Status:
COMPLETED
Conversion to Monotherapy Study With Keppra XR for Partial Seizures
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.
Eligibility Criteria
Inclusion
- Male or female subjects 12 to 75 years of age.
- Subjects must have inadequately controlled partial onset epilepsy.
- Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on one or two standard AED(s)
Exclusion
- A history of status epilepticus in the 6 months preceding randomization.
- Significant medical, psychiatric or neurological illness.
- Intake of benzodiazepines on more than an occasional basis
- History of previous treatment with levetiracetam or sensitivity to levetiracetam.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT00419094
Start Date
August 1 2007
End Date
September 1 2009
Last Update
September 5 2014
Active Locations (45)
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1
Dothan, Alabama, United States
2
Northport, Alabama, United States
3
Phoenix, Arizona, United States
4
Little Rock, Arkansas, United States