Training Program Reduces Placebo Effect By More Than 50% In ePRO Study

Migraine, a prevalent and incapacitating neurological disorder, impacts a staggering 39 million individuals solely in the United States. During an attack, the impact of migraine on patients' lives is significant, rendering 90% of individuals unable to work or carry out their daily activities effectively.1 Triptans, a current treatment for the condition, are reportedly not effective as headaches can reoccur within 24 hours after taking the migraine medication. Furthermore, the drug has been known to produce cardiovascular contraindications. In other studies, researchers found high placebo response rates, averaging 29% in migraine studies, can mask the true therapeutic effect of a drug.2

During a phase III CNS migraine study, a biopharmaceutical company sought to evaluate the efficacy and safety of its drug for the acute treatment of migraines. Specifically, the trial needed to prove that the treatment was statistically differentiated from a placebo on two coprimary endpoints. This would require the sponsor to minimize the placebo response rate to ensure the trial results were as accurate as possible.

Discover how a tailored online training program specific to the requirements of the sponsor’s migraine study was able to directly contribute to significantly lowering the placebo response rate in the phase III migraine CNS study.