Purpose of the Stillwater Program

The Stillwater Program is researching investigational medications for different forms of epilepsy, and you or your loved one may be able to take part. While participants can enroll in only one investigational study at a time in the Stillwater Program, involvement in this research may contribute to a larger effort working to find alternative treatments for epilepsy.

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Steamboat Study

Purpose of the Steamboat Study

The purpose of the Steamboat Study is to evaluate the safety and effect of an investigational medication, called NBI-827104, compared to a placebo (inactive drug) in children 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.

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.

Study Participation

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)