Early Treatment of Migraine With Rizatriptan: A Placebo-Controlled Study


  • Ninan T. Mathew MD,

  • Jayasree Kailasam MD,

  • Lori Meadors PA-C

  • From the Houston Headache Clinic, Houston, Texas.

Address all correspondence to Ninan T. Mathew, MD, Houston Headache Clinic, 1213 Hermann Drive, 350, Houston, TX 77004.


Objective.—To evaluate the efficacy of rizatriptan when administered early during a migraine attack.

Background.—Several studies indicate that triptans are more efficacious when administered early during a migraine attack, when the pain is still mild.

Methods.—One hundred and twelve rizatriptan-naïve patients aged 20 to 64 years with a history of migraine with or without aura that progressively worsened when left untreated were instructed to treat a total of three migraine attacks with either rizatriptan 10 mg or placebo as early as possible during each attack. Seventy-four patients (68 women and 6 men) were assigned to use the active drug and 38 (35 women and 3 men) to placebo. The primary efficacy endpoint was pain-free response at 2 hours after administration of the study drug. Secondary efficacy measures were pain-free response at 1 hour and sustained pain-free response lasting between 2 and 24 hours.

Results.—A total of 216 attacks were treated in the rizatriptan group and 109 in the placebo group. Pain-free response at 2 hours after early treatment was noted in 151 (70%) of attacks in the rizatriptan group and in 24 (22%) in the placebo group (P < .01). Pain-free response at 1 hour occurred in 97 (45%) and 9 (8%) attacks, respectively (P < .01). When the attacks were categorized by headache severity at the time of treatment, the pain-free response at 2 hours was higher for mild attacks than for moderate or severe attacks (P < .01). Sustained pain-free response after treatment was significantly higher for attacks treated with rizatriptan (60%) than for those treated with placebo (17%) (P < .001). Adverse events were observed in 62 patients in the rizatriptan group and 15 in the placebo group. Only 1 patient taking rizatriptan discontinued the study because of adverse events, and no serious adverse events were reported.

Conclusions.—Rizatriptan is significantly more likely than placebo to produce a pain-free response within 2 hours when the drug is administered early in the migraine attack, when pain is mild rather than moderate or severe.