Candesartan Versus Propranolol for Migraine Prevention

Phase 2

Completed

• Conditions: Migraine Without Aura; Migraine With Aura; Chronic Migraine
• Interventions: Drug: placebo; Drug: propranolol; Drug: Candesartan

• Registration Number: NCT00884663
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

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

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 Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-21
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-22
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3 Placebo	placebo	-
2 propranolol	propranolol	-
1 Candesartan	Candesartan	-

Primary Outcome Measures

Name	Time	Method
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	One year

Secondary Outcome Measures

Name	Time	Method
Number of responders (≥ 50% decrease in migraine days compared with baseline)	one year
Number of reported side effects	one year
Number of predefined retrospective side effects	one year
Doses of analgesics	one year
Doses of triptans	One year
Days with sick leave	one year
Days with headache	One year
Hours with headache	One year
Headache intensity (0-3 scale) on days with headache	one year

Trial Locations

Locations (1)

Norwegian National Headache Centre, St. Olavs University Hospital; 🇳🇴 Trondheim, Norway