Summary:
If your child has epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS), he or she may be able to take part in a clinical research study.
Study Purpose:
The purpose of the Steamboat Study is to evaluate the safety and effectiveness of an investigational medication compared to a placebo in children ages 4 to 12 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. The investigational medication is a once-daily minitablet formulation.
All participants who qualify will receive the investigational medication or a placebo, as well as study-related exams and study-related laboratory tests, at no cost. Compensation for time and travel may also be available.
Eligibility Criteria:
Eligible participants must:
- Be male or female between the ages of 4 and 12 (inclusive)
- Be diagnosed with EECSWS
- Be on stable dosage and stable time of intake of at least one and up to two anti-epileptic drugs excluding systemic corticosteroids, from four weeks prior to the screening period and anticipated to be stable from screening until the end of the study
- Vagal nerve stimulator (VNS) and ketogenic diet are not counted as anti-epileptic drugs
- If using a VNS, have had the VNS placed at least three months prior to the screening period with stable settings for at least one month
- Not have a history of tonic seizures during sleep
Other protocol-defined inclusion and exclusion criteria may apply.