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 study objectives are as follows: Primary • 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: Secondary • 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