Could a common cholesterol drug stop chronic migraine?

NCT ID NCT06485336

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study tests whether taking atorvastatin (a widely used cholesterol-lowering drug) every day for 12 weeks can reduce the number of migraine days in people with chronic migraine. About 300 adults aged 18–64 with chronic migraine will receive either atorvastatin or a placebo pill. The goal is to see if the drug prevents attacks better than placebo, with fewer side effects, and at a lower cost than current treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atorvastatin 40 mg tablet taken daily for 84 days
What this could lead to
If it works, this could offer a new, affordable, and well-tolerated daily pill to prevent chronic migraine attacks.
What could go wrong
This is a Phase 2 trial, so results are not yet confirmed. Previous smaller studies showed promise, but the larger study may not replicate those benefits, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18 to 64 years 2. Signed informed consent 3. Chronic migraine according to ICHD-3 criteria (32) 4. At inclusion, patients should retrospectively have at least 15 headache days per month wheof at least 8 migraine days during the last 3 months. This frequency must be confirmed in the headache diary before randomisation to treatment (See below). 5. Debut of migraine at least one year prior to inclusion based on information in the patient record or by careful examination of previous headache history 6. Start of migraine before age 50 years. 7. No use of other migraine prophylactics during the study 8. For women of child-bearing potential (WOCBP, see below) there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception (See below). After the baseline period, just before randomisation to the study drug, inclusion criteria will be evaluated once more, and the headache diary will be evaluated. If there are, according to the headache diary, fewer migraine days than 8 per month, the baseline period can be extended to 8 weeks. Exclusion Criteria: 1. Medication overuse headache requiring detoxification from acute medication (triptans, opioids). Exception could be made for those fulfilling A and B: A. Have tried a withdrawal period of at least 2 months without impact on headache frequency B: Use of opioids (of any type) ≤ 8 days /months. 2. Pregnancy, planning to get pregnant, inability to use contraceptives (See inclusion criteria, point 8), and lactating 3. Clinical information on or signs of cholestasis or decreased hepatic or renal function. 4. High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator 5. Hypersensitivity to statins or previous use of statins 6. History of angioneurotic oedema 7. Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study 8. Current use of antiviral treatment agaist hepatitis C 9. Significant psychiatric illness 10. Alcohol or illicit drug dependence. 11. Inability to understand study procedures and to comply with them for the entire length of the study 12. Treatment for hypothyroidism 13. Lactose intolerance

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Haukeland University Hospital

    RECRUITING

    Bergen, Norway

  • Oslo University Hospital, Rikshospitalet

    NOT_YET_RECRUITING

    Oslo, Norway

  • Oslo University Hospital, Ullevål

    NOT_YET_RECRUITING

    Oslo, Norway

  • St. Olavs hospital

    RECRUITING

    Trondheim, Norway

  • University Hospital Northern Norway

    RECRUITING

    Tromsø, Norway

  • University Hospital, Akershus

    NOT_YET_RECRUITING

    Lørenskog, Norway

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