Candesartan Versus Propranolol for Migraine Prevention

Last updated: December 22, 2013
Sponsor: Norwegian University of Science and Technology
Overall Status: Completed

Phase

2/3

Condition

Oral Facial Pain

Migraine (Pediatric)

Migraine (Adult)

Treatment

N/A

Clinical Study ID

NCT00884663
01-47-7006-2008
2008-002312-17
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 72
Study Start date:
April 01, 2009
Estimated Completion Date:
March 31, 2012

Study 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.

Connect with a study center

  • Norwegian National Headache Centre, St. Olavs University Hospital

    Trondheim, 7489
    Norway

    Site Not Available

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