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Treatment of Migraine With BMS180048: Response at 2 Hours
Author(s) -
Couch James R.,
Saper Joel,
Meloche Jacques P.
Publication year - 1996
Publication title -
headache: the journal of head and face pain
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.14
H-Index - 119
eISSN - 1526-4610
pISSN - 0017-8748
DOI - 10.1046/j.1526-4610.1996.3609523.x
Subject(s) - phonophobia , migraine , nausea , tolerability , medicine , placebo , photophobia , headaches , adverse effect , anesthesia , placebo response , surgery , aura , alternative medicine , pathology
BMS180048 is a 5HT 1D 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.