Candesartan for Migraine Prevention:

Launched by ST. OLAVS HOSPITAL · Oct 2, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called candesartan to see if it can help prevent migraines. Previous smaller studies have suggested that taking 16 mg of candesartan daily may reduce the number of migraine attacks, and this trial aims to confirm those findings in a larger group of people. Researchers will also test a lower dose of 8 mg to see if it is effective, as well as check if both doses have similar side effects.

To participate in the study, individuals must be between the ages of 18 and 75 and have a history of episodic migraines (meaning they have some migraine-free days) with 2 to 8 attacks per month over the last three months. Participants should not be using other migraine prevention medications during the study and must agree to follow study procedures. If you or someone you know is dealing with migraines and meets these criteria, this trial could be a potential option to explore for migraine relief. Keep in mind that there are certain health conditions and medications that would exclude someone from participating, so it's always best to discuss with a healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent
• • 2. Episodic migraine with or without aura according to ICHD-3 criteria
• • 3. At inclusion, patients should retrospectively have from 2 to 8 migraine attacks per month during the last 3 months. This frequency must be confirmed in the headache diary before randomization to treatment.
• • 4. Debut of migraine at least one year prior to inclusion
• • 5. Start of migraine before age 50 years
• • 6. No use of other migraine prophylactics during the study
• • 7. For women of child-bearing potential, use of highly effective contraception.
• Exclusion Criteria:
• • 1. Interval headache not distinguishable from migraine;
• • 2. Chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on ≥ 15 days/month
• • 3. Pregnancy, planning to get pregnant, inability to use contraceptives, lactating
• • 4. Clinical information on or signs of cholestasis or decreased hepatic or renal function. If in doubt, relevant blood tests should be performed
• • 5. High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator
• • 6. Hypersensitivity to candesartan
• • 7. History of angioneurotic oedema
• • 8. Current use of antihypertensive medication
• • 9. Current use of potassium supplements
• • 10. Current use of spironolactone
• • 11. Primary hyperaldosteronism (Conn's syndrome)
• • 12. Significant psychiatric illness
• • 13. Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study
• • 14. Having tried ≥ 3 prophylactic drugs against migraine during the last 10 years
• • 15. Previous use of candesartan
• • 16. Requiring detoxification from acute medication (triptans, opioids)
• • 17. Consistently failing to respond to any acute migraine medication
• • 18. Alcohol or illicit drug dependence.
• • 19. Inability to understand study procedures and to comply with them for the entire length of the study