Actively Recruiting
Prophylactic Treatment With Atorvastatin for Episodic Migraine.
Led by St. Olavs Hospital · Updated on 2026-02-19
450
Participants Needed
6
Research Sites
252 weeks
Total Duration
On this page
Sponsors
S
St. Olavs Hospital
Lead Sponsor
H
Haukeland University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prophylactic Treatment With Atorvastatin for Episodic Migraine.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years.
- Signed informed consent.
- Episodic migraine with or without aura according to ICHD-3 criteria.
- Retrospective confirmation of 4 to 14 migraine attacks per month during the last 3 months, verified by headache diary before randomization.
- Migraine onset at least one year before enrollment.
- Migraine started before age 50.
- No use of other migraine preventive treatments during the study.
- For women who can become pregnant, no pregnancy or planned pregnancy during study and use of highly effective contraception.
You will not qualify if you...
- Headaches that cannot be distinguished from migraine.
- Chronic migraine, chronic tension-type headache, medication overuse headache, or headaches occurring 15 or more days per month.
- Pregnancy, planned pregnancy, inability to use contraception, or breastfeeding.
- Signs of cholestasis or reduced liver or kidney function.
- Serious other medical conditions or frailty likely to reduce life expectancy or cause hospitalization.
- Allergic reaction to statins or previous statin use.
- History of angioneurotic edema.
- Use of migraine preventive medicines less than 4 weeks before study or botulinum toxin less than 16 weeks before.
- Current antiviral treatment for hepatitis C.
- Significant psychiatric illness.
- Tried 3 or more migraine preventive drugs in the last 10 years.
- Need for detoxification from acute medications.
- Consistent failure to respond to any acute migraine medication.
- Alcohol or drug dependence.
- Inability to understand or comply with study procedures.
- Treatment for hypothyroidism.
- Lactose intolerance.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Haukeland University Hospital
Bergen, Norway
Actively Recruiting
2
University Hospital, Akershus
Lørenskog, Norway
Not Yet Recruiting
3
Oslo University Hospital, Rikshospitalet
Oslo, Norway
Not Yet Recruiting
4
Oslo University Hospital, Ullevål
Oslo, Norway
Not Yet Recruiting
5
University Hospital Northern Norway
Tromsø, Norway
Actively Recruiting
6
St. Olavs hospital
Trondheim, Norway, 7022
Actively Recruiting
Research Team
L
Lise R Øie, Post.doc.
CONTACT
J
Joakim H Østhus, Cand.med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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