Status:
TERMINATED
Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
Lead Sponsor:
Neurocrine Biosciences
Conditions:
Epileptic Encephalopathy
Continuous Spike and Wave During Sleep
Eligibility:
All Genders
4-12 years
Phase:
PHASE2
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 sl...
Detailed Description
This study will enroll participants who completed treatment in the Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group Study NBI-827104-CSWS2010 (NCT04625101). Participa...
Eligibility Criteria
Inclusion
- Key
- 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).
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
June 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2025
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05301894
Start Date
June 7 2022
End Date
January 27 2025
Last Update
February 28 2025
Active Locations (12)
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1
Neurocrine Clinical Site
Orange, California, United States, 92868
2
Neurocrine Clinical Site
Aurora, Colorado, United States, 80045
3
Neurocrine Clinical Site
Washington D.C., District of Columbia, United States, 20010
4
Neurocrine Clinical Site
Miami, Florida, United States, 33155