Conversion to Monotherapy Study With Keppra XR for Partial Seizures

August 26, 2014 updated by: UCB Pharma

A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures

The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

228

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Aguascalientes, Mexico
      • Distrio federal, Mexico
      • Guadalajara, Mexico
      • Guadalajara Jalisco, Mexico
      • Mexico City, Mexico
      • Monterrey, Mexico
    • NL
      • Monterrey, NL, Mexico
  • Poland
      • Bialystok, Poland
      • Gdansk, Poland
      • Katowice, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Poznan, Poland
      • Szczecin, Poland
      • Warszawa, Poland
  • Russian Federation
      • Kalingrad, Russian Federation
      • Kazan, Russian Federation
      • Moscow, Russian Federation
      • Samara, Russian Federation
      • St Petersburg, Russian Federation
      • St. Petersburg, Russian Federation
      • Yaroslavl, Russian Federation
  • United States
    • Alabama
      • Dothan, Alabama, United States
      • Northport, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Bakersfield, California, United States
    • Florida
      • Jacksonville, Florida, United States
      • Loxahatchee, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Suwanee, Georgia, United States
    • Illinois
      • Winfield, Illinois, United States
    • Kansas
      • Witchita, Kansas, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Maryland
      • Bethesda, Maryland, United States
    • Michigan
      • Detroit, Michigan, United States
    • New Jersey
      • Camden, New Jersey, United States
      • New Brunswick, New Jersey, United States
    • New York
      • Buffalo, New York, United States
      • Cedarhurst, New York, United States
    • Ohio
      • Toledo, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • Oregon
      • Bend, Oregon, United States
    • Pennsylvania
      • Monaca, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Beaufort, South Carolina, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects 12 to 75 years of age.
  • Subjects must have inadequately controlled partial onset epilepsy.
  • Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on one or two standard AED(s)

Exclusion Criteria:

  • A history of status epilepticus in the 6 months preceding randomization.
  • Significant medical, psychiatric or neurological illness.
  • Intake of benzodiazepines on more than an occasional basis
  • History of previous treatment with levetiracetam or sensitivity to levetiracetam.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Keppra XR 1000 mg/day
1000 mg/day once daily for 18 weeks (administered as two levetiracetam XR tablets and two placebo tablets once daily)
Drug: Keppra XR
Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks
Drug: Keppra XR
Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks
Experimental: Keppra XR 2000 mg/day
2000 mg/day once daily for 18 weeks (administered as four levetiracetam XR tablets once daily)
Drug: Keppra XR
Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks
Drug: Keppra XR
Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
Time Frame: 112 days
Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678.
112 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase
Time Frame: 112 days
The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who prematurely discontinued for reasons unrelated to exit criteria, adverse event, or lack of efficacy were censored as of the last dose of study medication. Subjects who completed the study without having an exit event were censored as of Day 112.
112 days
The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase
Time Frame: 112 days
The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who completed the study without having an exit event were censored as of Day 112.
112 days
The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
Time Frame: 112 days
Keppra XR 1000 mg arm was not intended for inferential analysis (planned 3 to 1 randomization, Keppra XR 2000 mg: 1000 mg). The Exit Rate was based on the duration between the start date of previous AED tapering to the earliest date an exit crterion was met. Subjects who prematurely discontinued for reasons unrelated to exit criteria were censored as of the last dose of study medication. Subjects who completed the study without meeting an exit criterion were censored as of Day 112.
112 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Investigators

  • Study Director: UCB Clinical Trial Call Center, +1 877 822 9493

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

January 4, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (Estimate)

January 8, 2007

Study Record Updates

Last Update Posted (Estimate)

September 5, 2014

Last Update Submitted That Met QC Criteria

August 26, 2014

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01280
  • 2007-000897-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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