Candesartan for Migraine Prevention:

Last updated: April 4, 2024
Sponsor: St. Olavs Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

Oral Facial Pain

Chronic Pain

Migraine (Adult)

Treatment

Placebo oral tablet

Candesartan Oral Tablet 8 mg

Candesartan Oral Tablet 16 mg

Clinical Study ID

NCT04574713
63527
NFR 288699.
2019-003386-18
  • Ages 18-64
  • All Genders

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.

Eligibility Criteria

Inclusion

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 permonth during the last 3 months. This frequency must be confirmed in the headache diarybefore 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

Exclusion Criteria:

  1. Interval headache not distinguishable from migraine;
  2. Chronic migraine, chronic tension-type headache, medication overuse headache or otherheadache 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 renalfunction. If in doubt, relevant blood tests should be performed
  5. High degree of comorbidity and/or frailty associated with reduced life expectancy orhigh 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 toxinless 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 lengthof the study

Study Design

Total Participants: 450
Treatment Group(s): 3
Primary Treatment: Placebo oral tablet
Phase: 2
Study Start date:
April 26, 2020
Estimated Completion Date:
October 31, 2024

Connect with a study center

  • Tartu University Clinics

    Tartu,
    Estonia

    Site Not Available

  • Haukeland University Hospital

    Bergen,
    Norway

    Site Not Available

  • Nordland Hospital

    Bodø,
    Norway

    Site Not Available

  • Sørlandet Hospital

    Kristiansand,
    Norway

    Site Not Available

  • Akershus University Hospital AHUS

    Lørenskog,
    Norway

    Site Not Available

  • Møre and Romsdal Hospital Molde

    Molde,
    Norway

    Site Not Available

  • Rikshospitalet University Hospital

    Oslo,
    Norway

    Site Not Available

  • Ullevål University Hospital

    Oslo,
    Norway

    Site Not Available

  • University Hospital of North Norway

    Tromsø,
    Norway

    Site Not Available

  • St Olavs Hospital

    Trondheim,
    Norway

    Site Not Available

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