Using Atorvastatin to prevent episodic migraines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to confirm the preventative effects of Atorvastatin at doses of 40mg and 20mg per day on episodic migraines in a larger multicenter setting. It will evaluate the frequency of migraine attacks in participants who have been experiencing 4 to 14 attacks per month. Additionally, the study will assess the side effect profile of Atorvastatin and estimate the overall cost-effectiveness of the treatment. Participants will be randomly assigned to receive either Atorvastatin or a placebo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Haukeland University Hospital
  Bergen, Norway Recruiting
• University Hospital Northern Norway
  Tromsø, Norway Recruiting
• St. Olavs hospital
  Trondheim, Norway Recruiting
• University Hospital, Akershus
  Lørenskog, Norway Not yet recruiting
• Oslo University Hospital, Rikshospitalet
  Oslo, Norway Not yet recruiting
• Oslo University Hospital, Ullevål
  Oslo, Norway Not yet recruiting

Study contacts

• Principal investigator: Marte-Helene Bjørk, Professor — Haukeland University Hospital
• Study coordinator: Lise R Øie, Post.doc.
• Email: lise.r.oie@ntnu.no
• Phone: 0047 41419596

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gou-Teng-San (GTS) for adults with episodic migraine

  This trial will test whether the herbal formula Gou-Teng-San (GTS) can reduce migraine attacks and symptoms in adults with episodic migraine.

  Recruiting Phase 3 China Medical University, Taiwan · Taichung, South · NCT07496034

• Real-world use of anti-CGRP medicines for preventing migraine

  This project will follow people with episodic or chronic migraine who start anti-CGRP medicines to see if the treatments reduce migraine frequency and side effects over two years.

  Recruiting at 25 sites Hospital Universitari Vall d'Hebron Research Institute · Miami, Florida and 25 other locations · NCT07159750

• i-NEED: New migraine drugs database

  This project will collect real-life data to see how new migraine treatments—anti‑CGRP antibodies, gepants, ditans, and a sumatriptan‑naproxen combo—work and how well adults with episodic or chronic migraine tolerate them.

  Recruiting at 2 sites IRCCS San Raffaele Roma · Milan, Italy and 1 other locations · NCT07103694

• Effects of Atogepant on Neurophysiology and Biomolecules in Migraine

  This study is testing if a new migraine medication called atogepant can change brain activity and biochemistry in people who have frequent migraines.

  Recruiting IRCCS National Neurological Institute "C. Mondino" Foundation · Pavia, PAVIA · NCT06882122

• Analyzing CGRP Levels in Migraine Patients by Age and Sex

  This study looks at the levels of a substance linked to migraines in people with migraines and healthy individuals to see how age and sex might affect treatment responses.

  Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona, Barcelona · NCT06674772

• Assessing the safety and effectiveness of Atogepant for migraine prevention in Korean adults

  This study is testing how well and safely Atogepant works for preventing migraines in Korean adults who have chronic or episodic migraines.

  Recruiting at 36 sites AbbVie · Busan, Busan Gwang Yeogsi and 35 other locations · NCT06603558

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.