Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures
- Registration Number
- NCT05493293
- Lead Sponsor
- Neurocrine Biosciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 82
Inclusion Criteria
- Provided informed consent.
- Completed 11 weeks of treatment in Study NBI-921352-FOS2021.
- Stable treatment with at least 1 but not more than 4 antiseizure medicines.
Key
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NBI-921352 Treatment NBI-921352 Treatment for up to 107 weeks.
- Primary Outcome Measures
Name Time Method The occurrence of serious treatment-emergent adverse events (TEAEs) Through Week 111
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Neurocrine Clinical Site
🇪🇸Valencia, Spain