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
Eligibility Criteria
Inclusion
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 permonth during the last 3 months. This frequency must be confirmed in the headache diarybefore 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
Exclusion Criteria:
- Interval headache not distinguishable from migraine;
- Chronic migraine, chronic tension-type headache, medication overuse headache or otherheadache 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 renalfunction. If in doubt, relevant blood tests should be performed
- High degree of comorbidity and/or frailty associated with reduced life expectancy orhigh 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 toxinless 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 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,
EstoniaSite Not Available
Haukeland University Hospital
Bergen,
NorwaySite Not Available
Nordland Hospital
Bodø,
NorwaySite Not Available
Sørlandet Hospital
Kristiansand,
NorwaySite Not Available
Akershus University Hospital AHUS
Lørenskog,
NorwaySite Not Available
Møre and Romsdal Hospital Molde
Molde,
NorwaySite Not Available
Rikshospitalet University Hospital
Oslo,
NorwaySite Not Available
Ullevål University Hospital
Oslo,
NorwaySite Not Available
University Hospital of North Norway
Tromsø,
NorwaySite Not Available
St Olavs Hospital
Trondheim,
NorwaySite Not Available
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