On the methodology of drug trials in migraine with aura.
BACKGROUND
Specific problems occur in clinical treatment trials for migraine with aura that differ from those encountered in treatment trials for migraine without aura.


CONCLUSIONS
Based on our experience with four such trials, we point to a number of possible solutions and outline areas for future inquiry. We make recommendations about subject selection; the choice, definition and assessment of outcome measures; optimal treatments in relation to aura and headache; and we provide samples of study report forms used to record occurrence of aura and headache in this population.
Hauge
Anne Werner
AW
Danish Headache Center, Department of Neurology, University of Copenhagen, Faculty of Health Sciences, Glostrup Hospital, Glostrup, Denmark. ahauge@dadlnet.dk
Hougaard
Anders
A
Olesen
Jes
J
D001549:Benzamides / Q000627:therapeutic use*; D001578:Benzopyrans / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D020325:Migraine with Aura / Q000188:drug therapy* / Q000517:prevention & control*; D020326:Migraine without Aura / Q000188:drug therapy / Q000517:prevention & control; D018579:Patient Selection; D016896:Treatment Outcome
D001549:Benzamides; D001578:Benzopyrans; C118706:tonabersat