Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig) (NCT06485336) | Clinical Trial Compass
RecruitingPhase 2
Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig)
Norway300 participantsStarted 2024-05-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 to 64 years
. Signed informed consent
. Chronic migraine according to ICHD-3 criteria (32)
. At inclusion, patients should retrospectively have at least 15 headache days per month wheof at least 8 migraine days during the last 3 months. This frequency must be confirmed in the headache diary before randomisation to treatment (See below).
. 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 age 50 years.
. No use of other migraine prophylactics during the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. For women of child-bearing potential (WOCBP, see below) there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception (See below).
Exclusion criteria
. Medication overuse headache requiring detoxification from acute medication (triptans, opioids). Exception could be made for those fulfilling A and B:
. Pregnancy, planning to get pregnant, inability to use contraceptives (See inclusion criteria, point 8), 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 agaist hepatitis C