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NBI-827104 for Epilepsy (Steamboat 2 Trial)

Phase 2
Waitlist Available
Research Sponsored by Neurocrine Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Must not have
For Participants Who Do Not Enroll Directly from or Did Not Participate in Study NBI-827104-CSWS2010: Body weight <15 kg at Day 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug for safety, tolerability, and effectiveness in children with a rare genetic disorder called EECSWS. The trial will enroll children who have completed a previous study testing the same drug.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, the trial aims to monitor how well children tolerate NBI-827104 over an extended period and any adverse reactions they might have due to its continued use.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I weigh less than 15 kg and did not come from study NBI-827104-CSWS2010.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Caregiver Global Impression of Change score
Change from baseline in Clinical Global Impression of Severity score
Clinical Global Impression of Change score
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NBI-827104Experimental Treatment1 Intervention
NBI-827104 administered orally
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NBI-827104
2021
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor
75 Previous Clinical Trials
6,697 Total Patients Enrolled
1 Trials studying Epileptic Encephalopathy
24 Patients Enrolled for Epileptic Encephalopathy
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,550 Total Patients Enrolled
1 Trials studying Epileptic Encephalopathy
24 Patients Enrolled for Epileptic Encephalopathy

Media Library

NBI-827104 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05301894 — Phase 2
Epileptic Encephalopathy Research Study Groups: NBI-827104
Epileptic Encephalopathy Clinical Trial 2023: NBI-827104 Highlights & Side Effects. Trial Name: NCT05301894 — Phase 2
NBI-827104 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05301894 — Phase 2
~2 spots leftby Feb 2025
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