Candesartan for Migraine Prevention:

• Status: Recruiting
• Trial end date: 2024-10-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norwegian University of Science and Technology; St. Olavs Hospital
• Collaborators: Haukeland University Hospital; Molde Hospital; Nordlandssykehuset HF; Norwegian University of Science and Technology; Rikshospitalet University Hospital; Sorlandet Hospital HF; St. Olavs Hospital; Tartu University Hospital; Ullevaal University Hospital; University Hospital of North Norway; University Hospital, Akershus
• Treatments: Candesartan; Candesartan cilexetil

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