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Candesartan Versus Propranolol for Migraine Prevention

Primary Purpose

Migraine Without Aura, Migraine With Aura, Chronic Migraine

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Candesartan
propranolol
placebo
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Without Aura

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norwegian National Headache Centre, St. Olavs University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1 Candesartan

2 propranolol

3 Placebo

Arm Description

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
April 20, 2009
Last Updated
December 22, 2013
Sponsor
Norwegian University of Science and Technology
Collaborators
AstraZeneca, St. Olavs Hospital, Kragerø Tablettproduksjon as, Norway
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1. Study Identification

Unique Protocol Identification Number
NCT00884663
Brief Title
Candesartan Versus Propranolol for Migraine Prevention
Official Title
Candesartan vs Propranolol for Migraine Prevention: A Double Blind, Placebo Controlled, Double Dummy, Triple Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
AstraZeneca, St. Olavs Hospital, Kragerø Tablettproduksjon as, Norway

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Without Aura, Migraine With Aura, Chronic Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Candesartan
Arm Type
Experimental
Arm Title
2 propranolol
Arm Type
Active Comparator
Arm Title
3 Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Candesartan
Intervention Description
Candesartan cilexitil tablets, 16 mg once daily
Intervention Type
Drug
Intervention Name(s)
propranolol
Intervention Description
Propranolol hydrochloride capsules 160 mg once daily, slow release formulation
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablets and capsules
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Days with headache
Time Frame
One year
Title
Hours with headache
Time Frame
One year
Title
Headache intensity (0-3 scale) on days with headache
Time Frame
one year
Title
Doses of analgesics
Time Frame
one year
Title
Doses of triptans
Time Frame
One year
Title
Days with sick leave
Time Frame
one year
Title
Number of responders (≥ 50% decrease in migraine days compared with baseline)
Time Frame
one year
Title
Number of reported side effects
Time Frame
one year
Title
Number of predefined retrospective side effects
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars J Stovner, Ph.D.
Organizational Affiliation
Norwegian National Headache Centre, St. Olavs Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars J Stovner, Ph.D.
Organizational Affiliation
Norwegian National Headache Centre
Official's Role
Study Director
Facility Information:
Facility Name
Norwegian National Headache Centre, St. Olavs University Hospital
City
Trondheim
ZIP/Postal Code
7489
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
12503978
Citation
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.
Results Reference
background
PubMed Identifier
24335848
Citation
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.
Results Reference
result

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Candesartan Versus Propranolol for Migraine Prevention

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