Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures

August 26, 2014 updated by: UCB Pharma

An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures

To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

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
      • Guadalajara, Mexico
      • Guadalajara Jalisco, Mexico
      • Mexico City, Mexico
      • Mexico DF, Mexico
      • Monterrey, 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
      • Loxahatchee, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Suwanee, Georgia, United States
    • Kansas
      • Witchita, Kansas, United States
    • Michigan
      • Detroit, Michigan, United States
    • New Jersey
      • Camden, 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
    • Texas
      • San Antonio, Texas, 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:

  • Subjects who were randomized into study N01280 [NCT00419094], and completed the 2 week up titration period

Exclusion Criteria:

  • Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094]
  • Subjects who were discontinued prior to the end of titration period

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Keppra XR (Levetiracetam XR)
1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
Drug: Keppra XR (Levetiracetam XR)
500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).
Other Names:
  • Keppra XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
Time Frame: Duration of the Treatment Period (6 months-2 years)
An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Duration of the Treatment Period (6 months-2 years)
Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
Time Frame: Duration of the Treatment Period (6 months-2 years)
A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
Duration of the Treatment Period (6 months-2 years)
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period
Time Frame: Duration of the Treatment Period (6 months-2 years)
An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Duration of the Treatment Period (6 months-2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months
Time Frame: Study entry through 6 months
Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months.
Study entry through 6 months
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months
Time Frame: Study entry through 12 months
Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months.
Study entry through 12 months

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, MD, +1 877 822 9493 (UCB)

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.

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

December 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

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

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01281
  • 2007-000899-17 (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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