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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-002737-39 | EudraCT Number | ||
| 045-04 | Other Identifier | Norwegian National Headache Centre | |
| 10815 | Other Identifier | NSD |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
The purpose of this study is to determine whether candesartan cilexetil are effective prophylactic treatment of episodic Cluster headache
Cluster headache is an unilateral headache with periodic attacks, that usually lasts for 6 to 12 weeks. The pain is usually unbearable. The attacks are treated with injections of sumatriptan (migraine medication)and inhalation of oxygen.
The most common prophylactics today has limited effect and a risk of side effects.
Candesartan has in one study shown a clinically significant effect in migraine prophylaxis.
The angiotensin II receptor blocker, candesartan is well tolerated with side-effects not significantly different from placebo and with few drug interactions. We therefore wish to investigate the prophylactic effect in treatment of cluster in headache patients.
This will be a multicenter, double-blind, randomized, parallel study where the prophylactic effect of candesartan is compared to placebo in a period of 3 weeks. First week 16 mg and the following 2 weeks 32 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| candesartan | Experimental | candesartan cilexetil 16 mg (one tablet/day) in week 1 and 32 mg (2 tablets/day) in week 3, provided for the study by AstraZeneca |
|
| placebo | Placebo Comparator | placebo one tablet/day in week 1 and 2 tablets/day in week 3, provided for the study by AstraZeneca. Same size, weight, taste and appearance as experimental drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| candesartan cilexetil | Drug |
|
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| frequency of attacks per week | change from 'pseudobaseline' week 1 to week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| level of disability | 5-point scale; 0= no disability, 1= mild, 2= moderate, 3= severe, 4= unbearable | change from 'pseudobaseline' week 1 to week 3 |
| duration of attacks | change from 'pseudobaseline' week 1 to week 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars J Stovner, PhD | Norwegian National Headache Center St.Olavs Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwegian National Headache Centre St.Olavs Hospital | Trondheim | Trondheim | 7006 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12503978 | Background | 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. doi: 10.1001/jama.289.1.65. | |
| 23598371 | Result | Tronvik E, Wienecke T, Monstad I, Dahlof C, Boe MG, Tjensvoll AB, Salvesen R, Zwart JA, Jansson SO, Stovner LJ. Randomised trial on episodic cluster headache with an angiotensin II receptor blocker. Cephalalgia. 2013 Sep;33(12):1026-34. doi: 10.1177/0333102413484989. Epub 2013 Apr 18. |
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| C077793 | candesartan cilexetil |
| D057911 | Angiotensin Receptor Antagonists |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Drug |
|
| hours with cluster headache | change from 'pseudobaseline' week 1 to week 3 |
| days with cluster headache | change from 'pseudobaseline' week 1 to week 3 |
| occurrence of autonomic symptoms | change from 'pseudobaseline' week 1 to week 3 |
| number of treatments with sumatriptan or oxygen | change from 'pseudobaseline' week 1 to week 3 |
| patient satisfaction with treatment | scale from 1 to 10 with 1= very poor effect and 10= very good effect | change from 'pseudobaseline' week 1 to week 3 |
| headache severity index | product of level of disability and duration of attacks | change from baseline to 1 week and 3 week |
| candesartan-responders | patients with a 50% or more reduction in attack frequency in week 3 than in week 1 | 3 weeks |
| placebo-responders | patients with a 50% or more reduction in attack frequency in week 3 than in week 1 | 3 weeks |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |