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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

UCB, Inc.

ClinicalTrials.gov Identifier:

NCT00368069

First received: August 11, 2006

Last updated: August 30, 2011

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

August 11, 2006

Last Updated Date

August 30, 2011

Start Date ^ICMJE

August 2006

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population [ Time Frame: Treatment period (12 weeks) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
Number of POS over the treatment period standardized to 1 week period

Original Primary Outcome Measures ^ICMJE

partial onset seizure frequency reduction

Change History

Complete list of historical versions of study NCT00368069 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

POS Seizure Frequency Per Week Over Baseline and Treatment Period [ Time Frame: Baseline Period (8 weeks) - Treatment Period (12 weeks) ] [ Designated as safety issue: No ]
All (Type I+II+III) Seizures Frequency Per Week [ Time Frame: Treatment period (12 weeks) ] [ Designated as safety issue: No ]
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)
50% Response in Weekly POS Frequency [ Time Frame: Treatment period (12 weeks) ] [ Designated as safety issue: No ]
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.
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) ] [ Designated as safety issue: No ]
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.

Original Secondary Outcome Measures ^ICMJE

Total seizure frequency reduction
Responder rate
The categorical response to treatment (< -25%, -25% to < 25%, 25% to < 50%, 50% to < 75%, 75% to < 100% and 100%)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: Keppra® extended release formulation - XR
500mg extended release oral tablet, 2 tablets once daily

Other Name: Levetiracetam XR
Drug: Placebo
oral tablets, 2 tablets once daily

Study Arm (s)

Experimental: Keppra® XR
Keppra® extended release formulation -XR

Intervention: Drug: Keppra® extended release formulation - XR
Placebo Comparator: Placebo
placebo

Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

158

Completion Date

May 2007

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with a confirmed diagnosis of refractory epilepsy Patients must be receiving 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.

Gender

Both

Ages

12 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland, India, Mexico, Russian Federation, South Africa, Ukraine

Administrative Information

NCT Number ^ICMJE

NCT00368069

Other Study ID Numbers ^ICMJE

N01235, Eudra CT# 2006-000987-10

Has Data Monitoring Committee

Responsible Party

UCB, Inc.

Study Sponsor ^ICMJE

UCB, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

Information Provided By

UCB, Inc.

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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