Who May Qualify
Eligible participants must meet the following criteria, in addition to other criteria:
- Male or female between the ages of 4 and 12 years, inclusive
- 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 one and up to three antiseizure medications (ASMs) excluding pulse therapies such as systemic corticosteroids and intravenous immunoglobulin (IVIG), from four weeks prior to screening and anticipated to be stable from screening until the end of the study
- Vagal nerve stimulator (VNS) and ketogenic diet are not counted as ASMs
- If the potential participant is using a vagal nerve stimulator (VNS), the VNS must have been placed at least three months prior to the screening period with stable settings for at least one month and anticipated to remain stable throughout the duration of the study
- Does 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 and for the duration of the trial
Additional eligibility requirements apply. For more information on eligibility requirements, please click here.
Participation in the Steamboat Study lasts up to 21 weeks and consists of the following:
- Screening period: This period lasts up to four weeks and includes one overnight visit.
- Treatment period: This period lasts up to 13 weeks. Your child will have nine visits, two of which will be overnight stays at the study center. This period is divided into three sections as follows:
- Dose adjustment (or titration) period: This period lasts from Day 1 to the end of Week 3. Your child will take his or her first dose of the investigational medication or placebo. The dose will increase during Week 2 and Week 3.
- Maintenance period: This period lasts from the beginning of Week 4 to the end of Week 12.
- Dose reduction (or taper) period: This period lasts from the end of Week 12 to Week 13.
- Follow-up period: This period lasts up to four weeks. Your child will not take the investigational medication or placebo during this period.
If an open-label extension (OLE) study is available and eligible subjects 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.
Throughout the study, the study doctor may perform a number of tests and procedures, including but not limited to:
- Physical exams
- Vital sign measurements
- Blood and urine sample collection
- Electrocardiograms (ECG)
- Electroencephalograms (EEG)