Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Haukeland University Hospital | OTHER |
| University Hospital of North Norway | OTHER |
| University Hospital, Akershus | OTHER |
| Ullevaal University Hospital |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin 40mg | Active Comparator | Each participant in this arm will receive 40mg atorvastatin once daily for 84 days. |
|
| Atorvastatin 20mg | Active Comparator | Each participant in this arm will receive 20mg atorvastatin once daily for 84 days. |
|
| Placebo | Placebo Comparator | Each participant in this arm will receive placebo once daily for 84 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 40mg | Drug | Each tablet will be taken once daily for 84 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of migraine days | Change in number of migraine days/4 weeks from the baseline period to the treatment period. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of responders | Number of responders (≥ 50% improvement from baseline) | 12 weeks |
| Rate of adverse events | Number of patients with adverse events |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise R Øie, Post.doc. | Contact | 0047 41419596 | lise.r.oie@ntnu.no | |
| Joakim H Østhus, Cand.med. | Contact | 0047 93837036 | Joakim.h.osthus@ntnu.no |
| Name | Affiliation | Role |
|---|---|---|
| Marte-Helene Bjørk, Professor | Haukeland University Hospital | Principal Investigator |
| Kjersti G Vetvik, Ph.d. | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Recruiting | Bergen | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33267788 | Background | 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. | |
| 35410119 |
| Label | URL |
|---|---|
| Statins rarely cause adverse effects | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 7, 2026 | Feb 15, 2026 | Prot_006.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 25, 2024 | Jun 25, 2024 | ICF_005.pdf |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| OTHER |
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.
Not provided
Not provided
Triple blind (blinded to patients, study personnel, and statistician).
| Placebo | Drug | Each tablet will be taken once daily for 84 days |
|
| Atorvastatin 20mg | Drug | Each tablet will be taken once daily for 84 days. |
|
|
| 12 weeks |
| Number of doses with acute medication | Doses of triptans or analgesics per 4 weeks | 12 weeks |
| Number of days with sick leave | Days with sick leave per 4 weeks | 12 weeks |
| Bendik S Winsvold, Post.doc. |
| Oslo University Hospital, Ullevål |
| Principal Investigator |
| Anne H Aamodt, Senior researcher | Oslo University Hospital | Principal Investigator |
| Lise R Øie, Post.doc. | St. Olavs Hospital | Principal Investigator |
| Linn H Steffensen, Associate Professor II | University Hospital Northern Norway | Principal Investigator |
| University Hospital, Akershus | Not yet recruiting | Lørenskog | Norway |
|
| Oslo University Hospital, Rikshospitalet | Not yet recruiting | Oslo | Norway |
|
| Oslo University Hospital, Ullevål | Not yet recruiting | Oslo | Norway |
|
| University Hospital Northern Norway | Recruiting | Tromsø | Norway |
|
| St. Olavs hospital | Recruiting | Trondheim | 7022 | Norway |
|
| 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. |
| 19708964 | Background | 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. |
| 3886599 | Background | 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. |
| 3579659 | Background | 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. |
| 12503978 | Background | 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. |
| 24335848 | Background | 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. |
| 15624081 | Background | 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. |
| 14982912 | Background | Brandes JL, Saper JR, Diamond M, Couch JR, Lewis DW, Schmitt J, Neto W, Schwabe S, Jacobs D; MIGR-002 Study Group. Topiramate for migraine prevention: a randomized controlled trial. JAMA. 2004 Feb 25;291(8):965-73. doi: 10.1001/jama.291.8.965. |
| 15567552 | Background | 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. |
| 21070231 | Background | 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. |
| 31122188 | Background | 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. |
| 29392600 | Background | 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. |
| 26418341 | Background | 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. |
| 29746282 | Background | 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. |
| 33789774 | Background | 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. |
| 35037597 | Background | 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. |
| 1464741 | Background | Endo A. The discovery and development of HMG-CoA reductase inhibitors. J Lipid Res. 1992 Nov;33(11):1569-82. No abstract available. |
| 11182189 | Background | Musial J, Undas A, Gajewski P, Jankowski M, Sydor W, Szczeklik A. Anti-inflammatory effects of simvastatin in subjects with hypercholesterolemia. Int J Cardiol. 2001 Feb;77(2-3):247-53. doi: 10.1016/s0167-5273(00)00439-3. |
| 22720798 | Background | Yanuck D, Mihos CG, Santana O. Mechanisms and clinical evidence of the pleiotropic effects of the hydroxy-methyl-glutaryl-CoA reductase inhibitors in central nervous system disorders: a comprehensive review. Int J Neurosci. 2012 Nov;122(11):619-29. doi: 10.3109/00207454.2012.704455. Epub 2012 Aug 14. |
| 20424337 | Background | Zhou Q, Liao JK. Pleiotropic effects of statins. - Basic research and clinical perspectives -. Circ J. 2010 May;74(5):818-26. doi: 10.1253/circj.cj-10-0110. Epub 2010 Apr 15. |
| 27148902 | Background | Salagre E, Fernandes BS, Dodd S, Brownstein DJ, Berk M. Statins for the treatment of depression: A meta-analysis of randomized, double-blind, placebo-controlled trials. J Affect Disord. 2016 Aug;200:235-42. doi: 10.1016/j.jad.2016.04.047. Epub 2016 Apr 27. |
| 24274967 | Background | Millar PJ, Floras JS. Statins and the autonomic nervous system. Clin Sci (Lond). 2014 Mar;126(6):401-15. doi: 10.1042/CS20130332. |
| 14531725 | Background | Lennernas H. Clinical pharmacokinetics of atorvastatin. Clin Pharmacokinet. 2003;42(13):1141-60. doi: 10.2165/00003088-200342130-00005. |
| 12860216 | Background | 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. |
| 32722936 | Background | Diener HC, Tassorelli C, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ, Houle TT, Hoek TCVD, Martinelli D, Terwindt GM; International Headache Society Clinical Trials Committee. Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine attacks in episodic migraine in adults. Cephalalgia. 2020 Sep;40(10):1026-1044. doi: 10.1177/0333102420941839. Epub 2020 Jul 28. |
| 29368949 | Background | Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available. |
| 23125964 | Background | Bhatt A. Protocol deviation and violation. Perspect Clin Res. 2012 Jul;3(3):117. doi: 10.4103/2229-3485.100663. No abstract available. |
| 25424706 | Background | Buettner C, Burstein R. Association of statin use and risk for severe headache or migraine by serum vitamin D status: a cross-sectional population-based study. Cephalalgia. 2015 Aug;35(9):757-66. doi: 10.1177/0333102414559733. Epub 2014 Nov 25. |
| 24623264 | Background | Finegold JA, Manisty CH, Goldacre B, Barron AJ, Francis DP. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice. Eur J Prev Cardiol. 2014 Apr;21(4):464-74. doi: 10.1177/2047487314525531. Epub 2014 Mar 12. |
| 28476288 | Background | Gupta A, Thompson D, Whitehouse A, Collier T, Dahlof B, Poulter N, Collins R, Sever P; ASCOT Investigators. Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase. Lancet. 2017 Jun 24;389(10088):2473-2481. doi: 10.1016/S0140-6736(17)31075-9. Epub 2017 May 2. |
| 31881823 | Background | 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. |
| Treatment with statins | View source |
| Serendipity atorvastatin and vitamin D | View source |
| D009422 | Nervous System Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |