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Study on Atorvastatin for Preventing Chronic Migraine in Adults

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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 atorvastatin on individuals with chronic migraine. Chronic migraine is a condition characterized by frequent headaches, occurring at least 15 days per month, with at least 8 of those days being migraines. The purpose of this study is to determine if atorvastatin, which has shown positive results in smaller studies for episodic migraines, can also help prevent chronic migraines in a larger group of participants.

Participants in the study will be randomly assigned to receive either atorvastatin or a placebo, which is a substance with no active medication. The study will last for a period of time during which participants will take the medication daily. The effects of atorvastatin will be compared to the placebo to see if there is a difference in the number of migraine days experienced by participants. The study will also look at the number of headache days, any side effects reported, and the overall cost of treatment, including medication and lost work time.

The trial aims to provide more information on whether atorvastatin can be an effective preventative treatment for chronic migraine. Participants will be monitored throughout the study to ensure their safety and to gather data on the medication's effectiveness. This research could potentially lead to new treatment options for those suffering from chronic migraines.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to confirm your eligibility. This includes being between the ages of 18 and 65, having a history of chronic migraines, and meeting other specific criteria.
You will need to sign an informed consent form, which explains the study in detail and confirms your willingness to participate.
Step 2
Initial assessment
You will undergo an initial assessment to confirm your migraine history. This involves keeping a headache diary for a period to record the frequency and type of headaches you experience.
The diary will help ensure that you have at least 15 headache days per month, with at least 8 being migraine days, as required for the study.
Step 3
Randomization
After the initial assessment, you will be randomly assigned to one of two groups. One group will receive the medication atorvastatin, and the other will receive a placebo.
This process is done to compare the effects of the medication against no active treatment.
Step 4
Medication administration
If you are in the atorvastatin group, you will take a 40 mg dose of the medication once daily by mouth.
If you are in the placebo group, you will take a placebo pill once daily by mouth. The placebo looks like the atorvastatin pill but does not contain active medication.
Step 5
Ongoing monitoring
Throughout the study, you will continue to keep a headache diary to track the number of migraine and headache days.
You will also be asked to report any side effects you experience during the study period.
Step 6
Study completion
The study is expected to continue until the end of 2028. You will be informed about the duration of your participation and any follow-up assessments required.
At the end of the study, the results will be analyzed to determine the effectiveness of atorvastatin in reducing migraine days compared to the placebo.

Who can join the trial?

8 criteria

Age between 18 and 65 years
Must provide a signed informed consent, which means you agree to participate after understanding the study
Have chronic migraine as defined by the International Classification of Headache Disorders (ICHD-3)
At the start, you should have had at least 15 headache days per month, with at least 8 of those being migraine days, in the last 3 months. This must be confirmed in a headache diary before starting treatment
Started having migraines at least one year before joining the study
Started having migraines before the age of 50
Cannot use other migraine prevention medications during the study
For women who can become pregnant, there must be no pregnancy or plans to become pregnant during the study, and you must use highly effective birth control

Who cannot join the trial?

3 criteria

Patients who do not have chronic migraine cannot participate. Chronic migraine means having headaches on 15 or more days each month, with at least 8 of those days being migraines.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Akershus University Hospital
Verified
Lorenskog, Norway
Helse Bergen HF
Verified
Bergen, Norway
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

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Investigated drugs

Atorvastatin is a medication that is commonly used to lower cholesterol levels in the blood. In this clinical trial, it is being tested to see if it can help prevent chronic migraines. Previous smaller studies have suggested that it might be effective in reducing the frequency of migraines, and this trial aims to confirm those findings in a larger group of participants.

What is already known about the treatment

Atorvastatin – Atorvastatin is taken orally in the form of a tablet and is currently being studied for its potential to prevent chronic migraines. It is already well-known in the medical field as a medication primarily used to lower cholesterol levels and reduce the risk of heart disease. The main therapeutic indication being explored in this trial is its ability to prevent chronic migraines, building on previous smaller studies that showed promising results for episodic migraines. At the molecular level, atorvastatin works by inhibiting an enzyme in the liver that is responsible for producing cholesterol, which may also have effects on blood vessels and inflammation that could help in migraine prevention. It is classified pharmacologically as a statin, a type of drug used to manage cholesterol levels.

Investigated diseases

Chronic migraine – Chronic migraine is a neurological condition characterized by frequent headache episodes. It involves having headaches on 15 or more days per month, with at least 8 of those days being migraines, for more than three months. The progression of chronic migraine often begins with episodic migraines that increase in frequency over time. Symptoms include throbbing pain, often on one side of the head, sensitivity to light and sound, nausea, and sometimes aura. The condition can significantly impact daily activities and quality of life. Over time, the frequency and severity of the headaches may fluctuate, but they tend to persist without proper management.