Using Atorvastatin to prevent chronic migraines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Haukeland University Hospital
  Bergen, Norway Recruiting
• University Hospital Northern Norway
  Tromsø, Norway Recruiting
• St. Olavs hospital
  Trondheim, 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.