Clinical trial NCT04574713: Candesartan for Migraine Prevention:
Official title: Candesartan for Migraine Prevention: A Multicentre, Binational, Triple Blind, Placebo Controlled, Parallel Group Study of Two Doses of Candesartan (8 and 16 mg)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Keywords: Prevention and Control
Candesartan
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Nordlandssykehuset HF
name: Molde Hospital
name: Haukeland University Hospital
name: Sorlandet Hospital HF
name: University Hospital, Akershus
name: Ullevaal University Hospital
name: Rikshospitalet University Hospital
name: University Hospital of North Norway
name: Tartu University Hospital
First posted: 2020-10-05
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicentre, binational, triple blind, placebo controlled, parallel group study of two doses
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: change in number of migraine days per 4 weeks, from baseline
timeFrame: 20 weeks plus final visit 1 week after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Clinics
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Bodø
country: Norway
facility: Nordland Hospital
city: Kristiansand
country: Norway
facility: Sørlandet Hospital
city: Lørenskog
country: Norway
facility: Akershus University Hospital AHUS
city: Molde
country: Norway
facility: Møre and Romsdal Hospital Molde
city: Oslo
country: Norway
facility: Rikshospitalet University Hospital
city: Oslo
country: Norway
facility: Ullevål University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St Olavs Hospital, Dept Neurology & Clinical Neurophysiology
name: Christian Samsonsen, md phd
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology, Fac MH, Dept INB
name: Jorunn L Helbostad, prof
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology, Fac MH, Dept INB
name: Erling Tronvik, md prof
role: PRINCIPAL_INVESTIGATOR
References: