Prophylactic Treatment With Atorvastatin for Episodic Migraine.

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Number of migraine days [Срок оценки: 4 weeks]

Вторичные конечные точки (4)

• Number of responders [Срок оценки: 12 weeks]
• Rate of adverse events [Срок оценки: 12 weeks]
• Number of doses with acute medication [Срок оценки: 12 weeks]
• Number of days with sick leave [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Норвегия · 6 центров

• Haukeland University Hospital — Bergen
• University Hospital, Akershus — Lørenskog
• Oslo University Hospital, Rikshospitalet — Oslo
• Oslo University Hospital, Ullevål — Oslo
• University Hospital Northern Norway — Tromsø
• St. Olavs hospital — Trondheim

Публикации

• 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. PMID 33267788
• 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. PMID 35410119
• 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. PMID 19708964
• Langohr HD, Gerber WD, Koletzki E, Mayer K, Schroth G. Clomipramine and metoprolol in migraine prophylaxis--a double-blind crossover study. Headache. 1985 Mar;25(2):107-13. doi: 10.1111/j.1526-4610.1985.hed2502107.x. No abstract available. PMID 3886599
• 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. PMID 3579659
• 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. PMID 12503978
• 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. PMID 24335848
• Mei D, Capuano A, Vollono C, Evangelista M, Ferraro D, Tonali P, Di Trapani G. Topiramate in migraine prophylaxis: a randomised double-blind versus placebo study. Neurol Sci. 2004 Dec;25(5):245-50. doi: 10.1007/s10072-004-0350-0. PMID 15624081

Идентификаторы

NCT: NCT06248671 · 2022-502176-23-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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