A double-blind, randomized, placebo-controlled study of the efficacy, safety/tolerability, and pharmacokinetic profile of UCB0942 in adult patients with highly drug-resistant focal epilepsy
Phase 2
Completed
- Conditions
- epileptic seizuresfocal epilepsy10039911
- Registration Number
- NL-OMON44054
- Lead Sponsor
- CB Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>75% responder rate (75%RR: proportion of subjects with a 75% or greater<br /><br>reduction in focal seizure frequency during Treatment Period compared to<br /><br>Baseline Period)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- pharmacokinetics,<br /><br>- safety and<br /><br>-50% responder rate (50%RR), median % seizure reduction from baseline, partial<br /><br>seizure frequency, seizure freedom and seizure free days, SSQ, and QOLIE-31-P</p><br>