This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study NBI-921352-FOS2021. Eligible participants may enroll directly following the completion of the Week 11 study visit of Study NBI-921352-FOS2021 or after a gap following completion of that study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Tablets for oral administration
Neurocrine Clinical Site
Fitzroy, Australia
Neurocrine Clinical Site
Heidelberg, Australia
Neurocrine Clinical Site
Melbourne, Australia
Neurocrine Clinical Site
Brussels, Belgium
Neurocrine Clinical Site
Ghent, Belgium
Neurocrine Clinical Site
Leuven, Belgium
Neurocrine Clinical Site
Brno, Czechia
Neurocrine Clinical Site
Ostrava, Czechia
Neurocrine Clinical Site
Prague, Czechia
Neurocrine Clinical Site
Prague, Czechia
...and 16 more locations
The occurrence of serious treatment-emergent adverse events (TEAEs)
Time frame: Through Week 111
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