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Study on Atorvastatin for Preventing Episodic Migraine in Adults

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 atorvastatin on individuals who experience episodic migraine. Migraines are severe headaches that can cause intense throbbing or pulsing sensations, often accompanied by nausea, vomiting, and sensitivity to light and sound. The study will use two different doses of atorvastatin, 20 mg and 40 mg, in the form of film-coated tablets, to see if it can help reduce the number of migraine days experienced by participants. A placebo, which looks like the medication but does not contain the active ingredient, will also be used for comparison.

The purpose of this study is to confirm whether atorvastatin can effectively prevent migraines, as suggested by previous smaller studies. Participants will be randomly assigned to receive either atorvastatin or a placebo. The study will last for up to 12 months, during which participants will take the medication daily. The main focus will be on observing any changes in the number of migraine days over a four-week period, comparing those taking atorvastatin to those taking the placebo.

Throughout the study, researchers will also look at the number of headache days and the number of participants who experience a significant reduction in migraine days. This trial aims to provide more information on whether atorvastatin can be a helpful treatment for people with episodic migraines, potentially offering a new option for managing this condition.

The research process

The trial runs in 5 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, experiencing 4 to 14 migraine days per month, and having a history of migraines for at least one year.
You will need to provide signed informed consent, confirming your understanding and agreement to participate in the study.
Step 2
Initial assessment
An initial assessment will be conducted to record your baseline migraine frequency and other relevant health information.
This assessment will help in comparing changes in your migraine days throughout the study.
Step 3
Medication administration
You will be randomly assigned to one of three groups: one receiving atorvastatin 40 mg, another receiving atorvastatin 20 mg, and the third receiving a placebo. A placebo is a tablet that looks like the medication but does not contain the active substance.
The medication will be taken orally once daily in the form of a film-coated tablet.
Step 4
Ongoing monitoring
Throughout the study, you will be required to keep a diary of your migraine days and any other headaches you experience.
Regular check-ins will be scheduled to monitor your progress and any side effects you may experience.
Step 5
Final assessment
At the end of the study period, a final assessment will be conducted to evaluate changes in your migraine frequency compared to the baseline.
The results will help determine the effectiveness of atorvastatin in reducing migraine days.

Who can join the trial?

5 criteria

Aged 18 to 65 years with 4-14 migraine days per month
Signed informed consent
Episodic migraine with or without aura according to ICHD-3 criteria, debut of migraine at least one year prior to inclusion, and start of migraine before age 50 years
No use of other migraine prophylactics during the study
For women of child-bearing potential, there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception

Who cannot join the trial?

7 criteria

Patients who are currently pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to the study medication or similar drugs cannot participate.
Patients who have participated in another clinical trial within the last 30 days cannot participate.
Patients with uncontrolled high blood pressure cannot participate. Uncontrolled high blood pressure means that the blood pressure is consistently too high and not managed by medication or lifestyle changes.
Patients with severe liver disease cannot participate. Severe liver disease refers to serious conditions affecting the liver, such as cirrhosis or liver failure.
Patients with a history of drug or alcohol abuse within the past year cannot participate.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate cannot participate.

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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
Oslo Universitetssykehus HF
Verified
Oslo, Norway

Trial locations

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Investigated drugs

Atorvastatin is a medication commonly used to lower cholesterol levels in the blood. In this clinical trial, it is being tested to see if it can help prevent migraines. Migraines are severe headaches that can cause intense pain and other symptoms like nausea and sensitivity to light. The trial aims to find out if taking atorvastatin can reduce the frequency or severity of these headaches. The study is looking at how effective atorvastatin is in preventing migraines compared to not taking the medication.

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 migraines. It is already well-known in the medical field as a medication primarily used to lower cholesterol levels. The main therapeutic indication being explored in this trial is its ability to prevent 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 reducing migraine frequency. It is classified pharmacologically as a statin, which is a type of drug used to manage cholesterol levels.

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 varying frequency. Some individuals experience warning symptoms, known as aura, before the onset of a migraine. The progression of migraines can vary, with some people experiencing chronic migraines, where headaches occur on 15 or more days per month. The exact cause of migraines is not fully understood, but they are believed to involve genetic and environmental factors.