Study Stopped
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Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
Steamboat 2
Long-Term, Open-Label Extension Study to Evaluate the Safety and Tolerability of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
2 other identifiers
interventional
19
5 countries
12
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2022
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedStudy Start
First participant enrolled
June 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2025
CompletedResults Posted
Study results publicly available
February 13, 2026
CompletedFebruary 13, 2026
July 1, 2025
2.6 years
March 21, 2022
January 27, 2026
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs)
A TEAE is an adverse event (AE) that was not present prior to the initiation of study treatment or was an already present condition that worsened either in intensity or frequency following the initiation of study treatment.
Up to 884 days of treatment and 4-week safety follow-up (mean duration of exposure was 649.7 days)
Study Arms (1)
NBI-827104
EXPERIMENTALNBI-827104 administered orally
Interventions
Eligibility Criteria
You may qualify if:
- For participants who enroll directly following the completion of the Study NBI-827104-CSWS2010:
- Completed 12 weeks of treatment in Study NBI-827104-CSWS2010.
- For Participants Who Do Not Enroll Directly from or Did Not Participate in Study NBI-827104-CSWS2010:
- Have diagnosis of EECSWS confirmed by the Diagnosis Confirmation Panel (DCP).
You may not qualify if:
- For participants who enroll directly following the completion of the Study NBI-827104-CSWS2010:
- Have developed any other disorder for which the treatment takes priority over treatment of EECSWS or is likely to interfere with study treatment or impair treatment compliance.
- For Participants Who Do Not Enroll Directly from or Did Not Participate in Study NBI-827104-CSWS2010:
- Body weight \<15 kg at Day 1.
- Clinically relevant findings related to cardiovascular or laboratory parameters at screening as determined by the investigator.
- Presence of relevant neurological disorders other than EECSWS and its underlying conditions as judged by the investigator. Symptomatic conditions underlying EECSWS (for example, neonatal strokes) have to be stable for at least 1 year prior to screening.
- Planned surgical intervention related to structural abnormalities of the brain from screening through the Week 6 Visit.
- Used any active investigational drug other than NBI-827104 in the context of a clinical study within 30 days or 5 half-lives (whichever is longer) before screening or plans to use such an investigational drug (other than NBI-827104) during the study.
- Have developed any other disorder for which the treatment takes priority over treatment of EECSWS or is likely to interfere with study treatment or impair treatment compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Neurocrine Clinical Site
Orange, California, 92868, United States
Neurocrine Clinical Site
Aurora, Colorado, 80045, United States
Neurocrine Clinical Site
Washington D.C., District of Columbia, 20010, United States
Neurocrine Clinical Site
Miami, Florida, 33155, United States
Neurocrine Clinical Site
Rochester, Minnesota, 55905, United States
Neurocrine Clinical Site
Durham, North Carolina, 27705, United States
Neurocrine Clinical Site
Cleveland, Ohio, 44195, United States
Neurocrine Clinical Site
Dianalund, 4293, Denmark
Neurocrine Clinical Site
Barcelona, 08950, Spain
Neurocrine Clinical Site
Madrid, 28034, Spain
Neurocrine Clinical Site
Zurich, 8032, Switzerland
Neurocrine Clinical Site
London, WC1N 3JH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early by the Sponsor; therefore, no participants completed the study.
Results Point of Contact
- Title
- Neurocrine Medical Information Call Center
- Organization
- Neurocrine Biosciences
Study Officials
- STUDY DIRECTOR
Clinical Development Lead
Neurocrine Biosciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2022
First Posted
March 31, 2022
Study Start
June 7, 2022
Primary Completion
January 27, 2025
Study Completion
January 27, 2025
Last Updated
February 13, 2026
Results First Posted
February 13, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share