Methodologic issues in acute migraine clinical trials.

Abstract

Migraine is a common chronic condition with an ever-expanding therapeutic armamentarium. As new migraine therapies are investigated, the methodology of clinical trials has become increasingly important. Clinical trials should provide clinicians and patients with the information they need to assess the efficacy, safety, and comparative benefits of current and emerging therapies. The study design (e.g., crossover, parallel group) and methods, including determination of appropriate dosing, are key. The selection of primary efficacy end points is another critical factor. There is increasing evidence that complete pain relief powerfully predicts patient satisfaction with treatment and quality of life. Secondary end points, such as relief of migraine-associated symptoms, need for use of escape medication, and quality of life measurements, should also be carefully considered.