Prophylactic Treatment With Atorvastatin for Episodic Migraine.

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) 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.

Eligibility criteria

Qualifiers

Age 18 to 65 years.

Signed informed consent.

Episodic migraine with or without aura according to ICHD-3 criteria.

At inclusion, patients should retrospectively have from 4 to 14 migraine attacks per month during the last 3 months. This frequency must be confirmed in the headache diary before randomisation to treatment.

Disqualifiers

Interval headache not distinguishable from migraine.

Chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on ≥ 15 days/month.

Pregnancy, planning to get pregnant, inability to use contraceptives, and lactating.

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

Trial design

Treatments tested in this trial

  • Atorvastatin 40mg
  • Placebo
  • Atorvastatin 20mg

Treatment groups

450 Participants
are divided into 3 treatment groups

Sponsors and collaborators

St. Olavs Hospital

Lead sponsor

Haukeland University Hospital

Collaborator

University Hospital of North Norway

Collaborator

University Hospital, Akershus

Collaborator

Ullevaal University Hospital

Collaborator