Clinical trial NCT00184587: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cluster Headache
Keywords: prophylactic
episodic
cluster
candesartan
angiotensin II receptor blocker
randomized placebo controlled parallel study
headache diary
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: frequency of attacks per week
timeFrame: change from 'pseudobaseline' week 1 to week 3
Secondary outcomes:
measure: level of disability
timeFrame: change from 'pseudobaseline' week 1 to week 3
measure: duration of attacks
timeFrame: change from 'pseudobaseline' week 1 to week 3
measure: hours with cluster headache
timeFrame: change from 'pseudobaseline' week 1 to week 3
measure: days with cluster headache
timeFrame: change from 'pseudobaseline' week 1 to week 3
measure: occurrence of autonomic symptoms
timeFrame: change from 'pseudobaseline' week 1 to week 3
measure: number of treatments with sumatriptan or oxygen
timeFrame: change from 'pseudobaseline' week 1 to week 3
measure: patient satisfaction with treatment
timeFrame: change from 'pseudobaseline' week 1 to week 3
measure: headache severity index
timeFrame: change from baseline to 1 week and 3 week
measure: candesartan-responders
timeFrame: 3 weeks
measure: placebo-responders
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian National Headache Centre St.Olavs Hospital
Study officials:
affiliation: Norwegian National Headache Center St.Olavs Hospital
name: Lars J Stovner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.