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Treatment of Migraine With BMS180048: Response at 2 Hours

Authors


Dr. James R. Couch, Jr, Professor and Chair, Department of Neurology, The University of Oklahoma Health Sciences Center, 920 Stanton L. Young Boulevard, Room 3SP203, Oklahoma City, OK 73190-3048.

Abstract

BMS180048 is a 5HT1D agonist that was well-tolerated in early phase II trials. This study utilized a double-blind, parallel-group dose ranging format, comparing BMS180048 in doses of 25, 50, or 75 mg to placebo in effectiveness of treatment of a single migraine headache.

To assess tolerability of BMS180048, patients received a test dose of the medication they would receive for a headache in the clinic under observation. If no significant side effects occurred, patients were allowed to treat a headache. Headaches were moderate or severe in intensity before treatment, and response at 2 hours was tabulated. Reduction to mild or no headache was the criteria for successful response. Response rates at 2 hours were as follows:

• placebo - 19 of 53 subjects (35.8%)
• 25 mg - 21 of 53 subjects (40.3%)
• 50 mg - 34 of 53 subjects (64.2%)
• 75 mg - 35 of 55 subjects (63.6%)

The improvement for subjects treated with 50 or 75 mg of BMS180048 when compared to placebo was highly significant (P<.01). Nausea, photophobia, and phonophobia improved 35% to 50% for BMS180048-treated subjects and 20% to 24% in the placebo group. The improvement in these symptoms in comparison to placebo was statistically significant only for nausea in those treated with 75 mg of BMS180048 (P=.02). Side effects were mild for the most part, and no serious adverse events occurred. The study suggests BMS180048 is effective in acute symptomatic therapy of migraine.

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