Prophylactic Treatment of Episodic Cluster Headache

Norwegian University of Science and Technology

Status and phase: Completed; Phase 2

Conditions: Cluster Headache

Treatments: Drug: placebo; Drug: candesartan cilexetil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00184587

D2452L0004

2004-002737-39 (EudraCT Number)

10815 (Other Identifier)

045-04 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

candesartan

Experimental group

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

Treatment:

Drug: candesartan cilexetil

placebo

Placebo Comparator group

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

Treatment:

Drug: placebo