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NBI-921352

Phase 2

Focal Onset Seizure | Small molecule | Neurology |Neurocrine Biosciences, Inc.|Last Updated: Sep 26, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment101
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05159908A Study to Investigate How Effective, Safe and Tolerable the Drug NBI-921352 is When Used With Anti-seizure Medications in Adults With Focal Onset SeizuresPHASE2 COMPLETED 101 — — Nov 8, 2021Aug 21, 2023Sep 26, 202428 Australia, Belgium +5
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Study Endpoints
Primary Endpoints
Number of Participants with Serious Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation of Study Treatment, and Fatal TEAEs
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
Baseline to Week 11
Secondary Endpoints
Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Treatment Period
Baseline and Weeks 1 to 11
Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Maintenance period
Baseline and Weeks 4 to 11
Clinical Global Impression of Change (CGIC) Scores at Week 11
Week 11
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo schedulePLACEBO_COMPARATORParticipant follows Placebo schedule (13 weeks)
Dose schedule AEXPERIMENTALParticipant follows Dose schedule A (13 weeks)
Dose schedule BEXPERIMENTALParticipant follows Dose schedule B (13 weeks)
Dose schedule CEXPERIMENTALParticipant follows Dose schedule C (13 weeks)
Interventions
NameTypeDescription
NBI-921352DRUGTablets for oral administration
PlaceboDRUGMatching placebo tablets for oral administration
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites28

Key Inclusion Criteria: 1. Capable of providing consent and has completed the written informed consent. 2. Male or female, 18 to 65 years of age, inclusive, with a body mass index (BMI) \< 40 kg/m\^2. 3. Diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE)...

Countries:AustraliaBelgiumCzechiaFranceHungaryItalySpain
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