Candesartan for Migraine Prevention:

Study Overview
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Brief Summary
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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.

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

Conditions
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Migraine

Intervention / Treatment
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* Drug: Candesartan Oral Tablet 8 mg
* Drug: Candesartan Oral Tablet 16 mg
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A multicentre, binational, triple blind, placebo controlled, parallel group study of two doses
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Candesartan 8 mg<br> | Drug: Candesartan Oral Tablet 8 mg<br>* 1 over-encapsulated tablet once daily, containing candesartan 8 mg, for 12 weeks (84 days).<br>|
| Experimental: Candesartan 16 mg<br> | Drug: Candesartan Oral Tablet 16 mg<br>* 1 over-encapsulated tablet once daily, containing candesartan 16 mg, for 12 weeks (84 days).<br>|
| Placebo Comparator: Control group<br> | Drug: Placebo oral tablet<br>* 1 over-encapsulated tablet once daily, containing placebo, for 12 weeks (84 days).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in number of migraine days per 4 weeks, from baseline | participants will fill in a headache diary during 20 weeks treatment | 20 weeks plus final visit 1 week after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention and Control, Candesartan