Candesartan Versus Propranolol for Migraine Prevention

Norwegian University of Science and Technology

Status and phase: Completed; Phase 3; Phase 2

Conditions: Migraine With Aura; Chronic Migraine; Migraine Without Aura

Treatments: Drug: Candesartan; Drug: placebo; Drug: propranolol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00884663

2008-002312-17 (EudraCT Number)

01-47-7006-2008

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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72 participants in 3 patient groups, including a placebo group

1 Candesartan

Experimental group

Treatment:

Drug: Candesartan

2 propranolol

Active Comparator group

Treatment:

Drug: propranolol

3 Placebo

Placebo Comparator group

Treatment:

Drug: placebo