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Candesartan Versus Propranolol for Migraine Prevention

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ClinicalTrials.gov Identifier: NCT00884663
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : December 24, 2013
St. Olavs Hospital
Kragerø Tablettproduksjon as, Norway
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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

Condition or disease Intervention/treatment Phase
Migraine Without Aura Migraine With Aura Chronic Migraine Drug: Candesartan Drug: propranolol Drug: placebo Phase 2 Phase 3

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 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  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Candesartan vs Propranolol for Migraine Prevention: A Double Blind, Placebo Controlled, Double Dummy, Triple Cross-over Study
Study Start Date : April 2009
Primary Completion Date : March 2012
Study Completion Date : March 2012

Arm Intervention/treatment
Experimental: 1 Candesartan Drug: Candesartan
Candesartan cilexitil tablets, 16 mg once daily
Active Comparator: 2 propranolol Drug: propranolol
Propranolol hydrochloride capsules 160 mg once daily, slow release formulation
Placebo Comparator: 3 Placebo Drug: placebo
placebo tablets and capsules

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884663

Norwegian National Headache Centre, St. Olavs University Hospital
Trondheim, Norway, 7489
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Kragerø Tablettproduksjon as, Norway
Principal Investigator: Lars J Stovner, Ph.D. Norwegian National Headache Centre, St. Olavs Hospital
Study Director: Lars J Stovner, Ph.D. Norwegian National Headache Centre

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00884663     History of Changes
Other Study ID Numbers: 01-47-7006-2008
2008-002312-17 ( EudraCT Number )
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Candesartan cilexetil
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists