Study Stopped
The long-term extension study was terminated because the parent study NBI-921352-FOS2021 (NCT05159908) failed to meet its primary endpoint.
Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures
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)
2 other identifiers
interventional
82
7 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2022
Shorter than P25 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2022
CompletedFirst Posted
Study publicly available on registry
August 9, 2022
CompletedStudy Start
First participant enrolled
November 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2024
CompletedApril 12, 2024
April 1, 2024
1.3 years
August 5, 2022
April 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The occurrence of serious treatment-emergent adverse events (TEAEs)
Through Week 111
Study Arms (1)
NBI-921352 Treatment
EXPERIMENTALTreatment for up to 107 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Neurocrine Clinical Site
Fitzroy, 3065, Australia
Neurocrine Clinical Site
Heidelberg, 3084, Australia
Neurocrine Clinical Site
Melbourne, 3004, Australia
Neurocrine Clinical Site
Brussels, 1070, Belgium
Neurocrine Clinical Site
Ghent, 9000, Belgium
Neurocrine Clinical Site
Leuven, 3000, Belgium
Neurocrine Clinical Site
Brno, 65691, Czechia
Neurocrine Clinical Site
Ostrava, 708 52, Czechia
Neurocrine Clinical Site
Prague, 15006, Czechia
Neurocrine Clinical Site
Prague, 16000, Czechia
Neurocrine Clinical Site
Prague, 18600, Czechia
Neurocrine Clinical Site
Rychnov nad Kněžnou, 51601, Czechia
Neurocrine Clinical Site
Bron, 69677, France
Neurocrine Clinical Site
Lille, 59037, France
Neurocrine Clinical Site
Rennes, 35000, France
Neurocrine Clinical Site
Toulouse, 31059, France
Neurocrine Clinical Site
Budapest, 1145, Hungary
Neurocrine Clinical Site
Budapest, 40320, Hungary
Neurocrine Clinical Site
Pécs, 7623, Hungary
Neurocrine Clinical Site
Bologna, 40139, Italy
Neurocrine Clinical Site
Milan, 20133, Italy
Neurocrine Clinical Site
Pavia, 27100, Italy
Neurocrine Clinical Site
Barcelona, 8035, Spain
Neurocrine Clinical Site
Madrid, 28034, Spain
Neurocrine Clinical Site
Madrid, 28040, Spain
Neurocrine Clinical Site
Valencia, 46026, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Lead
Neurocrine Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2022
First Posted
August 9, 2022
Study Start
November 9, 2022
Primary Completion
March 11, 2024
Study Completion
March 11, 2024
Last Updated
April 12, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share