Phase
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
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 headachediary 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
Exclusion Criteria:
Interval headache not distinguishable from migraine;
Chronic migraine, chronic tension-type headache, medication overuse headache orother 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 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 entirelength of the study
Study Design
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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