Clinical trial NCT00884663: Candesartan Versus Propranolol for Migraine Prevention
Official title: Candesartan vs Propranolol for Migraine Prevention: A Double Blind, Placebo Controlled, Double Dummy, Triple Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Migraine Without Aura
Migraine With Aura
Chronic Migraine
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: St. Olavs Hospital
name: Kragerø Tablettproduksjon as, Norway
First posted: 2009-04-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main aim of the present study is to compare candesartan with propranolol for migraine prophylaxis.

Detailed description: Candesartan was shown to be effective for migraine prophylaxis in a randomized double blind cross-over study published in 2003. The drug is now widely used for this purpose in many countries, although no confirmatory study has been published. The aims of the present study are: 1) to see if the results in the first candesartan study can be replicated in a new patient population, including patients with chronic migraine, and, 2) to perform a head-to-head comparison of candesartan 16 mg/day with standard treatment with propranolol 160 mg slow release. We also intend to study whether responsiveness to these drugs may be related to heart rate variability and baroreceptor sensitivity.

Eligibility criteria: Inclusion Criteria:

* age 18 to 65 years
* retrospectively have ≥ 2 migraine attacks per month during the last 3 months
* during the baseline period have ≥ 2 migraine attacks
* debut of migraine at least one year prior to inclusion
* start of migraine before age 50 years.

Exclusion Criteria:

* interval headache not distinguishable from migraine
* chronic tension-type headache or other headache occurring on ≥ 15 days/month
* pregnancy, nursing or inability to use contraceptives
* heart conduction block on ECG or significant ECG abnormality on inclusion
* heart rate \< 54 after 3 minutes rest
* previous or present asthma, diabetes; decreased hepatic or renal function
* hypersensitivity to active substance
* history of angioneurotic edema
* significant psychiatric illness
* use of daily migraine prophylactics less than 4 weeks prior to start of study
* having tried ≥ 3 prophylactic drugs against migraine during the last 10 years
* previous use of propranolol or candesartan in adequate doses
* previous discontinuation of either Atacand or Inderal Retard (or another beta blocker) due to side effects
* current use of antihypertensive medication
* require use of rizatriptan (Maxalt) 10 mg tabl.
* subjects requiring detoxification from acute medication (ergotamines, opioids)
* patients who consistently fail to respond to any acute migraine medication
* patients with alcohol or illicit drug dependence

Primary outcomes:
measure: The number of days per 4 weeks with moderate or severe headache lasting ≥ 4 hours or is treated with the patient's usual headache medication
timeFrame: One year
Secondary outcomes:
measure: Days with headache
timeFrame: One year
measure: Hours with headache
timeFrame: One year
measure: Headache intensity (0-3 scale) on days with headache
timeFrame: one year
measure: Doses of analgesics
timeFrame: one year
measure: Doses of triptans
timeFrame: One year
measure: Days with sick leave
timeFrame: one year
measure: Number of responders (≥ 50% decrease in migraine days compared with baseline)
timeFrame: one year
measure: Number of reported side effects
timeFrame: one year
measure: Number of predefined retrospective side effects
timeFrame: one year
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian National Headache Centre, St. Olavs University Hospital
Study officials:
affiliation: Norwegian National Headache Centre, St. Olavs Hospital
name: Lars J Stovner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian National Headache Centre
name: Lars J Stovner, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Tronvik E, Stovner LJ, Helde G, Sand T, Bovim G. Prophylactic treatment of migraine with an angiotensin II receptor blocker: a randomized controlled trial. JAMA. 2003 Jan 1;289(1):65-9. doi: 10.1001/jama.289.1.65.
citation: Stovner LJ, Linde M, Gravdahl GB, Tronvik E, Aamodt AH, Sand T, Hagen K. A comparative study of candesartan versus propranolol for migraine prophylaxis: A randomised, triple-blind, placebo-controlled, double cross-over study. Cephalalgia. 2014 Jun;34(7):523-32. doi: 10.1177/0333102413515348. Epub 2013 Dec 11.