Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep

Study Overview
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Brief Summary
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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).

Detailed Description
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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). Participants who did not participate in Study NBI-827104-CSWS2010 may also be eligible for enrollment.

Official Title
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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

Conditions
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Epileptic Encephalopathy, Continuous Spike and Wave During Sleep

Intervention / Treatment
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* Drug: NBI-827104


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NBI-827104<br>NBI-827104 administered orally | Drug: NBI-827104<br>* T-type calcium channel blocker.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Occurrence of Serious Treatment-emergent Adverse Events (TEAEs) |  | Day 1 up to 238 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurocrine, Epilepsy, Epileptic Encephalopathy, NBI-827104, Steamboat 2