Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetira… (NCT00152503) | Clinical Trial Compass
CompletedPhase 2
Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
United States59 participantsStarted 2005-08-31
Plain-language summary
This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 levetiracetam (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 Antiepileptic Drug (AEDs).
What they're measuring
1
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Timeframe: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)