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Zolmitriptan 5 mg. Nasal Spray: Efficacy
and Onset of Action in the Acute
Treatment of Migraine -- Results From Phase 1
of the REALIZE Study (Real Life Intranasal
Zolmitriptan Exposure)
Gawel M, Aschoff J, May A, Charlesworth A.
Posted: February 2005  
Headache 2005;45:7-16


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. The primary efficacy endpoint was total symptom relief (freedom from pain, nausea, photophobia and phonophobia) one 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 one hour post-dose was significantly higher in the zolmitriptan nasal spray group than in the placebo group (14.5% vs. 5.1%); 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%), and a higher pain-free rate from 30 minutes post-dose (7.7% vs. 3.2%). Zolmitriptan nasal spray was also significantly superior to placebo in terms of sustained pain-free status and patientsí 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.