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Title: Phase 3 Trial Shows Telcagepant to Be a Safe, Effective Migraine Treatment

"Phase 3 Trial Shows Telcagepant to Be a Safe, Effective Migraine Treatment"

NEW YORK -- November 24, 2008 -- Telcagepant 300 mg is effective as an acute treatment for migraine with efficacy comparable to that of zolmitriptan 5 mg, but with fewer associated adverse effects, according to a study published early online and in an upcoming edition of [The Lancet.

Tony Ho, MD, Merck Research Laboratories, North Wales, Pennsylvania, and colleagues conducted a randomised, controlled phase 3 study and analysed 1,380 patients from 81 sites in the United States and Europe.

All patients had moderate or severe migraine as defined by International Headache Society criteria. Patients received telcagepant 150 mg (n = 333) or 300 mg (n = 354), zolmitriptan (n = 345), or placebo (n = 348).

Telcagepant 300 mg was more effective than placebo for freedom from pain (27% of patients vs 10%), pain relief (55% vs 28%), and absences of phonophobia (58% vs 37%), photophobia (51% vs 29%), and nausea (65% vs 55%).

Efficacy of telcagepant 300 mg and zolmitriptan 5 mg were similar, and both were more effective than telcagepant 150 mg. Adverse events were recorded for 31% taking telcagepant 150 mg, 37% taking telcagepant 300 mg, 51% taking zolmitriptan 5 mg, and 32% taking placebo.

"One potential benefit of the new calcitonin gene-related peptide (CGRP) receptor antagonist class of acute migraine treatments is the absence of vasoconstriction, a liability of the triptans, which may allow for the safe administration of telcagepant in patients with migraine with cardiovascular disease," the authors wrote.

"However, such patients were excluded from the present study because of the contraindication for zolmitriptan, and further studies are necessary to determine the safety of telcagepant in patients with cardiovascular disease. Additional studies are also necessary to assess the long-term efficacy and safety profile of telcagepant in patients treating more than 1 migraine attack."

In an accompanying comment, Lars Edvinsson, MD, Lund University, University Hospital, Lund, Sweden, said, "Telcagepant is associated with a lower incidence of side-effects than the triptan. This result marks a new era in migraine therapy. However, the remaining issue is to understand the site of action of the CGRP-receptor antagonists."

SOURCE: The Lancet

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