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

April 10, 2024 updated by: Neurocrine Biosciences

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Fitzroy, Australia, 3065
        • Neurocrine Clinical Site
      • Heidelberg, Australia, 3084
        • Neurocrine Clinical Site
      • Melbourne, Australia, 3004
        • Neurocrine Clinical Site
  • Belgium
      • Bruxelles, Belgium, 1070
        • Neurocrine Clinical Site
      • Ghent, Belgium, 9000
        • Neurocrine Clinical Site
      • Leuven, Belgium, 3000
        • Neurocrine Clinical Site
  • Czechia
      • Brno, Czechia, 65691
        • Neurocrine Clinical Site
      • Ostrava, Czechia, 708 52
        • Neurocrine Clinical Site
      • Prague, Czechia, 15006
        • Neurocrine Clinical Site
      • Praha 6, Czechia, 16000
        • Neurocrine Clinical Site
      • Praha 8, Czechia, 18600
        • Neurocrine Clinical Site
      • Rychnov Nad Kněžnou, Czechia, 51601
        • Neurocrine Clinical Site
  • France
      • Bron, France, 69677
        • Neurocrine Clinical Site
      • Lille, France, 59037
        • Neurocrine Clinical Site
      • Rennes, France, 35000
        • Neurocrine Clinical Site
      • Toulouse, France, 31059
        • Neurocrine Clinical Site
  • Hungary
      • Budapest, Hungary, 40320
        • Neurocrine Clinical Site
      • Budapest, Hungary, 1145
        • Neurocrine Clinical Site
      • Pecs, Hungary, 7623
        • Neurocrine Clinical Site
  • Italy
      • Bologna, Italy, 40139
        • Neurocrine Clinical Site
      • Milano, Italy, 20133
        • Neurocrine Clinical Site
      • Pavia, Italy, 27100
        • Neurocrine Clinical Site
  • Spain
      • Barcelona, Spain, 8035
        • Neurocrine Clinical Site
      • Madrid, Spain, 28034
        • Neurocrine Clinical Site
      • Madrid, Spain, 28040
        • Neurocrine Clinical Site
      • Valencia, Spain, 46026
        • Neurocrine Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NBI-921352 Treatment
Treatment for up to 107 weeks.
Drug: NBI-921352
Tablets for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The occurrence of serious treatment-emergent adverse events (TEAEs)
Time Frame: Through Week 111
Through Week 111

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage change from baseline in 28-day focal onset seizure frequency during the treatment period
Time Frame: Baseline and Week 105 or Early Termination
Baseline and Week 105 or Early Termination
Treatment response defined as ≥50% reduction in 28-day focal onset seizure frequency during the treatment period compared with baseline
Time Frame: Baseline and Week 105 or Early Termination
Baseline and Week 105 or Early Termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocrine Biosciences

Investigators

  • Study Director: Clinical Development Lead, Neurocrine Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2022

Primary Completion (Actual)

March 11, 2024

Study Completion (Actual)

March 11, 2024

Study Registration Dates

First Submitted

August 5, 2022

First Submitted That Met QC Criteria

August 5, 2022

First Posted (Actual)

August 9, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-921352-FOS2022
  • 2021-004265-12 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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