Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig)

Last updated: June 28, 2024
Sponsor: St. Olavs Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Migraine (Adult)

Migraine And Cluster Headaches

Migraine (Pediatric)

Treatment

Placebo

Atorvastatin 40mg

Clinical Study ID

NCT06485336
2022-502177-42-02
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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) the favorable side effect profile, seen in previous studies, can be confirmed, and whether it is even better with the smaller dose, and 2) estimating the cost of Atorvastatin treatment, considering cost of medicine, cost of acute attack medicine, and cost of lost worktime.

Eligibility Criteria

Inclusion

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 permonth wheof at least 8 migraine days during the last 3 months. This frequency mustbe 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 thepatient 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 pregnancyor planned pregnancy during the study period, and use of highly effectivecontraception (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

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 headachefrequency B: Use of opioids (of any type) ≤ 8 days /months.

  2. Pregnancy, planning to get pregnant, inability to use contraceptives (See inclusioncriteria, point 8), and lactating

  3. Clinical information on or signs of cholestasis or decreased hepatic or renalfunction.

  4. High degree of comorbidity and/or frailty associated with reduced life expectancy orhigh 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 toxinless 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 entirelength of the study

  12. Treatment for hypothyroidism

  13. Lactose intolerance

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
May 01, 2024
Estimated Completion Date:
February 28, 2029

Connect with a study center

  • Haukeland University Hospital

    Bergen,
    Norway

    Active - Recruiting

  • University Hospital, Akershus

    Lørenskog,
    Norway

    Site Not Available

  • Oslo University Hospital, Rikshospitalet

    Oslo,
    Norway

    Site Not Available

  • Oslo University Hospital, Ullevål

    Oslo,
    Norway

    Site Not Available

  • University Hospital Northern Norway

    Tromsø,
    Norway

    Active - Recruiting

  • St. Olavs hospital

    Trondheim,
    Norway

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.