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Atorvastatin in episodic migraine
EU CTIS ID: 2022-502176-23-01
What this study is testing
To evaluate whether the favourable preventative effect ofAtorvastin in two different doses seen in three smaller studies, can be confirmed in a larger multicentre randomized, controlled study
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged 18 to 65 years with 4-14 migraine days per month
- Signed informed consent
- Episodic migraine with or without aura according to ICHD-3 criteria, debut of migraine at least one year prior to inclusion, and start of migraine before age 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
You likely can't join if
- Interval headache not distinguishable from migraine or 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 or lactating.
- Clinical information on signs of cholestasis, decreased hepatic or renal function, high degree of comorbidity, frailty associated with reduced life expectancy, high likelihood of hospitalization at the discretion of the investigator,, history of angioneurotic oedema, current use of antiviral treatment against hepatitis C, significant psychiatric illness, alcohol or illicit drug dependence, inability to understand study procedures and to comply with them for the entire length of the study, and/or treatment for hypothyroidism
- 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
See the full eligibility criteria
- Aged 18 to 65 years with 4-14 migraine days per month
- Signed informed consent
- Episodic migraine with or without aura according to ICHD-3 criteria, debut of migraine at least one year prior to inclusion, and start of migraine before age 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
- Interval headache not distinguishable from migraine or 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 or lactating.
- Clinical information on signs of cholestasis, decreased hepatic or renal function, high degree of comorbidity, frailty associated with reduced life expectancy, high likelihood of hospitalization at the discretion of the investigator,, history of angioneurotic oedema, current use of antiviral treatment against hepatitis C, significant psychiatric illness, alcohol or illicit drug dependence, inability to understand study procedures and to comply with them for the entire length of the study, and/or treatment for hypothyroidism
- 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
- Consistently failing to respond to any acute migraine medication and/or requiring detoxification from acute medication (triptans, opioids)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.