NCT06248671 Prophylactic Treatment With Atorvastatin for Episodic Migraine.
| NCT ID | NCT06248671 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | St. Olavs Hospital |
| Condition | Episodic Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 450 participants in total. It began in 2024-05-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main objective of this study is to see whether the favorable preventative effect of Atorvastatin 40mg per day in episodic migraine, that was found previously in three smaller randomized controlled cross-over studies, can be confirmed in a larger, multicenter, randomized controlled parallel group study. In addition it will be investigated whether 1) there is an effect of a daily dose of 20mg Atorvastatin, 2) whether the favorable side effect profile, seen in previous studies, can be confirmed, and whether it is even better with the smaller dose, and 3) estimating the cost of Atorvastatin treatment, considering cost of medicine, cost of acute attack medicine, and cost of lost worktime.
Eligibility 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.
Contact & Investigator
Marte-Helene Bjørk, Professor
PRINCIPAL INVESTIGATOR
Haukeland University Hospital
Frequently Asked Questions
Who can join the NCT06248671 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Episodic Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06248671 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06248671 currently recruiting?
Yes, NCT06248671 is actively recruiting participants. Contact the research team at lise.r.oie@ntnu.no for enrollment information.
Where is the NCT06248671 trial being conducted?
This trial is being conducted at Bergen, Norway, Lørenskog, Norway, Oslo, Norway, Oslo, Norway and 2 additional locations.
Who is sponsoring the NCT06248671 clinical trial?
NCT06248671 is sponsored by St. Olavs Hospital. The principal investigator is Marte-Helene Bjørk, Professor at Haukeland University Hospital. The trial plans to enroll 450 participants.
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