Summary:
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.