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

September 15, 2023 updated by: Neurocrine Biosciences

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Neurocrine Clinical Site
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Neurocrine Clinical Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Neurocrine Clinical Site
      • Melbourne, Victoria, Australia, 3052
        • Neurocrine Clinical Site
      • Melbourne, Victoria, Australia, 3065
        • Neurocrine Clinical Site
      • Melbourne, Victoria, Australia, 3084
        • Neurocrine Clinical Site
  • Belgium
      • Bruxelles, Belgium, 1070
        • Neurocrine Clinical Site
      • Gent, Belgium, 9000
        • Neurocrine Clinical Site
      • Leuven, Belgium, 3000
        • Neurocrine Clinical Site
  • Czechia
      • Brno, Czechia, 656 91
        • Neurocrine Clinical Site
      • Ostrava, Czechia, 708 52
        • Neurocrine Clinical Site
      • Praha 5, Czechia, 150 06
        • Neurocrine Clinical Site
      • Praha 6, Czechia, 160 00
        • Neurocrine Clinical Site
      • Praha 8, Czechia, 186 00
        • Neurocrine Clinical Site
      • Rychnov Nad Kněžnou, Czechia, 516 01
        • Neurocrine Clinical Site
  • France
      • Bron, France, 69677
        • Neurocrine Clinical Site
      • Lille, France, 59037
        • Neurocrine Clinical Site
      • Paris, France, 75651
        • Neurocrine Clinical Site
      • Rennes, France, 35000
        • Neurocrine Clinical Site
      • Toulouse, France, 31059
        • Neurocrine Clinical Site
  • Hungary
      • Budapest, Hungary, 1145
        • Neurocrine Clinical Site
      • Debrecen, Hungary, 4032
        • Neurocrine Clinical Site
      • Kistarcsa, Hungary, 2143
        • Neurocrine Clinical Site
      • Pécs, Hungary, 7623
        • Neurocrine Clinical Site
  • Italy
      • Bologna, Italy, 40139
        • Neurocrine Clinical Site
      • Milano, Italy, 20133
        • Neurocrine Clinical Site
      • Pavia, Italy, 27100
        • Neurocrine Clinical Site
      • Pozzilli, Italy, 86077
        • Neurocrine Clinical Site
  • Spain
      • Barcelona, Spain, 08035
        • Neurocrine Clinical Site
      • Madrid, Spain, 28034
        • Neurocrine Clinical Site
      • Madrid, Spain, 28040
        • Neurocrine Clinical Site
      • Valencia, Spain, 46026
        • Neurocrine Clinical Site
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • Neurocrine Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocrine Biosciences

Investigators

  • Study Director: Clinical Development Lead, Neurocrine Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2021

Primary Completion (Actual)

August 21, 2023

Study Completion (Actual)

August 21, 2023

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-921352-FOS2021
  • 2021-001433-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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