Prophylactic Treatment of Episodic Cluster Headache

Study Overview
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Brief Summary
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The purpose of this study is to determine whether candesartan cilexetil are effective prophylactic treatment of episodic Cluster headache

Detailed Description
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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.

Official Title
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Prophylactic Treatment of Episodic Cluster Headache With an Angiotensin II Receptor Blocker (Candesartan Cilexetil); a Randomized, Placebo Controlled Parallel Study

Conditions
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Cluster Headache

Intervention / Treatment
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* Drug: candesartan cilexetil
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The episodic cluster headache must be diagnosed according to the IHS classification. Had at least one episode with cluster headache before inclusion. Previously had at least one cluster headache episode lasting one month or more. At the time of inclusion, the cluster headache period shall not have lasted more than 3 weeks Exclusion Criteria: Pregnancy, nursing, decreased hepatic og renal function, psychiatric illness, cardiac problems, hypersensitivity to candesartan, previous serious allergic reaction to medication, chronic cluster headache, drug/alcohol abuse, use of antipsychotic,antidepressants, lithium or other prophylactic treatment less than one month prior to inclusion, systolic blood pressure below 110 mmHg, use of other hypertensive medication, use og other specific attack medication than sumatriptan injection or oxygen 7-10l/min and inability to change medication, use of other triptans than sumatriptan during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: candesartan<br>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 | Drug: candesartan cilexetil<br> <br> * Other names: angiotensin II receptor blocker;|
| Placebo Comparator: placebo<br>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 | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of attacks per week |  | change from 'pseudobaseline' week 1 to week 3 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prophylactic, episodic, cluster, candesartan, angiotensin II receptor blocker, randomized placebo controlled parallel study, headache diary