CURE Epilepsy would like to pass on some information that some families might find helpful.
The Steamboat Study ([link removed]) is a clinical research study to evaluate the safety and effectiveness of an investigational medication compared to a placebo (inactive drug) in children ages 4 to 12 years with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS). The study is evaluating if the investigational medication is safe and if it improves brain activity caused by epilepsy while sleeping.

Participation in the Steamboat Study ([link removed]) will last up to 21 weeks; this includes a screening period (up to 4 weeks), treatment period (up to 13 weeks), and posttreatment follow-up period (up to 4 weeks). If an open-label extension (OLE) study is available and eligible participants choose to enroll directly into the OLE study from this study, the expected duration of study participation in this study is up to 16 weeks, including up to 4 weeks of screening and up to 12 weeks of study treatment. Participants in the Steamboat Study will be required to attend up to 11 visits over the course of the study. Three of these visits are overnight stays.

If you are interested in enrolling your child in this study, he or she will be evaluated to further determine eligibility. All participants who qualify will receive either the investigational medication or the placebo, as well as study-related medical exams and study-related laboratory tests, at no cost.

Eligible participants must:
* Be male or female between the ages of 4 and 12 (inclusive)
* Be diagnosed with EECSWS
+ Subjects with Landau-Kleffner syndrome are eligible to participate in the study if they meet all other specified diagnostic criteria
* Be on stable dosage and stable time of intake of at least 1 and up to 3 antiseizure medications (ASMs) excluding pulse therapies such as systemic corticosteroids and intravenous immunoglobulin (IVIG), from 4 weeks prior to the screening period and anticipated to be stable until the end of the study
+ Vagal nerve stimulator (VNS) and ketogenic diet are not counted as ASMs
* If using a VNS, have had the VNS placed at least 3 months prior to the screening period with stable settings for at least 1 month and anticipated to remain stable until the end of the study
* Not have a history of tonic seizures during sleep
* Not have taken pulse therapy such as systemic corticosteroids and IVIG for at least 8 weeks prior to screening


Additional eligibility criteria apply, along with what’s mentioned here. All criteria will be explained to you by a study doctor.

We know that any decision regarding your child’s health is never taken lightly. If you would like more information or are interested in seeing if your child may qualify, visit the Steamboat Study website, which is part of the Stillwater Program, at SteamboatResearchStudy.com ([link removed]) .

Thank you for your consideration of the Steamboat Study.
CURE Epilepsy is not affiliated with, nor has any financial investment in the Steamboat Study. CURE Epilepsy is sharing information about this external opportunity, and is not sponsoring nor is directly involved in this project. Should you choose to reach out to the Steamboat Study and/or become involved with this project, you would do so independently from CURE Epilepsy.
Our mission is to find a cure for epilepsy, by promoting and funding patient-focused research. CURE Epilepsy is a non-profit 501(c)(3) tax-exempt organization. Our tax identification number is 36-4253176.
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