Candesartan Versus Propranolol for Migraine Prevention

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Migraine Without Aura; Migraine With Aura; Chronic Migraine	Drug: Candesartan; Drug: propranolol; Drug: placebo	Phase 2; Phase 3

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 Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	72 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Candesartan vs Propranolol for Migraine Prevention: A Double Blind, Placebo Controlled, Double Dummy, Triple Cross-over Study
Study Start Date :	April 2009
Actual Primary Completion Date :	March 2012
Actual Study Completion Date :	March 2012

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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
Placebo Comparator: 3 Placebo	Drug: placebo; placebo tablets and capsules

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 Measures :

1. Days with headache [ Time Frame: One year ]
2. Hours with headache [ Time Frame: One year ]
3. Headache intensity (0-3 scale) on days with headache [ Time Frame: one year ]
4. Doses of analgesics [ Time Frame: one year ]
5. Doses of triptans [ Time Frame: One year ]
6. Days with sick leave [ Time Frame: one year ]
7. Number of responders (≥ 50% decrease in migraine days compared with baseline) [ Time Frame: one year ]
8. Number of reported side effects [ Time Frame: one year ]
9. Number of predefined retrospective side effects [ Time Frame: one year ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Norwegian University of Science and Technology

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

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

Other Publications:

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.

Responsible Party:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00884663 History of Changes
Other Study ID Numbers:	01-47-7006-2008; 2008-002312-17 ( EudraCT Number )
First Posted:	April 21, 2009
Last Update Posted:	December 24, 2013
Last Verified:	December 2013

Additional relevant MeSH terms:

Migraine Disorders; Migraine with Aura; Migraine without Aura; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Propranolol; Candesartan; Candesartan cilexetil	Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists