The effectiveness of zolmitriptan (Zomigon) as a treatment for acute migraine was established in five randomized, double-blind, placebo-controlled trials. The first was conducted in a clinical setting, while the other four were outpatient studies. Adult subjects received zolmitriptan (Zomigon) in dosages of 1 mg, 2.5mg, or 5mg. They were instructed to administer the drug when suffering from moderate to severe migraine pain.
Subjects were assessed one, two, and four hours after dosing. Response was defined as reduction in severity of headache pain from moderate or severe, to mild or no pain. In all studies, subjects who received 2.5mg or 5mg doses of zolmitriptan (Zomigon) achieved a significantly greater response compared to those receiving the lowest dosage or placebo. Of the two studies evaluating the 1mg dosage, only one reported subjects in the drug group achieving a significantly greater response than those in the placebo group.
Trials demonstrated efficacy of zolmitriptan (Zomigon) to be significant within one hour of dosing, with some patients experiencing relief within 30 minutes. One tablet provided relief up to 24 hours in the majority of subjects.
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