Prophylactic Treatment of Episodic Cluster Headache - Full Text View

Sponsor:	Norwegian University of Science and Technology
Collaborator:	AstraZeneca
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00184587

Purpose

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Prophylactic Treatment of Episodic Cluster Headache With an Angiotensin II Receptor Blocker (Candesartan Cilexetil); a Randomized, Placebo Controlled Parallel Study

Resource links provided by NLM:

MedlinePlus related topics: Headache

Drug Information available for: Angiotensin II CV 11974 Candesartan cilexetil Angiotensin II, ile(5)-

U.S. FDA Resources

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

Primary Outcome Measures:

frequency of attacks per week

Secondary Outcome Measures:

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

Estimated Enrollment:	64
Study Start Date:	March 2005
Estimated Study Completion Date:	December 2008

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184587

Contacts

Contact: Erling A Tronvik, MD

+47 73 86 84 20

erling.tronvik@ntnu.no

Locations

Norway
Norwegian National Headache Centre St.Olavs Hospital	Recruiting
Trondheim, Norway, 7006
Contact: Erling A. Tronvik, MD +47 73 86 84 20 erling.tronvik@ntnu.no
Contact: Lars J Stovner, PhD +47 73 86 84 16 lars.stovner@ntnu.no
Sub-Investigator: Erling A. Tronvik, MD
Principal Investigator: Lars J Stovner, PhD

Sponsors and Collaborators

Norwegian University of Science and Technology

AstraZeneca

Investigators

Principal Investigator:

Lars J Stovner, PhD

Norwegian National Headache Center St.Olavs Hospital

More Information

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.

Stoukides CA, McVoy HJ, Kaul AF. Candesartan cilexetil: an angiotensin II receptor blocker. Ann Pharmacother. 1999 Dec;33(12):1287-98. Review.

El Amrani M, Massiou H, Bousser MG. A negative trial of sodium valproate in cluster headache: methodological issues. Cephalalgia. 2002 Apr;22(3):205-8.

Yusuf S, Pfeffer MA, Swedberg K, Granger CB, Held P, McMurray JJ, Michelson EL, Olofsson B, Ostergren J; CHARM Investigators and Committees. Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: the CHARM-Preserved Trial. Lancet. 2003 Sep 6;362(9386):777-81.

Chaturvedi N, Sjoelie AK, Svensson A; DIRECT Programme Study Group. The DIabetic Retinopathy Candesartan Trials (DIRECT) Programme, rationale and study design. J Renin Angiotensin Aldosterone Syst. 2002 Dec;3(4):255-61.

Olesen J, Goadsby PJ, Cluster Headache and Related Conditions.Oxford University Press 1999

Lipton RB, Micieli G, Russell D, Solomon S, Tfelt-Hansen P, Waldenlind E. Guidelines for controlled trials of drugs in cluster headache. Cephalalgia. 1995 Dec;15(6):452-62. No abstract available.

Altman DG, Practical statistics for medical research. Chapman & Hall (1988)

Study ID Numbers:	D2452L0004, EudraCT nr. 2004-002737-39, Nr. 045-04, NSD 10815
Study First Received:	September 13, 2005
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00184587 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

prophylactic
episodic
cluster
candesartan

angiotensin II receptor blocker
randomized placebo controlled parallel study
headache diary

Additional relevant MeSH terms:

Cluster Headache
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Central Nervous System Diseases
Headache Disorders, Primary
Pain
Cardiovascular Agents
Antihypertensive Agents
Brain Diseases
Angiotensin II
Pharmacologic Actions

Headache Disorders
Angiotensin II Type 1 Receptor Blockers
Candesartan cilexetil
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Therapeutic Uses
Candesartan
Headache
Vasoconstrictor Agents
Neurologic Manifestations

ClinicalTrials.gov processed this record on November 27, 2009