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

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.

Timeline

Start

2022-11-09

Primary completion

2024-03-11

Completion

2024-03-11

Outcome

Outcome not reported

Stopped: “The long-term extension study was terminated because the parent study NBI-921352-FOS2021 (NCT05159908) failed to meet its primary endpoint.”

Drugs

Indications