Candesartan Versus Propranolol for Migraine Prevention

December 22, 2013 updated by: Norwegian University of Science and Technology

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

72

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7489
        • Norwegian National Headache Centre, St. Olavs University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3 Placebo
Drug: placebo
placebo tablets and capsules
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Days with headache
Time Frame: One year
One year
Hours with headache
Time Frame: One year
One year
Headache intensity (0-3 scale) on days with headache
Time Frame: one year
one year
Doses of analgesics
Time Frame: one year
one year
Doses of triptans
Time Frame: One year
One year
Days with sick leave
Time Frame: one year
one year
Number of responders (≥ 50% decrease in migraine days compared with baseline)
Time Frame: one year
one year
Number of reported side effects
Time Frame: one year
one year
Number of predefined retrospective side effects
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 20, 2009

First Submitted That Met QC Criteria

April 20, 2009

First Posted (Estimate)

April 21, 2009

Study Record Updates

Last Update Posted (Estimate)

December 24, 2013

Last Update Submitted That Met QC Criteria

December 22, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-47-7006-2008
  • 2008-002312-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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