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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
Gawel M, Aschoff J, May A, Charlesworth A.
Posted: February 2005
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
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