Status:
WITHDRAWN
Open Label Trial to Study the Long-term Safety and Efficacy of Seletracetam for the Treatment of Epilepsy
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
This is a safety and efficacy study of add-on therapy with seletracetam in epilepsy patients who have participated in a previous seletracetam study
Eligibility Criteria
Inclusion
- A signed and dated IRB/IEC approved written informed consent form
- Male/female age 18 years (16 years where permitted) to 65 years
- Minimum body weight of 40 kg
- Patients having participated in a previous seletracetam study
- Female patients without childbearing potential or using a medically accepted non-hormonal contraceptive method are eligible.
Exclusion
- Ongoing psychiatric disease other than mild controlled disorders
- Subject with clinically significant abnormalities in laboratory tests or ECG
- Poor compliance with visit schedule or medication intake in a previous seletracetam study
- Subject taking part in another clinical/pharmacological study, with the exception of seletracetam studies, in the 30 days preceding enrollment
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00175851
Start Date
May 1 2008
Last Update
May 28 2012
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