Atorvastatin in chronic migraine (StainMigChronic)
Key facts
- Where
- Bergen, Lorenskog, Oslo, Tromsoe és Trondheim, NorvégiaSee the 5 sites
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Norvégia
- Helse Bergen HFBergen, NorvégiaTaking people
- Akershus University HospitalLorenskog, NorvégiaTaking people
- Oslo University Hospital HFOslo, NorvégiaTaking people
- Universitetssykehuset Nord-Norge HFTromsoe, NorvégiaTaking people
- St. Olavs hospital HFTrondheim, NorvégiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- St. Olavs Hospital HF
- Trial code
- EU 2022-502177-42-02
- Record updated
- 2024. június 20.
- Original description
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 studyRead full original descriptionShow less
A multicentre, triple blind, placebo controlled, parallel group study of atorvastatin in chronic migraine
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
Inclusion: 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: 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; Hypersensitivity to statins or previous use of statins or lactose intolerance; Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study; 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; 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; Inability to understand study procedures and to comply with them for the entire length of the study.