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

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: Placebo; Drug: Keppra® extended release formulation - XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00368069

N01235

2006-000987-10 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 158 patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 2 patient groups, including a placebo group

Keppra® XR

Experimental group

Description:

Keppra® extended release formulation -XR

Treatment:

Drug: Keppra® extended release formulation - XR

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo