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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

Primary Purpose

Focal Onset Seizure, Focal Onset Epilepsy

Status
Enrolling by invitation
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NBI-921352
Sponsored by
Neurocrine Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focal Onset Seizure focused on measuring epilepsy, focal seizure, sodium channel, voltage-gated, alpha subunit, Nav1.6 inhibitor, antiseizure medicine, ASM, antiepileptic drug, AED, partial seizure, partial onset epilepsy

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NBI-921352 Treatment

Arm Description

Treatment for up to 107 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 5, 2022
Last Updated
July 18, 2023
Sponsor
Neurocrine Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT05493293
Brief Title
Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurocrine Biosciences

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Onset Seizure, Focal Onset Epilepsy
Keywords
epilepsy, focal seizure, sodium channel, voltage-gated, alpha subunit, Nav1.6 inhibitor, antiseizure medicine, ASM, antiepileptic drug, AED, partial seizure, partial onset epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NBI-921352 Treatment
Arm Type
Experimental
Arm Description
Treatment for up to 107 weeks.
Intervention Type
Drug
Intervention Name(s)
NBI-921352
Intervention Description
Tablets for oral administration
Primary Outcome Measure Information:
Title
The occurrence of serious treatment-emergent adverse events (TEAEs)
Time Frame
Through Week 111

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Lead
Organizational Affiliation
Neurocrine Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Neurocrine Clinical Site
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Neurocrine Clinical Site
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Facility Name
Neurocrine Clinical Site
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Facility Name
Neurocrine Clinical Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Neurocrine Clinical Site
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Neurocrine Clinical Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Neurocrine Clinical Site
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Neurocrine Clinical Site
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Neurocrine Clinical Site
City
Prague
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Neurocrine Clinical Site
City
Praha 6
ZIP/Postal Code
16000
Country
Czechia
Facility Name
Neurocrine Clinical Site
City
Praha 8
ZIP/Postal Code
18600
Country
Czechia
Facility Name
Neurocrine Clinical Site
City
Rychnov Nad Kněžnou
ZIP/Postal Code
51601
Country
Czechia
Facility Name
Neurocrine Clinical Site
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Neurocrine Clinical Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Neurocrine Clinical Site
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Neurocrine Clinical Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Neurocrine Clinical Site
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Neurocrine Clinical Site
City
Budapest
ZIP/Postal Code
40320
Country
Hungary
Facility Name
Neurocrine Clinical Site
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Neurocrine Clinical Site
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Neurocrine Clinical Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Neurocrine Clinical Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Neurocrine Clinical Site
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Neurocrine Clinical Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Neurocrine Clinical Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Neurocrine Clinical Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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