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CompletedNCT04574713CandMig-3Updated Aug 13, 2025

Candesartan for Migraine Prevention:

A Phase 2 interventional study of Candesartan Oral Tablet 8 mg and Candesartan Oral Tablet 16 mg in Migraine, sponsored by St. Olavs Hospital. Completed at 10 sites in 2 countries. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-08-13.

Sponsored by St. Olavs Hospital · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

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Conditions studied

  • Migraine

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Keywords

  • Prevention and Control
  • Candesartan
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 450 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

St. Olavs Hospital is the lead sponsor of 165 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
450 participants (actual)

Study arms

  • Experimental
    Candesartan 8 mg

    Drug: Candesartan Oral Tablet 8 mg

  • Experimental
    Candesartan 16 mg

    Drug: Candesartan Oral Tablet 16 mg

  • Placebo comparator
    Control group

    Drug: Placebo oral tablet

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).

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What researchers measure

Primary outcomes

  1. change in number of migraine days per 4 weeks, from baseline

    participants will fill in a headache diary during 20 weeks treatment

    Time frame: 20 weeks plus final visit 1 week after treatment

07

Study locations

10 sites
  • Tartu University Clinics
    Tartu, Estonia
  • 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, Norway
08

References and documents

Publications

  • Oie LR, Wergeland T, Salvesen O, Gravdahl GRB, Aschehoug I, Gulati S, Bj Rk MH, Lundqvist C, Alstadhaug KBR, Winsvold BS, Aamodt AH, Larsen IC, B E MG, Braschinsky M, Muller B, Vetvik KGT, Muller KI, Aaseth K, Khanevski AN, Ovrevik AB, Vegrim HM, Lindroos J, Eid K, Engstrand H, Bezgal B, Larsen MB, Osthus JHG, Stovner LJ, Tronvik E. Candesartan versus placebo for migraine prevention in patients with episodic migraine: a randomised, triple-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2025 Oct;24(10):817-827. doi: 10.1016/S1474-4422(25)00269-8. PubMed 40975098 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04574713
Lead sponsor
St. Olavs Hospital
Collaborators
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
Responsible party
Sponsor
First posted
Oct 5, 2020
Start date
Apr 9, 2021
Primary completion
Apr 12, 2024
Completion
Aug 8, 2024
Last update
Aug 13, 2025

Study contacts

Christian Samsonsen, md phd
study director · St Olavs Hospital, Dept Neurology & Clinical Neurophysiology
Jorunn L Helbostad, prof
study director · Norwegian University of Science and Technology, Fac MH, Dept INB
Erling Tronvik, md prof
principal investigator · Norwegian University of Science and Technology, Fac MH, Dept INB

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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