epileptic seizures focal epilepsy
Conditions
Interventions
Test treatment: 1 week titration to 400mg UCB0942 bid (Days T1 to T7) followed
by 10 weeks on 400mg UCB0942 bid during Inpatient (2 weeks, double-blind) and
Outpatient Maintenance Period (8 weeks op
Sponsors
UCB Pharma
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age *18 years BMI Between 16.0 and 40.0 kg/m2 Pathology - Subject is diagnosed with focal epilepsy - Subject has failed to achieve adequate seizure control with *4 appropriately chosen AED regimens of adequate dose and duration, including the current treatment
Exclusion criteria
Exclusion criteria: - Subject has a current or past psychiatric condition that, in the opinion of the Investigator, could compromise his/her safety or ability to participate in this study. - Subject has a history of status epilepticus or has been hospitalized for status epilepticus within the 6-month period prior to Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 75% responder rate (75%RR: proportion of subjects with a 75% or greater reduction in focal seizure frequency during Treatment Period compared to Baseline Period) | — |
Secondary
| Measure | Time frame |
|---|---|
| - pharmacokinetics, - safety and -50% responder rate (50%RR), median % seizure reduction from baseline, partial seizure frequency, seizure freedom and seizure free days, SSQ, and QOLIE-31-P | — |
Countries
Netherlands
Outcome results
None listed