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Sponsors and Collaborators: |
Norwegian University of Science and Technology AstraZeneca |
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Information provided by: | Norwegian University of Science and Technology |
ClinicalTrials.gov Identifier: | NCT00184587 |
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 |
Estimated Enrollment: | 64 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | December 2008 |
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 to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Erling A Tronvik, MD | +47 73 86 84 20 | erling.tronvik@ntnu.no |
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 |
Principal Investigator: | Lars J Stovner, PhD | Norwegian National Headache Center St.Olavs Hospital |
Study ID Numbers: | D2452L0004, EudraCT nr. 2004-002737-39, Nr. 045-04, NSD 10815 |
Study First Received: | September 13, 2005 |
Last Updated: | April 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00184587 |
Health Authority: | Norway: Norwegian Social Science Data Services |
prophylactic episodic cluster candesartan |
angiotensin II receptor blocker randomized placebo controlled parallel study headache diary |
Candesartan cilexetil Cluster Headache Signs and Symptoms Candesartan Headache Neurologic Manifestations |
Central Nervous System Diseases Pain Headache Disorders, Primary Angiotensin II Brain Diseases Headache Disorders |
Angiotensin II Type 1 Receptor Blockers Trigeminal Autonomic Cephalalgias Molecular Mechanisms of Pharmacological Action Therapeutic Uses Nervous System Diseases |
Vasoconstrictor Agents Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |