Candesartan Versus Propranolol for Migraine Prevention

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
St. Olavs Hospital
Kragerø Tablettproduksjon as, Norway
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00884663
First received: April 20, 2009
Last updated: December 22, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Migraine Without Aura
Migraine With Aura
Chronic Migraine
Drug: Candesartan
Drug: propranolol
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Days with headache [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Hours with headache [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Headache intensity (0-3 scale) on days with headache [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Doses of analgesics [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Doses of triptans [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Days with sick leave [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Number of responders (≥ 50% decrease in migraine days compared with baseline) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Number of reported side effects [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Number of predefined retrospective side effects [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: April 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884663

Locations
Norway
Norwegian National Headache Centre, St. Olavs University Hospital
Trondheim, Norway, 7489
Sponsors and Collaborators
Norwegian University of Science and Technology
AstraZeneca
St. Olavs Hospital
Kragerø Tablettproduksjon as, Norway
Investigators
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
  More Information

Publications:
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
Study First Received: April 20, 2009
Last Updated: December 22, 2013
Health Authority: Norway: Norwegian Medicines Agency

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
Propranolol
Candesartan
Candesartan cilexetil
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 26, 2014