Prophylactic Treatment of Episodic Cluster Headache
Information source: Norwegian University of Science and Technology
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cluster Headache
Intervention: candesartan cilexetil (angiotensin II receptor blocker) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Norwegian University of Science and Technology Official(s) and/or principal investigator(s):
Lars J Stovner, PhD, Principal Investigator, Affiliation: Norwegian National Headache Center St.Olavs Hospital
Overall contact:
Erling A Tronvik, MD, Phone: +47 73 86 84 20, Email: erling.tronvik@ntnu.no
Summary
The purpose of this study is to determine whether candesartan cilexetil are effective
prophylactic treatment of episodic Cluster headache
Clinical Details
Official title: Prophylactic Treatment of Episodic Cluster Headache With an Angiotensin II Receptor Blocker (Candesartan Cilexetil); a Randomized, Placebo Controlled Parallel Study
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: frequency of attacks per week
Secondary outcome: level of disabilityduration 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
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Erling A Tronvik, MD, Phone: +47 73 86 84 20, Email: erling.tronvik@ntnu.no
Norwegian National Headache Centre St.Olavs Hospital, Trondheim 7006, Norway; Recruiting
Erling A. Tronvik, MD, Phone: +47 73 86 84 20, Email: erling.tronvik@ntnu.no
Lars J Stovner, PhD, Phone: +47 73 86 84 16, Email: lars.stovner@ntnu.no
Erling A. Tronvik, MD, Sub-Investigator
Lars J Stovner, PhD, Principal Investigator
Additional Information
Related 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)
Starting date: March 2005
Ending date: December 2008
Last updated: April 28, 2009
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