Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSt. Olavs Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age 18 to 64 years

Signed informed consent

Chronic migraine according to ICHD-3 criteria (32)

At inclusion, patients should retrospectively have at least 15 headache days per month wheof at least 8 migraine days during the last 3 months. This frequency must be confirmed in the headache diary before randomisation to treatment (See below).

Disqualifiers

Pregnancy, planning to get pregnant, inability to use contraceptives (See inclusion criteria, point 8), and lactating

Clinical information on or signs of cholestasis or decreased hepatic or renal function.

High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator

Hypersensitivity to statins or previous use of statins

Trial design

Treatments tested in this trial

  • Atorvastatin 40mg
  • Placebo

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

St. Olavs Hospital

Lead sponsor

Haukeland University Hospital

Collaborator

Oslo University Hospital

Collaborator

University Hospital of North Norway

Collaborator

University Hospital, Akershus

Collaborator

Ullevaal University Hospital

Collaborator