Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig)
ChronicStatinMig. A Multicentre, Triple Blind, Placebo Controlled, Parallel Group Study of Atorvastatin in Chronic Migraine
St. Olavs Hospital
300 participants
May 1, 2024
INTERVENTIONAL
Conditions
Summary
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) the favorable side effect profile, seen in previous studies, can be confirmed, and whether it is even better with the smaller dose, and 2) estimating the cost of Atorvastatin treatment, considering cost of medicine, cost of acute attack medicine, and cost of lost worktime.
Eligibility
Inclusion Criteria19
- Age 18 to 64 years
- Signed informed consent
- Chronic migraine according to ICHD-3 criteria (32)
- 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).
- 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 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 (See below).
- 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 agaist 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
- Treatment for hypothyroidism
- Lactose intolerance
Exclusion Criteria2
- 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.
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Interventions
Each tablet will be taken once daily for 84 days.
Each tablet will be taken once daily for 84 days.
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06485336