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

Phase 2

Completed

• Conditions: Focal Onset Seizure; Focal Onset Epilepsy
• Interventions: Drug: Placebo; Drug: NBI-921352

• Registration Number: NCT05159908
• Lead Sponsor: Neurocrine Biosciences

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-08
• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2021-12-16
• Primary Completion: 2023-08-21
• Study Completion: 2023-08-21
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

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

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo schedule	Placebo	Participant follows Placebo schedule (13 weeks)
Dose schedule A	NBI-921352	Participant follows Dose schedule A (13 weeks)
Dose schedule B	NBI-921352	Participant follows Dose schedule B (13 weeks)
Dose schedule C	NBI-921352	Participant follows Dose schedule C (13 weeks)

Primary Outcome Measures

Name	Time	Method
Number of Participants with Serious Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation of Study Treatment, and Fatal TEAEs	Through Week 15
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	Baseline to Week 11

Secondary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Maintenance period	Baseline and Weeks 4 to 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
Clinical Global Impression of Change (CGIC) Scores at Week 11	Week 11
Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Treatment Period	Baseline and Weeks 1 to 11

Trial Locations

Locations (1)

Neurocrine Clinical Site; 🇪🇸 Valencia, Spain