A Phase 2 interventional study of Atorvastatin 40mg and Placebo in Chronic Migraine, sponsored by St. Olavs Hospital. Recruiting at 6 sites in Norway. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by St. Olavs Hospital · Phase 2, Interventional, and Prevention
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's planned enrollment of 300 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →St. Olavs Hospital is the lead sponsor of 165 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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.
Each participant in this arm will receive 40mg atorvastatin once daily for 84 days.
Drug: Atorvastatin 40mg
Each participant in this arm will receive placebo once daily for 84 days.
Drug: Placebo
Each tablet will be taken once daily for 84 days.
Also known as: Lipitor
Each tablet will be taken once daily for 84 days.
Number of migraine days
Change in number of migraine days/4 weeks from the baseline period to the intervention period.
Time frame: 4 weeks
Number of responders
Number of responders (≥ 50 % improvement from baseline)
Time frame: 12 weeks
Rate of adverse events
Number of patients with adverse events
Time frame: 12 weeks
Number of doses with acute medication
Doses of triptans or analgesics per 4 weeks
Time frame: 12 weeks
Number of days with sick leave
Days with sick leave per 4 weeks
Time frame: 12 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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St. Olavs Hospital