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Clinical Trial 45912

Rochester, MN 55905


Summary:

Study 45910 Flyer
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.




Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.