Candesartan for Migraine Prevention: (CandMig-3)

St. Olavs Hospital

Status and phase: Active, not recruiting; Phase 2

Conditions: Migraine

Treatments: Drug: Candesartan Oral Tablet 16 mg; Drug: Candesartan Oral Tablet 8 mg; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04574713

63527

NFR 288699. (Other Grant/Funding Number)

2019-003386-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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450 participants in 3 patient groups, including a placebo group

Candesartan 8 mg

Experimental group

Treatment:

Drug: Candesartan Oral Tablet 8 mg

Candesartan 16 mg

Experimental group

Treatment:

Drug: Candesartan Oral Tablet 16 mg

Control group

Placebo Comparator group

Treatment:

Drug: Placebo oral tablet