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Completed

NCT Number: NCT00884663

Candesartan Versus Propranolol for Migraine Prevention

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Norwegian National Headache Centre, St. Olavs University Hospital

Trondheim, 7489, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Candesartan

Drug

Candesartan cilexitil tablets, 16 mg once daily

Propranolol

Drug

Propranolol hydrochloride capsules 160 mg once daily, slow release formulation

Placebo

Drug

placebo tablets and capsules

Primary outcomes

  1. 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

Secondary outcomes

  1. Days with headache

    Time frame: One year

  2. Hours with headache

    Time frame: One year

  3. Headache intensity (0-3 scale) on days with headache

    Time frame: one year

  4. Doses of analgesics

    Time frame: one year

  5. Doses of triptans

    Time frame: One year

  6. Days with sick leave

    Time frame: one year

  7. Number of responders (≥ 50% decrease in migraine days compared with baseline)

    Time frame: one year

  8. Number of reported side effects

    Time frame: one year

  9. Number of predefined retrospective side effects

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • AstraZeneca
  • Kragerø Tablettproduksjon as, Norway
  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 21, 2009
Registry last updated
Dec 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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