NBI-827104 for Epilepsy
(Steamboat 2 Trial)
Recruiting at 11 trial locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Neurocrine Biosciences
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The primary objective for this study is to evaluate the long-term safety and tolerability of NBI-827104 in pediatric participants with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS).
Research Team
CD
Clinical Development Lead
Principal Investigator
Neurocrine Biosciences
Eligibility Criteria
This trial is for children with a specific brain condition called EECSWS. Those who completed a prior study (NBI-827104-CSWS2010) can join, as well as new participants with confirmed EECSWS diagnosis. Kids under 15kg, those with certain heart or lab issues, other neurological disorders not stable for at least a year, planned brain surgery within six weeks of the trial start, or recent use of investigational drugs cannot participate.Inclusion Criteria
My EECSWS diagnosis has been confirmed by a specialized panel.
If you were in another study before this one, you must have finished the treatment for at least 12 weeks.
Exclusion Criteria
I am scheduled for brain surgery due to structural abnormalities.
Your doctor found important heart or lab test results during your screening.
I weigh less than 15 kg and did not come from study NBI-827104-CSWS2010.
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Treatment Details
Interventions
- NBI-827104 (Unknown)
Trial OverviewThe study tests the long-term safety and effects of NBI-827104 in kids with EECSWS. It's an extension study meaning it continues from previous research to gather more data on how safe and tolerable this medication is over time for these pediatric patients.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: NBI-827104Experimental Treatment1 Intervention
NBI-827104 administered orally
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neurocrine Biosciences
Lead Sponsor
Trials
78
Recruited
6,600+
Kyle W. Gano
Neurocrine Biosciences
Chief Executive Officer since 2024
PhD in Pharmacology
Dr. Sanjay Keswani
Neurocrine Biosciences
Chief Medical Officer
MD