Status:
RECRUITING
Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig)
Lead Sponsor:
St. Olavs Hospital
Collaborating Sponsors:
Haukeland University Hospital
Oslo University Hospital
Conditions:
Chronic Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Age 18 to 64 years
- Signed informed consent
- Chronic migraine according to ICHD-3 criteria (32)
- 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).
- 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 age 50 years.
- No use of other migraine prophylactics during the study
- 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
- 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.
- Pregnancy, planning to get pregnant, inability to use contraceptives (See inclusion criteria, point 8), 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 agaist hepatitis C
- Significant psychiatric illness
- 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
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06485336
Start Date
May 1 2024
End Date
February 28 2029
Last Update
July 1 2025
Active Locations (6)
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1
Haukeland University Hospital
Bergen, Norway
2
University Hospital, Akershus
Lørenskog, Norway
3
Oslo University Hospital, Rikshospitalet
Oslo, Norway
4
Oslo University Hospital, Ullevål
Oslo, Norway