Phase
Condition
Migraine (Adult)
Migraine And Cluster Headaches
Migraine (Pediatric)
Treatment
Placebo
Atorvastatin 40mg
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 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).
Debut of migraine at least one year prior to inclusion based on information in thepatient 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 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:
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.
Pregnancy, planning to get pregnant, inability to use contraceptives (See inclusioncriteria, point 8), and lactating
Clinical information on or signs of cholestasis or decreased hepatic or renalfunction.
High degree of comorbidity and/or frailty associated with reduced life expectancy orhigh 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 toxinless 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 entirelength of the study
Treatment for hypothyroidism
Lactose intolerance
Study Design
Connect with a study center
Haukeland University Hospital
Bergen,
NorwayActive - Recruiting
University Hospital, Akershus
Lørenskog,
NorwaySite Not Available
Oslo University Hospital, Rikshospitalet
Oslo,
NorwaySite Not Available
Oslo University Hospital, Ullevål
Oslo,
NorwaySite Not Available
University Hospital Northern Norway
Tromsø,
NorwayActive - Recruiting
St. Olavs hospital
Trondheim,
NorwayActive - Recruiting
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