Results of the first study ever to assess efficacy across all symptoms commonly experienced during a migraine attack found that treatment with Zomig (zolmitriptan) nasal spray produced a significantly higher rate of total symptom relief, defined as freedom from pain, nausea, and sensitivity to light and sound, at one hour after the first dose compared to placebo.
The study, published this month in the American Headache Society’s journal Headache, examined patients in a setting closely resembling normal clinical practice where patients were free to treat an attack of any baseline intensity and at any time after onset.
“This is the first migraine study ever to look at total symptom relief at one hour compared to placebo,” said Professor Marek Gawel, consulting neurologist at Sunnybrook and Women’s College Health Sciences Centre, Toronto, Canada and lead investigator of the REALIZE study. “Historically, migraine studies have looked only at reducing headache pain and not the range of equally debilitating symptoms that can disrupt daily life activities.”
The total symptom relief rate one hour post-dose was significantly higher in patients using Zomig nasal spray than those using placebo (14.5% vs 5.1%). Within 30 minutes post-dose, nearly three times as many treated patients experienced total symptom relief (6.1% vs 2.1% for placebo), and about one-third of the patients using Zomig nasal spray experienced total symptom relief by two hours after treatment (32.6% vs 8.5% for placebo).
Almost half of patients treated with Zomig nasal spray reported the impact of migraine on normal activities was significantly reduced at two hours post-treatment (46.7% vs 18.7% for placebo). This result was consistent among subgroups of patients with mild, moderate and severe baseline pain intensity.
Most notably, one-third of Zomig nasal spray patients with headache of severe baseline intensity were able to perform normal activities 30 minutes post-dose (32.5% vs 17% for placebo).