Candesartan Versus Propranolol for Migraine Prevention
This study is ongoing, but not recruiting participants.
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
First received: April 20, 2009
Last updated: October 15, 2012
Last verified: October 2012
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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 Drug: propranolol Drug: placebo |
Phase 2 Phase 3 |
| 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
Drug Information available for:
Propranolol hydrochloride
Propranolol
Candesartan
Candesartan cilexetil
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
Candesartan cilexitil tablets, 16 mg once daily
|
| Active Comparator: 2 propranolol |
Drug: propranolol
Propranolol hydrochloride capsules 160 mg once daily, slow release formulation
|
| Placebo Comparator: 3 Placebo |
Drug: placebo
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
Locations
| Norway | |
| Norwegian National Headache Centre, St. Olavs University Hospital | |
| 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:
| Responsible Party: | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT00884663 History of Changes |
| Other Study ID Numbers: | 01-47-7006-2008, 2008-002312-17 |
| Study First Received: | April 20, 2009 |
| Last Updated: | October 15, 2012 |
| 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 May 23, 2013