Prophylactic Treatment of Episodic Cluster Headache
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|ClinicalTrials.gov Identifier: NCT00184587|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cluster Headache||Drug: candesartan cilexetil Drug: placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Prophylactic Treatment of Episodic Cluster Headache With an Angiotensin II Receptor Blocker (Candesartan Cilexetil); a Randomized, Placebo Controlled Parallel Study|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||December 2009|
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
Other Name: angiotensin II receptor blocker
Placebo Comparator: placebo
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
- frequency of attacks per week [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
- level of disability [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]5-point scale; 0= no disability, 1= mild, 2= moderate, 3= severe, 4= unbearable
- duration of attacks [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
- hours with cluster headache [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
- days with cluster headache [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
- occurrence of autonomic symptoms [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
- number of treatments with sumatriptan or oxygen [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
- patient satisfaction with treatment [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]scale from 1 to 10 with 1= very poor effect and 10= very good effect
- headache severity index [ Time Frame: change from baseline to 1 week and 3 week ]product of level of disability and duration of attacks
- candesartan-responders [ Time Frame: 3 weeks ]patients with a 50% or more reduction in attack frequency in week 3 than in week 1
- placebo-responders [ Time Frame: 3 weeks ]patients with a 50% or more reduction in attack frequency in week 3 than in week 1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184587
|Norwegian National Headache Centre St.Olavs Hospital|
|Trondheim, Norway, 7006|
|Principal Investigator:||Lars J Stovner, PhD||Norwegian National Headache Center St.Olavs Hospital|