Back to resultsProphylactic Treatment of Episodic Cluster Headache
Primary Purpose
Cluster Headache
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
candesartan cilexetil
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cluster Headache focused on measuring prophylactic, episodic, cluster, candesartan, angiotensin II receptor blocker, randomized placebo controlled parallel study, headache diary
Eligibility Criteria
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
Sites / Locations
- Norwegian National Headache Centre St.Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
candesartan
placebo
Arm Description
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 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
Outcomes
Primary Outcome Measures
frequency of attacks per week
Secondary Outcome Measures
level of disability
5-point scale; 0= no disability, 1= mild, 2= moderate, 3= severe, 4= unbearable
duration of attacks
hours with cluster headache
days with cluster headache
occurrence of autonomic symptoms
number of treatments with sumatriptan or oxygen
patient satisfaction with treatment
scale from 1 to 10 with 1= very poor effect and 10= very good effect
headache severity index
product of level of disability and duration of attacks
candesartan-responders
patients with a 50% or more reduction in attack frequency in week 3 than in week 1
placebo-responders
patients with a 50% or more reduction in attack frequency in week 3 than in week 1
Full Information
NCT ID
NCT00184587
First Posted
September 13, 2005
Last Updated
April 22, 2013
Sponsor
Norwegian University of Science and Technology
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT00184587
Brief Title
Prophylactic Treatment of Episodic Cluster Headache
Official Title
Prophylactic Treatment of Episodic Cluster Headache With an Angiotensin II Receptor Blocker (Candesartan Cilexetil); a Randomized, Placebo Controlled Parallel Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether candesartan cilexetil are effective prophylactic treatment of episodic Cluster headache
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cluster Headache
Keywords
prophylactic, episodic, cluster, candesartan, angiotensin II receptor blocker, randomized placebo controlled parallel study, headache diary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
candesartan
Arm Type
Experimental
Arm Description
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
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
candesartan cilexetil
Other Intervention Name(s)
angiotensin II receptor blocker
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
frequency of attacks per week
Time Frame
change from 'pseudobaseline' week 1 to week 3
Secondary Outcome Measure Information:
Title
level of disability
Description
5-point scale; 0= no disability, 1= mild, 2= moderate, 3= severe, 4= unbearable
Time Frame
change from 'pseudobaseline' week 1 to week 3
Title
duration of attacks
Time Frame
change from 'pseudobaseline' week 1 to week 3
Title
hours with cluster headache
Time Frame
change from 'pseudobaseline' week 1 to week 3
Title
days with cluster headache
Time Frame
change from 'pseudobaseline' week 1 to week 3
Title
occurrence of autonomic symptoms
Time Frame
change from 'pseudobaseline' week 1 to week 3
Title
number of treatments with sumatriptan or oxygen
Time Frame
change from 'pseudobaseline' week 1 to week 3
Title
patient satisfaction with treatment
Description
scale from 1 to 10 with 1= very poor effect and 10= very good effect
Time Frame
change from 'pseudobaseline' week 1 to week 3
Title
headache severity index
Description
product of level of disability and duration of attacks
Time Frame
change from baseline to 1 week and 3 week
Title
candesartan-responders
Description
patients with a 50% or more reduction in attack frequency in week 3 than in week 1
Time Frame
3 weeks
Title
placebo-responders
Description
patients with a 50% or more reduction in attack frequency in week 3 than in week 1
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars J Stovner, PhD
Organizational Affiliation
Norwegian National Headache Center St.Olavs Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian National Headache Centre St.Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
12503978
Citation
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.
Results Reference
background
PubMed Identifier
23598371
Citation
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.
Results Reference
result
Learn more about this trial
Prophylactic Treatment of Episodic Cluster Headache
We'll reach out to this number within 24 hrs