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.
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.
Interest in Genetic & Blood Markers in Kleine-Levin Syndrome Study
We are seeking volunteers to take part in a research study investigating the genetic basis of KLS. In this study researchers will conduct DNA genetic and blood protein biomarker measurements from blood samples to identify genes associated with KLS. Participation would require that you fill out a questionnaire related to your sleep and KLS symptoms which will be reviewed by our clinical research staff. If you are deemed eligible then you will be asked to donate a blood sample (we will provide instructions and all necessary materials, including financial compensation for sample collection/shipment) which would conclude your active participation in this study.
The investigator on this study is Dr. Emmanuel Mignot and the research staff at the Stanford Center for Narcolepsy and I am the clinical coordinator, Abigail Cirelli. This research study is sponsored by the Kleine-Levin Syndrome Foundation and is conducted at Stanford University.
If you are interested in learning more about the study, please select this link (https://redcap.link/kls_research) in order to review additional information on the study, and verify your interest in participating, and confirm your initial eligibility status. If you have any questions, please feel free to respond to this email and contact me directly at firstname.lastname@example.org.
If the link above does not work, try copying the url below into your web browser:
Thank you for your interest in helping advance research in KLS and please do not hesitate to reach out if you have any questions. We hope you are taking good care of yourself.
Abigail Cirelli and the KLS Research Team