Atorvastatin in chronic migraine (StainMigChronic)

Phase 1

Conditions: Chronic migraine
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: CTIS2022-502177-42-01

Lead Sponsor: St. Olavs Hospital HF

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate whether the favourable preventative effect of Atorvastin in three smaller studies in episodic migraine, can be confirmed in a larger multicentre randomized, controlled chronic migraine study;Secondary Objective: To evaluate number of responders and side effects;Primary end point(s): Difference between groups receiving atorvastatin 40 mg daily and placebo in change from baseline in number of migraine days per 4 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Number of reported side effects in the placebo and atorvastatin 40 mg;Secondary end point(s):Comparison of cost in the placebo and atorvastatin treatment, taking into consideration price of the medicine, price of acute medication, and lost worktime;Secondary end point(s):Difference between groups receiving atorvastatin 40 mg daily and placebo in change from baseline in number of days with headache