Atorvastatin in episodic migraine

Phase 1

Recruiting

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

Registration Number: CTIS2022-502176-23-01

Lead Sponsor: St. Olavs Hospital HF

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 450

Inclusion Criteria

Aged 18 to 65 years with 4-14 migraine days per month, Signed informed consent, Episodic migraine with or without aura according to ICHD-3 criteria, debut of migraine at least one year prior to inclusion, and start of migraine before age 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

Exclusion Criteria

Interval headache not distinguishable from migraine or 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 or lactating., Clinical information on signs of cholestasis, decreased hepatic or renal function, high degree of comorbidity, frailty associated with reduced life expectancy, high likelihood of hospitalization at the discretion of the investigator,, history of angioneurotic oedema, current use of antiviral treatment against 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, and/or treatment for hypothyroidism, Hypersensitivity to statins or previous use of statins, Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study, Having tried = 3 prophylactic drugs against migraine during the last 10 years, Consistently failing to respond to any acute migraine medication and/or requiring detoxification from acute medication (triptans, opioids)

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 ofAtorvastin in two different doses seen in three smaller studies, can be confirmed in a larger multicentre randomized, controlled study;Secondary Objective: Number of responders and evaluations of 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):Difference between groups receiving atorvastatin 40 mg daily and placebo in change from baseline in number of headache per 4 weeks;Secondary end point(s):Difference in change from baseline between groups receiving atorvastatin 20 mg daily and placebo in number of days with headache per 4 weeks,;Secondary end point(s):Number of responders (= 50% decrease in migraine days compared with baseline) between repectively Atorvastin 40 mg, Atorvastatin 20 mg and placebo