Clinical trial NCT05493293: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: 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
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2022-08-09
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The occurrence of serious treatment-emergent adverse events (TEAEs)
timeFrame: Through Week 111
Secondary outcomes:
Other outcomes:
Locations:
city: Fitzroy
country: Australia
facility: Neurocrine Clinical Site
city: Heidelberg
country: Australia
facility: Neurocrine Clinical Site
city: Melbourne
country: Australia
facility: Neurocrine Clinical Site
city: Bruxelles
country: Belgium
facility: Neurocrine Clinical Site
city: Ghent
country: Belgium
facility: Neurocrine Clinical Site
city: Leuven
country: Belgium
facility: Neurocrine Clinical Site
city: Brno
country: Czechia
facility: Neurocrine Clinical Site
city: Ostrava
country: Czechia
facility: Neurocrine Clinical Site
city: Prague
country: Czechia
facility: Neurocrine Clinical Site
city: Praha 6
country: Czechia
facility: Neurocrine Clinical Site
city: Praha 8
country: Czechia
facility: Neurocrine Clinical Site
city: Rychnov Nad Kněžnou
country: Czechia
facility: Neurocrine Clinical Site
city: Bron
country: France
facility: Neurocrine Clinical Site
city: Lille
country: France
facility: Neurocrine Clinical Site
city: Rennes
country: France
facility: Neurocrine Clinical Site
city: Toulouse
country: France
facility: Neurocrine Clinical Site
city: Budapest
country: Hungary
facility: Neurocrine Clinical Site
city: Budapest
country: Hungary
facility: Neurocrine Clinical Site
city: Pecs
country: Hungary
facility: Neurocrine Clinical Site
city: Bologna
country: Italy
facility: Neurocrine Clinical Site
city: Milano
country: Italy
facility: Neurocrine Clinical Site
city: Pavia
country: Italy
facility: Neurocrine Clinical Site
city: Barcelona
country: Spain
facility: Neurocrine Clinical Site
city: Madrid
country: Spain
facility: Neurocrine Clinical Site
city: Madrid
country: Spain
facility: Neurocrine Clinical Site
city: Valencia
country: Spain
facility: Neurocrine Clinical Site
Study officials:
affiliation: Neurocrine Biosciences
name: Clinical Development Lead
role: STUDY_DIRECTOR
References: