Study on Atorvastatin for Preventing Chronic Migraine in Adults

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What is this study about?

This clinical trial is focused on studying the effects of a medication called 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 study aims to determine if atorvastatin, which has shown positive results in smaller studies for episodic migraines, can also help prevent chronic migraines.

Participants in the study will be randomly assigned to receive either atorvastatin or a placebo, which is a tablet that looks like the medication but does not contain the active ingredient. The study will last for a period of 12 months, during which participants will take one tablet daily. The goal is to compare the number of migraine days experienced by those taking atorvastatin with those taking the placebo, as well as to monitor any side effects and evaluate the overall cost-effectiveness of the treatment.

This trial is designed to provide more information on whether atorvastatin can be an effective preventative treatment for chronic migraine, potentially offering a new option for those affected by this condition. Participants will be closely monitored throughout the study to ensure their safety and to gather accurate data on the medication’s effects.

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 migraine, and meeting specific criteria regarding the frequency of headaches and migraines.

You will need to provide signed informed consent, confirming your understanding and agreement to participate in the study.

2 initial assessment

An initial assessment will be conducted to confirm your migraine history and frequency. This involves maintaining a headache diary to record the number of headache and migraine days over a specified period.

The diary will help ensure that you meet the study’s criteria of having at least 15 headache days per month, with at least 8 being migraine days.

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. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

This process is triple-blind, meaning neither you, the researchers, nor the study staff will know which group you are in.

4 medication administration

If you are in the atorvastatin group, you will take a 40 mg film-coated tablet once daily by mouth. If you are in the placebo group, you will take a placebo tablet in the same manner.

The duration of the medication administration will be determined by the study protocol, and you will be informed of the specific timeframe.

5 ongoing monitoring

Throughout the study, you will be required to continue maintaining a headache diary to track the number of migraine and headache days.

Regular check-ins with the study team will be scheduled to monitor your progress and any side effects you may experience.

6 completion of the study

At the end of the study period, a final assessment will be conducted to evaluate the change in the number of migraine and headache days.

The results will help determine the effectiveness of atorvastatin in preventing chronic migraines compared to the placebo.

Who Can Join the Study?

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, 3rd edition (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, over 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 methods

Who Cannot Join the Study?

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 is not specified here, but it is important to check if you fit the required age group.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations may include groups like pregnant women, children, or those unable to give consent.
Patients who are not willing to follow the study procedures cannot participate. This means you must agree to follow the rules and guidelines of the study.
Patients who are currently participating in another clinical trial cannot participate. This is to ensure that the results of this study are not affected by other treatments.
Patients with certain medical conditions or taking certain medications that might interfere with the study cannot participate. It is important to discuss your medical history with the study team.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
St. Olavs Hospital HF	Trondheim	Norway
Oslo University Hospital HF	Oslo	Norway
Aocrgouw Uofgttovfs Hjiyvszf	Lorenskog	Norway
Huoao Bogeqt Ha	Bergen	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not yet recruiting	01.04.2023

Trial locations

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. Some 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 people. The goal is to see if taking atorvastatin can help people who suffer from chronic migraines experience fewer headaches.

Chronic migraine – Chronic migraine is a neurological condition characterized by frequent headache episodes, occurring on 15 or more days per month for at least three months, with at least eight of those days involving migraine features. The progression of chronic migraine often begins with episodic migraines that increase in frequency over time. Symptoms typically include throbbing or pulsating pain, often on one side of the head, accompanied by nausea, vomiting, and sensitivity to light and sound. The condition can lead to significant impairment in daily activities and quality of life. Over time, the frequency and severity of migraine attacks may fluctuate, and the condition can become more challenging to manage. Chronic migraine is distinct from other types of headaches due to its specific pattern and associated symptoms.

Trial ID:

2022-502177-42-01

Protocol code:

2022-502177-42-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Atorvastatin for Preventing Chronic Migraine in Adults

What is this study about?

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