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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3

Details

• Lead Sponsor: UCB Pharma

Criteria

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