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Candesartan Versus Propranolol for Migraine Prevention

NCT ID: NCT00884663

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Migraine Without Aura Migraine With Aura Chronic Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1 Candesartan

Group Type EXPERIMENTAL

Candesartan

Intervention Type DRUG

Candesartan cilexitil tablets, 16 mg once daily

2 propranolol

Group Type ACTIVE_COMPARATOR

propranolol

Intervention Type DRUG

Propranolol hydrochloride capsules 160 mg once daily, slow release formulation

3 Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo tablets and capsules

Interventions

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Candesartan

Candesartan cilexitil tablets, 16 mg once daily

Intervention Type DRUG

propranolol

Propranolol hydrochloride capsules 160 mg once daily, slow release formulation

Intervention Type DRUG

placebo

placebo tablets and capsules

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Kragerø Tablettproduksjon as, Norway

UNKNOWN

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars J Stovner, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Norwegian National Headache Centre, St. Olavs Hospital

Lars J Stovner, Ph.D.

Role: STUDY_DIRECTOR

Norwegian National Headache Centre

Locations

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Norwegian National Headache Centre, St. Olavs University Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Tronvik E, Stovner LJ, Helde G, Sand T, Bovim G. Prophylactic treatment of migraine with an angiotensin II receptor blocker: a randomized controlled trial. JAMA. 2003 Jan 1;289(1):65-9. doi: 10.1001/jama.289.1.65.

Reference Type BACKGROUND
PMID: 12503978 (View on PubMed)

Stovner LJ, Linde M, Gravdahl GB, Tronvik E, Aamodt AH, Sand T, Hagen K. A comparative study of candesartan versus propranolol for migraine prophylaxis: A randomised, triple-blind, placebo-controlled, double cross-over study. Cephalalgia. 2014 Jun;34(7):523-32. doi: 10.1177/0333102413515348. Epub 2013 Dec 11.

Reference Type RESULT
PMID: 24335848 (View on PubMed)

Other Identifiers

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2008-002312-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

01-47-7006-2008

Identifier Type: -

Identifier Source: org_study_id