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Initial Clinical Experience with the Use of Subcutaneous GR43175 in Treating Acute Migraine

Subcutaneous GR43175 was examined in patients with acute migraine for efficacy, tolerability and safety in an open, controlled, dose-ranging study. Ten patients with acute, non-medicated, migraine (15 attacks) were assessed for severity of headache and associated symptoms (nausea, vomiting and photophobia). GR43175 plasma samples were monitored serially after dosing. Doses of 2 mg or 3 mg gave rapid relief of all migraine symptoms. Thirteen attacks (86%) had either resolved completely or improved to a mild non-migraine residual headache within 40 min. Treatment was well tolerated at all doses, the only adverse effects being transient pain on injection. Peak plasma concentrations were obtained within 10–20 min; a decline in plasma drug concentration did not result in a relapse in headache severity.