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

Condition	Intervention	Phase
Cluster Headache	Drug: candesartan cilexetil (angiotensin II receptor blocker)	Phase II

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcomes: frequency of attacks per week
Secondary Outcomes: 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
Expected Total Enrollment:  64

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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00184587

 

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

Norway
      Norwegian National Headache Centre St.Olavs Hospital, Trondheim,  7006,  Norway; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  D2452L0004; EudraCT nr. 2004-002737-39; Nr. 045-04; NSD 10815
Last Updated:  July 24, 2006
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00184587
Health Authority: Norway: Norwegian Social Science Data Services
ClinicalTrials.gov processed this record on 2006-09-15