Candesartan Versus Propranolol for Migraine Prevention - Full Text View

Sponsor:	Norwegian University of Science and Technology
Collaborators:	AstraZeneca St. Olavs Hospital Kragerø Tablettproduksjon as, Norway
Information provided by (Responsible Party):	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00884663

Purpose

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

Condition	Intervention	Phase
Migraine Without Aura Migraine With Aura Chronic Migraine	Drug: candesartan cilexitil Drug: propranolol hydrochloride Drug: placebo tablets and capsules	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: CV 11974 Candesartan cilexetil Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

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 [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Days with headache [ Time Frame: One year ] [ Designated as safety issue: No ]
Hours with headache [ Time Frame: One year ] [ Designated as safety issue: No ]
Headache intensity (0-3 scale) on days with headache [ Time Frame: one year ] [ Designated as safety issue: No ]
Doses of analgesics [ Time Frame: one year ] [ Designated as safety issue: No ]
Doses of triptans [ Time Frame: One year ] [ Designated as safety issue: No ]
Days with sick leave [ Time Frame: one year ] [ Designated as safety issue: No ]
Number of responders (≥ 50% decrease in migraine days compared with baseline) [ Time Frame: one year ] [ Designated as safety issue: No ]
Number of reported side effects [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Number of predefined retrospective side effects [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	72
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Candesartan	Drug: candesartan cilexitil tablets, 16 mg once daily
Active Comparator: 2 propranolol	Drug: propranolol hydrochloride capsules 160 mg once daily, slow release formulation
Placebo Comparator: 3 Placebo	Drug: placebo tablets and capsules placebo tablets and capsules

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884663

Contacts

Contact: Lars Jacob Stovner, Ph.D.	+47 72 57 50 70	lars.stovner@ntnu.no
Contact: Knut Hagen, Ph.D	+47 72 57 50 80	knut.hagen@ntnu.no

Locations

Norway
Norwegian National Headache Centre, St. Olavs University Hospital	Recruiting
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

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, EUDRACT 2008-002312-17
Study First Received:	April 20, 2009
Last Updated:	September 6, 2011
Health Authority:	Norway: Norwegian Medicines Agency

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
Anti-Arrhythmia Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012