Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures
Reason given: The long-term extension study was terminated because the parent study NBI-921352-FOS2021 (NCT05159908) failed to meet its primary endpoint.
Key facts
- Where
- Brno, Ostrava, Prague, and Rychnov nad Kněžnou, CzechiaSee the 4 sites
- Phase
- Phase 2
Where in Czechia
- BrnoBrno, CzechiaNo longer taking part
- OstravaOstrava, CzechiaNo longer taking part
- PraguePrague, CzechiaNo longer taking part
- Rychnov nad KněžnouRychnov nad Kněžnou, CzechiaNo longer taking part
Trial details
- Who runs it
- Neurocrine Biosciences
- Trial code
- NCT05493293
- Record updated
- 12 April 2024
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: 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.