Candesartan for Migraine Prevention:

Migraine Clinical Trial

— CandMig-3  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04574713
• Other study ID #: 63527
• Secondary ID: 2019-003386-18NF
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 26, 2020
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: October 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Candesartan Oral Tablet 8 mg
1 over-encapsulated tablet once daily, containing candesartan 8 mg, for 12 weeks (84 days).
• Candesartan Oral Tablet 16 mg
1 over-encapsulated tablet once daily, containing candesartan 16 mg, for 12 weeks (84 days).
• Placebo oral tablet
1 over-encapsulated tablet once daily, containing placebo, for 12 weeks (84 days).

Locations

Country	Name	City	State
Estonia	Tartu University Clinics	Tartu
Norway	Haukeland University Hospital	Bergen
Norway	Nordland Hospital	Bodø
Norway	Sørlandet Hospital	Kristiansand
Norway	Akershus University Hospital AHUS	Lørenskog
Norway	Møre and Romsdal Hospital Molde	Molde
Norway	Rikshospitalet University Hospital	Oslo
Norway	Ullevål University Hospital	Oslo
Norway	University Hospital of North Norway	Tromsø
Norway	St Olavs Hospital	Trondheim

Sponsors (11)

Lead Sponsor	Collaborator
St. Olavs Hospital	Haukeland University Hospital, Molde Hospital, Nordlandssykehuset HF, Norwegian University of Science and Technology, Rikshospitalet University Hospital, Sorlandet Hospital HF, Tartu University Hospital, Ullevaal University Hospital, University Hospital of North Norway, University Hospital, Akershus

Countries where clinical trial is conducted

Estonia,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in number of migraine days per 4 weeks, from baseline	participants will fill in a headache diary during 20 weeks treatment	20 weeks plus final visit 1 week after treatment