NCT06248671

Prophylactic Treatment With Atorvastatin for Episodic Migraine.

EpisodicStatinMig. A Multicentre, Triple Blind, Placebo Controlled, Parallel Group Study of Atorvastatin in Episodic Migraine

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Episodic Migraine

Interventions

Type	Name	Description
DRUG	Atorvastatin 40mg	Each tablet will be taken once daily for 84 days.
DRUG	Placebo	Each tablet will be taken once daily for 84 days
DRUG	Atorvastatin 20mg	Each tablet will be taken once daily for 84 days.

Timeline

• Start date: 2024-05-01
• Primary completion: 2028-12-31
• Completion: 2029-02-28
• First posted: 2024-02-08
• Last updated: 2026-02-19

Locations

6 sites across 1 country: Norway