Zevra Therapeutics (formerly KemPharm): A Clinical Study in Adults With Idiopathic Hypersomnia
Zevra Therapeutics (formerly KemPharm) has initiated the KP1077.D01 study to evaluate the safety and efficacy of SDX, an investigational medication for treating excessive daytime sleepiness (EDS) in people with idiopathic hypersomnia age 18 years or older. SDX has a unique, slow release profile that could potentially provide stable control of sleepiness throughout the day, with low abuse potential.
In this study, researchers will evaluate the safety of the medication and its effect on symptoms and severity of IH, including the effect on EDS, sleep inertia (difficulty of waking up in the morning), and brain fog (lack of focus and mental clarity; forgetfulness and confusion).
This clinical study consists of the following:
Initial screening period during which eligibility criteria will be evaluated, including a confirmation of patient’s IHdiagnosis, if needed and during which trial participants will need to wash out all current medications.
A five-week dose optimization phase in which all eligible study participants will receive SDX.
A two-week double-blind randomized withdrawal phase in which study participants and physicians will not be aware of who is receiving SDX or placebo (a tablet that does not contain study drug).
Patients will be reimbursed for their participation, including coverage of travel costs to the clinical sites for all their clinic visits that are part of the clinical trial. Participants can talk to the staff of their clinical site to facilitate travel arrangements and reimbursements.
Adults (18 years of age or older) who meet the following criteria may be eligible to participate:
Able to give informed consent.
Have excessive daytime sleepiness as measured by sleepiness questionnaires.
Agree to wash out all current medications that may affect daytime sleepiness or nighttime sleep.
Are not pregnant, or do not plan to get pregnant or breastfeed during the study.
This is not a complete list of eligibility criteria. The study doctor will review all the requirements with potential participants.
For additional details about the study and enrollment, visit clincaltrials.gov (NCT05668754) or e-mail: firstname.lastname@example.org.
INTUNE: A Clinical Study in Adults With Idiopathic Hypersomnia (IH)
The INTUNE study is being conducted by Harmony Biosciences to evaluate the safety and efficacy of pitolisant, an investigational medication for treating excessive daytime sleepiness (EDS) in people with idiopathic hypersomnia age 18 years or older.
This study is also evaluating the effect of pitolisant on overall symptoms and severity of IH, sleep inertia, cognition, and general sleep-related impairment.
This clinical study consists of a screening period (up to 28 days), an 8-week Open-Label Phase in which all eligible study participants will receive pitolisant, followed by a 4-week Double-Blind Randomized Withdrawal Phase in which study participants and doctors won’t know who is receiving pitolisant or placebo (a tablet that does not contain study drug).
For more information or to find a participating clinical site visit: NCT05156047 at clinicaltrials.gov or www.intuneihstudy.com/.
Contact Harmony Biosciences by email at email@example.com.