Using Atorvastatin to prevent episodic migraines
EpisodicStatinMig. A Multicentre, Triple Blind, Placebo Controlled, Parallel Group Study of Atorvastatin in Episodic Migraine
This study is testing whether taking Atorvastatin can help people who get frequent migraines have fewer attacks each month.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | St. Olavs Hospital Academic / other |
| Locations | 6 sites (Bergen and 5 other locations) |
| Trial ID | NCT06248671 on ClinicalTrials.gov |
What this trial studies
This study aims to confirm the preventative effects of Atorvastatin at doses of 40mg and 20mg per day on episodic migraines in a larger multicenter setting. It will evaluate the frequency of migraine attacks in participants who have been experiencing 4 to 14 attacks per month. Additionally, the study will assess the side effect profile of Atorvastatin and estimate the overall cost-effectiveness of the treatment. Participants will be randomly assigned to receive either Atorvastatin or a placebo.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a history of episodic migraines, experiencing 4 to 14 attacks per month.
Not a fit: Patients who do not meet the inclusion criteria, such as those with chronic migraines or those currently using other migraine prophylactics, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency of migraine attacks for patients suffering from episodic migraines.
How similar studies have performed: Previous smaller studies have shown favorable results with Atorvastatin for migraine prevention, suggesting potential for success in this larger trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 to 65 years. * Signed informed consent. * Episodic migraine with or without aura according to ICHD-3 criteria. * At inclusion, patients should retrospectively have from 4 to 14 migraine attacks per month 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 based on information in the patient record or by careful examination of previous headache history. * Start of migraine before 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. After the baseline period, just before randomisation to the study drug, inclusion criteria will be evaluated once more, and the headache diary will be evaluated. If there are, according to the headache diary, fewer attacks than 4 or more than 14 per month, the baseline period can be extended to 8 weeks, and the patient can be randomized to a treatment then if there is a mean of 4-14 attacks per 4 weeks during the 8-week's period. Exclusion Criteria: * Interval headache not distinguishable from migraine. * 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, 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. * History of angioneurotic oedema. * Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study. * Current use of antiviral treatment against hepatitis C. * Significant psychiatric illness. * Having tried ≥ 3 prophylactic drugs against migraine during the last 10 years. * Requiring detoxification from acute medication (triptans, opioids). * Consistently failing to respond to any acute migraine medication. * Alcohol or illicit drug dependence. * Inability to understand study procedures and to comply with them for the entire length of the study. * Treatment for hypothyroidism. * Lactose intolerance.
Where this trial is running
Bergen and 5 other locations
- Haukeland University Hospital — Bergen, Norway (Recruiting)
- University Hospital, Akershus — Lørenskog, Norway (Not_yet_recruiting)
- Oslo University Hospital, Rikshospitalet — Oslo, Norway (Not_yet_recruiting)
- Oslo University Hospital, Ullevål — Oslo, Norway (Not_yet_recruiting)
- University Hospital Northern Norway — Tromsø, Norway (Recruiting)
- St. Olavs hospital — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Marte-Helene Bjørk, Professor — Haukeland University Hospital
- Study coordinator: Lise R Øie, Post.doc.
- Email: lise.r.oie@ntnu.no
- Phone: 0047 41419596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.