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Early Treatment of Acute Migraine With Almotriptan Provides Significant Clinical Benefit to Migraineurs: Presented at AAN

By Claire Sowerbutt

SAN DIEGO, C.A. -- April 5 2006 -- Almotriptan 12.5 mg provides significant efficacy in the acute treatment of migraine, when administered within 1 hour of onset of pain, according to results from AXERT Early MiGraine Intervention Study (AEGIS) released here at the 58^th Annual Meeting of the American Academy of Neurology (AAN).

"The difference in the response is seen in the 2-hour pain relief data, which show that 37% of patients who took almotriptan experienced pain relief at 2 hours compared with 23.9% of patients taking placebo (P <.010)," said presenter Ninan T. Mathew, director, Houston Headache Clinic, Houston, Texas, United States.

Results of the AEGIS study also confirm the findings from other migraine treatment studies, Dr. Mathew said, adding, "Treating when the pain is still mild is most effective."

The multicentre, randomised, double-blind, placebo-controlled, parallel-group trial was designed to determine the efficacy of 12.5 mg of almotriptan in the acute treatment of mild, moderate, and severe migraine. Patients were randomised in a 1:1 fashion and asked to treat 3 consecutive migraine attacks within 1 hour of onset. Rescue medication was permitted. The primary study endpoint was pain-free status at 2 hours postdose.

Results also show that 42% and 21.9% of almotriptan and placebo-treated patients achieved pain-free status at 4 hours postdose (P <.001).

Among the secondary endpoints, data for pain relief status at 2 hours postdose, defined as a "decrease in baseline intensity from severe or moderate to mild or no pain without the use of supplemental pain medication," show that 72.3% of the almotriptan arm and 48.4% of the placebo arm achieved pain relief within that time frame (P <.001).

Almotriptan also demonstrated significant benefit compared with placebo with respect to modified pain at 2 hours postdose (59.9% vs 42.6%, respectively, P <.001), and sustained pain-free status (24.7% vs16.1%, respectively, P =.04).

"All the endpoints we looked at were improved with early treatment -- treatment within the first hour -- particularly those patients with mild headache," Dr. Mathew said.

Fewer patients in the almotriptan arm required rescue medication at 4 and 24 hours postdose, compared with those receiving placebo, he noted.

Additionally, photophobia, phonophobia, and nausea were all significantly reduced with early almotriptan intervention compared with placebo. With respect to tolerability, almotriptan was similar to placebo.

These results suggest that medications such as almotriptan may encourage patients to treat their migraine attacks earlier, which may result in a reduced need for rescue medications, Dr. Mathew concluded.

The study was funded by Ortho-McNeil Janssen.


[Presentation title: Early Intervention With Almotriptan: Results of the AEGIS Trial (AXERT® Early MiGraine Intervention Study). Poster P01.118]

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