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Prophylactic Treatment With Atorvastatin for Episodic Migraine.

ConditionEpisodic 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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Atorvastatin 40mg

    Drug

    Each tablet will be taken once daily for 84 days.

  • Placebo

    Drug

    Each tablet will be taken once daily for 84 days

  • Atorvastatin 20mg

    Drug

    Each tablet will be taken once daily for 84 days.

Treatment groups

450 Participants
are divided into 3 treatment groups
Group A: Atorvastatin 40mgActive comparator 1 intervention
Group B: Atorvastatin 20mgActive comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of migraine days

Change in number of migraine days/4 weeks from the baseline period to the treatment period.

Time frame
4 weeks

Secondary outcomes

1

Number of responders

Number of responders (≥ 50% improvement from baseline)

Time frame
12 weeks
2

Rate of adverse events

Number of patients with adverse events

Time frame
12 weeks
3

Number of doses with acute medication

Doses of triptans or analgesics per 4 weeks

Time frame
12 weeks
4

Number of days with sick leave

Days with sick leave per 4 weeks

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Olavs Hospital

Lead sponsor

Haukeland University Hospital

Collaborator

University Hospital of North Norway

Collaborator

University Hospital, Akershus

Collaborator

Ullevaal University Hospital

Collaborator

Source ClinicalTrials.gov
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