Effectiveness of intranasal zolmitriptan in acute cluster headache: A randomized, placebo-controlled, double-blind crossover study

Archives of Neurology

Volumn 63, Issue 11, 2006, Pages 1537-1542

  Cittadini, Elizabeth ^a   May, Arne ^b   Straube, Andreas ^c   Evers, Stefan ^d   Bussone, Gennaro ^e   Goadsby, Peter J ^a  

^a NATIONAL HOSPITAL FOR NEUROLOGY AND NEUROSURGERY   (United Kingdom)

^b UNIVERSITY OF HAMBURG   (Germany)

^c UNIVERSITY OF MUNICH   (Germany)

^d UNIVERSITY OF MÜNSTER   (Germany)

^e DEPARTMENT OF NEUROSURGERY   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; SUMATRIPTAN SUCCINATE; ZOLMITRIPTAN;

ADULT; ANALGESIA; ARTICLE; CLINICAL FEATURE; CLINICAL TRIAL; CLUSTER HEADACHE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; DYSPNEA; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHEUMATIC DISEASE; TREATMENT OUTCOME; VOMITING;

ACUTE DISEASE; ADMINISTRATION, INTRANASAL; ADOLESCENT; ADULT; AGED; CLUSTER HEADACHE; COHORT STUDIES; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG EVALUATION; FEMALE; HUMANS; MALE; MIDDLE AGED; OXAZOLIDINONES; SEROTONIN AGONISTS; TIME FACTORS; TREATMENT OUTCOME; TRYPTAMINES;

EID: 33750626423     PISSN: 00039942     EISSN: 15383687     Source Type: Journal    
DOI: 10.1001/archneur.63.11.nct60002     Document Type: Article

References (30)

1. Headache Classification Committee of the International Headache Society. The International Classification of Headache Disorders (second edition). Cephalalgia. 2004;24(suppl 1):1-160.
2. Bahra A, May A, Goadsby PJ. Cluster headache: a prospective clinical study in 230 patients with diagnostic implications. Neurology. 2002;58:354-361.
3. van Vliet JA, Bahra A, Martin V, et al. Intranasal sumatriptan in cluster headache - randomized placebo-controlled double-blind study. Neurology. 2003;60:630-633.
4. Treatment of acute cluster headache with sumatriptan: the Sumatriptan Cluster Headache Study Group. N Engl J Med. 1991;325:322-326.
5. Ekbom K, Monstad I, Prusinski A, Cole JA, Pilgrim AJ, Noronha D. Subcutaneous sumatriptan in the acute treatment of cluster headache: a dose comparison study. Acta Neurol Scand. 1993;88:63-69.
6. Fogan L. Treatment of cluster headache: a double blind comparison of oxygen vs air inhalation. Arch Neurol. 1985;42:362-363.
7. Kudrow L. Response of cluster headache attacks to oxygen inhalation. Headache. 1981;21:1-4.
8. Robbins L. Intranasal lidocaine for cluster headache. Headache. 1995;35:83-84.
9. Andersson PG, Jespersen LT. Dihydroergotamine nasal spray in the treatment of attacks of cluster headache. Cephalalgia. 1986;6:51-54.
10. Bahra A, Gawel MJ, Hardebo J-E, Millson D, Brean SA, Goadsby PJ. Oral zolmitriptan is effective in the acute treatment of cluster headache. Neurology. 2000;54:1832-1839.
11. Palmer KJ, Spencer CM. Zolmitriptan. CNS Drugs. 1997;7:468-478.
12. 1B/1D receptor partial agonist, 311C90 (zolmitriptan). Br J Pharmacol. 1997;121:157-164.
13. Goadsby PJ, Edvinsson L. Peripheral and central trigeminovascular activation in cat is blocked by the serotonin (5HT)-1D receptor agonist 311C90. Headache. 1994;34:394-399.
14. 1B/D receptor agonist zolmitriptan (311C90): are brain stem sites a therapeutic target in migraine? Pain. 1996;67:355-359.
15. Goadsby PJ, Knight YE. Direct evidence for central sites of action of zolmitriptan (311C90): an autoradiographic study in cat. Cephalalgia. 1997;17:153-158.
16. Goadsby PJ, Yates R. Zolmitriptan intranasal: a review of the pharmacokinetics and clinical efficacy. Headache. 2006;46:138-149.
17. Charlesworth BR, Dowson AJ, Purdy A, Becker WJ, Boes-Hansen S, Farkkila M. Speed of onset and efficacy of zolmitriptan nasal spray in the acute treatment of migraine: a double-blind, placebo-controlled, dose-ranging study versus zolmitriptan tablet. CNS Drugs. 2003;17:653-667.
18. Zingmark P-H, Yates R, Hedlund C, Kagedal M. True nasopharyngeal absorption of zolmitriptan following administration of zolmitriptan nasal spray [abstract]. Eur J Neurol. 2003;10(suppl 1):76.
19. Mathew NT, Kailasam J, Seifer T, Bouton T. Zolmitriptan (Zomig) nasal spray in cluster headache attacks; a single-blind observation - a preliminary report [abstract]. Headache. 2004;44:483.
20. Cittadini E, May A, Straube A, Evers S, Bussone G, Goadsby PJ. Zolmitriptan nasal spray is effective and well tolerated in the acute treatment of cluster headache: a double-blind placebo-controlled crossover study [abstract]. Eur J Neurol. 2005;12(suppl 2):202.
21. Pilgrim AJ. Methodology of clinical trials of sumatriptan in migraine and cluster headache. Eur Neurol. 1991;31:295-299.
22. Siegel S. Non-parametric Statistics for the Behavioural Sciences. Tokyo, Japan: McGraw-Hill Kogakusha; 1956.
23. Tfelt-Hansen P. Efficacy and adverse events of subcutaneous, oral, and intranasal sumatriptan used for migraine treatment: a systematic review based on number needed to treat. Cephalalgia. 1998;18:532-538.
24. Snijders TAB, Bosker RJ. Multilevel Analysis: An Introduction to Basic and Advanced Multilevel Modelling. London, England: Sage Publications; 1999.
25. Multilevel modelling. Center for Multilevel Modelling Web site. http://www.mlwin.com. Accessed January 24, 2006.
26. Rosenberg RN, Aminoff M, Boller F, et al. Reporting clinical trials: full access to all the data. Neurology. 2002;58:347-348.
27. Yang M, Goldstein H, Heath A. Multilevel models for repeated binary outcomes: attitudes and voting over the electoral cycle. J R Stat Soc [Ser A]. 2000;163:49-62.
28. Goadsby PJ. Cluster headache and the clinical profile of sumatriptan. Eur Neurol. 1994;34(suppl):35-39.
29. Yates R, Nairn K, Dixon R, Kemp JV, Dane AL. Pharmacokinetics, dose proportionality, and tolerability of single and repeat doses of a nasal spray formulation of zolmitriptan in healthy volunteers. J Clin Pharmacol. 2002;42:1244-1250.
30. Paemeleire K, Bahra A, Evers S, Matharu MS, Goadsby PJ. Medication-overuse headache in cluster headache patients. Neurology. 2006;67:109-113.