SITUATION Migraine is a common and debilitating neurological disease, affecting 39 million people in the United States alone. It has a considerable impact on patients' lives, with 90% of people unable to work or function normally during an attack*. Current treatments, such as triptans, are not effective as headaches can reoccur within 24 hours after taking migraine medication — and also produce cardiovascular contraindications and warnings. High placebo response rates, averaging 29% in migraine studies, can mask the true therapeutic effect of a drug**. In this phase III CNS migraine study, a biopharmaceutical company sought to evaluate the efficacy and safety of its drug for the acute treatment of migraines. The trial needed to demonstrate that the treatment was statistically differentia

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