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

Sponsor

Neurocrine Biosciences (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05159908

Collaborator

(none)

100

Enrollment

Locations

Arms

17.7

Anticipated Duration (Months)

4.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the safety, pharmacokinetics, and efficacy of three different doses of NBI-921352 versus placebo in adults with focal onset seizures

Condition or Disease	Intervention/Treatment	Phase
Focal Onset Seizure Focal Onset Epilepsy	Drug: NBI-921352 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official 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)

Actual Study Start Date :

Nov 8, 2021

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo schedule Participant follows Placebo schedule (13 weeks)	Drug: Placebo Matching placebo tablets for oral administration
Experimental: Dose schedule A Participant follows Dose schedule A (13 weeks)	Drug: NBI-921352 Tablets for oral administration
Experimental: Dose schedule B Participant follows Dose schedule B (13 weeks)	Drug: NBI-921352 Tablets for oral administration
Experimental: Dose schedule C Participant follows Dose schedule C (13 weeks)	Drug: NBI-921352 Tablets for oral administration

Outcome Measures

Primary Outcome Measures

Number of Participants with Serious Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation of Study Treatment, and Fatal TEAEs [Through Week 15]
Average plasma concentration of NBI-921352 [Predose and up to 8 hours postdose throughout the study.]

Secondary Outcome Measures

Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Treatment Period [Baseline and Weeks 1 to 11]
Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Maintenance period [Baseline and Weeks 4 to 11]
Clinical Global Impression of Change (CGIC) Scores at Week 11 [Week 11]
Percentage of Participants with a ≥ 50% reduction in monthly (28 days) focal onset seizure frequency during the treatment period [Baseline and Weeks 1 to 11]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Capable of providing consent and has completed the written informed consent.
Male or female, 18 to 65 years of age, inclusive, with a body mass index (BMI) < 40 kg/m^2.
Diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017) at least 18 months before screening.
History of uncontrolled seizures despite adequate treatment with at least 1 anti-seizure medication (ASM) for at least 18 months prior to screening.
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.
Be able to keep accurate seizure diaries.
Documented seizure frequency in the baseline seizure diary of ≥8 countable focal seizures during the 8-week seizure baseline period.

Key Exclusion Criteria:

History of epilepsy with only nonmotor seizures without an observable component, psychogenic nonepileptic seizures, or primary generalized seizures.
Presence or previous history of developmental and/or epileptic encephalopathy.
Presence of seizure types other than FOS.
History of repetitive seizures within the 12-month period preceding study entry where the individual seizures cannot be counted.
Status epilepticus within the last 12 months before enrollment.
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.
History or presence of any significant medical or surgical condition, lab value, or concomitant medication that would place the subject at increased risk.
A known history of clinically concerning cardiac arrhythmia (including long QT syndrome) or prolongation of screening (pre-treatment) QT interval corrected for heart rate.
Require use of rescue medication more than once per week.
Multiple drug allergies or a severe drug reaction to an ASM(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
An implanted responsive neurostimulator system (RNS).

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Neurocrine Clinical Site	Bruxelles	Belgium	1070
2	Neurocrine Clinical Site	Gent	Belgium	9000
3	Neurocrine Clinical Site	Leuven	Belgium	3000
4	Neurocrine Clinical Site	Brno	Czechia	656 91
5	Neurocrine Clinical Site	Ostrava	Czechia	708 52
6	Neurocrine Clinical Site	Praha 5	Czechia	150 06
7	Neurocrine Clinical Site	Praha 6	Czechia	160 00
8	Neurocrine Clinical Site	Praha 8	Czechia	186 00
9	Neurocrine Clinical Site	Rychnov Nad Kněžnou	Czechia	516 01
10	Neurocrine Clinical Site	Bron	France	69677
11	Neurocrine Clinical Site	Lille	France	59037
12	Neurocrine Clinical Site	Paris	France	75651
13	Neurocrine Clinical Site	Rennes	France	35003
14	Neurocrine Clinical Site	Toulouse	France	31059
15	Neurocrine Clinical Site	Kistarcsa	Hungary	2143
16	Neurocrine Clinical Site	Milano	Italy	20133
17	Neurocrine Clinical Site	Pozzilli	Italy	86077
18	Neurocrine Clinical Site	Barcelona	Spain	08035
19	Neurocrine Clinical Site	Madrid	Spain	28034
20	Neurocrine Clinical Site	Madrid	Spain	28040
21	Neurocrine Clinical Site	Valencia	Spain	46026