| Dokumentenart: | Artikel | ||||
|---|---|---|---|---|---|
| Titel eines Journals oder einer Zeitschrift: | Headache: The Journal of Head and Face Pain | ||||
| Verlag: | BLACKWELL PUBLISHING INC | ||||
| Ort der Veröffentlichung: | MALDEN | ||||
| Band: | 45 | ||||
| Nummer des Zeitschriftenheftes oder des Kapitels: | 1 | ||||
| Seitenbereich: | S. 7-16 | ||||
| Datum: | 2005 | ||||
| Institutionen: | Medizin > Lehrstuhl für Neurologie | ||||
| Identifikationsnummer: |
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| Stichwörter / Keywords: | DOUBLE-BLIND; TOLERABILITY; MULTICENTER; POPULATION; PREVALENCE; ABSORPTION; IMPACT; zolmitriptan; migraine; nasal spray; efficacy; total symptom relief | ||||
| Dewey-Dezimal-Klassifikation: | 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin | ||||
| Status: | Veröffentlicht | ||||
| Begutachtet: | Ja, diese Version wurde begutachtet | ||||
| An der Universität Regensburg entstanden: | Ja | ||||
| Dokumenten-ID: | 71032 |
Web of ScienceZusammenfassung
Objectives.-The objective of phase 1 (reported here) of this two-phase study was to assess the efficacy of zolmitriptan 5 mg nasal spray, in terms of ability to provide relief from all migraine symptoms, in a controlled setting, designed to replicate clinical practice. Background.-Zolmitriptan nasal spray has been shown to be fast acting and highly effective in the treatment of migraine, as ...
Zusammenfassung
Objectives.-The objective of phase 1 (reported here) of this two-phase study was to assess the efficacy of zolmitriptan 5 mg nasal spray, in terms of ability to provide relief from all migraine symptoms, in a controlled setting, designed to replicate clinical practice. Background.-Zolmitriptan nasal spray has been shown to be fast acting and highly effective in the treatment of migraine, as assessed using standard endpoints, such as headache response and pain-free rates. Methods.-In the double-blind first phase of the study, patients with migraine were randomized to receive zolmitriptan 5 mg nasal spray or placebo to treat a single migraine attack. Attacks were treated according to patients' normal patterns of use, in order to closely reflect clinical practice; that is, no specific regimen was dictated in terms of time to treatment or at what level of pain intensity the headache should be treated. Patients could take a second dose of study medication or an agreed escape medication if adequate pain relief had not been achieved 2 hours after the first dose. The primary efficacy endpoint was total symptom relief (freedom from pain, nausea, photophobia, and phonophobia) 1 hour after the first dose. Secondary efficacy endpoints included headache response, pain-free status and sustained pain-free status, and ability to perform normal activities. Results.-The intention-to-treat population comprised 461 zolmitriptan nasal spray recipients and 451 placebo recipients. The total symptom relief rate 1 hour post-dose was significantly higher in the zolmitriptan 5 mg nasal spray group than in the placebo group (14.5% vs. 5. 1%; P <.0001); the difference between the groups was significant from 30 minutes post-dose. Treatment with zolmitriptan nasal spray, compared with placebo, also produced a higher headache response rate from 10 minutes post-dose (15.1% vs. 9.1%; P =.0079) and a higher pain-free rate from 30 minutes post-dose (7.7% vs. 3. 2%; P =.0039). Zolmitriptan nasal spray was also significantly superior to placebo in terms of sustained pain-free status and patients' ability to perform normal activities. Zolmitriptan nasal spray was well tolerated. Conclusions.-These findings confirm the efficacy demonstrated by zolmitriptan nasal spray in previous clinical trials.
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