigued. Migraine attacks can vary in frequency and intensity, impacting daily activities and quality of life.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513359-34-00Protocol codePRESTIGEEstimated enrolment40 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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