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Prophylactic Treatment of Episodic Cluster Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00184587
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 23, 2013
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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

Condition or disease Intervention/treatment Phase
Cluster Headache Drug: candesartan cilexetil Drug: placebo Phase 2

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: candesartan
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
Drug: placebo

Primary Outcome Measures :
  1. frequency of attacks per week [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]

Secondary Outcome Measures :
  1. 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

  2. duration of attacks [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
  3. hours with cluster headache [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
  4. days with cluster headache [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
  5. occurrence of autonomic symptoms [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
  6. number of treatments with sumatriptan or oxygen [ Time Frame: change from 'pseudobaseline' week 1 to week 3 ]
  7. 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

  8. headache severity index [ Time Frame: change from baseline to 1 week and 3 week ]
    product of level of disability and duration of attacks

  9. candesartan-responders [ Time Frame: 3 weeks ]
    patients with a 50% or more reduction in attack frequency in week 3 than in week 1

  10. placebo-responders [ Time Frame: 3 weeks ]
    patients with a 50% or more reduction in attack frequency in week 3 than in week 1

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00184587

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Norwegian National Headache Centre St.Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
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Principal Investigator: Lars J Stovner, PhD Norwegian National Headache Center St.Olavs Hospital
Publications of Results:
Other Publications:
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Responsible Party: Norwegian University of Science and Technology Identifier: NCT00184587    
Other Study ID Numbers: D2452L0004
2004-002737-39 ( EudraCT Number )
045-04 ( Other Identifier: Norwegian National Headache Centre )
10815 ( Other Identifier: NSD )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: September 2010
Keywords provided by Norwegian University of Science and Technology:
angiotensin II receptor blocker
randomized placebo controlled parallel study
headache diary
Additional relevant MeSH terms:
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Cluster Headache
Neurologic Manifestations
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Candesartan cilexetil
Angiotensin II
Angiotensin Receptor Antagonists
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents