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Study on the Effects of Cilostazol on Headaches in Men and Women with Migraine Without Aura

Verified siteRegistered drugNo placebo

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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 cilostazol in individuals who experience migraine without aura. A migraine is a type of headache that can cause severe throbbing pain or a pulsing sensation, usually on one side of the head. The study aims to explore how cilostazol, which is taken as a tablet, affects men and women differently when they have migraines. The trial will also involve a comparison with a placebo, which looks like the real medication but does not contain any active ingredients.

Participants in the study will be given either cilostazol or a placebo to take orally. The main goal is to observe any differences in the occurrence of migraine-like attacks between those taking cilostazol and those taking the placebo. Additionally, the study will look at differences in heart rate and blood pressure, as well as any side effects that may occur during the study period. The study will help researchers understand the role of a substance in the body called cAMP, which is thought to be involved in migraines.

The trial will take place over a period of time, with participants being monitored for up to 12 hours after taking the medication. This will allow researchers to gather information on how cilostazol affects migraine symptoms and whether there are any differences between men and women in their response to the medication. The findings from this study could provide valuable insights into the treatment of migraines and help improve the understanding of how migraines work in the body.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on criteria such as age, weight, and health status. You will be asked about your history of migraines and any other relevant medical information.
You will receive detailed information about the study, including its purpose and what to expect. You will have the opportunity to ask questions and will be required to provide informed consent to participate.
Step 2
Medication administration
You will be given a tablet containing either cilostazol or a placebo. A placebo is a tablet that looks like the real medication but does not contain any active ingredients. The purpose is to compare the effects of the actual medication with no treatment.
The tablet is taken orally, meaning you will swallow it with water. The dosage is 100 mg of cilostazol if you receive the active medication.
Step 3
Observation period
After taking the tablet, you will be observed for up to 12 hours. During this time, you will be monitored for any migraine-like symptoms or other side effects.
Your heart rate and blood pressure will be checked regularly, especially within the first 90 minutes after taking the tablet.
Step 4
Follow-up
After the observation period, you may be asked to return for follow-up visits. These visits are to ensure your well-being and to gather additional information about your response to the medication.
You will be asked to report any symptoms or side effects you experienced during the study period.

Who can join the trial?

5 criteria

Healthy men and women with a diagnosis of episodic migraine without aura according to the International Classification. Episodic migraine without aura means having migraine attacks that occur occasionally and do not include sensory disturbances like flashing lights or blind spots.
Age: 18-65 years
Weight: 50-100 kg
Safe contraception for women during the entire period of the study. This includes methods like hormonal therapies, intrauterine devices, and/or oral pills to prevent pregnancy.
Fluency in Danish or English

Who cannot join the trial?

9 criteria

Patients who are not between the ages of 18 and 65 cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of heart disease cannot participate.
Patients who have had a stroke cannot participate.
Patients with uncontrolled high blood pressure cannot participate. High blood pressure means the force of the blood against the artery walls is too high.
Patients who are currently using certain medications that affect blood flow cannot participate.
Patients with severe liver or kidney problems cannot participate. Liver and kidney are organs that help filter and clean the blood.
Patients with a history of severe allergic reactions cannot participate. Allergic reactions are when the body reacts strongly to something harmless, like certain foods or medicines.
Patients who have participated in another clinical trial within the last 30 days cannot participate.

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Verified sites

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Syddansk Universitet (University of Southern Denmark)
Odense, Denmark

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Investigated drugs

Cilostazol is a medication that is being studied for its effects on people who suffer from migraines without aura. It works by increasing the levels of a substance in the body called cAMP, which is involved in many cellular processes. The study aims to understand how this medication might cause headaches in people with migraines and whether there are differences in how men and women respond to it. By doing this, researchers hope to learn more about the role of cAMP in migraines and potentially find new ways to treat or prevent these headaches.

What is already known about the treatment

Cilostazol – Cilostazol is administered orally in tablet form and is currently being studied for its effects on migraines, particularly in understanding how it affects men and women differently. It is primarily used to treat certain types of circulation problems, but in this study, it is being investigated for its potential role in migraines. The medication works by increasing the levels of a molecule called cAMP inside cells, which helps to relax blood vessels and improve blood flow. Cilostazol is classified as a phosphodiesterase inhibitor, which means it blocks an enzyme that breaks down cAMP, leading to increased levels of this molecule in the body.

Investigated diseases

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often on one side of the head. These headaches can be accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine attacks can last from a few hours to several days and may occur with or without an aura, which is a sensory disturbance that can include visual changes or tingling sensations. The frequency and severity of migraines can vary widely among individuals. Triggers for migraines can include stress, certain foods, hormonal changes, and environmental factors. The condition is more common in women and can significantly impact daily activities.