Prospective, Long-Term, Interventional, Active Extension Study to Evaluate the Safety and Tolerability of NBI-921352 as Adjunctive Therapy in Subjects With Focal Onset Seizures (FOS)

Neurocrine Biosciences1 site in 1 country82 target enrollmentNovember 9, 2022

ConditionsFocal Onset Seizure Focal Onset Epilepsy

InterventionsNBI-921352

DrugsNBI-921352

Overview

Phase: Phase 2
Intervention: NBI-921352
Conditions: Focal Onset Seizure
Sponsor: Neurocrine Biosciences
Enrollment: 82
Locations: 1
Primary Endpoint: The occurrence of serious treatment-emergent adverse events (TEAEs)
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 9, 2022

End Date

March 11, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Neurocrine Biosciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provided informed consent.
•Completed 11 weeks of treatment in Study NBI-921352-FOS
•Stable treatment with at least 1 but not more than 4 antiseizure medicines.

Exclusion Criteria

•Have developed any other disorder for which the treatment takes priority over the treatment of focal onset seizure or is likely to interfere with study treatment or impair treatment compliance.