NBI-827104 for Epilepsy

(Steamboat 2 Trial)

Recruiting at 11 trial locations

Overseen By Neurocrine Medical Information Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Neurocrine Biosciences

Must not be taking: Investigational drugs

Disqualifiers: Cardiovascular, Neurological, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

19 Participants Needed

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NBI-827104 orally to evaluate long-term safety and tolerability

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue to receive NBI-827104 to assess long-term effects

Long-term

Treatment Details

Interventions

• NBI-827104

Trial Overview The 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

Group I: NBI-827104 Experimental Treatment 1 Intervention

NBI-827104 administered orally

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