Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution

November 18, 2014 updated by: UCB Pharma

Observational Sentinel Sites Study in Infants Younger Than 12 Months Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution in Usual Clinical Practice

The purpose of this observational study is to broaden the knowledge of the known safety and efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than 12 months when treated according to routine clinical practice. Their data will be collected until they reach the age of 13 months.

Study Overview

Status

Completed

Conditions

Detailed Description

This non-interventional sentinel sites post-authorization safety study (PASS) aims to collect additional data on use of Keppra® (Levetiracetam) oral solution in clinical practice, and on efficacy and safety of Keppra® (Levetiracetam) in infants younger than12 months. Epileptic patients between the age of 1 month and 11 months inclusive can be invited for participation to the non-interventional sentinel sites PASS, after the physician has decided to initiate therapy with Keppra® (Levetiracetam) oral solution (100 mg/ml bottle) and patient has so far been treated with Keppra® (Levetiracetam) for no longer than 10 days. The patients will be followed and their data will be collected until they reach the age of 13 months.

Study Type

Observational

Enrollment (Actual)

101

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

      • Amiens, France
        • 012
      • Bron, France
        • 010
      • Paris, France
        • 011
      • Berlin, Germany
        • 027
      • Bielefeld, Germany
        • 024
      • Heidelberg, Germany
        • 026
      • Kehl Kork, Germany
        • 021
      • Kiel, Germany
        • 023
      • Muenster, Germany
        • 022
      • Athens, Greece
        • 072
      • Patras, Greece
        • 071
      • Bologna, Italy
        • 037
      • Calambrone, Italy
        • 031
      • Milano, Italy
        • 032
      • Roma, Italy
        • 034
      • Verona, Italy
        • 035
      • Gdansk, Poland
        • 065
      • Lodz, Poland
        • 064
      • Szczecin, Poland
        • 063
      • Warszawa, Poland
        • 062
      • Barcelona, Spain
        • 043
      • Madrid, Spain
        • 044
      • Madrid, Spain
        • 045
      • Murcia, Spain
        • 046
      • Birmingham, United Kingdom
        • 057
      • Liverpool, United Kingdom
        • 052
      • London, United Kingdom
        • 051

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

1 month to 11 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients coming to day clinic for consultation by specialist

Description

Inclusion Criteria:

  • diagnosis of epilepsy
  • being treated with Keppra® Oral Solution
  • aged between 1 month and 11 months inclusive at study baseline

Exclusion Criteria:

  • none

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

Cohorts and Interventions

Group / Cohort
Patients, 1 - 11 months old, prescribed Keppra® oral solution
Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who are between 1 and 11 months old. The patients will be followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, is made independently by the physician in the regular course of practice and is not influenced by the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit
Time Frame: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
Number of patients with any Treatment-Emergent Adverse Events (TEAEs) as reported by the patient's parent and/or caregiver or observed by the treating physician during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).
From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up
Time Frame: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)
Number of patients with any serious Treatment-Emergent Adverse Events (TEAEs) during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).
From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)
Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit
Time Frame: From Baseline through the last Treatment Visit (maximum 12 months)
Number of patients with any Treatment-Emergent Adverse Events (TEAEs) leading to temporary or permanent discontinuation of Keppra® (Levetiracetam) during the Treatment Period (maximum 12 months).
From Baseline through the last Treatment Visit (maximum 12 months)
Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit
Time Frame: From Baseline to the last Treatment Visit (maximum 12 months)
Number of patients with presence of deviation from the normal milestones of psychomotor development during the Treatment Period (maximum 12 months). The treating physician evaluated at each visit, as part of standard clinical practice, the psychomotor development of the patient. The evaluation of the patient's psychomotor development was categorized by the motor development, the social development and the language development.
From Baseline to the last Treatment Visit (maximum 12 months)
Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit
Time Frame: From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)
For each visit, body weight was measured and standardization for gender and age was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the mean of the differences of individual body weight z-scores from Safety Follow-up Visit to Baseline was determined.
From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)
Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit
Time Frame: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
For each visit, body length was measured and age standardization was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the difference of body length z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.
From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit
Time Frame: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
For each visit, head circumference was measured and age standardization was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the difference of head circumference z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.
From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit
Time Frame: From Baseline to the last Treatment Visit (maximum 12 months)

Number of patients with abnormalities noted during physical examination over the Treatment Period (maximum 12 months). Any abnormal findings during the physical examination during the study were reported as Adverse Events (AEs).

The Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit cannot be given because abnormalities at Screening are listed only and worsening after Screening were handled as AEs and tabulated along with the other AEs.

From Baseline to the last Treatment Visit (maximum 12 months)
Number of Patients With Abnormalities Noted During Neurological Examination From Baseline to the Last Treatment Visit
Time Frame: From Baseline to the last Treatment Visit (maximum 12 months)
The Number of Patients With Abnormalities Noted During Neurological Examination cannot be given because abnormality frequencies were only determined for single parameters of the neurological examination and therefore a subject might have been counted several times.
From Baseline to the last Treatment Visit (maximum 12 months)
Global Evaluation Scale of the Psychomotor Development (GES)
Time Frame: From Baseline to the last Treatment Visit (maximum 12 months)

Global evaluation scale of the psychomotor development (GES): physician's assessment of the change from Baseline in the psychomotor development at the last Treatment Visit (maximum timeframe is 12 months). The GES is a 7-point scale with the following options:

7=Marked improvement

6=Moderate improvement

5=Slight improvement

4=No Change

3=Slight worsening

2=Moderate worsening

1=Marked worsening

As a variant of this variable, a 3-class variable was derived as follows

  • "Marked improvement," "Moderate improvement," and "Slight improvement" were defined as "Improved."
  • "No change" was defined as "Stable."
  • "Slight worsening," "Moderate worsening," and "Marked worsening" were defined as "Worsened."
From Baseline to the last Treatment Visit (maximum 12 months)
Global Evaluation Scale of Epilepsy Severity (GES)
Time Frame: From Baseline to the last Treatment Visit (maximum time frame is 12 months)

Global evaluation scale of epilepsy severity (GES): physician's assessment of the change from Baseline of the epilepsy severity at the last Treatment Visit (maximum 12 months). The GES is a 7-point scale that assesses change in the severity of the patient's illness. The GES is a 7-point scale with the following options:

7=Marked improvement

6=Moderate improvement

5=Slight improvement

4=No Change

3=Slight worsening

2=Moderate worsening

1=Marked worsening

As a variant of this variable, a 3-class variable was derived as follows

  • "Marked improvement," "Moderate improvement," and "Slight improvement" were defined as "Improved."
  • "No change" was defined as "Stable."
  • "Slight worsening," "Moderate worsening," and "Marked worsening" were defined as "Worsened."
From Baseline to the last Treatment Visit (maximum time frame is 12 months)
Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period
Time Frame: From Baseline through the last Treatment Visit (maximum 12 months)
Number of patients who withdraw due to lack or loss of efficacy during the Treatment Period (maximum 12 months).
From Baseline through the last Treatment Visit (maximum 12 months)

Collaborators and Investigators

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

Sponsor

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.

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

January 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

September 23, 2010

First Submitted That Met QC Criteria

September 27, 2010

First Posted (Estimate)

September 28, 2010

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • N01357
  • 2009-017333-21 (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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