Idiopathic Hypersomnia (IH) is a chronic neurological sleep disorder primarily characterized by excessive daytime sleepiness (EDS) that is unrelated to nighttime sleep quality or duration. 

This whitepaper provides a comprehensive overview of clinical trial considerations for IH, covering diagnosis criteria, epidemiology, and pivotal endpoints used to assess therapeutic efficacy. It explores key challenges in endpoint determination, reviews FDA-approved treatments, and examines drug candidates that failed to reach approval, highlighting common pitfalls in trial design and execution. Safety concerns and their implications for trial protocols are analyzed, along with strategies to enhance clinical trial frameworks, ultimately aiming to advance therapeutic options for IH patients. 

iNGENū’s team of researchers and clinicians is dedicated to advancing bladder cancer research. Through innovative trial designs and a patient-centered approach, we work to accelerate the development of new treatments that could offer improved options and outcomes for those affected by bladder cancer.