Status:
COMPLETED
A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
12-70 years
Phase:
PHASE3
Brief Summary
This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.
Eligibility Criteria
Inclusion
- Patients with a confirmed diagnosis of refractory epilepsy
- Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED)
- Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method
Exclusion
- Seizures occurring in clusters
- Status epilepticus within 3 months of Visit 1
- History of non-epileptic seizures
- Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
- Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00368069
Start Date
August 1 2006
End Date
May 1 2007
Last Update
July 15 2020
Active Locations (34)
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1
N01235 1007
Curitiba, Brazil
2
N01235 2001
Kuopio, Finland
3
N01235 2003
Tampere, Finland
4
N01235 2002
Turku, Finland