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Completed

NCT Number: NCT04574713

Candesartan for Migraine Prevention:

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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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tartu University Clinics, Tartu, Estonia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Candesartan Oral Tablet 8 mg

Drug

1 over-encapsulated tablet once daily, containing candesartan 8 mg, for 12 weeks (84 days).

Candesartan Oral Tablet 16 mg

Drug

1 over-encapsulated tablet once daily, containing candesartan 16 mg, for 12 weeks (84 days).

Placebo oral tablet

Drug

1 over-encapsulated tablet once daily, containing placebo, for 12 weeks (84 days).

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: CandMig-3

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 5, 2020
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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