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
- 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 more than one month
- Does not have a history of tonic seizures during sleep
Additional eligibility requirements apply.
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. 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.
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)