Clinical Trial 53010

Houston, TX 77070


KP1077.D01: A Clinical Study in Adults with Idiopathic Hypersomnia (IH)
NOW ENROLLING adults (18 years and older) with IH

Study KP1077.D01 is being conducted by KemPharm, Inc to evaluate the safety and efficacy of KP1077 capsules in patients with IH.

KP1077 capsules contain serdexmethylphenidate (SDX), a prodrug of dexmethylphenidate. It is an investigational medication for treating excessive daytime sleepiness (EDS) and other symptoms of IH, including sleep inertia (difficulty of waking up in the morning), and brain fog (lack of focus and mental clarity; forgetfulness and confusion). SDX has a unique, slow release profile that could potentially provide stable control of sleepiness throughout the day, with low abuse potential.

The clinical study consists of a screening period (up to 5 weeks), a 5-week open-label dose optimization period during which the optimal SDX dose will be determined, followed by a 2-week double-blind, randomized withdrawal period.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.