Clinical Trial 45911

Aurora, CO 80045


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.




Available At:

A special website has been created to provide more information about the Steamboat Study. The website includes information on what to expect if your child is enrolled. CLICK HERE for more information.

Click here for a list of study sites.

 


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.