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The mad viking
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Clusterheadachestudies in Norway
« on: Sep 15th, 2006, 5:15am » |
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Prophylactic Treatment of Episodic Cluster Headache
This study is currently recruiting patients.
Verified by Norwegian University of Science and Technology July 2006
Sponsors and Collaborators:
Norwegian University of Science and Technology
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
MedlinePlus related topics: Headache
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
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
Study start: March 2005; Expected completion: December 2007
Last follow-up: December 2007; Data entry closure: December 2007
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.
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The mad viking
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Re: Clusterheadachestudies in Norway
« Reply #1 on: Sep 15th, 2006, 5:15am » |
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Eligibility
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
Location and Contact Information
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
Erling A. Tronvik, MD +47 73 86 84 20 erling.tronvik@ntnu.no
Lars J Stovner, PhD +47 73 86 84 16 lars.stovner@ntnu.no
Erling A. Tronvik, MD, Sub-Investigator
Lars J Stovner, PhD, Principal Investigator
Study chairs or principal investigators
Lars J Stovner, PhD, Principal Investigator, 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.
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.
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 2006-09-14
U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
Copyright, Privacy, Accessibility, Freedom of Information Act
Thanks to Totka2 that did tip me of this release.
Svenn
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| « Last Edit: Sep 15th, 2006, 5:17am by The mad viking » |
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