Using Atorvastatin to prevent chronic migraines

ChronicStatinMig. A Multicentre, Triple Blind, Placebo Controlled, Parallel Group Study of Atorvastatin in Chronic Migraine

This study is testing if taking Atorvastatin every day can help prevent chronic migraines for people who suffer from them.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: St. Olavs Hospital (other)
• Locations: 6 sites (Bergen and 5 other locations)
• Trial ID: NCT06485336 on ClinicalTrials.gov

What this trial studies

This study aims to confirm the preventative effects of Atorvastatin 40mg daily on chronic migraines, building on findings from smaller studies. It will evaluate the side effects of Atorvastatin and assess the cost-effectiveness of treatment, including medication costs and lost work time. Participants will be randomly assigned to receive either Atorvastatin or a placebo, with their migraine frequency monitored through a headache diary. The study will involve multiple centers to gather a larger patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 64 with a history of chronic migraines, experiencing at least 15 headache days per month.

Not a fit: Patients who have not experienced migraines for at least a year 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 and severity of chronic migraines for patients.

How similar studies have performed: Previous smaller studies have shown favorable results with Atorvastatin for episodic migraines, suggesting potential success in this larger trial.

Eligibility criteria

Inclusion Criteria:

1. Age 18 to 64 years
2. Signed informed consent
3. Chronic migraine according to ICHD-3 criteria (32)
4. 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 (See below).
5. 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
6. Start of migraine before age 50 years.
7. No use of other migraine prophylactics during the study
8. 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 (See below).

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 migraine days than 8 per month, the baseline period can be extended to 8 weeks.

Exclusion Criteria:

1. Medication overuse headache requiring detoxification from acute medication (triptans, opioids). Exception could be made for those fulfilling A and B:

   A. Have tried a withdrawal period of at least 2 months without impact on headache frequency B: Use of opioids (of any type) ≤ 8 days /months.
2. Pregnancy, planning to get pregnant, inability to use contraceptives (See inclusion criteria, point 8), and lactating
3. Clinical information on or signs of cholestasis or decreased hepatic or renal function.
4. High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator
5. Hypersensitivity to statins or previous use of statins
6. History of angioneurotic oedema
7. Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study
8. Current use of antiviral treatment agaist hepatitis C
9. Significant psychiatric illness
10. Alcohol or illicit drug dependence.
11. Inability to understand study procedures and to comply with them for the entire length of the study
12. Treatment for hypothyroidism
13. 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.

Conditions: Chronic Migraine, Migraine, Atorvastatin, Randomized controlled trial