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Chronic MigrainePhase 2NCT06485336

Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig)

A Phase 2 study testing Atorvastatin 40mg in people with Chronic Migraine, run by St. Olavs Hospital at 6 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Chronic Migraine
What is being tested?
Atorvastatin 40mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
6 sitesNorway
Study dates
1 May 2024to 28 Feb 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 64 years
  • Signed informed consent
  • Chronic migraine according to ICHD-3 criteria (32)
  • At inclusion, patients should retrospectively have at least 15 headache days per month wheof at least 8 migraine days during the last 3 months. This frequency must be confirmed in the headache diary before randomisation to treatment (See below).
  • 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 age 50 years.
Show all 9Show fewer
  • No use of other migraine prophylactics during the study
  • For women of child-bearing potential (WOCBP, see below) there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception (See below).
  • 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 migraine days than 8 per month, the baseline period can be extended to 8 weeks.

Who cannot join

  • Medication overuse headache requiring detoxification from acute medication (triptans, opioids). Exception could be made for those fulfilling A and B:
  • Have tried a withdrawal period of at least 2 months without impact on headache frequency B: Use of opioids (of any type) ≤ 8 days /months.
  • Pregnancy, planning to get pregnant, inability to use contraceptives (See inclusion criteria, point 8), 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 14Show 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 agaist hepatitis C
  • Significant psychiatric illness
  • 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.

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

6 sites in 1 country

Norway6 sites, 6 recruiting

  • Haukeland University Hospital

    Bergen

    Marte-Helene Bjørk, Professor, marte.bjork@uib.no

    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. Winsvold, Post. doc., bendik.s.winsvold@gmail.com

    Not yet recruiting

  • University Hospital Northern Norway

    Tromsø

    Linn H Steffensen, Associate Professor II, linn.steffensen@unn.no

    Recruiting

  • St. Olavs hospital

    Trondheim

    Lise R Øie, Post.doc, lise.r.oie@ntnu.no

    Joakim H Østhus, Cand.med, 93837036 ext. 0047, Joakim.h.osthus@ntnu.no

    Recruiting

Other trials in Norway

About this study

Official title: ChronicStatinMig. A Multicentre, Triple Blind, Placebo Controlled, Parallel Group Study of Atorvastatin in Chronic 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) the favorable side effect profile, seen in previous studies, can be confirmed, and whether it is even better with the smaller dose, and 2) estimating the cost of Atorvastatin treatment, considering cost of medicine, cost of acute attack medicine, and cost of lost worktime.

Being tested
Atorvastatin 40mg, Placebo
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.

Study groups in NCT06485336
Study groupRoleWhat they receive
Atorvastatin 40mgActive comparatorEach participant in this arm will receive 40mg atorvastatin once daily for 84 days.
Receives: Drug: Atorvastatin 40mg
PlaceboPlacebo comparatorEach 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.

  1. Number of migraine days

    Change in number of migraine days/4 weeks from the baseline period to the intervention period.

    Measured: 4 weeks

Secondary outcomes (4)

  1. Number of responders

    Number of responders (≥ 50 % improvement from baseline)

    Measured: 12 weeks

  2. Rate of adverse events

    Number of patients with adverse events

    Measured: 12 weeks

  3. Number of doses with acute medication

    Doses of triptans or analgesics per 4 weeks

    Measured: 12 weeks

  4. 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.

  1. First posted3 Jul 2024
  2. Study start1 May 2024
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

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 two arms, comparing Atorvastatin 40mg against placebo. Each participant will receive 84 encapsulated tablets. The participants 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
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06485336
Sponsor's protocol ID
2022-502177-42-02
Status last verified
Jul 2026
First submitted
10 Jun 2024
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
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 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 15624081

  • 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.

    PubMed 14982912

  • 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.

    PubMed 15567552

  • 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.

    PubMed 21070231

  • 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.

    PubMed 31122188

  • 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.

    PubMed 29392600

  • 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.

    PubMed 26418341

  • 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.

    PubMed 29746282

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atorvastatin 40mg in people with Chronic Migraine, run by St. Olavs Hospital at 6 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lise R. Øie, Post.doc. (0047 41419596, lise.r.oie@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of migraine days (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06485336, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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