Extension study to evaluate how safe and tolerable the drug NBI-921352 is when used as adjunctive therapy in participants with SCN8A developmental and epileptic encephalopathy syndrome (SCN8A-DEE).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Administered orally
UCSF Medical Center
San Francisco, California, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
University of Rochester
Rochester, New York, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
The participant incidence of serious treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation of study treatment, and fatal TEAEs
Time frame: Day 1 to Week 168
Percentage change from baseline in 28-day seizure frequency for countable motor seizures
Time frame: Baseline, up to Week 162
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