2022-502177-42-02RecruitingPhase 2
Atorvastatin in chronic migraine (StainMigChronic)
A multicentre, triple blind, placebo controlled, parallel group study of atorvastatin in chronic migraine
Source: EU CTIS (euclinicaltrials.eu) · Last updated 20 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 22 Mar 2023
- Start date
- 13 May 2024
- Lead sponsor
- St. Olavs Hospital HF
- Diseases
- Migraine
- EU CT number
- 2022-502177-42-02
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 300
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic migraine to test whether atorvastatin helps prevent migraine attacks.
- Age
- 18 to 65 years in the criteria text; the registry lists 18 to 64 years.
- Sex
- All sexes can join.
- Disease stage
- Chronic migraine (ICHD-3 criteria). At least 15 headache days per month, with at least 8 migraine days during the last 3 months, confirmed in a headache diary. Migraine started at least one year ago and before age 50.
- Earlier treatment
- No previous use of statins. No other migraine preventive medicine during the study. No migraine preventive medicine in the 4 weeks before the start, and no botulinum toxin in the 16 weeks before.
Main reasons for not taking part
- Medication overuse headache needing withdrawal from acute medicines
- Pregnant, planning pregnancy, breastfeeding, or unable to use contraception
- Signs of cholestasis, or reduced liver or kidney function
- Allergy to statins, or lactose intolerance
- Significant psychiatric illness, or alcohol or drug dependence
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Helse Bergen HF | Bergen | Norway | Recruiting |
| Akershus University Hospital | Lorenskog | Norway | Recruiting |
| Oslo University Hospital HF | Oslo | Norway | Recruiting |
| Universitetssykehuset Nord-Norge HF | Tromsoe | Norway | Recruiting |
| St. Olavs hospital HF | Trondheim | Norway | Recruiting |
The registry text, word for word
This page is information, not medical advice. Discuss any trial with your doctor.