Cluster HeadachePhase 2NCT00184587
Prophylactic Treatment of Episodic Cluster Headache
A Phase 2 study testing candesartan cilexetil in people with Cluster Headache, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether candesartan cilexetil are effective prophylactic treatment of episodic Cluster headache Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cluster Headache
- What is being tested?
- candesartan cilexetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2005to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian National Headache Centre St.Olavs Hospital
Trondheim, Trondheim, 7006
About this study
Official title: Prophylactic Treatment of Episodic Cluster Headache With an Angiotensin II Receptor Blocker (Candesartan Cilexetil); a Randomized, Placebo Controlled Parallel Study
The purpose of this study is to determine whether candesartan cilexetil are effective prophylactic treatment of episodic Cluster headache
Read the 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.
- Conditions
- Cluster Headache
- Being tested
- candesartan cilexetil, placebo
- Keywords
- prophylactic, episodic, cluster, candesartan, angiotensin II receptor blocker, randomized placebo controlled parallel study, headache diary
- Medical subject headings
- Cluster Headache, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
candesartan cilexetilDrug
Also called angiotensin II receptor blocker
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: candesartan cilexetil |
| 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 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of attacks per week
Measured: change from 'pseudobaseline' week 1 to week 3
Secondary outcomes (10)
level of disability
5-point scale; 0= no disability, 1= mild, 2= moderate, 3= severe, 4= unbearable
Measured: change from 'pseudobaseline' week 1 to week 3
duration of attacks
Measured: change from 'pseudobaseline' week 1 to week 3
hours with cluster headache
Measured: change from 'pseudobaseline' week 1 to week 3
days with cluster headache
Measured: change from 'pseudobaseline' week 1 to week 3
occurrence of autonomic symptoms
Measured: change from 'pseudobaseline' week 1 to week 3
number of treatments with sumatriptan or oxygen
Measured: 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
Measured: change from 'pseudobaseline' week 1 to week 3
headache severity index
product of level of disability and duration of attacks
Measured: 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
Measured: 3 weeks
placebo-responders
patients with a 50% or more reduction in attack frequency in week 3 than in week 1
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionJun 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Lars J Stovner, PhD, Principal investigator, Norwegian National Headache Center St.Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184587
- Sponsor's protocol ID
- D2452L0004
- Other IDs
- 2004-002737-39, 045-04, 10815, 2004
- Status last verified
- Sep 2010
- First submitted
- 13 Sep 2005
- Last updated
- 23 Apr 2013
- Results posted
- No
Publications
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.
PubMed 12503978Tronvik 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.
PubMed 23598371
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Treatment of Episodic Cluster Headache With an Angiotensin II Receptor Blocker (Candesartan Cilexetil); a Randomized, Placebo Controlled Parallel Study
- ClinicalTrials.gov ID
- NCT00184587
- Acronym / sponsor ID
- D2452L0004
- Conditions
- Cluster Headache
- Keywords
- prophylactic, episodic, cluster, candesartan, angiotensin II receptor blocker, randomized placebo controlled parallel study, headache diary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Mar 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| candesartan | Experimental | Drug: candesartan cilexetilcandesartan 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 | Drug: placeboplacebo 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| candesartan cilexetilAlso: angiotensin II receptor blocker | Drug | candesartan |
| placebo | Drug | placebo |
Primary outcome
frequency of attacks per week
Time frame: change from 'pseudobaseline' week 1 to week 3
10 secondary outcomes
level of disability
Time frame: change from 'pseudobaseline' week 1 to week 3
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
headache severity index
Time frame: change from baseline to 1 week and 3 week
candesartan-responders
Time frame: 3 weeks
placebo-responders
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
- Background: PubMed 12503978Tronvik 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 publication: PubMed 23598371Tronvik 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars J Stovner, PhD principal investigator
Norwegian National Headache Center St.Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing candesartan cilexetil in people with Cluster Headache, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of attacks per week (time frame: change from 'pseudobaseline' week 1 to week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00184587, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.