Treatment of migraine with BMS180048: response at 2 hours. North American BMS180048 Study Group.
BMS180048 is a 5HT 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.
Department of Neurology, University of Oklahoma Health Sciences Center, Oklahoma City 73190-2048, USA.
J R
JR
Couch
J
J
Saper
J P
JP
Meloche
D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D012008:Recurrence; D017366:Serotonin Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D014363:Tryptamines
D007211:Indoles; D017366:Serotonin Receptor Agonists; D013449:Sulfonamides; D014363:Tryptamines; C103231:avitriptan