Status:
COMPLETED
Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
Lead Sponsor:
UCB Pharma SA
Conditions:
Epilepsy, Partial
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 31 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2006
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00152503
Start Date
August 31 2005
End Date
May 12 2006
Last Update
September 7 2023
Active Locations (17)
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1
Phoenix, Arizona, United States
2
Little Rock, Arkansas, United States
3
St. Petersburg, Florida, United States
4
Springfield, Illinois, United States