Clinical trials of
migraine therapy often require treatment when
migraine pain intensity is moderate or severe, but many physicians find this practice artificial and patients often prefer to treat while
pain is mild. This randomized, placebo-controlled study assessed the efficacy of
zolmitriptan 2.5 mg in treating
migraine while
pain is mild, in patients who typically experience
migraine attacks that are initially mild, but progress to moderate or severe. The intent-to-treat population comprised 280 patients (138
zolmitriptan; 148 placebo), with mean MIDAS grades of 29.6 (
zolmitriptan) and 27.6 (placebo).
Zolmitriptan 2.5 mg provided a significantly higher
pain-free rate at 2 h (43.4% vs. 18.4% placebo; P < 0.0001). Significantly fewer
zolmitriptan patients reported progression of
headache pain to moderate or severe intensity 2 h postdose (53.7% vs. 70.4% placebo; P < 0.01), or required further medication within 24 h (46.4% vs. 71.1% placebo; P < 0.0001). The efficacy of
zolmitriptan was more pronounced in patients treating during the first 15 min following
pain onset. Adverse events were reported in 31.2% of patients treated with
zolmitriptan (vs. 11.3% for placebo), and the incidence was lower in patients who treated early after attack onset.
Zolmitriptan provides high efficacy when treating
migraine while
pain is mild, with the clinical benefits being more pronounced when treating early after
migraine onset.