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Oral Sumatriptan for the Acute Treatment of
Probable Migraine: First Randomized, Controlled Study
Tepper SJ, Cady R, Dodick D, et al.
Posted: February 2006  
Headache 2006

Objective:   To evaluate the efficacy and tolerability of sumatriptan tablets in adults who meet International Headache Society (IHS) criteria for probable migraine but who do not meet IHS criteria for migraine with or without aura.

Background:   Headache with some but not all of the features of migraine meet criteria for probable migraine, a form of migraine recognized by the HIS. Probable migraine attacks are also prevalent and frequently underdiagnosed.

Methods:   This was a randomized, multicenter, double-blind, placebo-controlled, parallel-group study. Adults with a 1-year history of headaches that met 2004 HIS criteria for probable migraine without aura were eligible for enrollment. All patients were triptan- and ergot-naive and had never been diagnosed with migraine. Patients were randomized to receive sumatriptan 25, 50, or 100 mg. conventional tablets or matching placebo and were instructed to treat a single moderate or severe probable migraine attack. A post hoc analysis was conducted to evaluate the population of patients who achieved headache relief sustained throughout the immediate posttreatment period. Patients who reported relief within 2 hours and subsequently lost headache relief within 4 hours were considered nonresponders.

Results:   At 2 hours, more patients treated with sumatriptan achieved headache relief, the primary efficacy measure compared with placebo, but differences only approached statistical significance for 100 mg. The 2-hour headache relief rate in the sumatriptan 25 or 50 mg. groups was not significantly different than placebo. The time to use of rescue was significantly shorter in the placebo group compared with the sumatriptan 100 mg. group. The time to use of rescue in the sumatriptan 25 or 50 mg. groups was not significantly different than placebo. More patients treated with placebo lost headache relief within 4 hours compared with patients treated with sumatriptan 25 mg., 50 mg., or 100 mg. A post hoc analysis demonstrated that at 2 hours, headache relief sustained through 4 hours was achieved in 44%, 49%, and 57% of patients treated with sumatriptan 25, 50 and 100 mg. respectively, compared with 34% of patients treated with placebo. All doses of sumatriptan were well tolerated and no serious adverse events were reported.