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

UCB

Status and phase: Withdrawn; Phase 3

Conditions: Epilepsy

Treatments: Drug: Seletracetam (ucb 44212)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00175851

Not yet available

N01197

Details and patient eligibility

About

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

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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