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A study to evaluate the effect of rimegepant in patients with migraine and obesity

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What is this trial about?

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

This study examines Migraine, a condition characterized by intense, recurring headaches that can be accompanied by symptoms like sensitivity to light or sound and nausea. The research focuses on how rimegepant, an oral medication, works in individuals with different body compositions. Specifically, the study aims to evaluate how obesity, body weight, and body fat might influence the effectiveness of the treatment.

Participants in the study will receive either rimegepant or a placebo. The medication is provided in an oral lyophilisate form, which is a substance designed to dissolve quickly in the mouth. During the study, participants will report on their experience with headache pain and other related symptoms to help researchers understand how the medication performs in different people.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Medication administration
Take rimegepant (vydura) as an oral lyophilisate, which is a powder that dissolves in the mouth. the dosage is either 75 mg or 2x75 mg (two doses of 75 mg each) taken during a migraine episode.
Report the status of pain freedom or the disappearance of the most bothersome migraine-associated symptom (a symptom caused by the migraine, other than the headache itself) 2 hours after taking the medication.
Step 2
Symptom monitoring
Monitor for relief from photophobia (sensitivity to light), phonophobia (sensitivity to sound), and nausea (feeling sick to the stomach) 2 hours after the dose is taken.
Track if any rescue medication (additional medicine used to treat breakthrough pain) is needed within 24 hours after the dose.
Record pain relief and whether pain returns between 2 hours and 48 hours after taking the medication.
Step 3
Medical assessments
Provide blood samples to measure sex steroid levels, the concentration of rimegepant in the blood, and CGRP (a protein involved in migraine attacks).
Undergo measurements for body weight, total body water, fat mass, and free mass (the weight of the body excluding fat).

Who can join the trial?

16 criteria

You must provide signed written informed consent, which is a document where you agree to take part in the study after being given all the necessary information.
Your body mass index (BMI), which is a measurement used to determine if a person is at a healthy weight for their height, must be 30 or higher.
You must have a history of migraine, which is a type of severe headache, for at least one year.
Your migraine attacks must have started before you turned 50 years old.
Each untreated migraine attack should last between 4 and 72 hours.
You must have had no more than 8 moderate or severe migraine attacks per month during the last 3 months.
You must be able to tell the difference between a migraine and other types of headaches, such as tension headaches (headaches caused by muscle tightness) or cluster headaches (severe headaches that occur in patterns).
You must have experienced at least 2 moderate or severe migraine attacks in each of the 3 months before the study starts.
You must have had fewer than 15 total headache days per month during the 3 months before the study starts.
If you take prophylactic medication, which is medicine used to prevent headaches from happening, you must have been on the same dose for at least 3 months.
You must be at least 18 years old.
Women who could become pregnant and men who are not sterile must use two effective forms of contraception, which are methods used to prevent pregnancy, during the study.
Men who have had a vasectomy, a surgical procedure to prevent pregnancy, more than 6 months ago are considered sterile.
You must not have any important health problems found during medical or laboratory tests.
Women must have a negative urine pregnancy test before receiving the study medication.
Women who are breastfeeding cannot participate in this study.

Who cannot join the trial?

19 criteria

You cannot participate if you have a history of basilar migraine or hemiplegic migraine, which are specific, complex types of severe headaches.
You are excluded if you have a history of HIV, a disease caused by a virus that affects the body's immune system.
You cannot join if you have cardiovascular disease, which refers to problems with the heart or blood vessels, that is currently uncontrolled or unstable.
You are excluded if you have had a myocardial infarction (a heart attack), acute coronary syndrome (a sudden decrease of blood flow to the heart), percutaneous coronary intervention (a procedure to open blocked heart arteries), cardiac surgery, a stroke (when blood flow to the brain is interrupted), or a transient ischemic attack (a temporary period of symptoms similar to a stroke) within the last 6 months.
You cannot participate if you have uncontrolled hypertension (high blood pressure) or uncontrolled diabetes (high blood sugar), unless these conditions have been stable for at least 3 months.
You are excluded if you have major depression, other pain syndromes, psychiatric conditions like schizophrenia (a serious mental disorder), dementia (memory loss and thinking problems), or other major neurological disorders (brain or nerve problems) that might interfere with the study.
You are excluded if you have had gastric or small intestinal surgery (surgery on the stomach or the first part of the intestine) or have a condition that causes malabsorption (when the body cannot properly soak up nutrients from food).
You cannot join if you have congenital heart disease (heart problems present from birth), arrhythmia (irregular heartbeat), hepatitis B or C (infections of the liver), or cancer that makes participating unsafe.
You are excluded if you have a history of alcohol or drug abuse within the last 12 months or meet the medical criteria for a substance use disorder.
You cannot participate if you test positive for drugs of abuse that could affect your safety or the study results.
You are excluded if you have any allergies to medications that make it unsafe for you to join the study.
Women who are pregnant or breastfeeding cannot participate.
Women of child-bearing potential (able to become pregnant) who cannot or will not use effective contraception (birth control) or avoid pregnancy during the study and for 56 days after are excluded.
You are excluded if your eGFR (a test used to see how well your kidneys are filtering blood) is 40 ml/min/1.73m2 or lower.
You cannot join if your QTc interval (a measurement of the time it takes for your heart muscle to recharge between beats) is longer than 470 msec.
You are excluded if your heart tests show a left bundle branch block, a right bundle branch block with a long QRS duration (a measure of the time it takes for the lower chambers of the heart to contract), or an intraventricular conduction defect (a problem with how electrical signals move through the heart).
You are excluded if your serum bilirubin (a substance made during the breakdown of red blood cells that can indicate liver issues) is higher than 1.0 mg/dl.
You cannot participate if your neutrophil count (a type of white blood cell that helps fight infection) is 40% or lower.
You are excluded if your AST or ALT levels (enzymes found in the liver that are measured through blood tests) are higher than 45 U/l.

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Konvent Der Barmherzigen Brueder
Linz, Austria

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Investigated drugs

Rimegepant is a medication used to help prevent and treat migraine headaches by blocking a protein in the body that is involved in the pain process.

Rimegepant

What is already known about the treatment

Rimegepant - This medication is taken by mouth in the form of a powder that dissolves quickly, and it is currently used as an approved treatment for preventing and treating migraine headaches. It belongs to a group of drugs called calcitonin gene-related peptide (CGRP) receptor antagonists, which work by blocking a specific protein in the brain that causes pain and inflammation during a migraine attack. By stopping this protein from attaching to its receptor, the medicine helps to prevent the intense pain signals associated with migraines.

Investigated diseases

Migraine - This is a neurological condition that causes recurring episodes of intense, throbbing pain, usually on one side of the head. These episodes can be accompanied by symptoms such as sensitivity to light and sound, or feelings of nausea. The attacks can range in severity and may last from a few hours to several days. During an episode, certain activities or environmental triggers might worsen the discomfort. The condition typically progresses through phases, starting with early warning signs before the headache itself begins.