Open Label Study (Everyone Who Participates Receives Drug) to Further Determine How Safe and Effective Oral Treatment of Seletracetam is in Patients With Refractory Epilepsy.

Phase 3

Withdrawn

• Conditions: Epilepsy

• Registration Number: NCT00175864
• Lead Sponsor: UCB Pharma

Brief Summary

This is a safety and efficacy study of add on therapy with seletracetam in patients experiencing refractory epilepsy.

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: 2006-02
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-19
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

• An IRB/IEC approved written informed consent form signed and dated Male/Female patients age 18 (or 16 years where permitted by law) to 65.
• Minimum body weight of 40 kg.
• Patients with a confirmed diagnosis of refractory epilepsy of ≥ 6 months.
• Patients must be receiving 1 - 3 concomitant AEDs.
• Female patients without childbearing potentials (2 years post-menopausal or surgical sterilization) are eligible. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method.

Exclusion Criteria

• Seizures occurring in clusters (seizures occurring either too frequently or indistinctly separated to be reliably counted).
• Status epilepticus within 3 months of Visit 1.
• History of non-epileptic seizures.
• Patients on vigabatrin.
• Patients on felbamate, unless treatment has been continuous for ≥ 18 months.
• Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant AEDs.
• Ongoing psychiatric disease other than mild controlled disorders.
• Patients with a clinically significant organ dysfunction.
• Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients.
• Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control.

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