Prophylactic Treatment With Atorvastatin for Episodic Migraine.

NCT ID: NCT06248671

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2029-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Episodic Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel group study with three arms, comparing Atorvastatin 20 mg and 40 mg against placebo. Each participant will receive 84 encapsulated tablets. The participant will take one capsule orally each day, preferably at the same time of the day.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Triple blind (blinded to patients, study personnel, and statistician).

Study Groups

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Atorvastatin 40mg

Each participant in this arm will receive 40mg atorvastatin once daily for 84 days.

Group Type ACTIVE_COMPARATOR

Atorvastatin 40mg

Intervention Type DRUG

Each tablet will be taken once daily for 84 days.

Atorvastatin 20mg

Each participant in this arm will receive 20mg atorvastatin once daily for 84 days.

Group Type ACTIVE_COMPARATOR

Atorvastatin 20mg

Intervention Type DRUG

Each tablet will be taken once daily for 84 days.

Placebo

Each participant in this arm will receive placebo once daily for 84 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Each tablet will be taken once daily for 84 days

Interventions

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Atorvastatin 40mg

Each tablet will be taken once daily for 84 days.

Intervention Type DRUG

Placebo

Each tablet will be taken once daily for 84 days

Intervention Type DRUG

Atorvastatin 20mg

Each tablet will be taken once daily for 84 days.

Intervention Type DRUG

Other Intervention Names

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Lipitor Lipitor

Eligibility Criteria

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Inclusion Criteria

* 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.
* Debut of migraine at least one year prior to inclusion based on information in the patient record or by careful examination of previous headache history.
* Start of migraine before 50 years.
* No use of other migraine prophylactics during the study.
* For women of child-bearing potential, there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception.

Exclusion Criteria

* 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.
* 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.
* History of angioneurotic oedema.
* Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study.
* Current use of antiviral treatment against hepatitis C.
* Significant psychiatric illness.
* Having tried ≥ 3 prophylactic drugs against migraine during the last 10 years.
* Requiring detoxification from acute medication (triptans, opioids).
* Consistently failing to respond to any acute migraine medication.
* Alcohol or illicit drug dependence.
* Inability to understand study procedures and to comply with them for the entire length of the study.
* Treatment for hypothyroidism.
* Lactose intolerance.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role collaborator

Ullevaal University Hospital

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marte-Helene Bjørk, Professor

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Kjersti G Vetvik, Ph.d.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Bendik S Winsvold, Post.doc.

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital, Ullevål

Anne H Aamodt, Senior researcher

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Lise R Øie, Post.doc.

Role: PRINCIPAL_INVESTIGATOR

St. Olavs Hospital

Linn H Steffensen, Associate Professor II

Role: PRINCIPAL_INVESTIGATOR

University Hospital Northern Norway

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status RECRUITING

University Hospital, Akershus

Lørenskog, , Norway

Site Status NOT_YET_RECRUITING

Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Site Status NOT_YET_RECRUITING

Oslo University Hospital, Ullevål

Oslo, , Norway

Site Status NOT_YET_RECRUITING

University Hospital Northern Norway

Tromsø, , Norway

Site Status RECRUITING

St. Olavs hospital

Trondheim, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Lise R Øie, Post.doc.

Role: CONTACT

0047 41419596

Joakim H Østhus, Cand.med.

Role: CONTACT

0047 93837036

Facility Contacts

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Marte-Helene Bjørk, Professor

Role: primary

Kjersti G Vetvik, Ph.d.

Role: primary

Anne H Aamodt, Senior researcher

Role: primary

Bendik S Windsvold, Post.doc.

Role: primary

Linn H Steffensen, Associate Professor II

Role: primary

Lise R Øie, Post.doc

Role: primary

41419596 ext. 0047

Joakim H. Østhus, Cand.med

Role: backup

93837036 ext. 0047

References

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Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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2022-502176-23-01

Identifier Type: -

Identifier Source: org_study_id

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