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NCT04574713CompletedPhase 2

Candesartan for Migraine Prevention:

Candesartan for Migraine Prevention: A Multicentre, Binational, Triple Blind, Placebo Controlled, Parallel Group Study of Two Doses of Candesartan (8 and 16 mg)

Source: ClinicalTrials.gov · Last updated 13 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
450 (actual)
First submitted
28 Sept 2020
Start date
9 Apr 2021
Primary completion date
12 Apr 2024
Lead sponsor
St. Olavs Hospital
Diseases
Migraine
NCT number
NCT04574713
EudraCT number
2019-003386-18

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 450
  • From 9 Apr 2021 to the primary completion date, 12 Apr 2024
  • 10 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on ≥ 15 days/month
  • Current use of antihypertensive medication
  • 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.

Other illness

  • Hypersensitivity to candesartan
  • History of angioneurotic oedema
  • Primary hyperaldosteronism (Conn's syndrome)
  • Significant psychiatric illness

Lab values

  • Current use of potassium supplements

Other

  • Interval headache not distinguishable from migraine;
  • 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
  • Current use of spironolactone
  • Inability to understand study procedures and to comply with them for the entire length of the study

Who the study is looking for

  • 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.

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tartu University Clinics
Coordinator of this site? Confirm its status
TartuEstoniaUnknown status
Haukeland University Hospital
Coordinator of this site? Confirm its status
BergenNorwayUnknown status
Nordland Hospital
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BodøNorwayUnknown status
Sørlandet hospital
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KristiansandNorwayUnknown status
Akershus University Hospital (Ahus)
Coordinator of this site? Confirm its status
LørenskogNorwayUnknown status
Møre and Romsdal Hospital Molde
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MoldeNorwayUnknown status
Rikshospitalet University Hospital
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OsloNorwayUnknown status
Ullevål University Hospital
Coordinator of this site? Confirm its status
OsloNorwayUnknown status
University Hospital of North Norway
Coordinator of this site? Confirm its status
TromsøNorwayUnknown status
St Olavs Hospital
Coordinator of this site? Confirm its status
TrondheimNorwayUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.