Status:
COMPLETED
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures
Lead Sponsor:
UCB S.A. - Pharma Sector
Conditions:
Epilepsy, Partial
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This trial will evaluate the efficacy and safety of ucb 44212 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 Antiepileptic Drug (AEDs)
- Female subjects without childbearing potential; Female subjects with childbearing potential are eligible if they use a medically accepted non-hormonal 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
- Subjects currently taking levetiracetam (LEV)
- 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 :
May 19 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2006
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00152451
Start Date
May 19 2005
End Date
May 3 2006
Last Update
March 29 2024
Active Locations (7)
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1
N01191 108
Little Rock, Arkansas, United States, 72205
2
N01191 105
San Francisco, California, United States, 94115
3
N01191 102
Stanford, California, United States, 94305
4
N01191 107
Columbus, Ohio, United States, 43210