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New treatment option for Episodic Migraine
Official title Prophylactic Treatment With Atorvastatin for Episodic Migraine.
ClinicalTrials.gov ID: NCT06248671
What this study is testing
What is Atorvastatin 40mg?
Atorvastatin 40mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for episodic migraine.
Also referred to as Lipitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Age 18 to 65 years.
- Signed informed consent.
- Episodic migraine with or without aura according to ICHD-3 criteria.
- At inclusion, patients should retrospectively have from 4 to 14 migraine attacks per month during the last 3 months. This frequency must be confirmed...
- Debut of migraine at least one year prior to inclusion based on information in the patient record or by careful examination of previous headache...
You likely can't join if
- Interval headache not distinguishable from migraine.
- 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, 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...
- Hypersensitivity to statins or previous use of statins.
See the full eligibility criteria
- Age 18 to 65 years.
- Signed informed consent.
- Episodic migraine with or without aura according to ICHD-3 criteria.
- At inclusion, patients should retrospectively have from 4 to 14 migraine attacks per month 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 based on information in the patient record or by careful examination of previous headache history.
- Start of migraine before 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. After the baseline period, just before randomisation to the study...
- Interval headache not distinguishable from migraine.
- 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, 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 against hepatitis C.
- Significant psychiatric illness.
- Having tried ≥ 3 prophylactic drugs against migraine during the last 10 years.
- Requiring detoxification from acute medication (triptans, opioids).
- Consistently failing to respond to any acute migraine medication.
- Alcohol or illicit drug dependence.
- Inability to understand study procedures and to comply with them for the entire length of the study.
- Treatment for hypothyroidism.
- Lactose intolerance.
The study team makes the final eligibility decision.
Where it's taking place
- Bergen, Norway
- Lørenskog, Norway
- Oslo, Norway
- Tromsø, Norway
- Trondheim, Norway
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 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bergen, Norway; Lørenskog, Norway; Oslo, Norway; Tromsø, Norway; Trondheim, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.