Episodic MigrainePhase 2EStatinMigNCT06248671
Prophylactic Treatment With Atorvastatin for Episodic Migraine.
A Phase 2 study testing Atorvastatin 40mg and Atorvastatin 20mg in people with Episodic Migraine, run by St. Olavs Hospital at 6 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Episodic Migraine
- What is being tested?
- Atorvastatin 40mg and Atorvastatin 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 6 sitesNorway
- Study dates
- 1 May 2024to 28 Feb 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Norway6 sites, 6 recruiting
- Recruiting
Haukeland University Hospital
Bergen
Marte-Helene Bjørk, Professor, Marte.Bjork@uib.no
- Not yet recruiting
University Hospital, Akershus
Lørenskog
Kjersti G Vetvik, Ph.d., kjersti.grotta.vetvik2@ahus.no
- Not yet recruiting
Oslo University Hospital, Rikshospitalet
Oslo
Anne H Aamodt, Senior researcher, a.h.aamodt@medisin.uio.no
- Not yet recruiting
Oslo University Hospital, Ullevål
Oslo
Bendik S Windsvold, Post.doc., bendik.s.winsvold@gmail.com
- Recruiting
University Hospital Northern Norway
Tromsø
Linn H Steffensen, Associate Professor II, linn.steffensen@unn.no
- Recruiting
St. Olavs hospital
Trondheim, 7022
Lise R Øie, Post.doc, 41419596 ext. 0047, lise.r.oie@ntnu.no
Joakim H. Østhus, Cand.med, 93837036 ext. 0047, Joakim.h.osthus@ntnu.no
About this study
Official title: 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.
- Conditions
- Episodic Migraine
- Being tested
- Atorvastatin 40mg, Placebo, Atorvastatin 20mg
- Keywords
- Migraine, Atorvastatin, Randomized controlled trial
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 40mgDrug
Also called Lipitor
Each tablet will be taken once daily for 84 days.
PlaceboDrug
Each tablet will be taken once daily for 84 days
Atorvastatin 20mgDrug
Also called Lipitor
Each tablet will be taken once daily for 84 days.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin 40mg | Active comparator | Each participant in this arm will receive 40mg atorvastatin once daily for 84 days. Receives: Drug: Atorvastatin 40mg |
| Atorvastatin 20mg | Active comparator | Each participant in this arm will receive 20mg atorvastatin once daily for 84 days. Receives: Drug: Atorvastatin 20mg |
| Placebo | Placebo comparator | Each participant in this arm will receive placebo once daily for 84 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of migraine days
Change in number of migraine days/4 weeks from the baseline period to the treatment period.
Measured: 4 weeks
Secondary outcomes (4)
Number of responders
Number of responders (≥ 50% improvement from baseline)
Measured: 12 weeks
Rate of adverse events
Number of patients with adverse events
Measured: 12 weeks
Number of doses with acute medication
Doses of triptans or analgesics per 4 weeks
Measured: 12 weeks
Number of days with sick leave
Days with sick leave per 4 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 May 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Episodic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, University Hospital of North Norway, University Hospital, Akershus, Ullevaal University Hospital
- Responsible party
- Sponsor
- Investigators
- Marte-Helene Bjørk, Professor, Principal investigator, Haukeland University HospitalKjersti G Vetvik, Ph.d., Principal investigator, University Hospital, AkershusBendik S Winsvold, Post.doc., Principal investigator, Oslo University Hospital, UllevålAnne H Aamodt, Senior researcher, Principal investigator, Oslo University HospitalLise R Øie, Post.doc., Principal investigator, St. Olavs HospitalLinn H Steffensen, Associate Professor II, Principal investigator, University Hospital Northern Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248671
- Sponsor's protocol ID
- 2022-502176-23-01
- Acronym
- EStatinMig
- Status last verified
- Jul 2026
- First submitted
- 19 Jan 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33267788Stovner 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.
PubMed 35410119Evers 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.
PubMed 19708964Langohr 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.
PubMed 3886599Ziegler 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.
PubMed 3579659Tronvik 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.
PubMed 12503978Stovner 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.
PubMed 24335848Mei 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.
PubMed 15624081Brandes 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.
PubMed 14982912Bulut 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.
PubMed 15567552Couch 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.
PubMed 21070231Sacco 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.
PubMed 31122188Katsarava 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.
PubMed 29392600Buettner 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.
PubMed 26418341Hesami 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.
PubMed 29746282