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Study on Atorvastatin for Preventing Episodic 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 who experience episodic migraine. Episodic migraine is a type of headache that occurs with varying frequency, often accompanied by symptoms like nausea and sensitivity to light. The study aims to determine if atorvastatin, which is commonly used to lower cholesterol, can help reduce the number of migraine days in a month.

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 compare the effects of two different doses of atorvastatin, 20 mg and 40 mg, to see if they can decrease the frequency of migraines. The trial will last for several weeks, during which participants will take the medication daily and report the number of migraine days they experience.

The purpose of this study is to confirm whether the positive effects of atorvastatin observed in smaller studies can be replicated in a larger group of people. By participating, individuals will help researchers understand if atorvastatin can be an effective preventative treatment for those suffering from episodic migraines. The study is designed to be thorough and will involve multiple centers to ensure a comprehensive evaluation of the medication's effects.

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 informed about the trial's purpose and procedures. You will be required to sign an informed consent form, confirming your understanding and agreement to participate.
Eligibility criteria include being aged 18 to 65 years, experiencing 4-14 migraine days per month, and having a history of migraines for at least one year. Women of child-bearing potential must use effective contraception and not be pregnant or planning pregnancy during the study.
Step 2
Initial assessment
An initial assessment will be conducted to establish a baseline for your migraine condition. This may include recording the number of migraine days and headaches you experience over a four-week period.
Step 3
Medication administration
You will be randomly assigned to receive either atorvastatin or a placebo. Atorvastatin will be administered in doses of either 20 mg or 40 mg daily, taken orally.
The duration of medication administration will be determined by the study protocol, and you will be required to take the medication as instructed.
Step 4
Ongoing monitoring
Throughout the study, you will be monitored regularly to assess the effectiveness of the medication. This will involve tracking changes in the number of migraine days and headaches you experience every four weeks.
You may be asked to maintain a headache diary to record your symptoms and any side effects experienced during the trial.
Step 5
Final assessment
At the end of the study period, a final assessment will be conducted to evaluate the overall impact of the medication on your migraine condition.
The results will be compared to the initial baseline data to determine any changes in the frequency and severity of your migraines.

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?

9 criteria

Patients who are not diagnosed with migraine cannot participate.
Patients who are under 18 years old cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial within the last 30 days cannot participate.
Patients with a history of allergic reactions to Atorvastatin or similar medications cannot participate.
Patients with severe liver disease cannot participate.
Patients with uncontrolled high blood pressure cannot participate.
Patients with a history of drug or alcohol abuse within the last year cannot participate.
Patients with any other medical condition that the study doctors think might 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
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, 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 pain, nausea, and sensitivity to light and sound. 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 administered orally in the form of tablets. It is currently being studied in clinical trials to assess its effectiveness in preventing episodic migraines, building on promising results from smaller studies. The main therapeutic indication for atorvastatin in this context is the prevention of migraine episodes. At the molecular level, atorvastatin works by inhibiting an enzyme involved in cholesterol production, which may also influence pathways related to migraine prevention. It is classified pharmacologically as a statin, a type of medication primarily used to lower 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 migraine 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.