Episodic Migraine
Conditions
Keywords
Migraine, Atorvastatin, Randomized controlled trial
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 cross-over studies, can be confirmed in a larger, multicenter, randomized controlled parallel group study. In addition it will be investigated whether 1) there is an effect of a daily dose of 20mg Atorvastatin, 2) whether the favorable side effect profile, seen in previous studies, can be confirmed, and whether it is even better with the smaller dose, and 3) estimating the cost of Atorvastatin treatment, considering cost of medicine, cost of acute attack medicine, and cost of lost worktime.
Interventions
Each tablet will be taken once daily for 84 days.
DRUGPlacebo
Each tablet will be taken once daily for 84 days
DRUGAtorvastatin 20mg
Each tablet will be taken once daily for 84 days.
Sponsors
St. Olavs Hospital
Haukeland University Hospital
University Hospital of North Norway
University Hospital, Akershus
Ullevaal University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Triple blind (blinded to patients, study personnel, and statistician).
Intervention model description
Parallel group study with three arms, comparing Atorvastatin 20 mg and 40 mg against placebo. Each participant will receive 84 encapsulated tablets. The participant will take one capsule orally each day, preferably at the same time of the day.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18 to 65 years. * Signed informed consent. * Episodic migraine with or without aura according to ICHD-3 criteria. * At inclusion, patients should retrospectively have from 4 to 14 migraine attacks per month during the last 3 months. This frequency must be confirmed in the headache diary before randomisation to treatment. * 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 50 years. * No use of other migraine prophylactics during the study. * For women of child-bearing potential, there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception. 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 attacks than 4 or more than 14 per month, the baseline period can be extended to 8 weeks, and the patient can be randomized to a treatment then if there is a mean of 4-14 attacks per 4 weeks during the 8-week's period.
Exclusion criteria
* Interval headache not distinguishable from migraine. * Chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on ≥ 15 days/month. * Pregnancy, planning to get pregnant, inability to use contraceptives, 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 against hepatitis C. * Significant psychiatric illness. * Having tried ≥ 3 prophylactic drugs against migraine during the last 10 years. * Requiring detoxification from acute medication (triptans, opioids). * Consistently failing to respond to any acute migraine medication. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of migraine days | 4 weeks | Change in number of migraine days/4 weeks from the baseline period to the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of responders | 12 weeks | Number of responders (≥ 50% improvement from baseline) |
| Rate of adverse events | 12 weeks | Number of patients with adverse events |
| Number of doses with acute medication | 12 weeks | Doses of triptans or analgesics per 4 weeks |
| Number of days with sick leave | 12 weeks | Days with sick leave per 4 weeks |
Countries
Norway
Contacts
CONTACTLise R Øie, Post.doc.
CONTACTJoakim H Østhus, Cand.med.
PRINCIPAL_INVESTIGATORMarte-Helene Bjørk, Professor
Haukeland University Hospital
PRINCIPAL_INVESTIGATORKjersti G Vetvik, Ph.d.
University Hospital, Akershus
PRINCIPAL_INVESTIGATORBendik S Winsvold, Post.doc.
Oslo University Hospital, Ullevål
PRINCIPAL_INVESTIGATORAnne H Aamodt, Senior researcher
Oslo University Hospital
PRINCIPAL_INVESTIGATORLise R Øie, Post.doc.
St. Olavs Hospital
PRINCIPAL_INVESTIGATORLinn H Steffensen, Associate Professor II
University Hospital Northern Norway
Outcome results
None listed