Candesartan Versus Propranolol for Migraine Prevention | NCT00884663

Studies
Candesartan Versus Propranolol for Migraine Prevention

NCT00884663

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Dec 24, 2013Estimated

Enrollment

72Actual

Phase

Phase 2Phase 3

Conditions

Migraine Without Aura
Migraine With Aura
Chronic Migraine

Interventions

Candesartan
propranolol
placebo

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-002312-17	EudraCT Number

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Apr 20, 2009

First Submission Date that Met QC Criteria

Apr 20, 2009

First Posted Date

Apr 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2013

Last Update Posted Date

Dec 24, 2013Estimated

Name	Class
AstraZeneca	INDUSTRY
St. Olavs Hospital	OTHER
Kragerø Tablettproduksjon as, Norway	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1 Candesartan	Experimental	Drug: Candesartan
2 propranolol	Active Comparator	Drug: propranolol
3 Placebo	Placebo Comparator	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Candesartan	Drug	Candesartan cilexitil tablets, 16 mg once daily	1 Candesartan

Outcomes Module

Primary Outcomes

Measure	Description	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		One year

Secondary Outcomes

Measure	Description	Time Frame
Days with headache		One year
Hours with headache		One year
Headache intensity (0-3 scale) on days with headache

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars J Stovner, Ph.D.	Norwegian National Headache Centre, St. Olavs Hospital	Principal Investigator
Lars J Stovner, Ph.D.	Norwegian National Headache Centre	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Norwegian National Headache Centre, St. Olavs University Hospital		Trondheim		7489	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12503978	Background	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.
24335848	Result	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.

ID	Term
D020326	Migraine without Aura
D020325	Migraine with Aura

ID	Term
D008881	Migraine Disorders
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols