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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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.

Primary:

• frequency of attacks per week

Secondary:

• level of disability
• duration of attacks
• hours with cluster headache
• days with cluster headache
• hours with headache
• days with headache
• occurrence of autonomic symptoms
• number of attacks treated with sumatriptan or oxygen
• doses of sumatriptan
• acceptability of treatment
• comparison between the last two weeks on medication and yhe week with headache diary only
• days with sick leave
• headache severity index
• doses of analgesics
• candesartan-responders
• placebo-responders

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

Lead Sponsor: Norwegian University of Science and Technology

Norwegian National Headache Centre St.Olavs Hospital

Trondheim  7006 Norway

Overall Clinical Trial Officials and Contacts

Lars J Stovner, PhD Principal Investigator Norwegian National Headache Center St.Olavs Hospital  

Overall Contact: Erling A Tronvik, MD +47 73 86 84 20 erling.tronvik@ntnu.no

Information obtained from ClinicalTrials.gov on July 23, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00184587

Study ID Number: D2452L0004

ClinicalTrials.gov Identifier: NCT00184587

Health Authority: Norway: Norwegian Social Science Data Services