Episodic migraine with and without aura MedDRA version: 20.0 Level: HLT Classification code 10027603 Term: Migraine headaches System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Candesartan cilexetil
Product Name: Candesartan cilexetil
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Department of Neurology and Clinical Neurophysiology, St Olavs Hospital, Trondheim University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 to 64 years 2. Signed informed consent 3. Episodic migraine with or without aura according to ICHD-3 criteria(17) 4. 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 randomisation to treatment . 5. Debut of migraine at least one year prior to inclusion 6. Start of migraine before age 50 years. 7. For women of child-bearing potential (WOCBP, see below) there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception (See below). After the baseline period, just before randomisation to the study drug, inclusion criteria will be evaluated once more, and the headache diary will be evaluated. If there are, according to the headache diary, fewer attacks than 2 or more than 8 per month, the baseline period can be extended to 8 weeks, and the patient can be randomized to a treatment then if there is a mean of 2-8 attacks per 4 weeks during the 8-week’s period. In WOCBP, a pregnancy test in the urine must be performed before start of the treatment period. The women can proceed in the study only if the test is negative. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Interval headache not distinguishable from migraine; 2) 2) Chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on = 15 days/month 3) Pregnancy, planning to get pregnant, nursing or inability to use contraceptives (See inclusion criteria, point 7) 4) Clinical information on or signs of cholestasis or decreased hepatic or renal function. If in doubt, relevant blood tests should be performed (See 4.2.3) 5) High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization , at the discretion of the investigator 6) Hypersensitivity to candesartan 7) History of angioneurotic edema 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 toxin less than 16 weeks, prior to start of study 14) Having tried = 2 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 length of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Can the favourable effect of candesartan 16 mg daily as migraine prophylactic, seen in the two smaller single-centre crossover studies , be confirmed in a larger parallel group multicentre and binational study? ;Secondary Objective: 1)Is there any effect of a daily dose of 8 mg, half of what has been used in the two previous studies? 2) Is the favourable side effect profile, seen in the previous studies, replicated in this larger study, and is it even better with a daily dose of 8 mg as compared to 16 mg? 3) What is the cost of candesartan treatment, considering cost of the medicine, of acute medicines for attacks, and lost worktime? ;Primary end point(s): Number of migraine days per 4 weeks. Migraine days are defined as days with moderate or severe headache accompanied by nausea, and/or phono- and photophobia, and lasting = 4 hours or is treated with the patient’s usual migraine medication (usually a triptan). ;Timepoint(s) of evaluation of this end point: In each patient, this will be evaluated after 12 weeks' treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Per 4 weeks, number of: 1. Days with headache 2. Hours with headache 3. Doses of analgesics 4. Doses of triptans 5. Days with sick leave In addition: 6. Headache intensity (0-3 scale) on days with headache 7. Number of responders (= 50% decrease in migraine days compared with baseline) 8. Number of reported side effects 9. Health economic analysis: Comparison of cost in the placebo and candesartan treatment groups, taking into consideration price of the medicine, price of acute medication, and lost worktime. ;Timepoint(s) of evaluation of this end point: In each patient, this will be evaluated after 12 weeks' treatment. Side effect will in addition be evaluated twice during the treatment period | — |
Countries
Estonia, Norway
Contacts
Public ContactHeadache research group
Department of Neuromedicine and Movement Science, NTNU- The Norwegian University of Science and Technology
Outcome results
None listed