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Candesartan Versus Propranolol for Migraine Prevention

Information source: Norwegian University of Science and Technology
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine Without Aura; Migraine With Aura; Chronic Migraine

Intervention: candesartan cilexitil (Drug); propranolol hydrochloride (Drug); placebo tablets and capsules (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

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

Overall contact:
Lars Jacob Stovner, Ph.D., Phone: +47 72 57 50 70, Email: lars.stovner@ntnu.no

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 headache

Hours 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

Lars Jacob Stovner, Ph.D., Phone: +47 72 57 50 70, Email: lars.stovner@ntnu.no

Norwegian National Headache Centre, St. Olavs University Hospital, Trondheim 7489, Norway; Recruiting
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: September 6, 2011

Page last updated: December 08, 2011

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