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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05493293




Registration number
NCT05493293
Ethics application status
Date submitted
5/08/2022
Date registered
9/08/2022
Date last updated
12/04/2024

Titles & IDs
Public title
Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures
Scientific 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)
Secondary ID [1] 0 0
2021-004265-12
Secondary ID [2] 0 0
NBI-921352-FOS2022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Focal Onset Seizure 0 0
Focal Onset Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NBI-921352

Experimental: NBI-921352 Treatment - Treatment for up to 107 weeks.


Treatment: Drugs: NBI-921352
Tablets for oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The occurrence of serious treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Through Week 111

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
67 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/03/2024
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Neurocrine Clinical Site - Fitzroy
Recruitment hospital [2] 0 0
Neurocrine Clinical Site - Heidelberg
Recruitment hospital [3] 0 0
Neurocrine Clinical Site - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Ghent
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Czechia
State/province [4] 0 0
Brno
Country [5] 0 0
Czechia
State/province [5] 0 0
Ostrava
Country [6] 0 0
Czechia
State/province [6] 0 0
Prague
Country [7] 0 0
Czechia
State/province [7] 0 0
Praha 6
Country [8] 0 0
Czechia
State/province [8] 0 0
Praha 8
Country [9] 0 0
Czechia
State/province [9] 0 0
Rychnov Nad Knežnou
Country [10] 0 0
France
State/province [10] 0 0
Bron
Country [11] 0 0
France
State/province [11] 0 0
Lille
Country [12] 0 0
France
State/province [12] 0 0
Rennes
Country [13] 0 0
France
State/province [13] 0 0
Toulouse
Country [14] 0 0
Hungary
State/province [14] 0 0
Budapest
Country [15] 0 0
Hungary
State/province [15] 0 0
Pecs
Country [16] 0 0
Italy
State/province [16] 0 0
Bologna
Country [17] 0 0
Italy
State/province [17] 0 0
Milano
Country [18] 0 0
Italy
State/province [18] 0 0
Pavia
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Spain
State/province [21] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Neurocrine Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT05493293
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Development Lead
Address 0 0
Neurocrine Biosciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05493293