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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
T-type calcium channel blocker.
Neurocrine Clinical Site
Orange, California, United States
Neurocrine Clinical Site
Aurora, Colorado, United States
Neurocrine Clinical Site
Washington D.C., District of Columbia, United States
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.
Time frame: Up to 884 days of treatment and 4-week safety follow-up (mean duration of exposure was 649.7 days)
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Neurocrine Clinical Site
Miami, Florida, United States
Neurocrine Clinical Site
Rochester, Minnesota, United States
Neurocrine Clinical Site
Durham, North Carolina, United States
Neurocrine Clinical Site
Cleveland, Ohio, United States
Neurocrine Clinical Site
Dianalund, Denmark
Neurocrine Clinical Site
Barcelona, Spain
Neurocrine Clinical Site
Madrid, Spain
...and 2 more locations