Could a $4 statin be the migraine cure We've been missing?
NCT ID NCT06248671
First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times
Summary
This study tests whether atorvastatin, a common cholesterol medicine, can prevent migraine attacks in adults with episodic migraine (4-14 attacks per month). Researchers will compare a 20mg dose, a 40mg dose, and a placebo over several months. The goal is to see if the drug reduces the number of migraine days and is safe, building on promising results from smaller studies.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 450 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Age 18 to 65 years. * Signed informed consent. * Episodic migraine with or without aura according to ICHD-3 criteria. * At inclusion, patients should retrospectively have from 4 to 14 migraine attacks per month during the last 3 months. This frequency must be confirmed in the headache diary before randomisation to treatment. * 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. * Start of migraine before 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. 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 attacks than 4 or more than 14 per month, the baseline period can be extended to 8 weeks, and the patient can be randomized to a treatment then if there is a mean of 4-14 attacks per 4 weeks during the 8-week's period. Exclusion Criteria: * Interval headache not distinguishable from migraine. * Chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on ≥ 15 days/month. * Pregnancy, planning to get pregnant, inability to use contraceptives, and lactating. * Clinical information on or signs of cholestasis or decreased hepatic or renal function. * High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator. * Hypersensitivity to statins or previous use of statins. * History of angioneurotic oedema. * Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study. * Current use of antiviral treatment against hepatitis C. * Significant psychiatric illness. * Having tried ≥ 3 prophylactic drugs against migraine during the last 10 years. * Requiring detoxification from acute medication (triptans, opioids). * Consistently failing to respond to any acute migraine medication. * Alcohol or illicit drug dependence. * Inability to understand study procedures and to comply with them for the entire length of the study. * Treatment for hypothyroidism. * 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.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Haukeland University Hospital
RECRUITINGBergen, Norway
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Oslo University Hospital, Rikshospitalet
NOT_YET_RECRUITINGOslo, Norway
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Oslo University Hospital, Ullevål
NOT_YET_RECRUITINGOslo, Norway
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St. Olavs hospital
RECRUITINGTrondheim, 7022, Norway
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University Hospital Northern Norway
RECRUITINGTromsø, Norway
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University Hospital, Akershus
NOT_YET_RECRUITINGLørenskog, Norway
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Steroid boost for headache nerve blocks? new study checks
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- Thousands to test new migraine meds in largest Real-Life study
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