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

NCT ID: NCT05493293

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-09

Study Completion Date

2024-03-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Focal Onset Seizure Focal Onset Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

For participants who enroll directly from Study NBI-921352-FOS2021, the study will include a Blinded Dose Conversion Period (1 week) before proceeding to the Open-Label Treatment Period.

Study Groups

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NBI-921352 Treatment

Treatment for up to 107 weeks.

Group Type EXPERIMENTAL

NBI-921352

Intervention Type DRUG

Tablets for oral administration

Interventions

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NBI-921352

Tablets for oral administration

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neurocrine Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Development Lead

Role: STUDY_DIRECTOR

Neurocrine Biosciences

Locations

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Neurocrine Clinical Site

Fitzroy, , Australia

Site Status

Neurocrine Clinical Site

Heidelberg, , Australia

Site Status

Neurocrine Clinical Site

Melbourne, , Australia

Site Status

Neurocrine Clinical Site

Brussels, , Belgium

Site Status

Neurocrine Clinical Site

Ghent, , Belgium

Site Status

Neurocrine Clinical Site

Leuven, , Belgium

Site Status

Neurocrine Clinical Site

Brno, , Czechia

Site Status

Neurocrine Clinical Site

Ostrava, , Czechia

Site Status

Neurocrine Clinical Site

Prague, , Czechia

Site Status

Neurocrine Clinical Site

Prague, , Czechia

Site Status

Neurocrine Clinical Site

Prague, , Czechia

Site Status

Neurocrine Clinical Site

Rychnov nad Kněžnou, , Czechia

Site Status

Neurocrine Clinical Site

Bron, , France

Site Status

Neurocrine Clinical Site

Lille, , France

Site Status

Neurocrine Clinical Site

Rennes, , France

Site Status

Neurocrine Clinical Site

Toulouse, , France

Site Status

Neurocrine Clinical Site

Budapest, , Hungary

Site Status

Neurocrine Clinical Site

Budapest, , Hungary

Site Status

Neurocrine Clinical Site

Pécs, , Hungary

Site Status

Neurocrine Clinical Site

Bologna, , Italy

Site Status

Neurocrine Clinical Site

Milan, , Italy

Site Status

Neurocrine Clinical Site

Pavia, , Italy

Site Status

Neurocrine Clinical Site

Barcelona, , Spain

Site Status

Neurocrine Clinical Site

Madrid, , Spain

Site Status

Neurocrine Clinical Site

Madrid, , Spain

Site Status

Neurocrine Clinical Site

Valencia, , Spain

Site Status

Countries

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Australia Belgium Czechia France Hungary Italy Spain

Other Identifiers

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2021-004265-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NBI-921352-FOS2022

Identifier Type: -

Identifier Source: org_study_id

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