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Early Treatment of Migraine With Rizatriptan Reduces Cutaneous Sensitivity: Presented at IHS

By Claire Sowerbutt

KYOTO, JAPAN -- October 17, 2005 -- Data from the Treat a Migraine Early (TAME) study show that rizatriptan is significantly efficacious in reducing symptoms of cutaneous sensitivity in patients with mild migraine as early as 2 hours postadministration.

The results, presented here on October 12^th during the12^th Congress of the International Headache Society (IHS), are from a substudy of TAME, in which the investigators sought to determine if symptoms of cutaneous sensitivity could be predictive of treatment response.

Cutaneous allodynia is known to impact the response to migraine treatment, according to lead investigator Vincent Martin, MD, professor of internal medicine, University of Cincinnati, Cincinnati, Ohio.

"It is not currently known if patient-reported symptoms of cutaneous sensitivity respond to effective therapy, nor if [symptom] presence predicts response to acute migraine therapy," Dr. Martin said.

TAME was a randomized, placebo-controlled, parallel, double-blind, single-attack study, in patients with mild migraine, defined as pain that was present for less than 60 minutes. The researchers treated 351 patients with a single dose 10 mg of rizatriptan and 177 patients with placebo. Rescue treatment for nonresponsive or recurrent headache was allowed 2 hours postrizatriptan administration.

Outcome measures included freedom from pain at 2 hours, sustained pain freedom at 24 hours, efficacy of rizatriptan versus placebo as measured by the percentage of patients with symptoms of cutaneous sensitivity 1 and 2 hours postdose, presence of cutaneous sensitivity at baseline as a predictor of response to treatment, and consistency of rizatriptan efficacy across the subgroups of patients with and without cutaneous sensitivity at baseline.

While the symptoms themselves were not found to be predictive of response to treatment, the researchers found that there were significantly greater rates of both freedom from pain at 2 hours (57% vs 31%; P < .001), and sustained freedom from pain between 2 and 24 hours (43% vs 23%; P < .001) in patients treated with rizatriptan compared with placebo, respectively.

"One thing that is different between this study and many of the other migraine studies is that other headache diagnoses were not excluded. For example, chronic tension-type headache, chronic daily headache, and episodic tension-type headaches were all permitted, as long as the patient could accurately identify their migraine headache as migraine," Dr. Martin said during his presentation. "It's really more real-life than most randomized, controlled trials."

"Early treatment with rizatriptan significantly reduced the percentage of patients with symptoms of cutaneous sensitivity at 2 hours postadministration," he concluded.


[Presentation title: Symptoms of Cutaneous Sensitivity Pretreatment and Posttreatment: Results from the Rizatriptan TAME Study. Oral Presentation: Scientific Session 6]

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