Candesartan Versus Propranolol for Migraine Prevention

Chronic Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884663
• Other study ID #: 01-47-7006-2008
• Secondary ID: 2008-002312-17
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 20, 2009
• Last updated: December 22, 2013
• Start date: April 2009
• Est. completion date: March 2012

Study information

• Verified date: December 2013
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders
• Migraine with Aura
• Migraine Without Aura

Intervention

Drug:
• Candesartan
Candesartan cilexitil tablets, 16 mg once daily
• propranolol
Propranolol hydrochloride capsules 160 mg once daily, slow release formulation
• placebo
placebo tablets and capsules

Locations

Country	Name	City	State
Norway	Norwegian National Headache Centre, St. Olavs University Hospital	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	AstraZeneca, Kragerø Tablettproduksjon as, Norway, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. 2013 Dec 11;34(7 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Days with headache		One year	No
Secondary	Hours with headache		One year	No
Secondary	Headache intensity (0-3 scale) on days with headache		one year	No
Secondary	Doses of analgesics		one year	No
Secondary	Doses of triptans		One year	No
Secondary	Days with sick leave		one year	No
Secondary	Number of responders (= 50% decrease in migraine days compared with baseline)		one year	No
Secondary	Number of reported side effects		one year	Yes
Secondary	Number of predefined retrospective side effects		one year	Yes