Tests atorvastatin for preventing episodic migraine attacks
Tests whether atorvastatin, a cholesterol drug, helps prevent episodic migraine in adults.
Plain-language title generated from the registry record
Registry title: Prophylactic Treatment With Atorvastatin for Episodic Migraine.
Key facts
- Where
- Bergen, Lørenskog, Oslo, Tromsø, and Trondheim, NorwaySee the 6 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06248671, who can take part
Where in Norway
- Haukeland University HospitalBergen, NorwayTaking people
- University Hospital, AkershusLørenskog, NorwayNot yet recruiting
- Oslo University Hospital UllevålOslo, NorwayNot yet recruiting
- Oslo University Hospital, RikshospitaletOslo, NorwayNot yet recruiting
- University Hospital Northern NorwayTromsø, NorwayTaking people
- St Olavs HospitalTrondheim, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- St. Olavs Hospital
- Trial code
- NCT06248671
- Record updated
- 14 July 2026
- Original description
The main objective of this study is to see whether the favorable preventative effect of Atorvastatin 40mg per day in episodic migraine, that was found previously in three smaller randomized controlled cross-over studies, can be confirmed in a larger, multicenter, randomized controlled parallel group study. In addition it will be investigated whether 1) there is an effect of a daily dose of 20mg Atorvastatin, 2) whether the favorable side effect profile, seen in previous studies, can be confirmed, and whether it is even better with the smaller dose, and 3) estimating the cost of Atorvastatin treatment, considering cost of medicine, cost of acute attack medicine, and cost of lost worktime.Read full original descriptionShow less
EpisodicStatinMig. A Multicentre, Triple Blind, Placebo Controlled, Parallel Group Study of Atorvastatin in Episodic Migraine
The main objective of this study is to see whether the favorable preventative effect of Atorvastatin 40mg per day in episodic migraine, that was found previously in three smaller randomized controlled cross-over studies, can be confirmed in a larger, multicenter, randomized controlled parallel group study. In addition it will be investigated whether 1) there is an effect of a daily dose of 20mg Atorvastatin, 2) whether the favorable side effect profile, seen in previous studies, can be confirmed, and whether it is even better with the smaller dose, and 3) estimating the cost of Atorvastatin treatment, considering cost of medicine, cost of acute attack medicine, and cost of lost worktime.
Inclusion: 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: Chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on ≥ 15 days/month; Hypersensitivity to statins or previous use of statins; Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study; 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; History of angioneurotic oedema; Current use of antiviral treatment against hepatitis C; Significant psychiatric illness; Interval headache not distinguishable from migraine; 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; Inability to understand study procedures and to comply with them for the entire length of the study; Treatment for hypothyroidism; Lactose intolerance.