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Completed

NCT Number: NCT00368069

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

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

N01235 1007, Curitiba, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Keppra® extended release formulation - XR

Drug

500mg extended release oral tablet, 2 tablets once daily

Other names: Levetiracetam XR

Placebo

Drug

oral tablets, 2 tablets once daily

Primary outcomes

  1. 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.

  2. 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

  1. POS Seizure Frequency Per Week Over Baseline and Treatment Period

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

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

    Time frame: Treatment period (12 weeks)

    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)

  3. 50% Response in Weekly POS Frequency

    Time frame: Treatment period (12 weeks)

    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.

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

    Time frame: over the treatment period (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.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

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.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 24, 2006
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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