A Double-blind, Placebo-controlled, Randomized Efficacy and Safety Study of Keppra® Extended Release Formulation - XR Once Daily as add-on Therapy in Subjects From 12 to 70 Years With Refractory Epilepsy Suffering From Partial Onset Seizures.

UCB Pharma34 sites in 7 countries158 target enrollmentAugust 2006

ConditionsEpilepsy

InterventionsKeppra® extended release formulation - XR Placebo

DrugsKeppra® extended release formulation - XR Placebo

Overview

Phase: Phase 3
Intervention: Keppra® extended release formulation - XR
Conditions: Epilepsy
Sponsor: UCB Pharma
Enrollment: 158
Locations: 34
Primary Endpoint: Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

May 2007

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

UCB Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with a confirmed diagnosis of refractory epilepsy
•Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED)
•Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method

Exclusion Criteria

•Seizures occurring in clusters
•Status epilepticus within 3 months of Visit 1
•History of non-epileptic seizures
•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

Arms & Interventions

Keppra® XR

Keppra® extended release formulation -XR

Intervention: Keppra® extended release formulation - XR

Placebo

placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population

Time Frame: Treatment period (12 weeks)

Number of POS over the treatment period standardized to 1 week period.

Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population

Time Frame: Treatment Period (12 weeks)

Number of POS over the treatment period standardized to 1 week period

Secondary Outcomes

POS Seizure Frequency Per Week Over Baseline and Treatment Period(Baseline Period (8 weeks) - Treatment Period (12 weeks))
All (Type I+II+III) Seizures Frequency Per Week(Treatment period (12 weeks))
50% Response in Weekly POS Frequency(Treatment period (12 weeks))
Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks(over the treatment period (12 weeks))