Actively Recruiting
Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig)
Led by St. Olavs Hospital · Updated on 2025-07-01
300
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) the favorable side effect profile, seen in previous studies, can be confirmed, and whether it is even better with the smaller dose, and 2) 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 Chronic Migraine (ChronicStatinMig)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 64 years
- Signed informed consent
- Chronic migraine according to ICHD-3 criteria
- At least 15 headache days per month with at least 8 migraine days during the last 3 months, confirmed by headache diary
- Migraine onset at least one year before inclusion
- Migraine started before age 50 years
- No use of other migraine prophylactics during the study
- For women of child-bearing potential: no pregnancy or planned pregnancy during the study and use of highly effective contraception
You will not qualify if you...
- Medication overuse headache requiring detoxification from acute medication (triptans, opioids), except those who have tried withdrawal for at least 2 months without impact on headaches and use opioids 8 days or less per month
- Pregnancy, planning pregnancy, inability to use contraceptives, or lactating
- Signs of cholestasis or decreased liver or kidney function
- High comorbidity or frailty with reduced life expectancy or high hospitalization risk
- Hypersensitivity or previous use of statins
- History of angioneurotic oedema
- Use of migraine prophylaxis medications less than 4 weeks or botulinum toxin less than 16 weeks before study
- Current antiviral treatment against hepatitis C
- Significant psychiatric illness
- 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
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
2
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