Gawel, Marek and Aschoff, Juergen and May, Arne and Charlesworth, Bruce R. (2005) Zolmitriptan 5 mg nasal spray: Efficacy and onset of action in the acute treatment of migraine - Results from phase 1 of the REALIZE study. HEADACHE, 45 (1). pp. 7-16. ISSN 0017-8748,
Full text not available from this repository.Abstract
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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | DOUBLE-BLIND; TOLERABILITY; MULTICENTER; POPULATION; PREVALENCE; ABSORPTION; IMPACT; zolmitriptan; migraine; nasal spray; efficacy; total symptom relief |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 02 Jun 2021 08:19 |
| Last Modified: | 02 Jun 2021 08:19 |
| URI: | https://pred.uni-regensburg.de/id/eprint/36701 |
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