A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR

Phase 3CompletedNCT00368069

UCB Pharma158 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

158

Conditions

Epilepsy

Interventions

Keppra® extended release formulation - XRDRUG

500mg extended release oral tablet, 2 tablets once daily

PlaceboDRUG

oral tablets, 2 tablets once daily

Eligibility

Sex: ALLMin age: 12 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (34)

N01235 1007

Curitiba, Brazil

Outcomes

Primary Outcomes

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

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

Time frame: Treatment period (12 weeks)

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

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

Time frame: Treatment Period (12 weeks)

Secondary Outcomes

POS Seizure Frequency Per Week Over Baseline and Treatment Period

Time frame: Baseline Period (8 weeks) - Treatment Period (12 weeks)

All (Type I+II+III) Seizures Frequency Per Week

Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures)

Time frame: Treatment period (12 weeks)

50% Response in Weekly POS Frequency

A subject is considered as a 50% responder in POS if he/she has a \>= 50% decrease from Baseline in the POS frequency/week over Treatment period.

Time frame: Treatment period (12 weeks)

Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks

The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration.

Time frame: over the treatment period (12 weeks)

Data from ClinicalTrials.gov

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