On the methodology of drug trials in migraine with aura.

INTRODUCTION

Specific problems occur in clinical treatment trials for migraine with aura that differ from those encountered in treatment trials for migraine without aura.

DISCUSSION

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.