Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06485336

Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig)

Led by St. Olavs Hospital · Updated on 2025-07-01

300

Participants Needed

6

Research Sites

252 weeks

Total Duration

On this page

Sponsors

S

St. Olavs Hospital

Lead Sponsor

H

Haukeland University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig)

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 64 years
  • Signed informed consent
  • Chronic migraine according to ICHD-3 criteria
  • At least 15 headache days per month with at least 8 migraine days during the last 3 months, confirmed by headache diary
  • Migraine onset at least one year before inclusion
  • Migraine started before age 50 years
  • No use of other migraine prophylactics during the study
  • For women of child-bearing potential: no pregnancy or planned pregnancy during the study and use of highly effective contraception
Not Eligible

You will not qualify if you...

  • Medication overuse headache requiring detoxification from acute medication (triptans, opioids), except those who have tried withdrawal for at least 2 months without impact on headaches and use opioids 8 days or less per month
  • Pregnancy, planning pregnancy, inability to use contraceptives, or lactating
  • Signs of cholestasis or decreased liver or kidney function
  • High comorbidity or frailty with reduced life expectancy or high hospitalization risk
  • Hypersensitivity or previous use of statins
  • History of angioneurotic oedema
  • Use of migraine prophylaxis medications less than 4 weeks or botulinum toxin less than 16 weeks before study
  • Current antiviral treatment against hepatitis C
  • Significant psychiatric illness
  • Alcohol or drug dependence
  • Inability to understand or comply with study procedures
  • Treatment for hypothyroidism
  • Lactose intolerance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Haukeland University Hospital

Bergen, Norway

Actively Recruiting

2

University Hospital, Akershus

Lørenskog, Norway

Not Yet Recruiting

3

Oslo University Hospital, Rikshospitalet

Oslo, Norway

Not Yet Recruiting

4

Oslo University Hospital, Ullevål

Oslo, Norway

Not Yet Recruiting

5

University Hospital Northern Norway

Tromsø, Norway

Actively Recruiting

6

St. Olavs hospital

Trondheim, Norway

Actively Recruiting

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Research Team

L

Lise R. Øie, Post.doc.

CONTACT

J

Joakim H. Østhus, Cand.med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig) | DecenTrialz