Candesartan Versus Propranolol for Migraine Prevention
Information source: Norwegian University of Science and Technology
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine Without Aura; Migraine With Aura; Chronic Migraine
Intervention: Candesartan (Drug); propranolol (Drug); placebo (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Norwegian University of Science and Technology Official(s) and/or principal investigator(s): Lars J Stovner, Ph.D., Principal Investigator, Affiliation: Norwegian National Headache Centre, St. Olavs Hospital Lars J Stovner, Ph.D., Study Director, Affiliation: Norwegian National Headache Centre
Summary
The main aim of the present study is to compare candesartan with propranolol for migraine
prophylaxis.
Clinical Details
Official title: Candesartan vs Propranolol for Migraine Prevention: A Double Blind, Placebo Controlled, Double Dummy, Triple Cross-over Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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: Days with headacheHours 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
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Norwegian National Headache Centre, St. Olavs University Hospital, Trondheim 7489, Norway
Additional Information
Related 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.
Starting date: April 2009
Last updated: December 22, 2013
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