Prophylactic Treatment With Atorvastatin for Episodic Migraine.
NCT ID: NCT06248671
Last Updated: 2025-07-01
Study Results
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Basic Information
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RECRUITING
PHASE2
450 participants
INTERVENTIONAL
2024-05-01
2029-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Atorvastatin 40mg
Each participant in this arm will receive 40mg atorvastatin once daily for 84 days.
Atorvastatin 40mg
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.
Atorvastatin 20mg
Each tablet will be taken once daily for 84 days.
Placebo
Each participant in this arm will receive placebo once daily for 84 days.
Placebo
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.
Placebo
Each tablet will be taken once daily for 84 days
Atorvastatin 20mg
Each tablet will be taken once daily for 84 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Haukeland University Hospital
OTHER
Oslo University Hospital
OTHER
University Hospital of North Norway
OTHER
University Hospital, Akershus
OTHER
Ullevaal University Hospital
OTHER
St. Olavs Hospital
OTHER
Responsible Party
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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
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, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z; Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137. doi: 10.1186/s10194-020-01208-0. No abstract available.
Stovner LJ, Hagen K, Linde M, Steiner TJ. The global prevalence of headache: an update, with analysis of the influences of methodological factors on prevalence estimates. J Headache Pain. 2022 Apr 12;23(1):34. doi: 10.1186/s10194-022-01402-2.
Evers S, Afra J, Frese A, Goadsby PJ, Linde M, May A, Sandor PS; European Federation of Neurological Societies. EFNS guideline on the drug treatment of migraine--revised report of an EFNS task force. Eur J Neurol. 2009 Sep;16(9):968-81. doi: 10.1111/j.1468-1331.2009.02748.x.
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Ziegler DK, Hurwitz A, Hassanein RS, Kodanaz HA, Preskorn SH, Mason J. Migraine prophylaxis. A comparison of propranolol and amitriptyline. Arch Neurol. 1987 May;44(5):486-9. doi: 10.1001/archneur.1987.00520170016015.
Tronvik E, Stovner LJ, Helde G, Sand T, Bovim G. Prophylactic treatment of migraine with an angiotensin II receptor blocker: a randomized controlled trial. JAMA. 2003 Jan 1;289(1):65-9. doi: 10.1001/jama.289.1.65.
Stovner LJ, Linde M, Gravdahl GB, Tronvik E, Aamodt AH, Sand T, Hagen K. A comparative study of candesartan versus propranolol for migraine prophylaxis: A randomised, triple-blind, placebo-controlled, double cross-over study. Cephalalgia. 2014 Jun;34(7):523-32. doi: 10.1177/0333102413515348. Epub 2013 Dec 11.
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Bulut S, Berilgen MS, Baran A, Tekatas A, Atmaca M, Mungen B. Venlafaxine versus amitriptyline in the prophylactic treatment of migraine: randomized, double-blind, crossover study. Clin Neurol Neurosurg. 2004 Dec;107(1):44-8. doi: 10.1016/j.clineuro.2004.03.004.
Couch JR; Amitriptyline Versus Placebo Study Group. Amitriptyline in the prophylactic treatment of migraine and chronic daily headache. Headache. 2011 Jan;51(1):33-51. doi: 10.1111/j.1526-4610.2010.01800.x. Epub 2010 Nov 10.
Sacco S, Bendtsen L, Ashina M, Reuter U, Terwindt G, Mitsikostas DD, Martelletti P. Correction to: European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. J Headache Pain. 2019 May 23;20(1):58. doi: 10.1186/s10194-019-0972-5.
Katsarava Z, Mania M, Lampl C, Herberhold J, Steiner TJ. Poor medical care for people with migraine in Europe - evidence from the Eurolight study. J Headache Pain. 2018 Feb 1;19(1):10. doi: 10.1186/s10194-018-0839-1.
Buettner C, Nir RR, Bertisch SM, Bernstein C, Schain A, Mittleman MA, Burstein R. Simvastatin and vitamin D for migraine prevention: A randomized, controlled trial. Ann Neurol. 2015 Dec;78(6):970-81. doi: 10.1002/ana.24534. Epub 2015 Nov 13.
Hesami O, Sistanizad M, Asadollahzade E, Johari MS, Beladi-Moghadam N, Mazhabdar-Ghashghai H. Comparing the Effects of Atorvastatin With Sodium Valproate (Divalproex) on Frequency and Intensity of Frequent Migraine Headaches: A Double-blind Randomized Controlled Study. Clin Neuropharmacol. 2018 May/Jun;41(3):94-97. doi: 10.1097/WNF.0000000000000280.
Ganji R, Majdinasab N, Hesam S, Rostami N, Sayyah M, Sahebnasagh A. Does atorvastatin have augmentative effects with sodium valproate in prevention of migraine with aura attacks? A triple-blind controlled clinical trial. J Pharm Health Care Sci. 2021 Apr 1;7(1):12. doi: 10.1186/s40780-021-00198-8.
Sherafat A, Sahebnasagh A, Rahmany R, Mohammadi F, Saghafi F. The preventive effect of the combination of atorvastatin and nortriptyline in migraine-type headache: a randomized, triple-blind, placebo-controlled trial. Neurol Res. 2022 Apr;44(4):311-317. doi: 10.1080/01616412.2021.1981105. Epub 2022 Jan 17.
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Jones PH, Davidson MH, Stein EA, Bays HE, McKenney JM, Miller E, Cain VA, Blasetto JW; STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial). Am J Cardiol. 2003 Jul 15;92(2):152-60. doi: 10.1016/s0002-9149(03)00530-7.
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Jenssen AB, Stovner LJ, Tronvik E, Sand T, Helde G, Gravdahl GB, Hagen K. The crossover design for migraine preventives: an analyses of four randomized placebo-controlled trials. J Headache Pain. 2019 Dec 27;20(1):119. doi: 10.1186/s10194-019-1067-z.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
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Product information atorvastatin
Statins rarely cause adverse effects
Treatment with statins
Serendipity atorvastatin and vitamin D
Other Identifiers
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2022-502176-23-01
Identifier Type: -
Identifier Source: org_study_id
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