Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig)

Launched by ST. OLAVS HOSPITAL · Jun 28, 2024

Keywords

ClinConnect Summary

This clinical trial, called ChronicStatinMig, is investigating whether taking Atorvastatin, a medication commonly used to lower cholesterol, can help prevent chronic migraines. Previous smaller studies have shown that it might reduce the frequency of migraine headaches, and this larger study aims to confirm those findings. Researchers are also looking at the side effects of Atorvastatin and the overall costs associated with migraine treatment, including the cost of medication and lost work time due to headaches.

To participate in this trial, individuals need to be between 18 and 64 years old and have been diagnosed with chronic migraines, experiencing at least 15 headache days a month with 8 of those being migraines. Participants must not be using other migraine prevention medications during the study. If eligible, participants will be randomly assigned to either receive Atorvastatin or a placebo (a pill with no active ingredients) and will keep a diary to track their headaches. The study is currently recruiting, and participants can expect regular check-ins and support throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 to 64 years
• • 2. Signed informed consent
• • 3. Chronic migraine according to ICHD-3 criteria (32)
• • 4. 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).
• • 5. 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
• • 6. Start of migraine before age 50 years.
• • 7. No use of other migraine prophylactics during the study
• • 8. 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).
• • 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 migraine days than 8 per month, the baseline period can be extended to 8 weeks.
• Exclusion Criteria:
• 1. Medication overuse headache requiring detoxification from acute medication (triptans, opioids). Exception could be made for those fulfilling A and B:
• • A. Have tried a withdrawal period of at least 2 months without impact on headache frequency B: Use of opioids (of any type) ≤ 8 days /months.
• • 2. Pregnancy, planning to get pregnant, inability to use contraceptives (See inclusion criteria, point 8), and lactating
• • 3. Clinical information on or signs of cholestasis or decreased hepatic or renal function.
• • 4. High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator
• • 5. Hypersensitivity to statins or previous use of statins
• • 6. History of angioneurotic oedema
• • 7. Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study
• • 8. Current use of antiviral treatment agaist hepatitis C
• • 9. Significant psychiatric illness
• • 10. Alcohol or illicit drug dependence.
• • 11. Inability to understand study procedures and to comply with them for the entire length of the study
• • 12. Treatment for hypothyroidism
• • 13. Lactose intolerance