Prophylactic Treatment With Atorvastatin for Episodic Migraine.

Episodic Migraine Clinical Trial

— EStatinMig  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06248671
• Other study ID #: 2022-502176-23-01
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: February 28, 2029

Study information

• Verified date: June 2024
• Source: St. Olavs Hospital
• Contact: Lise R Øie, Post.doc.
• Phone: 0047 41419596
• Email: lise.r.oie[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: February 28, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine Disorders

Intervention

Drug:
• Atorvastatin 40mg
Each tablet will be taken once daily for 84 days.
• Placebo
Each tablet will be taken once daily for 84 days
• Atorvastatin 20mg
Each tablet will be taken once daily for 84 days.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	University Hospital, Akershus	Lørenskog
Norway	Oslo University Hospital, Rikshospitalet	Oslo
Norway	Oslo University Hospital, Ullevål	Oslo
Norway	University Hospital Northern Norway	Tromsø
Norway	St. Olavs hospital	Trondheim

Sponsors (6)

Lead Sponsor	Collaborator
St. Olavs Hospital	Haukeland University Hospital, Oslo University Hospital, Ullevaal University Hospital, University Hospital of North Norway, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of migraine days	Change in number of migraine days/4 weeks from the baseline period to the treatment period.	4 weeks
Secondary	Number of responders	Number of responders (= 50% improvement from baseline)	12 weeks
Secondary	Rate of adverse events	Number of patients with adverse events	12 weeks
Secondary	Number of doses with acute medication	Doses of triptans or analgesics per 4 weeks	12 weeks
Secondary	Number of days with sick leave	Days with sick leave per 4 weeks	12 weeks

External Links

•   Product information atorvastatin
•   Serendipity atorvastatin and vitamin D
•   Statins rarely cause adverse effects
•   Treatment with statins