Candesartan for Migraine Prevention:
CandMig-3
3 other identifiers
interventional
450
2 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2021
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedStudy Start
First participant enrolled
April 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2024
CompletedAugust 13, 2025
August 1, 2025
3 years
September 28, 2020
August 12, 2025
Conditions
Keywords
Outcome Measures
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
20 weeks plus final visit 1 week after treatment
Study Arms (3)
Candesartan 8 mg
EXPERIMENTALCandesartan 16 mg
EXPERIMENTALControl group
PLACEBO COMPARATORInterventions
1 over-encapsulated tablet once daily, containing candesartan 8 mg, for 12 weeks (84 days).
1 over-encapsulated tablet once daily, containing candesartan 16 mg, for 12 weeks (84 days).
1 over-encapsulated tablet once daily, containing placebo, for 12 weeks (84 days).
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Episodic migraine with or without aura according to ICHD-3 criteria
- Start of migraine before age 50 years
- No use of other migraine prophylactics during the study
- For women of child-bearing potential, use of highly effective contraception.
You may not qualify if:
- Interval headache not distinguishable from migraine;
- Chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on ≥ 15 days/month
- Pregnancy, planning to get pregnant, inability to use contraceptives, lactating
- Clinical information on or signs of cholestasis or decreased hepatic or renal function. If in doubt, relevant blood tests should be performed
- High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator
- Hypersensitivity to candesartan
- History of angioneurotic oedema
- Current use of antihypertensive medication
- Current use of potassium supplements
- Current use of spironolactone
- Primary hyperaldosteronism (Conn's syndrome)
- Significant psychiatric illness
- Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study
- Having tried ≥ 3 prophylactic drugs against migraine during the last 10 years
- Previous use of candesartan
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Olavs Hospitallead
- Norwegian University of Science and Technologycollaborator
- Nordlandssykehuset HFcollaborator
- Molde Hospitalcollaborator
- Haukeland University Hospitalcollaborator
- Sorlandet Hospital HFcollaborator
- University Hospital, Akershuscollaborator
- Ullevaal University Hospitalcollaborator
- Rikshospitalet University Hospitalcollaborator
- University Hospital of North Norwaycollaborator
- Tartu University Hospitalcollaborator
Study Sites (10)
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
Related Publications (1)
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.
PMID: 40975098DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christian Samsonsen, md phd
St Olavs Hospital, Dept Neurology & Clinical Neurophysiology
- STUDY DIRECTOR
Jorunn L Helbostad, prof
Norwegian University of Science and Technology, Fac MH, Dept INB
- PRINCIPAL INVESTIGATOR
Erling Tronvik, md prof
Norwegian University of Science and Technology, Fac MH, Dept INB
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2020
First Posted
October 5, 2020
Study Start
April 9, 2021
Primary Completion
April 12, 2024
Study Completion
August 8, 2024
Last Updated
August 13, 2025
Record last verified: 2025-08