About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Atorvastatin 40mg
- Placebo
- Atorvastatin 20mg
Treatment groups
Locations
6Sponsors and collaborators
St. Olavs Hospital
Lead sponsor
Haukeland University Hospital
Collaborator
University Hospital of North Norway
Collaborator
University Hospital, Akershus
Collaborator
Ullevaal University Hospital
Collaborator