MigrainePhase 2CandMig-3NCT04574713
Candesartan for Migraine Prevention:
A Phase 2 study testing Candesartan Oral Tablet 8 mg and Candesartan Oral Tablet 16 mg in people with Migraine, run by St. Olavs Hospital at 10 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Migraine
- What is being tested?
- Candesartan Oral Tablet 8 mg and Candesartan Oral Tablet 16 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 9 Apr 2021to 8 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent
- Episodic migraine with or without aura according to ICHD-3 criteria
- 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.
- Debut of migraine at least one year prior to inclusion
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
- Requiring detoxification from acute medication (triptans, opioids)
- Consistently failing to respond to any acute migraine medication
- Alcohol or illicit drug dependence.
- Inability to understand study procedures and to comply with them for the entire length of the study
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Norway9 sites
Haukeland University Hospital
Bergen
Nordland Hospital
Bodø
Sørlandet Hospital
Kristiansand
Akershus University Hospital AHUS
Lørenskog
Møre and Romsdal Hospital Molde
Molde
Rikshospitalet University Hospital
Oslo
Ullevål University Hospital
Oslo
University Hospital of North Norway
Tromsø
St Olavs Hospital
Trondheim
About this study
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)
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.
- Conditions
- Migraine
- Being tested
- Candesartan Oral Tablet 8 mg, Candesartan Oral Tablet 16 mg, Placebo oral tablet
- Keywords
- Prevention and Control, Candesartan
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan Oral Tablet 8 mgDrug
1 over-encapsulated tablet once daily, containing candesartan 8 mg, for 12 weeks (84 days).
Candesartan Oral Tablet 16 mgDrug
1 over-encapsulated tablet once daily, containing candesartan 16 mg, for 12 weeks (84 days).
Placebo oral tabletDrug
1 over-encapsulated tablet once daily, containing placebo, for 12 weeks (84 days).
| Study group | Role | What they receive |
|---|---|---|
| Candesartan 8 mg | Experimental | Not described Receives: Drug: Candesartan Oral Tablet 8 mg |
| Candesartan 16 mg | Experimental | Not described Receives: Drug: Candesartan Oral Tablet 16 mg |
| Control group | Placebo comparator | Not described Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in number of migraine days per 4 weeks, from baseline
participants will fill in a headache diary during 20 weeks treatment
Measured: 20 weeks plus final visit 1 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start9 Apr 2021
- Primary completion12 Apr 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicentre, binational, triple blind, placebo controlled, parallel group study of two doses
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Christian Samsonsen, md phd, Study director, St Olavs Hospital, Dept Neurology & Clinical NeurophysiologyJorunn L Helbostad, prof, Study director, Norwegian University of Science and Technology, Fac MH, Dept INBErling Tronvik, md prof, Principal investigator, Norwegian University of Science and Technology, Fac MH, Dept INB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574713
- Sponsor's protocol ID
- 63527
- Other IDs
- 2019-003386-18, NFR 288699., 2019
- Acronym
- CandMig-3
- Status last verified
- Aug 2025
- First submitted
- 28 Sep 2020
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04574713
- Acronym / sponsor ID
- CandMig-3 / 63527
- Conditions
- Migraine
- Keywords
- Prevention and Control, Candesartan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- 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
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- A multicentre, binational, triple blind, placebo controlled, parallel group study of two doses
| Arm | Type | Receives |
|---|---|---|
| Candesartan 8 mg | Experimental | Drug: Candesartan Oral Tablet 8 mg |
| Candesartan 16 mg | Experimental | Drug: Candesartan Oral Tablet 16 mg |
| Control group | Placebo comparator | Drug: Placebo oral tablet |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed informed consent
- Episodic migraine with or without aura according to ICHD-3 criteria
- 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.
- Debut of migraine at least one year prior to inclusion
- Start of migraine before age 50 years
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candesartan Oral Tablet 8 mg1 over-encapsulated tablet once daily, containing candesartan 8 mg, for 12 weeks (84 days). | Drug | Candesartan 8 mg |
| Candesartan Oral Tablet 16 mg1 over-encapsulated tablet once daily, containing candesartan 16 mg, for 12 weeks (84 days). | Drug | Candesartan 16 mg |
| Placebo oral tablet1 over-encapsulated tablet once daily, containing placebo, for 12 weeks (84 days). | Drug | Control group |
Primary outcome
change in number of migraine days per 4 weeks, from baseline
Time frame: 20 weeks plus final visit 1 week after treatment
participants will fill in a headache diary during 20 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Derived from this study: PubMed 40975098Oie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Candesartan Oral Tablet 8 mg and Candesartan Oral Tablet 16 mg in people with Migraine, run by St. Olavs Hospital at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Norway, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in number of migraine days per 4 weeks, from baseline (time frame: 20 weeks plus final visit 1 week after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04574713, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.