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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05159908




Registration number
NCT05159908
Ethics application status
Date submitted
30/11/2021
Date registered
16/12/2021

Titles & IDs
Public title
A Study to Investigate How Effective, Safe and Tolerable the Drug NBI-921352 is When Used With Anti-seizure Medications in Adults With Focal Onset Seizures
Scientific title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of NBI-921352 as Adjunctive Therapy in Adult Subjects With Focal Onset Seizures (FOS)
Secondary ID [1] 0 0
2021-001433-39
Secondary ID [2] 0 0
NBI-921352-FOS2021
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
Treatment: Drugs - Placebo

Placebo comparator: Placebo schedule - Participant follows Placebo schedule (13 weeks)

Experimental: Dose schedule A - Participant follows Dose schedule A (13 weeks)

Experimental: Dose schedule B - Participant follows Dose schedule B (13 weeks)

Experimental: Dose schedule C - Participant follows Dose schedule C (13 weeks)


Treatment: Drugs: NBI-921352
Tablets for oral administration

Treatment: Drugs: Placebo
Matching placebo tablets for oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Serious Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation of Study Treatment, and Fatal TEAEs
Timepoint [1] 0 0
Through Week 15
Primary outcome [2] 0 0
NBI-921352 exposure-efficacy response relationship, defined as the slope of the relationship between reduction in monthly focal onset seizure frequency and plasma concentration at steady state
Timepoint [2] 0 0
Baseline to Week 11
Secondary outcome [1] 0 0
Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Treatment Period
Timepoint [1] 0 0
Baseline and Weeks 1 to 11
Secondary outcome [2] 0 0
Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Maintenance period
Timepoint [2] 0 0
Baseline and Weeks 4 to 11
Secondary outcome [3] 0 0
Clinical Global Impression of Change (CGIC) Scores at Week 11
Timepoint [3] 0 0
Week 11
Secondary outcome [4] 0 0
Percentage of Participants with a = 50% reduction in monthly (28 days) focal onset seizure frequency during the treatment period
Timepoint [4] 0 0
Baseline and Weeks 1 to 11

Eligibility
Key inclusion criteria
Key

1. Capable of providing consent and has completed the written informed consent.
2. Male or female, 18 to 65 years of age, inclusive, with a body mass index (BMI) < 40 kg/m^2.
3. Diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017) at least 18 months before screening.
4. History of uncontrolled seizures despite adequate treatment with at least 1 anti-seizure medication (ASM) for at least 18 months prior to screening.
5. Treatment with at least 1 but not more than 4 ASMs for at least 1 month before screening, during the baseline seizure diary data collection, and throughout the duration of the study.
6. Be able to keep accurate seizure diaries.
7. Documented seizure frequency in the baseline seizure diary of =8 countable focal seizures during the 8-week seizure baseline period.

Key
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of epilepsy with only nonmotor seizures without an observable component, psychogenic nonepileptic seizures, or primary generalized seizures.
2. Presence or previous history of developmental and/or epileptic encephalopathy.
3. Presence of seizure types other than FOS.
4. History of repetitive seizures within the 12-month period preceding study entry where the individual seizures cannot be counted.
5. Status epilepticus within the last 12 months before enrollment.
6. Any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS in the 2 years before screening, a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt.
7. History or presence of any significant medical or surgical condition, lab value, or concomitant medication that would place the subject at increased risk.
8. A known history of clinically concerning cardiac arrhythmia (including long QT syndrome) or prolongation of screening (pre-treatment) QT interval corrected for heart rate.
9. Require use of rescue medication more than once per week.
10. Multiple drug allergies or a severe drug reaction to an ASM(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
11. An implanted responsive neurostimulator system (RNS).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/08/2023
Sample size
Target
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Neurocrine Clinical Site - Randwick
Recruitment hospital [2] 0 0
Neurocrine Clinical Site - Brisbane
Recruitment hospital [3] 0 0
Neurocrine Clinical Site - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3052 - Melbourne
Recruitment postcode(s) [5] 0 0
3065 - Melbourne
Recruitment postcode(s) [6] 0 0
3084 - 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
Gent
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
Praha 5
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
Paris
Country [13] 0 0
France
State/province [13] 0 0
Rennes
Country [14] 0 0
France
State/province [14] 0 0
Toulouse
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
Hungary
State/province [16] 0 0
Debrecen
Country [17] 0 0
Hungary
State/province [17] 0 0
Kistarcsa
Country [18] 0 0
Hungary
State/province [18] 0 0
Pécs
Country [19] 0 0
Italy
State/province [19] 0 0
Bologna
Country [20] 0 0
Italy
State/province [20] 0 0
Milano
Country [21] 0 0
Italy
State/province [21] 0 0
Pavia
Country [22] 0 0
Italy
State/province [22] 0 0
Pozzilli
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Spain
State/province [25] 0 0
Valencia
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Cardiff

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05159908