A multicentre, triple blind, placebo controlled, parallel group study of atorvastatin in chronic migraine - 2022-502177-42-00

St. Olavs Hospital HF0 个研究点目标入组 300 人开始时间: 2022年12月5日最近更新: 2024年7月22日

适应症

试验速览

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•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

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