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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings