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No acute antimigraine efficacy of CP‐122,288, a highly potent inhibitor of neurogenic inflammation: Results of two randomized, double‐blind, placebo‐controlled clinical trials
Author(s) -
Roon K. I.,
Olesen J.,
Diener H. C.,
Ellis P.,
Hettiarachchi J.,
Poole P. H.,
Christianssen I.,
Kleinermans D.,
Kok J. G.,
Ferrari M. D.
Publication year - 2000
Publication title -
annals of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.764
H-Index - 296
eISSN - 1531-8249
pISSN - 0364-5134
DOI - 10.1002/1531-8249(200002)47:2<238::aid-ana15>3.0.co;2-l
Subject(s) - placebo , medicine , extravasation , randomization , crossover study , anesthesia , pharmacology , clinical trial , migraine , gastroenterology , pathology , alternative medicine
CP‐122,288 is a highly potent inhibitor of neurogenic plasma extravasation in animal models at doses without vasoconstrictor effect. We evaluated the acute antimigraine efficacy of intravenous and oral CP‐122,288 in two double‐blind studies. In a crossover design, patients randomly received 31.25 μg of CP‐122,288 intravenously, placebo, or both. In the oral study, patients received placebo or one of four doses of CP‐122,288 between 3.125 and 312.5 μg, using a novel “up and down” design for randomization. Both studies were stopped prematurely when target efficacy could not be achieved. Responder rates were 29% for CP‐122,288 versus 30% for placebo (difference, −1%; 95% CI, −24–22%; intravenous study) and an overall rate of 25% for CP‐122,288 versus 0% for placebo (difference, 25%; 95% CI; 10–40%; oral study). CP‐122,288 was not clinically effective at doses and plasma concentrations in excess of those required to inhibit neurogenic plasma extravasation in animals. Neurogenic plasma extravasation is unlikely to play a crucial role in the pathophysiology of migraine headache. Ann Neurol 2000;47:238–241