TerminatedPhase 2

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

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

Australia, Belgium82 participantsStarted 2022-11-09

Plain-language 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.

Who can participate

Age range18 Years – 67 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key 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.

What they're measuring

The occurrence of serious treatment-emergent adverse events (TEAEs)

Timeframe: Through Week 111

Trial details

NCT IDNCT05493293

SponsorNeurocrine Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-11

View on ClinicalTrials.gov More Focal Onset Seizure trials