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Atorvastatin in chronic migraine (StainMigChronic)
EU CTIS ID: 2022-502177-42-02
What this study is testing
To evaluate whether the favourable preventative effect of Atorvastin in three smaller studies in episodic migraine, can be confirmed in a larger multicentre randomized, controlled chronic migraine 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
- Age 18 to 65 years
- Signed informed consent
- Chronic migraine according to ICHD-3 criteria
- 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
- Debut of migraine at least one year prior to inclusion
- Start of migraine before age 50 years.
You likely can't join if
- Medication overuse headache requiring detoxification from acute medication (triptans, opioids). Exception could be made for those fulfilling having tried a withdrawal period of at least 2 months without impact on headache frequency and use of opiods (of any type) ≤ 8 days /months.
- Pregnancy, planning to get pregnant, inability to use contraceptives 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 or lactose intolerance
- History of angioneurotic oedema, current use of antiviral treatment agaist hepatitis C, and/or treatment for hypothyroidism
See the full eligibility criteria
- Age 18 to 65 years
- Signed informed consent
- Chronic migraine according to ICHD-3 criteria
- 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
- Debut of migraine at least one year prior to inclusion
- Start of migraine before age 50 years.
- No use of other migraine prophylactics during the study
- 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
- Medication overuse headache requiring detoxification from acute medication (triptans, opioids). Exception could be made for those fulfilling having tried a withdrawal period of at least 2 months without impact on headache frequency and use of opiods (of any type) ≤ 8 days /months.
- Pregnancy, planning to get pregnant, inability to use contraceptives 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 or lactose intolerance
- History of angioneurotic oedema, current use of antiviral treatment agaist hepatitis C, and/or treatment for hypothyroidism
- Significant psychiatric illness and/or alcohol or illicit drug dependence
- Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study
- Inability to understand study procedures and to comply with them for the entire length of the study
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.