Partial Onset Seizures
Conditions
Brief summary
Pharmacokinetic assessment for cenobamate in plasma after a single dose 2. Pharmacokinetic assessment for cenobamate in plasma after multiple dosing
Detailed description
Safety and Tolerability • Treatment-emergent Adverse events, including AEs of special interest • Concomitant medication reporting • Safety laboratory tests • Electrocardiogram • Vital signs • Physical and neurological examination including growth measurements • Acceptability and palatability assessment, Efficacy • Seizure frequency data as the exploratory assessment of efficacy will be collected via seizure diary
Interventions
Sponsors
Sk Life Science Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic assessment for cenobamate in plasma after a single dose 2. Pharmacokinetic assessment for cenobamate in plasma after multiple dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability • Treatment-emergent Adverse events, including AEs of special interest • Concomitant medication reporting • Safety laboratory tests • Electrocardiogram • Vital signs • Physical and neurological examination including growth measurements • Acceptability and palatability assessment, Efficacy • Seizure frequency data as the exploratory assessment of efficacy will be collected via seizure diary | — |
Countries
Hungary, Spain
Outcome results
None listed