Prophylactic Treatment With Atorvastatin for Episodic Migraine.

Launched by ST. OLAVS HOSPITAL · Feb 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Atorvastatin to help prevent episodic migraines. The researchers want to find out if taking 40 mg of Atorvastatin daily can effectively reduce the number of migraine attacks. They will also look at whether a lower dose of 20 mg has a similar effect and if the side effects are better with the smaller dose. Additionally, they will consider the costs associated with using Atorvastatin, such as the price of the medication itself and any costs from missed work due to migraines.

To participate in the trial, you must be between 18 and 65 years old and have a history of episodic migraines, meaning you experience between 4 to 14 migraine attacks each month. You should have had migraines for at least a year, and women must be using effective birth control during the study. Participants will be monitored closely, and their headache frequency will be recorded to ensure they meet the eligibility criteria. This study is currently recruiting participants, and it aims to provide more insight into how Atorvastatin might help those struggling with migraines.

Gender

ALL

Eligibility criteria

• Inclusion 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 drug, inclusion criteria will be evaluated once more, and the headache diary will be evaluated. If there are, according to the headache diary, fewer attacks than 4 or more than 14 per month, the baseline period can be extended to 8 weeks, and the patient can be randomized to a treatment then if there is a mean of 4-14 attacks per 4 weeks during the 8-week's period.
• Exclusion Criteria:
• • 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.