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Phase 2
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06248671

Evaluation of Daily Atorvastatin 20mg and 40mg for Preventing Episodic Migraine in Adults Aged 18 to 65

Led by St. Olavs Hospital · Updated on 2026-07-14

450

Participants Needed

6

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of Atorvastatin, a medication given daily at doses of 20mg or 40mg, for preventing episodic migraine in adults aged 18 to 65. This phase 2, randomized, triple-blind, multicenter study aims to confirm previous findings of Atorvastatins potential to reduce migraine frequency, explore the impact of a lower dose, assess its side effect profile, and estimate treatment costs including medication and work loss. Participants are assigned to one of three groups receiving either 40mg Atorvastatin, 20mg Atorvastatin, or a placebo once daily for 84 days. The study uses a parallel design to compare these treatments over the three-month period, with careful monitoring of migraine attacks and medication use. During the study, participants will keep a headache diary to record migraine frequency and medication use. Researchers will measure the number of migraine days every 4 weeks as the primary outcome, and secondary outcomes include responder rates, adverse events, use of acute migraine medication, and days of sick leave over 12 weeks. Monitoring includes regular assessments throughout the treatment period to evaluate effectiveness and safety.

CONDITIONS

Brief Title

Prophylactic Treatment With Atorvastatin for Episodic Migraine.

Research Team

L

Lise R Øie, Post.doc.

J

Joakim H Østhus, Cand.med.

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