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

Neurocrine Biosciences

Status and phase: Terminated; Phase 2

Conditions: Focal Onset Epilepsy; Focal Onset Seizure

Treatments: Drug: NBI-921352

Study type: Interventional

Funder types: Industry

Identifiers

NCT05493293

NBI-921352-FOS2022

2021-004265-12 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 67 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

NBI-921352 Treatment

Experimental group

Description:

Treatment for up to 107 weeks.

Treatment:

Drug: NBI-921352