Status:
COMPLETED
Candesartan Versus Propranolol for Migraine Prevention
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
AstraZeneca
St. Olavs Hospital
Conditions:
Migraine Without Aura
Migraine With Aura
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00884663
Start Date
April 1 2009
End Date
March 1 2012
Last Update
December 24 2013
Active Locations (1)
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1
Norwegian National Headache Centre, St. Olavs University Hospital
Trondheim, Norway, 7489