Migraine
Conditions
Keywords
Prevention and Control, Candesartan
Brief summary
The main objective of this study is to see whether the favorable preventative effect of candesartan 16 mg per day in episodic migraine, that was found previously in two 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) also a smaller dose of 8 mg is effective, and 2) whether the favorable side effect profile, seen in previous studies, can be confirmed, and whether it is even better with the smaller dose.
Interventions
DRUGCandesartan Oral Tablet 8 mg
1 over-encapsulated tablet once daily, containing candesartan 8 mg, for 12 weeks (84 days).
DRUGCandesartan Oral Tablet 16 mg
1 over-encapsulated tablet once daily, containing candesartan 16 mg, for 12 weeks (84 days).
DRUGPlacebo oral tablet
1 over-encapsulated tablet once daily, containing placebo, for 12 weeks (84 days).
Sponsors
Norwegian University of Science and Technology
Nordlandssykehuset HF
Molde Hospital
Haukeland University Hospital
Sorlandet Hospital HF
University Hospital, Akershus
Ullevaal University Hospital
Rikshospitalet University Hospital
University Hospital of North Norway
Tartu University Hospital
St. Olavs Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
A multicentre, binational, triple blind, placebo controlled, parallel group study of two doses
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in number of migraine days per 4 weeks, from baseline | 20 weeks plus final visit 1 week after treatment | participants will fill in a headache diary during 20 weeks treatment |
Countries
Estonia, Norway
Outcome results
None listed