Open Label Trial to Study the Long-term Safety and Efficacy of Seletracetam for the Treatment of Epilepsy

Phase 3

Withdrawn

• Conditions: Epilepsy

• Registration Number: NCT00175851
• Lead Sponsor: UCB Pharma

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Study Start: 2008-05
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-25
• Last Update Posted: 2012-05-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety profile of seletracetam

Secondary Outcome Measures

Name	Time	Method
Reduction in seizure frequency