The main aim of the present study is to compare candesartan with propranolol for migraine prophylaxis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Candesartan cilexitil tablets, 16 mg once daily
Propranolol hydrochloride capsules 160 mg once daily, slow release formulation
placebo tablets and capsules
Norwegian National Headache Centre, St. Olavs University Hospital
Trondheim, Norway
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
Time frame: One year
Days with headache
Time frame: One year
Hours with headache
Time frame: One year
Headache intensity (0-3 scale) on days with headache
Time frame: one year
Doses of analgesics
Time frame: one year
Doses of triptans
Time frame: One year
Days with sick leave
Time frame: one year
Number of responders (≥ 50% decrease in migraine days compared with baseline)
Time frame: one year
Number of reported side effects
Time frame: one year
Number of predefined retrospective side effects
Time frame: one year
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