Trial | NCT00884663  Report issue

Title

Candesartan Versus Propranolol for Migraine Prevention
Candesartan vs Propranolol for Migraine Prevention: A Double Blind, Placebo Controlled, Double Dummy, Triple Cross-over Study

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    72
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 Started
Apr 30
2009
Primary Completion
Mar 31
2012
Study Completion
Mar 31
2012
Last Update
Dec 24
2013
Estimate

Drug Candesartan

Candesartan cilexitil tablets, 16 mg once daily

Drug propranolol

Propranolol hydrochloride capsules 160 mg once daily, slow release formulation

Drug placebo

placebo tablets and capsules

1 Candesartan Experimental

2 propranolol Active Comparator

3 Placebo Placebo Comparator

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
No Results Posted