NCT05493293

Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 67 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Focal Onset Seizure
• Focal Onset Epilepsy

Interventions

Type	Name	Description
DRUG	NBI-921352	Tablets for oral administration

Timeline

• Start date: 2022-11-09
• Primary completion: 2024-03-11
• Completion: 2024-03-11
• First posted: 2022-08-09
• Last updated: 2024-04-12

Locations

26 sites across 7 countries: Australia, Belgium, Czechia, France, Hungary, Italy, Spain