Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial will evaluate the efficacy and safety of ucb 44212 as add-on therapy in subjects with focal epilepsy.

• Phase: Phase 2

Details

• Lead Sponsor: UCB Pharma
• Treatments: Etiracetam

Criteria

Inclusion Criteria:

• Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)

• Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized.

• Subjects who have been treated for epilepsy for ≥6 months and are currently uncontrolled while being treated with 1-3 concomitant AED(s), inclusive of LEV.

• Female subjects without childbearing potential or those who are using an acceptable contraceptive method

Exclusion Criteria:

• Seizures occurring in clusters. Status epilepticus within 6 months of Visit 1. History of non-epileptic seizures

• Subjects on vigabatrin

• Subjects on felbamate, unless treatment has been continuous for >2 years

• Ongoing psychiatric disease other than mild controlled disorders.

• Subjects with clinically significant organ dysfunction

• Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients

• Pregnant or lactating women.

• Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant AEDs.