Study on Headache Effects of Sildenafil and Placebo in Men and Women with Episodic Migraine Without Aura

1 1 1

What is this study about?

This clinical trial is focused on studying the effects of the medication sildenafil on individuals who experience migraine without aura. Migraines are severe headaches that can cause throbbing pain, often accompanied by nausea and sensitivity to light and sound. The study aims to understand how sildenafil, a medication commonly used for other conditions, might influence the occurrence of headaches and migraine-like attacks in both men and women who suffer from this type of migraine.

Participants in the study will receive either sildenafil or a placebo, which is a substance with no active medication, to compare the effects. The study will observe the differences in headache occurrences between those treated with sildenafil and those given a placebo. The trial will also look at how sildenafil affects heart rate and blood pressure in men with migraines, as well as any side effects that may occur.

The study will take place over a period of time, during which participants will be monitored for any changes in their migraine patterns and overall health. The goal is to gather information that could help in understanding the potential role of sildenafil in managing migraines without aura, providing insights that could benefit future treatments for this condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, weight, and frequency of migraine attacks.

Participants must be between 18 and 50 years old, weigh between 60 and 90 kg, and have experienced between one and six migraine attacks in the last 8 weeks.

2 initial assessment

An initial assessment is conducted to gather baseline data. This includes a review of medical history and current health status.

Participants are required to be fluent in Danish or English and, for women, to use safe contraception throughout the study.

3 medication administration

Participants receive either sildenafil or a placebo. Sildenafil is administered in the form of a 100 mg film-coated tablet taken orally.

The purpose is to observe the occurrence of headache and migraine-like attacks in those treated with sildenafil compared to those receiving a placebo.

4 monitoring and data collection

Participants are monitored for the occurrence of migraine-like attacks and headaches.

Data on heart rate and mean arterial pressure (MAP) are collected to assess any differences between sildenafil and placebo treatments.

5 evaluation of adverse events

The incidence of any adverse events is recorded and compared between the sildenafil and placebo groups.

This step ensures the safety and well-being of participants throughout the trial.

6 completion of the trial

The trial is estimated to conclude by May 31, 2025.

Final assessments are conducted to evaluate the primary and secondary endpoints, including the difference in migraine-like attacks and headaches between the treatment groups.

Who Can Join the Study?

Healthy men and women with a diagnosis of migraine without aura. This means they have migraines but do not experience the visual or sensory disturbances that can sometimes come before a migraine.
Experience migraines between one and six times in the last 8 weeks.
Are between 18 and 50 years old.
Weigh between 60 and 90 kg.
Can speak and understand Danish or English fluently.
Women must use safe contraception during the entire study. This includes methods like hormonal therapies, intrauterine devices, or oral pills.

Who Cannot Join the Study?

Individuals who do not have migraine without aura. A migraine without aura is a type of headache that does not have warning signs like visual disturbances before it starts.
Individuals who are not within the specified age range for the study.
Individuals who are not male or female, as the study includes both genders.
Individuals who are considered part of a vulnerable population, which means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Syddansk Universitet (University of Southern Denmark)	Odense	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.09.2024

Trial locations

Investigated drugs:

Sildenafil is a medication commonly used to treat erectile dysfunction and pulmonary hypertension. In this clinical trial, it is being studied to understand its effects on inducing headaches and migraine-like attacks in men and women who experience episodic migraines without aura. The trial aims to observe how this medication might trigger such symptoms in the participants.

Investigated diseases:

Migraine without aura

Migraine without aura – This is a type of migraine characterized by recurrent headaches that typically affect one side of the head. The pain is often described as throbbing or pulsating and can be moderate to severe in intensity. Unlike migraines with aura, there are no sensory disturbances or visual changes before the headache begins. The headache can last from a few hours to several days and is often accompanied by nausea, vomiting, and sensitivity to light and sound. Physical activity can worsen the symptoms, leading individuals to seek rest in a quiet, dark environment. The frequency and severity of these headaches can vary widely among individuals.

Trial ID:

2024-512014-17-02

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Headache Effects of Sildenafil and Placebo in Men and Women with Episodic Migraine Without Aura

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?