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

An Open-label, Multicenter, Follow-up Trial to Evaluate the Long-term Safety and Efficacy of Seletracetam Used as Adjunctive Treatment Using a Flexible Dosing Scheme of 4 to 80 mg b.i.d. in Subjects Aged 16 Years or Older Suffering From Epilepsy

This is a safety and efficacy study of add-on therapy with seletracetam in epilepsy patients who have participated in a previous seletracetam study

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