Focal Onset Seizures (FOS) MedDRA version: 21.1 Level: LLT Classification code 10016843 Term: Focal seizures System Organ Class: 100000004852
Conditions
Sponsors
Neurocrine Biosciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following 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 =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if they meet any of the following 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 or type 5 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 as determined by the investigator. • A known history of clinically concerning cardiac arrhythmia (including long QT syndrome) or prolongation of screening (pre-treatment) QT interval corrected for heart rate. • Currently taking disallowed medications listed in Section 7.1.1 or it is anticipated that the subject will require treatment with at least 1 of the disallowed concomitant medications during the study. • Past use of vigabatrin without stable visual fields tested twice in the 12 months after the last dose of vigabatrin. • 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study is designed to facilitate the selection of a suitable dose range of NBI-921352 for use in subsequent efficacy and safety studies in adult subjects with FOS. The primary study objective is to assess the safety and tolerability and to characterize the PK and PK/pharmacodynamic (PD) relationship of NBI-921352 in adults with FOS taking concomitant background ASMs.;Secondary Objective: To assess the efficacy of NBI-921352 on FOS frequency and on Clinical Global Impression of Change (CGIC) scores.;Primary end point(s): Primary: • Number of participants with Serious Treatment-emergent Adverse Events ( TEAEs), TEAEs leading to discontinuation of study treatment, and fatal TEAEs • NBI-921352 PK/PD, including exposure-efficacy response relationship;Timepoint(s) of evaluation of this end point: Baseline, Treatment Period: Day 1 to Week 11 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary: • Percent change from baseline in monthly Focal onset seizure frequency during the treatment period • Percent change from baseline in monthly focal onset seizure frequency during the maintenance period • Clinical Global Impression of Change (CGIC) scores at Week 11 • Treatment response defined as =50% reduction in monthly (28 days) FOS frequency during the treatment period compared to the seizure baseline period. ;Timepoint(s) of evaluation of this end point: Baseline, Treatment Period: Day 1 to Week 11; Maintenance Period: Week 4 to Week 11 | — |
Countries
Australia, Belgium, Czechia, Czech Republic, France, Hungary, Italy, Spain, United Kingdom
Contacts
Public ContactMedical Information Call Center
Neurocrine Biosciences Inc.
Outcome results
None listed