This study will evaluate the safety, pharmacokinetics, and efficacy of three different doses of NBI-921352 versus placebo in adults with focal onset seizures
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
101
Tablets for oral administration
Matching placebo tablets for oral administration
Neurocrine Clinical Site
Randwick, New South Wales, Australia
Number of Participants with Serious Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation of Study Treatment, and Fatal TEAEs
Time frame: Through Week 15
NBI-921352 exposure-efficacy response relationship, defined as the slope of the relationship between reduction in monthly focal onset seizure frequency and plasma concentration at steady state
Time frame: Baseline to Week 11
Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Treatment Period
Time frame: Baseline and Weeks 1 to 11
Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Maintenance period
Time frame: Baseline and Weeks 4 to 11
Clinical Global Impression of Change (CGIC) Scores at Week 11
Time frame: Week 11
Percentage of Participants with a ≥ 50% reduction in monthly (28 days) focal onset seizure frequency during the treatment period
Time frame: Baseline and Weeks 1 to 11
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