Prophylactic Treatment With Atorvastatin for Episodic Migraine. (EStatinMig)

April 3, 2024 updated by: St. Olavs Hospital

EpisodicStatinMig. A Multicentre, Triple Blind, Placebo Controlled, Parallel Group Study of Atorvastatin in Episodic Migraine

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

After the baseline period, just before randomisation to the study drug, inclusion criteria will be evaluated once more, and the headache diary will be evaluated. If there are, according to the headache diary, fewer attacks than 4 or more than 14 per month, the baseline period can be extended to 8 weeks, and the patient can be randomized to a treatment then if there is a mean of 4-14 attacks per 4 weeks during the 8-week's period.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Atorvastatin 40mg
Each participant in this arm will receive 40mg atorvastatin once daily for 84 days.
Drug: Atorvastatin 40mg
Each tablet will be taken once daily for 84 days.
Other Names:
  • Lipitor
Active Comparator: Atorvastatin 20mg
Each participant in this arm will receive 20mg atorvastatin once daily for 84 days.
Drug: Atorvastatin 20mg
Each tablet will be taken once daily for 84 days.
Other Names:
  • Lipitor
Placebo Comparator: Placebo
Each participant in this arm will receive placebo once daily for 84 days.
Drug: Placebo
Each tablet will be taken once daily for 84 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of migraine days
Time Frame: 4 weeks
Change in number of migraine days/4 weeks from the baseline period to the treatment period.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of responders
Time Frame: 12 weeks
Number of responders (≥ 50% improvement from baseline)
12 weeks
Rate of adverse events
Time Frame: 12 weeks
Number of patients with adverse events
12 weeks
Number of doses with acute medication
Time Frame: 12 weeks
Doses of triptans or analgesics per 4 weeks
12 weeks
Number of days with sick leave
Time Frame: 12 weeks
Days with sick leave per 4 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Collaborators

Ullevaal University Hospital
Oslo University Hospital
University Hospital of North Norway
Haukeland University Hospital
University Hospital, Akershus

Investigators

  • Principal Investigator: Marte-Helene Bjørk, Professor, Haukeland University Hospital
  • Principal Investigator: Kjersti G Vetvik, Ph.d., University Hospital, Akershus
  • Principal Investigator: Bendik S Winsvold, Post.doc., Oslo University Hospital, Ullevål
  • Principal Investigator: Anne H Aamodt, Senior researcher, Oslo University Hospital, Ullevål
  • Principal Investigator: Lise R Øie, Post.doc., St. Olavs Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

February 28, 2029

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-502176-23-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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