Open Label, Multicenter Study of the Safety and Efficacy of Oral Treatment With Immediate Release Seletracetam (Ucb 44212) at Individualized Doses up to a Maximum of 160mg/Day in Refractory Epileptic Patients.

UCB Pharma0 sitesStarted: February 2006Last updated: March 20, 2012

ConditionsEpilepsy

Overview

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

•An IRB/IEC approved written informed consent form signed and dated Male/Female patients age 18 (or 16 years where permitted by law) to
•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.

•Seizures occurring in clusters (seizures occurring either too frequently or indistinctly separated to be reliably counted).
•Status epilepticus within 3 months of Visit
•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.

Safety profile of seletracetam

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