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Zolmitriptan Nasal Spray Exhibits Good
Long-Term Safety and Tolerability in
Migraine: Results of the INDEX Trial
Dowson AJ, Charlesworth BR, Green J, et al
Posted: February 2005  
Headache 2005;45:17-24


Background:   Previous studies have shown that zolmitriptan 5 mg. nasal spray has a fast onset of action, high efficacy, and good tolerability in the acute treatment of migraine.

Objective:   This open-label, noncomparative, multicenter, multinational phase III study was designed to further evaluate the long-term safety and tolerability of zolmitriptan 5 mg. nasal spray in a population of migraineurs largely na´ve to triptan nasal sprays who treated multiple migraine attacks over a 1-year period.

Methods:   Patients were required to have an established diagnosis of migraine with or without aura (based on IHS criteria), a high frequency of migraine attacks, and were allowed to treat migraine with any baseline headache intensity. A secondary objective of the study was to assess the long-term efficacy of zolmitriptan nasal spray. A subgroup analysis aimed to determine whether rhinitis had any influence on outcomes of treatment.

Conclusions:   Zolmitriptan 5 mg. nasal spray demonstrated a well-tolerated and efficacious profile in the acute treatment of multiple migraine attacks over a 1-year period.