Prophylactic Treatment With Atorvastatin for Episodic Migraine.

NCT06248671 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2026-02-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER
  • University Hospital of North Norway

    collaborator OTHER
  • University Hospital, Akershus

    collaborator OTHER
  • Ullevaal University Hospital

    collaborator OTHER
  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Marte-Helene Bjørk, Professor · Haukeland University Hospital

  • Kjersti G Vetvik, Ph.d. · University Hospital, Akershus

  • Bendik S Winsvold, Post.doc. · Oslo University Hospital, Ullevål

  • Anne H Aamodt, Senior researcher · Oslo University Hospital

  • Lise R Øie, Post.doc. · St. Olavs Hospital

  • Linn H Steffensen, Associate Professor II · University Hospital Northern Norway

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2028-12-31
Completion
2029-02-28

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06248671 on ClinicalTrials.gov